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Healthcare Today

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Kevin Klinkenberg

April 9, 2021

The Senate Finance Committee will hold confirmation hearings for Center for Medicaid and Medicare Services (CMS) Administrator-nominee Chiquita Brooks-LaSure and Deputy of Health and Human Services (HHS) Secretary-nominee Andrea Palm on April 15th. If confirmed, Brooks-LaSure will become the first black woman to lead CMS. She previously served in the Obama administration as a senior CMS official helping to implement the Affordable Care Act’s coverage expansion and insurance-market reforms. Palm previously served in the Obama administration and most recently was secretary-designee for Wisconsin’s Department of Health and Human Services.

Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky said this week that Pfizer’s COVID-19 vaccine could be expanded to children as young as 12 years old as soon as May and Moderna’s vaccine could be available to children by this summer. Pfizer/BioNTech announced last week that in clinical trial results its COVID-19 vaccine was 100% effective and well tolerated in adolescents.

CMS issued a number of proposed new payment rules this week. CMS has proposed increasing payments to inpatient rehabilitation facilities by 2.2 percent; proposed adopting one new measure and updating the specifications for another measure used for the Inpatient Rehabilitation Facility Quality Reporting Program, a pay-for-reporting program; and estimates that the overall payment increase to inpatient rehab facilities would be $160 million in fiscal 2022. For skilled nursing facilities, CMS proposed a $444 million increase in Medicare payments for fiscal year 2022 which would amount to close to a 1% increase. Two new measures were also proposed by CMS to the quality reporting program for nursing facilities that could penalize nursing facilities by a 2% payment reduction if they do not meet the quality metrics. CMS proposing the adoption of a new measure that aims to require skilled nursing facilities, rehabilitation facilities, and psychiatric facilities to report vaccination coverage of healthcare personnel.

Secretary of State Antony Blinken announced this week that Gayle Smith will lead the Biden administration’s global COVID-19 response. Smith is a former U.S. Agency for International Development administrator, chief executive of the ONE Campaign to eradicate poverty and preventable disease, and helped lead the Obama administration’s response to Ebola. She will step into a new role at the State Department and will be in charge of trying to coordinate the international response to the pandemic.

We are hearing that the United States stockpile of the AstraZeneca COVID-19 vaccine has reached over 20 million doses. AstraZeneca has yet to request Food and Drug Administration (FDA) approval, but many public health experts believe that if it receives an FDA authorization then the United States should donate all of the AstraZeneca doses as the United States has large supply of the vaccine. AstraZeneca is also searching for a new manufacturing partner for millions of its coronavirus shots after its contractor, Emergent BioSolutions, had production problems with Johnson & Johnson and the AstraZeneca vaccine. Johnson & Johnson will take over the entire manufacturing plant and AstraZeneca is now working with the government to find a new manufacturing plant.

We encourage you to never, never, never give up on this National Winston Churchill Day!

April 2, 2021

A manufacturing error at an Emergent BioSolutions facility in Baltimore impacted and ruined up to 15 million doses of the Johnson & Johnson COVID-19 vaccine. Workers at the facility accidentally contaminated the doses of  vaccine and forced regulators to delay authorization of the plant’s production lines. The mistake didn’t impact any of the doses that have been delivered or shipped, as those were produced in the Netherlands, but delivery of 24 million doses of the vaccine from the Baltimore facility are now in question. In a statement this week Johnson & Johnson said the steps they were now taking with Emergent would enable them to deliver 24 million doses by the end of April.

Pfizer/BioNTech announced this week that its COVID-19 vaccine is 100% effective and well tolerated in adolescents. The clinical trial results found that its efficacy is 100% and well-tolerated in kids aged 12-15. Pfizer/BioNTech plans to submit the data to the U.S. Food and Drug Administration as soon as possible for expanded emergency use authorization of the two-dose vaccine. In other vaccine news, Moderna’s experimental booster shot to protect against the South African variant of COVID-19 has moved into human testing. The trial is being led by the National Institute of Allergy and Infectious Diseases (NIAID) and is being tested on 210 volunteers. Monderna’s vaccine appears to protect against the new variants, but NIAID Director Anthony Fauci said out of an abundance of caution they are evaluating the variant vaccine candidate should there be a need for an updated vaccine.

President Biden released his “American Jobs Plan” this week. The $2.25 trillion proposal is a wide-ranging infrastructure plan that will be funded by tax increases. House Speaker Nancy Pelosi (D-CA) has said that she wants the House to pass the bill by July 4th. Health provisions included in the package include $400 billion in funding to expand home and community-based care; $30 billion in funding over the next four years to the Strategic National Stockpile in hopes of preventing the next pandemic; and $18 billion in funding to upgrade VA hospitals and clinics. In a speech this week, President Biden indicated that he would like to work with Republicans on this package, but it is unlikely they will support a multitrillion dollar package or the tax increases on corporations.

The FDA approved additional at-home COVID-19 tests. The FDA authorized the use of the BD Veritor System for Rapid Detection of SARS-CoV-2; multiple configurations of the Abbott BinaxNOW; and the Quidel QuickVue At-Home OTC COVID-19 test. These rapid antigen tests also offer faster results with less lab work and will be used to frequently test people and screen asymptomatic individuals. As life begins to return to normal, public health officials believe that these rapid antigen tests will be important to see how COVID-19 spreads.

This week, the Federal Trade Commission (FTC) filed an administrative complaint and authorized a federal court lawsuit to block Illumina’s $7.1 billion proposed acquisition of Grail. Grail makes a non-invasive, early detection liquid biopsy test that can screen for multiple types of cancer in asymptomatic patients at very early stages using DNA sequencing. The FTC said that the deal would diminish innovation in early cancer detection tests in the U.S. and that this vertical merger could harm development of additional multi-cancer detection tests. Illumina said in a statement that it will fight the FTC case.

The Department of Health and Human Services announced this week that premium tax credit calculations for the marketplaces on HealthCare.gov will now be adjusted so that most consumers qualify for more substantial advance payments of premium tax credits. The increased tax credits are more generous for low-income customers and are being extended for the first time to middle-income Americans. HHS will also spend an additional $50 million to promote the new subsidies in Affordable Care Act plans with advertisements on TV, digital, email, radio, and streaming networks in the hopes of reaching the uninsured.

For those who are celebrating Easter and Passover, we wish you a blessed and joyous celebration.

March 27,2021

The Senate voted this week to pass a bill that would postpone a 2% Medicare cut that is scheduled to go into effect April 1st. Sens. Jeanne Shaheen (D-NH) and Susan Collins (R-ME) introduced an amendment to H.R. 1868 that sets the end of the moratorium at the end of the year and makes technical fixes aimed at helping rural health clinics and Disproportionate Share Hospitals in California. The Senate bill is different from the House-passed version as it would not only extend the Medicare sequester moratorium but also waived from the PAYGO scorecard the budgetary impacts of the American Rescue Plan. The Senate bill will now have to pass through the House. The House is not expected to return until April 13th and the American Hospital Association hopes CMS will hold claims until the House returns to session and has a chance to vote on the Senate version of the extension.

On Wednesday, AstraZeneca reported its COVID-19 vaccine had an efficacy rate of 76% at preventing COVID-19 with symptoms after they released updated data. Earlier this week, AstraZeneca had reported its vaccine had an efficacy rate of 79%, but the Data and Safety Monitoring Board (DSMB) rebuked its statement. The DSMB which is an independent panel and is overseeing the U.S. trial of AstraZeneca said that it was concerned the company chose to use data that was outdated and potentially misleading instead of the most recent and complete findings. The data problems have created more uncertainty and public support for the vaccine which is also dealing with low public support of the vaccine in Europe. The Food and Drug Administration (FDA) will now begin its own stringent review of the vaccine. In other vaccine news, manufacturing of Johnson & Johnson’s COVID-19 vaccine got a boost after Catalent received FDA clearance to begin shipping out shots. Catalent is a “fill-finish” facility that bottles vaccines and will seek to help Johnson & Johnson reach its promise of 20 million shots to the U.S. by the end of March.

The U.S. Senate voted this week to confirm the nominations of Dr. Vivek Murthy for U.S. Surgeon General and Dr. Rachel Levine for Assistant Secretary for Health. Murthy was confirmed with a bipartisan vote and will once again be the U.S. Surgeon General, a position he held under President Obama from 2014 to 2017. Levine was confirmed in a mostly party-line vote with Sen. Susan Collins (R-ME) and Sen. Lisa Murkowski (R-AK) joining Democrats to confirm her. Levine became the first openly transgender official to be confirmed by the U.S. Senate and brings her experience as Pennsylvania Health Secretary to her new role as Assistant Health and Human Services (HHS) Secretary.

The Centers for Disease Control and Prevention announced that schools can allow social distancing of three feet rather than the previous six feet between students in classrooms unless they’re in areas of high community transmission. The CDC said that schools that decide on less than six feet of physical distance can use COVID-19 testing to provide added protection. The CDC also said that when transporting students, windows should be opened and students should be wearing masks. This is seen as a boost to reopening schools nationwide, but the American Federation of Teachers said this week that the evidence does not support the guidance released by the CDC. The American Federation of Teachers have asked that the CDC provide further federal guidance on proper mitigation measures and a CDC study of those efforts in urban schools.

Valisure, an online pharmacy that tests products for quality and consistency, found that a number of hand sanitizers that entered the market when popular sanitizers were sold out from retail outlets contained high levels of benzene. According to the department of HHS Benzene causes cancer and the World Health Organization’s cancer research arm places it in the highest risk category on par with asbestos. Vailsure analyzed 260 bottles from 168 brands and found 17% of the samples contained detectable levels of benzene and twenty-one bottles or 8% of those bottles contained benzene above two parts per million which was the temporary limit the Food and Drug Administration (FDA) set for liquid hand sanitizers. Valisure filed a citizen petition this week with the FDA that includes the list of brands identified with high benzene levels.

We hope you enjoy a healthy salad tonight on National Spinach Day!

March 19, 2021

The Senate voted this week to narrowly confirm Xavier Becerra as Health and Human Services Secretary. Sen. Susan Collins (R-ME) joined all present Senate Democrats in supporting his nomination. Becerra previously  served in the House for more than two decades before becoming California’s Attorney General and will now become the first Latino to lead the federal health department. The Senate Health, Education, Labor and Pensions (HELP) Committee voted this week to advance the nominations of Dr. Vivek Murthy for U.S. Surgeon General and Dr. Rachel Levine for Assistant Secretary for Health. Both Murthy and Levine were voted out of the Committee in bipartisan votes.

President Biden’s chief medical adviser Dr. Anthony Fauci, CDC Director Rochelle Walensky, director of the FDA’s Center for Biologics Evaluation and Research Peter Marks, and ex-FDA chief and the chief science officer for the U.S. government’s coronavirus response, David Kessler, testified this week in front of the Senate HELP Committee on the government’s response to COVID-19. Senate Republicans grilled the witnesses to change agency guidelines and make it easier for America’s schools to reopen. This morning, the CDC did update its social distancing guidelines for children in schools, reducing that distance from 6 feet to 3 feet in light of new data.

Moderna has started to test its COVID-19 vaccine in children ages six months through 11 years old in the United States and Canada. The study is expected to enroll 6,750 healthy children. A separate study by Moderna is testing its vaccine in 3,000 children ages 12 to 17. Each child in Moderna’s study will receive two shots and the study will have two parts. In the first part, children aged 2 years to less than 12 may receive two doses of 50 or 100 micrograms each. Those under 2 years may receive two shots of 25, 50, or 100 micrograms. Pfizer is also testing its vaccine in children ages 12 to 15 and has plans to test with younger groups as well.

The House passed a measure today that would eliminate $36 billion in automatic cuts to Medicare in 2022. The bill would also waive the need for automatic spending cuts known as sequestration, triggered under statutory “pay-as-you-go” (PAYGO) requirements because Democrats didn’t offset the cost of the $1.9 trillion COVID-19 relief package that was signed into law last week. The PAYGO law was passed in 2010 by Democrats and requires that the costs of legislation be offset with revenue increases or spending cuts, or else enactment would trigger automatic cuts to mandatory programs. While the House passed the bill with several Republican votes, it is unclear if there will be bipartisan support for this bill in the Senate to waive the PAYGO rules as Congress did in 2017 for cuts that would have been triggered by the American Tax Cuts and Jobs Act.

The Biden administration tossed out Medicaid work rules in Arkansas and New Hampshire this week. Medicaid officials sent letters to health officials in those states telling them that the administration had formally scrapped the federal government’s permission for the states to mandate that some enrollees work, volunteer, or attend school as a condition of coverage. The Supreme Court is still deciding if they will review the lower court rulings against work rules in Arkansas and New Hampshire but revoking these programs could lead the Supreme Court to cancel the work rules case. The Supreme Court has already called off a scheduled a March 29th hearing, but it has yet to dismiss the case.

Let’s give thanks and praise for their service to all of the nurses we know on National Certified Nurses Day!

March 12, 2021

The Senate advanced Xavier Becerra’s nomination to lead the Department of Health and Human Services (HHS). Becerra was approved through the Senate mostly along party lines by a vote of 51-48, but he did win the support of Sen. Susan Collins (R-ME). The procedural vote was necessary after the Senate Finance Committee voted evenly along party lines. A final confirmation vote is expected next week, where we anticipate Becerra will be confirmed as Secretary of HHS.

In his first primetime address to the nation since his inauguration, President Biden gave Americans hope that we are on a path to normalcy. President Biden said that if the nation can reach its vaccination goals then America will be on track to gather in small groups on July 4th to celebrate. Biden also said that he would direct states to make all adults eligible for the vaccine and that his administration was on track to reach his goal of 100 million shots in his first 100 days in office by his 60th day as president. The White House also has plans to increase the number of community health centers distributing shots in low-income neighborhoods; double the number of pharmacies giving out shots; double the number of FEMA-run mass-vaccination sites; authorize dentists, EMTs, midwives, paramedics, veterinarians, medical students and other professionals to administer COVID-19 vaccines; set up a federal website and call center by May 1 that will help anyone in the country book a vaccination appointment; and release CDC guidance for vaccinated individuals on travel, participate in small gatherings, and go to work and houses of worship.

President Biden signed his $1.9 trillion COVID-19 relief bill into law on Thursday afternoon. The House and Senate voted mostly along party lines with only one Democrat joining all Republicans in opposition to the bill providing the Biden administration with its first major legislative win. The bill contains $160 billion for vaccine and testing programs to stop COVID-19’s spread; includes $130 billion for reopening schools; provides a federal subsidy covering 100% of the costs of continuing health insurance through September for laid-off workers; increases subsidies for the purchase of health plans offered through the Affordable Care Act’s marketplaces; provides additional federal funding to states that newly adopt Medicaid expansion; provides Americans with a third stimulus check; extends unemployment insurance through September 6th; and expands the child tax credit.

The Department of HHS announced this week that it would extend the public comment period for proposed modifications to modify the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule. The comment period was extended from March 22, 2021, to May 6, 2021. The proposed rule would modify the HIPAA’s standards that could impede the transition to value-based health care by limiting care coordination and case management communications among hospitals, physicians, other health care providers, and insurers. The Office for Civil Rights at HHS has encouraged comments from all stakeholders.

The Centers for Medicare & Medicaid Services (CMS) issued updated guidance this week for visits for nursing homes. The new guidance expands visitation options during the COVID-19 pandemic public health emergency. Under the updated guidance, facilities should allow responsible indoor visitation at all times and for all residents, regardless of vaccination status of the resident, or visitor, unless certain scenarios arise. There are certain scenarios that would limit visitation for unvaccinated residents, such as if the COVID-19 county positivity rate is greater than 10 percent and less than 70 percent of residents in the facility are fully vaccinated; residents with confirmed COVID-19 infection have not met the criteria to discontinue transmission-based precautions whether they are vaccinated or unvaccinated; or residents in quarantine, whether vaccinated or unvaccinated, have not met criteria for release from quarantine.

The administration is launching a national COVID-19 testing strategy in hopes of bringing the pandemic to an end. HHS hopes to open a testing hub in April as part of a public-private partnership that could add up to 25 million tests per month and aims to conduct 150,000 tests per week by the end of April without interfering with existing testing supply chain and testing infrastructure. The federal government will start by creating a list of preferred COVID-19 tests for use in schools and other congregate settings. They will also seek applications during March from diagnostic manufacturers, commercial labs, academic labs, and other health care groups to run four coordinating hubs across the country for six months.

We hope you enjoy your thin mints and samoas on National Girl Scout Day!

March 5, 2021

President Biden’s $1.9 trillion COVID-19 relief package is expected to be voted upon by the end of the week. The bill contains $160 billion for vaccine and testing programs to help stop COVID-19’s spread; $130 billion for reopening schools; a federal subsidy covering 100% of the costs of continuing health insurance through September for laid-off workers; and an increase in unemployment benefits. The package also includes $8.5 billion for rural hospitals affected by the COVID-19 pandemic; delays the proposal to end the cap on Medicaid’s drug rebate program by one year; and would empower the Department of Health and Human Services to temporarily pay ambulance providers for services they deliver to Medicare beneficiaries outside a hospital. The Senate will debate the bill today and are expected to vote on the package on Saturday.

This week, the Senate Finance Committee voted evenly along party lines on advancing Xavier Becerra for Health and Human Services Secretary. Democrats will now need to bring up a motion to discharge his nomination and hold an additional four hours of debate on the Senate floor before a confirmation vote because of the tie vote in the Finance Committee. Becerra is likely to face a close confirmation vote with Republicans questioning his lack of medical expertise, but we anticipate that Becerra will be confirmed as Secretary of HHS.

President Biden announced this week that Merck will partner with Johnson & Johnson to increase production of its single-shot vaccine after it received its Emergency Use Authorization. The introduction of a new vaccine authorized Saturday for use in the U.S. will speed up the overall timetable for most Americans to be vaccinated. Biden also said J&J’s previous delivery timetable is being accelerated and that the United States would have enough COVID-19 vaccine doses for every adult American by the end of May. This is an accelerated timeline from the Administration’s previous estimate of having enough shots for every adult by July.

The Centers for Disease Control and Prevention (CDC) is not releasing its guidance for vaccinated Americans as originally planned. The guidelines were expected to say that vaccinated individuals should continue to adhere to mask and social distancing guidance in public, but people who receive a full course of a COVID-19 vaccine could socialize with other vaccinated people in small groups in the home without masks. The CDC did remind Americans to stay vigilant and is advising against close, indoor gatherings with non-household members ahead of St. Patrick’s Day in an effort to prevent further COVID-19 spread.

Novavax’s CEO Stanley Erck said this week that the FDA could issue an emergency use authorization to  Novavax for its COVID-19 vaccine as early as May. Novavax has a deal with the U.S. government to supply 110 million doses of its COVID-19 vaccine and the company believes they could complete the shipments in June or July. Novavax’s 30,000 participant phase three trial in the U.S. is still ongoing and the hope is that the FDA will allow it to use data from its clinical trial conducted in the U.K. when it files its emergency use authorization later this year. The Emergency Use Authorization could be pushed back one or two months if the FDA chooses to use Novavax’s U.S. trial data.

We hope you enjoy your dessert on National Oreo Cookie Day over the weekend!

February 26, 2021

President Biden’s nominee for the Department of Health and Human Services, Xavier Becerra, had confirmation hearings before the Senate Health, Education, Labor, and Pensions (HELP) Committee and Senate Finance Committee this week. Becerra told both Committees that he would be working on expanding the current private sector insurance scheme rather than push for Medicare for All. Becerra also said that any Medicare expansion will not be funded by the Medicare Trust Fund; he’s committed to improving health equity issues; the Biden administration will defer to local officials on when and how to reopen schools; and he will recuse himself from all lawsuits he’s been involved in as California’s attorney general. Vivek Murthy, Biden’s nominee for surgeon general, and Rachel Levine, the assistant secretary for health nominee, also testified before the Senate HELP Committee this week. Murthy promised to focus on clear scientific messaging if confirmed and Levine defended her role in Pennsylvania’s handling of COVID-19.

Rep. Robin Kelly (D-IL) introduced two bills that seek to reduce America’s rising maternal mortality rate. Rep. Kelly introduced legislation with Rep. Bob Latta (R-OH) that would establish best practices for all Medicaid-covered maternal care providers and clinicians to better screen, monitor, and treat at-risk pregnancies. Kelly also introduced legislation with Sen. Tammy Duckworth (D-IL) and Sen. Dick Durbin (D-IL) that would address and reduce maternal deaths by establishing national obstetric emergency protocols through a federal expert committee; ensuring dissemination of best shared practices and coordination amongst maternal mortality review committees; standardizing data collection and reporting; improving access to culturally competent care throughout the care continuum; and expanding Medicaid coverage to new mom’s entire post-partum period.

Analysis from the Food and Drug Administration (FDA) has found the Johnson & Johnson COVID-19 vaccine provides strong protection against severe disease and death from COVID-19. The FDA is expected to authorize the vaccine as soon as Saturday and it will likely become the third effective COVID-19 vaccine developed in under a year. A Johnson & Johnson spokesman said a total of 20 million doses will be ready by the end of March, which is 17 million fewer doses than the federal contract outlined, but he insisted that Johnson & Johnson will fulfill its promise of 100 million doses by the end of June. The Johnson & Johnson vaccine is seen as especially important as it can be stored at normal refrigeration temperatures and only requires one dose.

The Energy and Commerce Subcommittee on Oversight and Investigations held a hearing this week with COVID-19 vaccine manufacturers who said that the supply chain of vaccines was improving. Moderna said that it received a positive reaction from regulators on its plan to expand the number of COVID-19 vaccine doses in each vial. If its plan is authorized by the FDA, then it would be able to put as many as 15 doses in each vial compared to the ten doses that vials currently hold. Pfizer said that improvements to its manufacturing efforts will allow them to ship 13 million doses of its vaccine per week by mid-March, which is an increase from the 4 to 5 million of doses a week it was shipping in early February.

In other vaccine news, the FDA also announced this week that the Pfizer COVID-19 vaccine would be allowed to be stored and transported at standard freezer temperatures instead of at ultracold temperatures, a move which could speed distribution to low-income and rural areas of the country.

The House is expected to vote today on President Joe Biden’s $1.9 trillion relief package after the House Budget Committee voted to advance the package earlier this week. The bill contains funding for distributing vaccines, scaling up testing, reopening schools, and beefing up unemployment benefits, and is likely to pass through the narrow Democratic majority in the House. The Senate parliamentarian ruled late last night that the provision to raise the minimum wage to $15 per hour by 2025 cannot pass using budget reconciliation rules, imperiling its chances of passing at this time.

We are mindful and hope to raise additional awareness for all of those who are suffering from lymphedema and other rare disorders on National Rare Disease Day on Sunday.

February 19, 2021

President Joe Biden’s pick to lead the Department of Health and Human Services (HHS) Xavier Becerra will appear before the Senate HELP and Senate Finance Committee next week. Becerra will appear before the Senate HELP committee on Tuesday and before the Senate Finance Committee on Wednesday. President Biden also announced that he will nominate Chiquita Brooks-LaSure as Administrator of the Centers for Medicare and Medicaid. Brooks-LaSure served in the Obama administration as a senior CMS official helping to implement the Affordable Care Act’s coverage expansion and insurance-market reforms. HHS also announced a number of staff appointments this week that can be found here.

The Centers for Disease Control and Prevention (CDC) released its return-to-school guidance this week. The guidance said that face masks and social distancing of at least six feet should be prioritized for teachers and students in K-12 schools as they reopen. The CDC urged states to prioritize school educators for vaccinations. But the CDC’s guidance reiterated that access to vaccines “should not be considered a condition for reopening schools for in-person instruction.” The guidelines also say that with proper mitigation, such as masking, physical distancing, and hygiene, elementary schools can operate in person at any level of community virus transmission.

The CDC is tracking three worrisome COVID-19 variants that initially emerged in the United Kingdom, Brazil, and South Africa. The Biden administration announced a new effort to increase tracking of the new COVID-19 variants and has pledged nearly $200 million to better identify the emerging threats and track the emerging COVID-19 variants. The investment seeks to result in a significant increase in the number of positive virus samples that laboratories can sequence. CDC Director Rochelle Walensky also said that the CDC is already working with makers of current vaccines to see if they can tweak their shots to work better against the variants.

The Biden administration plans to invest over $1 billion toward improving COVID-19 testing. The investments seek to expand COVID-19 testing in schools and underserved communities and ramp up domestic manufacturing of testing supplies and materials to address shortages. Public health officials hope that the increase in testing will help Americans safely return to school and work. The Department of Health and Human Services (HHS) and Department of Defense (DOD) will invest $650 million to expand testing in K-8 schools and “underserved congregate settings, such as homeless shelters, and also invest $815 million to increase domestic manufacturing of testing supplies and raw materials that have created shortage issues.

At a town hall event in Milwaukee this week, President Biden said that he invoked the Defense Production Act to increase doses of COVID-19 vaccine. He said that Moderna Inc. and Pfizer Inc. agreed to sell more doses of their coronavirus vaccine to the U.S. faster than planned after he invoked federal law that could force their production. This news comes after Moderna and Pfizer announced that they will deliver additional doses of each of their vaccines to the U.S. by the end of July which puts the United States on schedule to have enough supply of the COVID-19 vaccine to inoculate 300 million Americans by the end of July

COVID-19 cases and hospitalizations fell for a fifth week in a row in the United States. There was a 23% drop in new cases of COVID-19 and a 16% fall in the number of people hospitalized with the virus. The COVID-19 tracking project has found that the overall seven-day average of new cases has declined in 40 states and territories, remained the same in eight, and increased in three states. The seven-day average for hospitalizations has also decreased in 45 states and territories and remained the same in the rest.

We hope you thank your nurses, parents, spouses, siblings, children, and all the other people in your life giving you care and support on National Caregivers Day!

February 12, 2021

President Biden announced that the U.S. finalized deals to provide an additional 100 million additional COVID-19 vaccine doses each from Pfizer and Moderna bringing the total order from those companies to 600 million doses. If the delivery timeline is met, the United States is expected to have enough supply of the COVID-19 vaccine to inoculate 300 million Americans by the end of July. The challenge remains for federal, state, and local governments to successfully administer shots of the vaccine given the logistical problems with administration.

The Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) for Eli Lilly’s combination antibody therapy to fight COVID-19. Late stage trials showed that Lilly’s combination therapy of two antibodies, bamlanivimab and etesevimab, cut the risk of hospitalization and death in COVID-19 by 70%. Lilly has indicated that 100,000 doses of the antibody therapy will be ready immediately and an additional 150,000 doses will be available throughout the first quarter.

Department of Transportation Secretary Pete Buttigieg said this week that the Biden administration is considering a rule that would require negative COVID-19 test results for domestic air travel. The negative tests would seek to be another mitigation measure to stop the spread of the virus. Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky also said that the agency is considering testing requirements and reiterated the need for everyone to keep their guard up as the continued proliferation of COVID-19 variants remains a great concern. Airline CEOs virtually met with the Biden administration today and it appears that the Biden administration is not likely to move ahead with such a proposal, but that it could be revisited in the future.

Democrats in the House are using budget reconciliation to push a number of health provisions including the expansion Medicaid and the subsidization of continued health coverage (COBRA). The House Energy and Commerce Committee budget reconciliation proposal includes a number of Medicaid provisions including a 5 percentage point increase on traditional Medicaid spending for 2 years to provide states with an incentive to implement the Affordable Care Act Medicaid expansion; a new option for states to extend Medicaid postpartum coverage from 60 days to 12 months with full state plan benefits; lifting the cap on Medicaid drug rebates starting in 2023;; and allowing Medicaid coverage for those in jail or prison for 30 days prior to release to ensure extension of addiction treatment and services. The House Ways and Means and House Education and Labor Committees budget reconciliation proposals would subsidize 85% of insurance premiums for workers who are eligible for COBRA after they lost their job or had their hours reduced and give employers a payroll tax credit to help cover costs of extending COBRA coverage to workers.

The Biden administration filed a letter with the United States Supreme Court that changes the government’s position on the California vs. Texas Affordable Care Act case. The Trump administration had argued the entire law is invalid due to the individual mandate’s lack of constitutionality. The letter said that the Department of Justice now believes that the individual mandate provision is lawful and that if the court finds that it is not, the provision may be removed while the rest of the act remains standing. A ruling in the case is expected in the case is still expected in late spring or early summer.

The CDC will host a nationwide forum on the safest and most effective ways to vaccinate Americans. The event will be held from February 22-24 and will be with national, state, local, and tribal medical practitioners. The event will try to communicate national standards for how best to build trust and confidence in vaccines and to ensure equitable vaccine access and uptake to all populations.

We recommend you go back and reread the inspirational Gettysburg Address on President Lincoln’s birthday.

February 5, 2021

Johnson & Johnson submitted an emergency use authorization to the Food and Drug Administration (FDA) for its one-dose coronavirus vaccine on Thursday. The FDA scheduled a February 26th meeting at which a panel of outside advisers will consider the request and make a recommendation about whether to grant it. Johnson & Johnson have said that they would be ready to begin shipping vaccines upon receiving an authorization. The Johnson & Johnson vaccine is seen as important in the U.S. immunization effort as the vaccine is long-lasting and doesn’t require freezing like Moderna and Pfizer-BioNTech’s shots, and would be the first to protect from COVID-19 with a single dose.
This morning, the Senate voted 51-50, with Vice President Kamala Harris breaking the tie, to adopt a budget resolution for President Joe Biden’s $1.9 trillion COVID-19 relief package after considering hundreds of amendments. The House passed the Senate’s budget resolution today. This is a key procedural step that will set up the ability for Democrats to pass President Biden’s COVID-19 relief package without the threat of a filibuster from Republicans. The House had already adopted its budget resolution but will have to vote again Friday to agree on the Senate’s language.
The Biden administration announced that it will begin to provide COVID-19 vaccines directly to pharmacies in an effort to speed up the country’s crucial inoculation effort and address equity concerns. They will begin shipping around one million doses per week to about 6,500 pharmacies across the U.S. as a trial run beginning on February 11th. These vaccines sent to pharmacies will be in addition to the millions of doses that are already sent weekly to states, territories, and tribes and that are sometimes administered at local pharmacies. A network of independent pharmacies as well as CVS, Walgreens, Rite Aid, Walmart, and Costco will be receiving the vaccines directly from the federal government.
The FDA announced this week that it plans to issue new standards it will propose guidelines on how manufacturers of coronavirus vaccines, therapeutics and diagnostic tests should deal with new variants of the virus. The FDA is expected to utilize its experience with influenza to inform its path forward. They are considering approaches to help expedite drug development to be effective against some of the COVID-19 variants. They are also monitoring new mutations and communicating information to the public.
In some good news, there are now more Americans who have been vaccinated than have contracted COVID-19. According to Bloomberg’s Vaccine Tracker, over 26.5 million people in the country have received one or two doses of either the Moderna or Pfizer vaccine which surpasses the 26.3 million documented U.S. cases of coronavirus since the pandemic began.
We hope you enjoy rooting for your favorite young or old quarterback this weekend!

January 29, 2021

President Joe Biden signed an Executive Order this week that will reopen enrollment on the federal Affordable Care Act exchanges. The Department of Health and Human Services (HHS) will reopen enrollment on healthcare.gov from February 15th until May 1st to those who need coverage. The Trump administration had cut enrollment time in half – to six weeks – and ended enrollment on December 15. Biden will now allow the uninsured to select policies under a special enrollment period. The Department of HHS will mount a marketing campaign to gain public awareness of the special enrollment period.

An investigation by the Inspector General of the Department of HHS, overseen by the Office of Special Counsel, found that hundreds of millions of dollars intended for the development of vaccines, drugs and therapies by theBiomedical Advanced Research and Development Authority (BARDA) were used to pay for unrelated projects. An unidentified whistleblower alleged that officials in the office of the Assistant Secretary for Preparedness and Response at HHS said that the agency wrongly spent money set aside for developing lifesaving medicines, beginning in fiscal 2010 and continuing through at least fiscal 2019, spanning both the Obama and Trump administrations.

Johnson &Johnson announced today that its one dose COVID-19 vaccine provided strong protection against COVID-19. The vaccine efficacy rate was 72 percent in the United States, and while it is less effective than the Pfizer and Moderna vaccine, it is still considered a strong vaccine by scientists. However, the vaccine had only 57 percent efficacy against the highly contagious variant from South Africa which is driving most COVID-19 cases. The Johnson &Johnson vaccine is seen as important in the U.S. immunization effort as the vaccine is long-lasting and doesn’t require freezing like Moderna and Pfizer-BioNTech’s shots and would be the first to protect from COVID-19 with a single dose. Johnson & Johnson said that it plans to apply for Emergency Use Authorization from the Food and Drug Administration and could receive clearance in late February.

Sanofi has agreed to produce millions of doses of the BioNTech SE and Pfizer Inc.’s COVID-19 vaccine in an effort to speed vaccination efforts. The agreement will produce over 100 million doses of the messenger RNA vaccine for the European Union in Frankfurt. Sanofi’s own COVID-19 vaccine has been delayed and this abnormal agreement raises hopes that more pharmaceutical companies will come together to produce additional COVID-19 vaccines.

This week, Congressional Democrat leadership signaled they will move forward with budget reconciliation to pass an additional COVID-19 economic relief package and begin work on a package as soon as next week. The relief package includes $160 billion to contain COVID-19 including $20 billion for vaccine distribution, an additional $50 billion for expanded testing, investments into treatments, a public health jobs program, and an emergency relief fund. Also included in the package were plans to subsidize continuation health coverage (COBRA) through the end of September, and an expansion and increase in the value of the Premium Tax Credit to lower or eliminate health insurance premiums and ensure enrollees do not pay more than 8.5 percent of their income for coverage.

Researchers at the Centers for Disease Control and Prevention (CDC) wrote in a medical journal that schools should reopen as soon as possible if precautions are taken. The journal found that the “preponderance of available evidence” indicates that in-person instruction can be carried out safely as long as mask-wearing and social distancing are maintained. The researchers also noted that local officials also must be willing to impose limits on other settings including indoor dining, bars, or poorly ventilated gyms in order to keep infection rates low in the community at large. School administrators are also urged to limit risky activities including indoor gatherings and indoor sports.

Please don’t get too grumpy on this Curmudgeons Day!

January 22, 2021

President Biden and Vice President Kamala Harris were officially sworn into office on Wednesday and issued several Executive Orders to combat the COVID-19 pandemic. In his first three days in office, Biden has signed Executive Orders that will accelerate manufacturing and delivery of supplies for vaccination, testing, and PPE; create a COVID-19 Health Equity Task Force; direct FEMA to expand reimbursement to states to fully cover the cost for National Guard personnel and emergency supplies; establish a Pandemic Testing Board to expand US coronavirus testing capacity; direct the Departments of Education and Health and Human Services (HHS) to provide guidance for safely reopening and operating schools, childcare providers, and institutions of higher education; direct FEMA to create federally-supported community vaccination centers; enhance the nation’s collection, production, sharing, and analysis of coronavirus data; call on the Occupational Safety and Health Administration (OSHA) to release clear guidance on COVID-19; establish a preclinical program to boost development of therapeutics in response to pandemic threats; require mask wearing in airports and on certain modes of transportation; and the launch of a “100 Days Masking Challenge” asking Americans to wear masks for 100 days,  along with the requirement of masks and physical distancing in federal buildings, on federal lands, and by government contractors. President Biden also unveiled his National Strategy for the COVID-19 Response and Pandemic Preparedness this week.

President Biden also signed an Executive Order announcing that the United States would be rejoining the World Health Organization (WHO). Dr. Anthony Fauci will be the head of the United States delegation to the agency’s executive board. In remarks to the WHO by video conference, Fauci said that the United States intends to fulfill its financial obligations to the WHO and work with partners to strengthen and importantly reform the WHO. Dr. Fauci also said that the Biden administration intends to be fully engaged in advancing global health, and that President Biden would sign a directive to join the COVAX initiative and support the ACT-Acceleratorto advance multilateral efforts for COVID-19 vaccine, therapeutic, and diagnostic distribution, equitable access, and research and development. COVAX is a WHO-backed effort to ensure every country has access to COVID-19 and the United States was one of the last countries to join the effort.

President Biden announced a number of his health team members this week including nominations of Wisconsin health official Andrea Palm, leader of the Wisconsin coronavirus pandemic response, to be the Deputy Secretary of HHS, and Pennsylvania Health Secretary Rachel Levine to be his Assistant Secretary of health which would make her the first openly transgender federal official to be confirmed by the U.S. Senate. Biden also announced Norris Cochran as Acting Secretary of the Department of Health and Human Services; Regina LaBelle as Acting Head of the Office of National Drug Control Policy; Liz Richter as acting CMS Administrator; and Janet Woodcock as acting FDA Commissioner.

Data released from the Medicare Shared Savings Program found that the number of accountable care organizations (ACOs) taking part has reached a five-year low. The number of ACOs enrolled in the program have dropped to 477 participants from a peak of 561 participants in 2018. Provider groups have argued that the reason for the drop was due to the Trump administration’s “Pathways to Success” reforms that they believe discouraged participation by increasing downside risks.

We hope you enjoy your spicy dinner and blonde brownie for desert on this National Hot Sauce Day and National Blonde Brownie Day!

January 15, 2021

President-elect Biden announced an ambitious $1.9 trillion COVID-19 economic relief package last night. Included in the package was $160 billion to contain COVID-19, including $20 billion for COVID-19 vaccine distribution, an additional $50 billion for expanded COVID-19 testing, investments into COVID-19 treatments, a public health jobs program, and an emergency relief fund. Also included in the package were plans to subsidize continuation health coverage (COBRA) through the end of September and expand and increase the value of the Premium Tax Credit to lower or eliminate health insurance premiums and ensure enrollees do not pay more than 8.5 percent of their income for coverage. A longer summary of the American Rescue Plan from our team at Prime can be found here and a full summary of the plan can be found here. Biden is expected to announce specifics around his vaccine distribution plan this afternoon.

This week, the Department of Health and Human Services (HHS) Secretary Alex Azar urged states to offer vaccines to millions more Americans as COVID-19 infections continue to soar. HHS recommended states begin immunizing all residents 65 and older, along with all those between 16 and 64 with medical conditions that make them more vulnerable to serious disease. Azar also said that there would be changes to the allocation of vaccines and they will now be allocating vaccines based on the pace of administration, as reported by states and by the size of the 65-years-old and over population in each state.

HHS also issued new guidance that lets physicians prescribe buprenorphine without first obtaining the “X” waiver. The “X” waiver required physicians to complete an eight-hour course to receive a license before prescribing the drug. Physicians have supported the new guidance and believe that the removal of the waiver will allow help with the worsening opioid crisis.

According to reports, Johnson and Johnson has fallen behind on production of its one-shot COVID-19 vaccine and the delay could put them as much as two months behind schedule. Johnson and Johnson announced this week that it doesn’t expect its single-dose COVID-19 Vaccine to be authorized for use until March and that they expect to meet its 2021 supply commitments signed with the government. The Johnson and Johnson vaccine is seen as important in the U.S. immunization effort as the vaccine is long-lasting and doesn’t require freezing like Moderna and Pfizer-BioNTech’s shots and would be the first to protect from COVID-19 with a single dose.

The Centers for Medicare and Medicaid Services (CMS) finalized a rule this week that allows breakthrough-designated medical devices designated by the Food and Drug Administration (FDA) to be sold and reimbursed for new devices for millions of Medicare beneficiaries on the day of market approval and coverage would last for four years. In a press release, CMS said that the new rule will encourage manufacturers to voluntarily develop evidence to show these treatments improve the health of Medicare patients and offer Medicare beneficiaries nation-wide predictable access to new, breakthrough devices to help improve their health outcomes. Critics of the regulation have argued that the rule is a giveaway to the device industry and that CMS should force manufacturers to develop clinical evidence for medical devices instead of relying on manufacturers to do so voluntarily

The New England Journal of Medicine published findings that a combination of anti-addiction drugs for opioids and smoking could be the first pharmaceutical therapy to treat methamphetamine use disorder. Researchers reported Wednesday that 13.6% of participants in the treatment group treated with the two drugs had repeated urine tests free of methamphetamine, compared to just 2.5% of those who were given placebos. In an interview, the director of the National Institute on Drug Abuse said that the trial shows the largest effects to date for a pharmaceutical intervention to address meth use disorder. There are no medications on the market for meth use disorder, but researchers used naltrexone and bupropion as a potential combination therapy which have both been approved by the FDA.

We hope you all enjoy the holiday weekend and take some time to remember Dr. Martin Luther King Jr.’s legacy and his lasting impact on our country.

January 8, 2021

President-elect Biden announced plans to release nearly all available COVID-19 vaccine doses to speed delivery to more people. This policy would be a shift from the Trump administration’s policy of reversing half of the available supply for second shots in a two-dose regimen. This decision comes after eight Democratic Governors wrote to Department of Health and Human Services (HHS) Secretary Alex Azar asking them to ship out as much of the vaccine as possible. The Food and Drug Administration (FDA) said earlier this week that they did not support changes to COVID-19 dosing. FDA Commissioner Stephen Hahn noted that changing the FDA-authorized dosing or schedules of COVID-19 vaccines at this time is “premature and not rooted solidly in the available evidence.” Hahn believes that making changes to the dosing schedule to ensure the vaccine can get to the public faster could be counterproductive to public health and decisions needto be made based off data and science. Hahn also said that he supports discussions to make the FDA more independent and insulated from political rhetoric.

The HHS announced this week that they would provide more than $22 billion in funding to states, localities, and territories in support of the nation’s response to the COVID-19 pandemic. The funding will go towards immunizations, vaccines, testing, contract tracing, surveillance, containment, and mitigation to monitor and suppress the spread of COVID-19. Award recipients include 64 jurisdictions including all 50 states, the District of Columbia, five major cities, and U.S. territories/islands and will be distributed under a population-based formula.

Californians with HIV have proposed a class action suit against CVS Caremark that could lead to more litigation against Pharmacy Benefit Managers (PBMs) that control how drug benefits operate. The class action suit was approved by a federal appeals court last month and the plaintiffs argue that CVS Caremark threatened their health and privacy by forcing them to get specialty prescriptions filled by mail order or drop shipment to a CVS pharmacy. Under this policy, patients would have to pay out-of-network insurance rates or full price to get their drugs at a pharmacy of their choosing. CVS Caremark has argued that it treats all specialty drugs the same and includes treatments for both disabled and non-disabled individuals. The case could bring more clarity into how the Affordable Care Act antidiscrimination protections are interpreted.

President-elect Biden plans to phase out Operation Warp Speed Co-Leader Moncef Slaoui. Slaoui will work as a consultant on rollout of the COVID-19 vaccines for four to six weeks before leaving the administration. General Gus Perna, Operation Warp Speed Chief Operating Officer is expected to continue working in the Biden administration and will focus on the logistics of vaccine distribution.

The National Institute of Health (NIH) scientists are studying whether COVID-19 vaccines will provide protection against new strains of the virus. New strains of the SARS-Cov-2 virus have been discovered in the United Kingdom and South Africa which appear to transmit more easily but do not make patients any sicker than other strains of the virus. Kizzmekia S. Corbett, scientific lead for the coronavirus vaccines team at the National Institute of Allergy and Infectious Diseases, has said that there needs to be fundamental scientific understanding of the variations to know how well the vaccines protect patients against the new strains.

We wish a happy birthday to the late great Elvis Presley!

December 18, 2020

*Healthcare Today is taking a break for the holidays and will return January 8th.*

The Food and Drug Administration (FDA) announced this week that it authorized Abbott Labs’ rapid COVID-19 test for at-home use. The test is an antigen test that will deliver results in about 15 minutes. The test was previously authorized for at-home use by trained personnel only, but the FDA authorization will now allow the test to be used completely at home with virtual assistance from a doctor. Abbot has partnered with telehealth provider eMed to help with the testing process and will cost $25 for at-home use. This week, the FDA also authorized a rapid antigen COVID-19 test developed by the Australian digital diagnostics company Ellume. This test will be available at drug stores without a prescription and taken at home with results coming in as little as 20 minutes. The test involves collecting a sample using a nasal swab and then placing the swab into a Bluetooth-connected analyzer that syncs with a smartphone app. The FDA said the test correctly identified 96 percent of positive samples and 100 percent of negative samples in people with symptoms of COVID-19. The test correctly identified 91 percent of positive samples and 96 percent of negative samples in asymptomatic people.

The Moderna COVID-19 vaccine moved closer to emergency use authorization as the FDA Advisory Committee Panel voted 20-0 with one abstention to endorse the emergency use of the vaccine. The FDA is now expected to grant emergency use as soon as today or tomorrow. The Moderna vaccine has an efficacy of over 94% and is expected to be able to be distributed more widely and with less difficulty as it can be stored at normal freezer temperatures unlike the Pfizer vaccine. If given the greenlight, the U.S. supply of a vaccine would be nearly doubled adding 20 million doses to Pfizer’s 25 million doses. The U.S. government has agreed to double its purchase of Moderna’s vaccine to 200 million doses by the end of June.

The first Americans were given Pfizer’s COVID-19 vaccines this week, giving Americans hope as the U.S. passed 300,000 COVID-19 deaths this week. Vaccination rollout began throughout the country on Monday with doctors, nurses, and nursing home residents receiving the vaccine first. Health officials expect as many as 20 million people will get the first of two required doses of the vaccine by the end of the year. In good news, pharmacists and doctors noticed that Pfizer’s vials actually contained six or seven doses instead of the expected five. The FDA announced that vaccine vials contain extra doses that could supply up to 40% more of the vaccine and advised doctors to use every full dose obtainable in vials provided by Pfizer.

A COVID-19 economic relief package was released this week by a group of bipartisan members of Congress. One package included new unemployment benefits, small business aid, and other programs that received broad bipartisan support, while a second package included the contentious issues of liability protections for businesses and aid for state and local governments. Negotiations continue between leadership in the House and Senate as well as the administration. It is unclear when they will come to an agreement, but we are optimistic that a big relief package will be passed before the end of the year.

Leaders of the House Energy and Commerce Committee, House Ways and Means Committee, House Education and Labor Committee, and Senate Health, Education, Labor, and Pensions (HELP) Committee agreed on a bipartisan, bicameral deal in principle that seeks to end surprise medical bills. Under the legislation, patients would only be responsible for their in-network cost-sharing amounts for both emergency services, including air ambulances, and some non-emergency; health insurers would be required to have up-to-date lists of in-network providers; and a system for health providers and insurers to resolve disputes would be arranged. The agreement has gained support from a bipartisan group of members in Congress as well the administration, but Senate Majority Leader Mitch McConnell (R-KY) has yet to publicly comment on it. The powerful American Medical Association and American Hospital Association both opposed passage of the bill.

The House Democratic Steering Committee announced Exclusive Committee Assignments for the 117th Congress. Rep. Stacey Plaskett (D-VI) was appointed to the Ways and Means Committee and Rep. Angie Craig (D-MN), Rep. Lizzie Fletcher (D-TX), Rep. Kathleen Rice (D-NY), Rep. Kim Schrier (D-WA), and Rep. Lori Trahan (D-MA) were appointed to the Energy and Commerce Committee. Notably, centrist Rep. Rice (D-NY) defeated progressive Rep. Alexandria Ocasio-Cortez by a vote of 46-13 for the last spot on the Energy and Commerce Committee.

We hope you donned your favorite ugly sweater today on National Ugly Sweater Day!

December 11, 2020

The Food and Drug Administration (FDA) vaccine advisory panel voted Thursday by a vote of 17-4 to recommend the FDA to authorize the Pfizer COVID-19 vaccine. One member of the vaccine panel abstained in favor of emergency authorization for people 16 and older. The FDA is now expected to grant an Emergency Use Authorization for the drug as soon as Sunday with an initial shipment of 6.4 million doses to leave warehouses within 24 hours of it being cleared by the FDA. Health care workers and nursing home residents are expected to be prioritized to receive the vaccine first. This news comes after Canada’s regulatory agency, Health Canada, approved the Pfizer drug earlier in the week. Health Canada approved the vaccine for people over the age of 16. Canada is set to receive up to 249,000 doses this month and health officials expect to administer 30,000 doses as soon as next week after an initial batch of the vaccine is shipped from Belgium.

California Attorney General Xavier Becerra was selected to be Secretary of the Department of Health and Human Services by President-elect Joe Biden. As Attorney General of California, Becerra led 20 states and the District of Columbia in a campaign to protect the Affordable Care Act from the Trump administration and Republican Attorneys General efforts to invalidate the law. Becerra also filed an antitrust lawsuit against Sutter Health that resulted in a $575 million settlement last year. Additionally, the Biden transition team announced the nominations of Dr. Rochelle Walensky as Director of the Centers for Disease Control and Prevention (CDC) and Dr. Vivek Murthy as Surgeon General. Dr. Walensky previously was Chief of the Division of Infectious Diseases at Massachusetts General Hospital and Professor of Medicine at Harvard Medical School. Dr. Murthy would be returning to a post he held during the Obama administration.

The CDC issued additional guidance urging mask wearing as COVID-19 has entered a phase of “high level transmission.” The new guidance advises state and local officials to impose mask mandates when not at home. The guidance states that mask use is most crucial for indoor settings when not at home and in outdoor spaces where social distancing cannot be maintained. The CDC also noted that mitigation measures are especially essential as recent research suggests around 50 percent of transmission of COVID-19 is from asymptomatic people.

The House of Representatives passed a bill with strong bipartisan support sponsored by Rep. Earl Blumenauer (D-OR) and Rep. Andy Harris (R-MD) that would make it easier for scientists to conduct marijuana research in states where the drug has been legalized. Currently, the United States only allows marijuana research under federal law to a few variations of the crop that are grown by the University of Mississippi. Scientists have long complained that the current system of research is inadequate and doesn’t resemble marijuana used by most people. This becomes the second marijuana related bill passed by the House within a week as the House passed the MORE Act last week that would end federal marijuana penalties and erase some past convictions.

The House also passed Rep. Donald Payne’s (D-NJ) legislation to waive Medicare coinsurance for certain procedures done during a colon cancer screening test as well as require drugmakers to report certain pricing information to Medicare passed the House by voice vote this week. The bill was one of the most popular in congress with 342 co-sponsors.

We hope you enjoy your sweets this weekend while celebrating Gingerbread House Day and National Ice Cream Day over the weekend!

December 4, 2020

President-elect Biden announced that one of his first moves in combatting the pandemic will be to ask Americans to wear masks for the first 100 days of his presidency. He believes that widespread adoption of mask wearing would result in a significant reduction of COVID-19 cases. Biden also said that he will issue an order that masks must be worn in federal buildings and on interstate transportation, such as on airplanes and buses that cross state lines. Dr. Anthony Fauci praised Biden for the idea and said that plan would help blunt the surge in COVID-19 cases in the United States.

A $908 billion COVID-19 economic relief package was released this week by a group of bipartisan Senators. Senate Minority Leader Chuck Schumer (D-NY) and House Speaker Nancy Pelosi (D-CA) said that the bipartisan relief package should be used as a starting point for a COVID-19 relief package. Senate Majority Leader Mitch McConnell (R-KY) has pushed for a smaller deal and has yet to announce his support for the bipartisan package. McConnell has also said that any legislation needs to include legislation to protect businesses from virus-related lawsuits. There definitely appears to be more momentum for a deal than there has been in some time, and the fact that conversations between the Senate Majority Leader and Speaker have been happening is a good sign.

The Advisory Committee on Immunization Practices recommended to the Centers for Disease Control and Prevention (CDC) that health care workers and residents at long-term care centers should be first in line for the COVID-19 vaccine. The Advisory Committee’s recommendation was approved by a 13 to 1 vote and cited the high risk for infection within these groups and the positive impact these recommendations would have on hospitals. The recommendation comes as Food and Drug Administration (FDA) regulators are set to rule on an emergency use authorization of a Pfizer-BioNTech vaccine as well as a decision on a Moderna vaccine.

The CDC has issued new guidance for the length of quarantine for people exposed to COVID-19, lowering itfrom 14 days to 10 days — and just seven days if the person has tested negative. The CDC’s revised recommendations are based on a range of new data on the virus’ behavior that has been compiled by the agency. The CDC is also recommending that people stay at home for the upcoming holiday season just as it did before Thanksgiving. If people do travel, the guidelines suggest that individuals should get a coronavirus test one to three days before travel and then three to five days after travel, combined with quarantine for seven days after arriving.

President-elect Biden has added three new members to his COVID-19 team. Jane Hopkins, Jill Jim, and David Michaels are all joining the COVID-19 taskforce. Hopkins is a Sierra Leonean immigrant and has worked for more than 20 years as a bedside nurse and has a long history in union work; Jim serves as the executive director at the Navajo Nation Department of Health and has worked for 18 years in nonprofit, state and federal agencies, and tribal government; and Michaels serves as an epidemiologist and professor of Public Health at George Washington University and previously was assistant secretary of Labor for occupational safety and health during the Obama administration.

Rep. Cathy McMorris Rodgers (R-WA) made history this week as she becomes the first woman from either party to assume a top spot on the House Energy and Commerce Committee. The House Republican conference approved the GOP Steering Committee’s recommendation for Rodgers to become the Ranking Member on Energy and Commerce. House Democrats elected Rep. Rosa DeLauro (D-CT) as the next chair of the Appropriations Committee. DeLauro was chosen over Reps. Debbie Wasserman Schultz (D-FL) and Marcy Kaptur (D-OH).

We hope you enjoy a chocolate chip, oatmeal and raisin, snickerdoodle or whatever your favorite is tonight for dessert on National Cookie Day!

November 20, 2020

With the Thanksgiving holiday coming up next week, Healthcare Today is going to take a brief vacation and will return on December 4th.

President Trump is expected to announce several health rules today as his administration attempts to finalize a number of policy changes before President-elect Biden takes office. President Trump is expected to announce two rules aimed at lowering drug prices. One rule would tie Medicare Part B payments of drugs to an international index of drug prices. The most favored nation plan has garnered criticism from Republicans on the Hill and the pharmaceutical industry. The second rule on drug prices is a rebate rule that would end the current drug rebate program in which pharmacy benefit managers pass on manufacturer rebates to health plans, which then use the funds to discount premium prices for all members. The rationale behind this change is to allow direct-to-consumer discounts. The Trump administration is also likely to finalize a rule that would overhaul the Stark Law and anti-kickback statute. The final rule is expected to allow further hospital-physician arrangements.

Pfizer announced that they will seek emergency use authorization from the Food and Drug Administration for its coronavirus vaccine. Pfizer and its German partner, BioNTech, would become the first coronavirus vaccine developers to submit their vaccine for review by U.S. regulators. The companies released data this week that found its vaccine was safe and 95 percent effective with only mild side effects in a late-stage trial with nearly 44,000 participants. The FDA’s independent vaccine advisory group is expected to review the data at a meeting in early December where the FDA could choose to grant the emergency use authorization for the vaccine. If granted the emergency use authorization, Pfizer expects they could begin distributing the first vaccine batches in 2020.

The Government Accountability Office (GAO) announced that they are committed to examining the health care costs associated with firearm injuries. The GAO said that its key questions are around initial hospital costs associated with firearm injuries in the United States and specifically the costs to Medicaid and Medicare and what additional health care services may be required for survivors of firearm injuries and what the known associated costs to those services are. The decision to study gun violence health costs was praised by Sen. Elizabeth Warren (D-MA), Rep. Robin Kelly (D-IL), and Rep. Carolyn Maloney (D-NY) in a letter stating the study is a good step towards confronting and addressing the gun violence crisis.

Senate Finance Committee Chairman Chuck Grassley (R-IA) and Sen. Elizabeth Warren (D-MA) urged the FDA to initiate its rules for over-the-counter (OTC) hearing aids. The OTC Hearing Aid Act that was sponsored by Grassley and Warren was signed into law in 2017 removed outdated regulations that block consumer access to affordable hearing aids and required the FDA to issue proposed regulations no later than August 18, 2020. In a letter to FDA Commissioner Stephen Hahn, Grassley and Warren urged the FDA to make OTC hearing aids regulations a priority and to release a proposed rule without delay to make hearing aids available over-the-counter.

Moderna announced that its vaccine candidate was nearly 95 percent effective in its Phase III trial. Moderna said that its vaccine appears to have prevented severe infections, but it is unclear how long immunity would be offered by the vaccine. Unlike Pfizer’s vaccine that needs to be stored at extreme temperatures of negative 94 degrees, Moderna’s vaccine can be stored at regular refrigerated temperatures for up to a month and be kept in ordinary freezers for long-term use, making it more viable for long-term use in the U.S. and elsewhere. Moderna is expected to file for FDA emergency use authorization soon which could allow Americans to get vaccinated as soon as next month.

The Centers for Medicare and Medicaid Services (CMS) announced a Request for Application for the Value in Opioid Use Disorder Treatment initiative that seeks to increase access to opioid use disorder (OUD) treatment services to eligible Medicare Fee-For-Service (FFS) beneficiaries. The Value in Opioid Use Disorder Treatment is a four-year demonstration program that will create two new payments to participating providers through a per beneficiary per month care management fee and a performance-based incentive payment. These two payments will be made in addition to the opioid use disorder treatment services currently covered by Medicare. CMS will seek to implement the demonstration by April 1, 2021 and participants will be able to apply from November 19, 2020 thru January 3, 2021.

We hope that you and your family and friends enjoy a socially-distanced Thanksgiving holiday next week with your favorite foods, football, and parade watching!

November 13, 2020

President-elect Biden announced the creation of a COVID-19 transition team that will be dedicated to coordinating the federal response to the pandemic. The team will include transition officials from nearly every major federal agency. The transition team will be broken down into domestic policy, national security/foreign policy, and tech strategy delivery policy areas with central team leaders heading each of the policy areas. Sarah Bianchi, a former top policy aide to Biden, is among the group leading the domestic policy work;   Dylan George, a former Obama administration biological threats specialist, and Georgetown’s Rebecca Katz will lead the national security and foreign policy group; and the tech strategy delivery specialty group will be led by a five-person team including Mina Hsiang of Devoted Health and Amy Pitelka, a tech legal and policy expert. Biden also named Ron Klain as his new Chief of Staff. Klain has deep experience working in Washington and was the Obama administration’s Ebola response coordinator in late 2014 and early 2015 where he was praised for his management of that pandemic.

The United States Supreme Court heard oral arguments this week on the California vs. Texas Affordable Care Act case that the Trump administration and several Republican-led states are asking the Court to strike down the law. The Trump administration and Republican states are arguing the entire law is invalid due to the individual mandate’s lack of constitutionality. Early indications suggest the Court is unlikely to strike down the entire law as both Supreme Court Chief Justice John Roberts and Justice Brett Kavanaugh suggested Tuesday that it wasn’t the Supreme Court’s role to invalidate the entirety of the Affordable Care Act. It is too early to tell whether the justices will strike down the insurance markets reform with the individual mandate or let them stand.

The Senate Appropriations Committee released its fiscal year 2021 appropriations bills this week. The Labor, Health and Human Services, Education, and Related Agencies bill would provide $44 billion to the National Institutes of Health, $3.9 billion in total for the opioid crisis, $4 billion for mental health programs, increase funding for all disease preparedness programs including $30 million extra for the CDC’s Public Health Emergency Preparedness cooperative, and increase by more than $200 million the “Ending HIV Epidemic” initiative providing a total of $518 million. The Agriculture, Rural Development, Food and Drug Administration (FDA), and Related Agencies bill would provide $3.21 billion in discretionary funding for the FDA, a $40 million net increase to base funding for medical products, food safety activities, and infrastructure needs for the FDA, and total FDA funding of $5.88 billion.

Pfizer announced this week that preliminary data showed its COVID-19 vaccine candidate was more than 90% effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection in the first interim efficacy analysis. The level of efficacy was a surprise as scientists had predicted a COVID-19 vaccine would be similar to a flu vaccine and have only 50% effectiveness and require yearly immunizations. Pfizer has estimated it could have 50 million doses available globally by the end of 2020 which would be enough for 25 million people. Public Citizen, a consumer advocacy group, warned that the release contains preliminary and incomplete data and that enthusiasm must be tempered.

The FDA announced it authorized the emergency use of Eli Lilly’s antibody treatment for COVID-19. The emergency use authorization allows the drug to be used in adults and children over the age of 12 with mild to moderate COVID-19 symptoms who are at high risk of progressing to severe disease or requiring hospitalization. The FDA said that the treatment should not be used for patients already in the hospital, but has shown in clinical trials to reduce COVID-19-related hospitalization or emergency room visits in patients at high risk for disease progression within 28 days after treatment when compared to a placebo. Eli Lilly said it has enough doses to treat up to one million people by the end of the year and that they will be able to significantly increase production next year.

At a meeting this week, the Medicare Payment Advisory Commission (MedPAC) said that Medicare Advantage plans’ dialysis payments needed to be revamped to reduce costs as the market becomes more dominated by two companies. MedPAC staff found that on average Medicare Advantage contracts paid 14% more per dialysis treatment than those paid by fee-for-service plans. Industry leaders said that a number of plans are paying too much as they cannot negotiate down to fee-for-service levels. MedPAC commissioners noted that 74% of dialysis outpatient facilities were run by two companies and that could be a reason for high costs.

Please make sure to safely spread the love on this National Hug a Musician Day!

November 6, 2020

Enrollment for the Affordable Care Act (ACA) coverage is underway and will go until December 15th. Millions of Americans who have lost health insurance during the COVID-19 pandemic will now be able to qualify for government-subsidized plans. However, starting in 2023, Georgia residents will no longer have a central website for all ACA plans and will now rely on private entities, agents, and brokers that sell ACA plans, after the Trump administration approved a plan to let Georgia leave the federal exchange.  Centers for Medicare and Medicaid Services (CMS) Administrator Seema Verma acknowledged that the policy will likely lead to lawsuits as critics say it will likely lead to a drop in the number of people with compliant coverage, which isn’t allowed under the ACA’s state innovation waiver system.

CMS issued a final rule that updated payment policies and rates under the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) for renal dialysis services furnished to beneficiaries enrolled in Medicare Part B on or after January 1, 2021. The final rule also updated the acute kidney injury AKI) dialysis payment rate for renal dialysis services furnished by ESRD facilities to individuals with AKI and finalizes changes to the ESRD Quality Incentive Program (QIP). In addition to technical updates, the rule provides an update to the ESRD PPS wage index to adopt the 2018 Office of Management and Budget delineations; changes the eligibility criteria for the transitional add-on payment adjustment for new and innovative equipment and supplies (TPNIES); changes the low-volume payment adjustment eligibility criteria and requirement to account for the public health emergency; and an addition to the ESRD PPS base rate to add the inclusion of calcimimetics in the ESRD PPS bundled payment.

Arizona, Mississippi, Montana, New Jersey, and South Dakota all voted to allow cannabis use for medicinal or recreational use. Arizona voters approved a ballot question that would legalize recreational cannabis for people ages 21 and older and proposed a process to expunge drug offenses related to marijuana; Mississippi voters legalized medical cannabis; Montana voters approved the legalization of recreational and medical cannabis and let people convicted of marijuana offenses apply for resentencing or records expungement; New Jersey Voters legalized recreational cannabis for people 21 and older and subjected marijuana to a state sales tax; and in South Dakota voters legalized recreational and medical cannabis.

The Department of Health and Human Services (HHS) announced a proposed rule that would require the Department to assess its regulations every ten years to determine whether they are subject to review under the Regulatory Flexibility Act (RFA). Under the proposed rule, most regulations issued by HHS will not be effective ten years after it is issued unless the department performs an assessment of the regulation. The assessment will review the economic impact under standards set out under the RFA and a more detailed review that considers the continued need for the rule, complaints about the rule, the rules complexity, the extent to which it supplicates other rules, and if technological, economic, and legal changes favor amending or removal of the rule.

Pfizer announced that they will be building its own distribution system instead of relying on the federal government for the distribution of its COVID-19 vaccine once it has reached approval. Pfizer’s COVID-19 vaccine is expected to need to be shipped in dry ice to stay at -94 degrees Fahrenheit. Once shipped, the vaccine can only be refrigerated for up to 24 hours and kept at room temperature for no more than two hours.  Pfizer will ship direct from either Kalamazoo, Michigan or Pleasant Prairie, Wisconsin and plans to work with the Trump Administration’s Operation Warp Speed to allocate the vaccine if they secure emergency use authorization for the vaccine.

We hope you enjoy a cold margarita tonight with your nachos on this National Nachos Day!

October 30, 2020

The Department of Health and Human Services (HHS) Office of the National Coordinator (ONC) for Health IT announced they would extend the dates for the compliance deadlines for health care information blocking and interoperability regulations. This is the second time that HHS has pushed back the compliance dates due to the COVID-19 pandemic and under the interim rule. Providers won’t be required to come into compliance for the information blocking requirements until April 5, 2021, and new standardized application programming interfaces functionality won’t be required until December 2022. HHS officials said that this extension provides the health care system with additional flexibility and time to respond to public health threats caused by COVID-19, but that they still strongly support the provisions in the final rule and are not removing the requirements outlined in the Cures Act Final Rule.

The Department of HHS, the Department of Labor, and the Department of the Treasury issued a final rule that will require health insurers to provide customers with advance notice on the cost of care. The rule will require almost all health insurance companies and self-insured plans to disclose pricing and cost-sharing information to customers. Starting in 2022, insures will have to provide patients with accessible digital data on the prices they pay for covered prescription drugs and for providers as well as negotiated rates or charges billed by out-of-network doctors and hospitals. By 2023, plans and issuers will be required to make cost-sharing information available for 500 specified items and services for plans and policies, and beginning in January 2024 cost-sharing information for all treatment and care must be made available for all policy years or plans. The rule seeks to bring greater transparency and competition to the private health care industry in hopes of driving down costs.

The Centers for Medicare and Medicaid Services (CMS) announced a proposed a new payment rule for durable medical equipment (DME). CMS is proposing to increase pay for DME in rural and non-bid areas, cover external infusion pumps as DME under Medicare Part B, and classify continuous glucose monitors as DME while establishing payment amounts for these items. The proposed rule also sets up a new process for coding, coverage, and payment for the new DME that will determine whether an item falls into a DME benefit category when a certain Medicare billing code is requested.

The FBI, HHS, and the Cybersecurity and Infrastructure Security Agency (CISA), which is part of the Department of Homeland Security, said in an advisory this week that hackers were targeting United States hospitals and health care providers. The advisory warned that hospitals and health care providers were the target of an increased and imminent cyberwar threat. The advisory warned that hackers would possibly use ransomware for financial gain. At least three hospitals were hit by a cybercrime group this week and targeted hospitals and health providers with emails that claim to be corporate communications but contain links to malware.

Johnson & Johnson and AstraZeneca COVID-19 vaccines will both resume clinical trials after investigators found that illnesses in both trials appeared to be unconnected to the vaccines. An independent data safety monitoring board cleared the Johnson & Johnson drug trial to continue, while the Food and Drug Administration cleared the AstraZeneca drug to continue. Both Johnson & Johnson and AstraZeneca are considered by many to be among the front-runners to find a vaccine and will now be able to continue trials.

Eli Lily is ending a clinical trial of its antibody drug after federal researchers found the therapy did not produce a marked improvement in patients. The National Institutes of Health concluded that the drug was unlikely help hospitalized patients recover from an advanced stage of COVID-19. Eli Lilly officials believe the antibody drug may prevent the progression of the disease for patients earlier in their course of COVID-19 and are still pursuing additional trials with the NIH.

We hope you enjoy your Halloween night and are not creeped out by the full moon – the first one on Halloween since 1955!

October 23, 2020

The Department of Health and Human Services (HHS) announced changes to its Provider Relief Fund reporting requirements after receiving pushback from hospitals and providers. In response to those concerns, HHS will not define the revenue that providers have lost during the pandemic by comparing how much they earned in 2019 to 2020. HHS will now allow providers to use remaining Provider Relief Funds (PRF) to cover any lost revenue that is measured as a negative change in year-over-year actual revenue after they reimburse healthcare related expenses that are attributable to the coronavirus. HHS also announced the latest PRF application period has been expanded to include provider applicants such as residential treatment facilities, chiropractors, and eye and vision providers that have not yet received PRF distributions. These providers and all Phase 3 applicants will have until 11:59PM EST on November 6, 2020 to submit their applications for payment consideration.

The Food and Drug Administration (FDA) approved Gilead’s antiviral therapy drug remdesivir for use in adult and pediatric patients making it the first drug to receive approval as treatment for COVID-19 in the United States. Under the approval, remdesivir can treat patients that require hospitalization for COVID-19 if they are 12 years of age or older. Gilead said that the medication should only be administered in a hospital or health-care setting that can provide acute care that is comparable to inpatient hospital care.

HHS announced an agreement with CVS and Walgreens to provide and administer COVID-19 vaccines to residents of long-term care facilities (LTCF) nationwide with no out-of-pocket costs. The program will be free of charge to facilities available in most rural areas, available for residents in all long-term care settings, and available to all LTCF staff. CVS and Walgreens will schedule and coordinate on-site clinic dates with the facilities, and both companies anticipate that three visits over two months will be needed to administer the vaccine to both staff and residents.

White House Chief of Staff Mark Meadows announced this week that he didn’t anticipate the plan to send $200 for prescription drugs to American seniors getting done before the election. Meadows said that the Administration is currently working on the plan and that the cards will likely be sent out in November or December. This comes after the general counsel at HHS, Robert Charrow, instructed the Administration to seek guidance from the DOJ’s public integrity office to ensure it didn’t run afoul of election laws. The proposal has faced criticism from Democrats in Congress. In a letter to HHS Secretary Alex Azar, House Energy and Commerce Committee Chairman Frank Pallone (D-NJ), House Ways and Means Committee Chairman Richard Neal (D-MA), and Senate Finance Ranking Member Ron Wyden (D-OR) questioned the legality of the plan and said it was “an apparent attempt to buy votes ahead of the election.” In a separate letter to Center for Medicare and Medicaid Services Administrator  Seema Verma, 25 Congressional Democrats called on her to abandon the drug plan and prioritize substantial drug pricing reforms.

Opioid manufacturer Purdue Pharma will plead guilty to three federal criminal charges and will now pay over $8 billion in fines after Purdue admitted to violating federal anti-kickback laws by paying doctors through a speaking program to induce them to write more prescriptions, using electronic health records software to influence pain medication prescription, and reporting misleading information to the Drug Enforcement Administration to boost manufacturing quotas. The guilty pleas settle federal probes into how Purdue Pharma marketed OxyContin, a highly addictive painkiller which federal officials believe fueled the prescription opioid epidemic. The Sackler family, Purdue Pharma’s owners, will lose all control over the company and Purdue will become a public benefit company that is governed by a trust that has to balance the trust’s interests against those of the American public and public health.

CMS announced that they will delay the start date for its new radiation oncology alternative payment model until July 2021 from January 2021. CMS said that it had heard from a number of stakeholders about the challenges of preparing to implement the model and that they are pursuing a rulemaking to make that change. The payment model will test prospective, bundled payments to providers for 16 cancer types and payments would cover 90-day episodes of care.

The Centers for Disease Control and Prevention (CDC) issued new guidance on wearing masks while using public transportation. The guidance urged passengers to wear face masks on trains, planes, and other forms of public transportation.  The guidance says that using public transportation can increase the spread of the COVID-19 and that all passengers and employees should wear masks to stop the spread of COVID-19. The CDC says that, while travelling, masks should cover a person’s nose and mouth and that operators should require them for the entire time of travel and deny entry to those not wearing one. The guidance says there are some instances where people do not have to wear a mask including eating, drinking, or taking medication, and exemptions for any children under the age of 2 and to briefly verify one’s identity during a security screening.

We hope you practice appropriate social distancing in dealing your blow on National Slap Your Annoying Coworker Day.

October 16, 2020

The number of new COVID-19 cases is surging throughout the country with 44 states and the District of Colombia reporting higher cases of COVID-19 than they were a month ago and the United States topping 60,000 daily COVID-19 infections for the first time since early August. The virus is spreading throughout the country and is now impacting rural communities with Wisconsin, Indiana, Illinois, Ohio, New Mexico, North Dakota, Montana, and Colorado all reporting record high daily case numbers this week. The increase in cases and hospitalizations has coincided with only a modest rise in COVID-19 deaths which could be attributed to better patient and greater availability of treatments. Epidemiologists warn that the virus isn’t going away and that cases are likely to rise in the winter as more people spend time indoors.

2020 has been a successful year for the insurance industry according to a Kaiser Family Foundation study that shows increases in profits. The study found that insurer profits on Medicare Advantage plans grew by 41 percent group market plans gross margins increased by 22 percent compared to the first two quarters of last year. The study also found that individual market insurers profits and loss ratios maintained flat compared to the first two quarters of last year. The pandemic induced drop in health care service use has contributed to the increase in profits but presents uncertainty for insurers who anticipate a pent-up demand for services and the need to provide coverage for a potential COVID-19 vaccine.

The Centers for Medicare and Medicaid Services (CMS) announced this week an additional set of telehealth services that Medicare will pay for during the COVID-19 Public Health Emergency. CMS is adding 11 new services to the Medicare telehealth services list.  Effective immediately and for the duration of the PHE, Medicare will start paying eligible practitioners who provide certain neurostimulator analysis and programming services, and cardiac and pulmonary rehabilitation services. Since the beginning of the PHE, CMS has now added 144 services that Medicare will pay for performed via telehealth.

Johnson & Johnson and Eli Lilly both announced this week that they will be pausing vaccine trials this week. Johnson & Johnson paused recruitment and dosing of its coronavirus vaccine due to an unexplained illness in a study participant. Eli Lilly’s antibody trial was paused over a potential safety concern related to the health difference between the group that received the drug and the group that received a placebo. Health experts notes that in large clinical trials it is not uncommon for a vaccine trial to be paused and that often the trial ends up continuing.

AstraZeneca began two phase three trials for its COVID-19 antibody drug. One trial will evaluate the safety and efficacy of the experimental treatment to prevent infection for up to 12 months in about 5,000 participants and a second trial will evaluate post-exposure preventative and pre-emptive treatment in roughly 1,100 participants. As part of Operation Warp Speed, the U.S. government provided AstraZeneca with $486 million to develop and secure supplies of up to 100,000 doses of COVID-19 antibody treatment.

States are working to draft comprehensive COVID-19 vaccine distribution plans that are due today to the Centers for Disease Control and Prevention. State health officials were given 30 days to draft a comprehensive COVID-19 vaccine distribution plan. States have been tasked with coming up with a plan that will solve a number of issues including the transport of the vaccine from manufacturer to hospitals, physician practices, and clinics; deciding who will receive the first doses of the vaccine; and implanting a strategy to convince citizens that the vaccine is safe. This week, Gov. Andrew Cuomo (D-NY) and Gov. Asa Hutchinson (R-AK) sent a letter to President Trump on behalf of the National Governors Association asking for a meeting to discuss numerous questions they had surrounding a national vaccination process.

At the conclusion of the World Food Prize on World Food Day, we are reminded of all the efforts of late great Alan Borlaug to combat hunger globally.

October 9, 2020

President Trump returned to the White House this week after a three-night stay at Walter Reed Hospital. Dr. Sean Conley, the White House physician, said that since returning home the President’s condition has remained stable and that he has responded well to treatment. The President is hoping to be considered healthy enough to return to public events on Saturday barring any changes in his condition.

In a call with reporters this week, Centers for Medicare and Medicaid Services (CMS) Administrator Seema Verma announced that hospitals that fail to report COVID-19 data could be removed from both Medicare and Medicaid and not receive reimbursement from those programs. In early September, CMS issued a rule that required hospitals to report full COVID-19 data to the federal government including the number of patients and ventilators they have. Hospitals are also required to report influenza data. CMS began sending letters this week to hospitals notifying them if they have been complying and later this month the Department of Health and Human Services (HHS) will begin posting a list of hospitals that are out of compliance. Hospitals will have 14 weeks to come into compliance and after receiving multiple notifications from CMS and HHS, hospitals could lose funding as soon as mid-January. Hospitals have struggled with the new reporting system that have added another layer of administrative burden.

The Food and Drug Administration (FDA) issued guidance this week on what is expected from drug companies seeking Emergency Use Authorization for COVID-19 vaccines. The guidelines advise vaccine developers to monitor half of clinical trial participants for at least two months following their final dose of vaccine or placebo before applying for emergency authorization; they should wait to apply until at least five severe cases of COVID-19 have been reported among trial participants receiving the placebo; and that any drug maker seeking authorization should expect a public Vaccines and Related Biological Products Advisory Committee meeting to discuss the safety and effectiveness of the drug. President Trump criticized the guidelines claiming they were a “political hit job” that would make it more difficult to speed up vaccine approval.

The Supreme Court heard arguments this week on the state regulation of prescription drug benefit companies. Pharmacy Benefit Managers (PBMs) are fighting an Arkansas law that prohibits PBMs from reimbursing pharmacies at a lower rate than it costs to dispense the drug. The Arkansas law also allows pharmacists to refuse to sell a drug if the upper limit that a plan will pay for drugs is too low. The Pharmaceutical Care Management Association (PCMA) is arguing the law violates the Employee Retirement Income Security Act of 1974 (ERISA) that preempts state laws that regulate the plan administration of health insurance to better create a uniform program. Arkansas Attorney General Leslie Rutledge argues that the law doesn’t dictate how health plans must be run and earlier Supreme Court precedent has allowed states to regulate rates. The Supreme Court’s decision could affect at least 40 states that regulate PBMs in some form. The Supreme Court could come to a decision by the end of the year, but a decision is more likely to happen in 2021.

President Trump announced this week that the administration would end negotiations with House Speaker Nancy Pelosi on an additional coronavirus relief package. President Trump did indicate his support for a smaller package that would extend the small business paycheck protection program, provide relief for airline industry, and distribute $1,200 direct relief payments to individuals and $500 per dependent. The President promised that immediately after he wins the election, he would pass a major stimulus bill. However, we understand that conversations between Speaker Pelosi and Secretary Mnuchin are ongoing, though the two sides remain far apart.

Senate Finance Committee Chairman Chuck Grassley (R-IA) announced this week that he wants Congress to address funding issues for children’s hospitals. Children’s hospitals are at risk of losing millions in payments after the Supreme Court declined to take up the Childrens’ Hospital Association of Texas v. HHS case that challenged the legality of an HHS rule that decreases Medicaid payments to safety-net hospitals that serve low-income patients as well as patients with Medicare or private insurance. Grassley wants the calculation for disproportionate share hospital (DSH) payments to be amended to leave payments from Medicare and private insurance out of that formula which would boost payments to children’s hospitals.

We hope you enjoy your dessert tomorrow night on National Cake Decorating Day.

October 2, 2020

President Trump and First Lady Melania Trump have both contracted COVID-19. President Trump reportedly has mild symptoms of the virus and will now quarantine in the White House for an unspecified amount of time. Vice President Mike Pence underwent his daily test and tested negative. The election will go forward on November 3 as is mandated by statute, and as of today nothing about the process will change. It is too early to speculate on the status of the presidential debates scheduled for October 15 and 22. However, as many of us have learned in recent months, videoconferencing is a useful tool and could provide the possibility for the next two presidential debates to be held virtually with the candidates and moderator at remote locations away from each other. Given what we know at this point, the vice-presidential debate is expected to be held as planned next Wednesday. We send our thoughts and prayers to the President and First Lady for a swift recovery.

This week, the House Oversight and Reform Committee concluded an 18-month committee probe that found drug makers drastically increased the cost of medications with two hearings. The first hearing’s witnesses were former Celgene CEO Mark Alles, Bristol Myers Squibb CEO Giovanni Caforio, and Teva CEO Kåre Schultz. The Committee report found that Celgene more than tripled the price of its cancer drug Revlimid since 2005, when former Celgene CEO Mark Alles called for an emergency price increase for Revlimid to meet quarterly revenue targets, and Teva hiked the price of Copaxone 27 times and intentionally reintroduced new formulations to avoid competition. The CEOs defended the business practices citing the need for price hikes to fund innovation and new medication developments and defended executives’ compensation.

Amgen CEO Robert Bradway, Mallinckrodt Pharmaceuticals CEO Mark Trudeau and Novartis U.S. President Thomas Kendris all testified at the second day of hearings. The Committee also found that Mallinckrodt hiked the price of Acthar gel to almost $40,000 per vial leading to Medicare Part D spending to be 14 times higher since 2011, Novartis’ cancer drug Gleevec raised the price of the drug 22 times since 2003 and the company delayed generic competition for the drug, and Amgen increased prices on its rheumatoid arthritis biologic Enbrel and its kidney failure drug Sensipar while executives received millions in bonuses. Amgen CEO Robert Bradway said that prices are higher in the U.S. because 46 cents of every dollar are in the hands of the pharmaceutical supply chain and not in innovative companies. Novartis’ President Thomas Kendris defended price increases citing the exponential value increase of Gleevec since it was introduced onto the U.S. market as it gained five new indications in rare cancers and saved tens of thousands of patients’ lives.

Department of Health and Human Services Secretary (HHS) Alex Azar testified today before the House Select Subcommittee on the Coronavirus Crisis. Azar told the Committee that we currently have four vaccine candidates in phase 3 clinical trials and promised the Committee that the vaccine process would be guided by science and evidence and not politics. Democrats on the Committee questioned Azar on the politicization of public health agencies in the midst of a pandemic and presidential campaign.

House Speaker Nancy Pelosi (D-CA) released a new version of the HEROES Act this week. The $2.2 trillion relief package passed the House Thursday. The bill would provide another round of $1,200 direct relief payments to individuals and $500 per dependent, $75 billion for coronavirus testing, contact tracing and isolation measures, and $28 billion for procurement, distribution and education campaigns for a safe and effective vaccine. Senate Majority Leader Mitch McConnell (R-KY) has already indicated his lack of support for the proposal and that it will not be brought up for a vote in the Senate. President Trump has indicated he would support a $1.5 trillion relief package, while Senate Republicans released a “skinny” relief package of $650 billion last month.

HHS announced this week that they will provide an additional $20 billion in new funding for providers on the frontlines of the coronavirus pandemic in Phase 3 general distribution funding. Previous ineligible providers including those who began practicing in 2020 and an expanded group of behavioral health providers who are confronting the emerging mental health and substance use issues will be invited to apply for  funds beginning October 5th.

The Bipartisan Policy Center released a report this week on how the U.S. spent $7.6 billion in federal funds to combat the opioid crisis during the fiscal year of 2019. The report found that around three-quarters of spending went towards prevention, recovery, and treatment efforts, while the rest of the funding went towards research, criminal justice initiatives and law enforcement. The Bipartisan Policy Center recommend Congress increase funding for the Substance Abuse and Mental Health Services Administration’s substance abuse prevention and treatment block grant; make the administration’s pandemic-prompted expansion of telehealth services permanent, and target grant funding to address gaps with minority populations. The report found that incarcerated individuals in many areas of the country still do not have access to medication assisted treatment.

We were glad to see the continuing resolution pass the Senate and signed into law without drama, so we wish you a happy fiscal new year!

September 25, 2020

The House-passed short-term funding bill that would keep the government running through December 11th included a provision that would limit any increase in 2021 Medicare Part B premiums to around $4 a month. House Democrats have indicated they included the increase limit as premiums would likely increase by a larger amount due to budget shortfalls in the program. Senate Finance Committee Chairman Chuck Grassley (R-IA) has previously proposed a similar provision in a coronavirus relief package that Senate Republicans proposed in July and indicated his support of the language in the bill. The bill extends the repayment period and reduce the interest rate for Medicare providers that participated in the Medicare accelerated and advanced payment program. Funding for Medicare and Medicaid extenders was also extended until December 11th for a number of programs including the Special Diabetes Programs; Community Mental Health Services Demonstration; State Health Insurance Programs; and Aging Disability and Resource Centers. Finally, the bill delays cuts to Medicaid disproportionate share hospitals until Dec. 11th and extends the geographic practice cost index floor at 1.0 under the Medicare program for all localities. The Senate is expected to pass this bill next week.

President Trump announced in two executive orders this week his plans to protect patients with preexisting conditions should the Supreme Court overturn the Affordable Care Act and that he would ban surprise medical bills if Congress didn’t come up with a solution by the end of the year. The first executive order states that it’s national policy to protect coverage of people with preexisting conditions. The executive order on surprise billing directs Congress to pass surprise billing legislation by January 1st. Should Congress fail to pass surprise billing legislation then the Department of Health and Human Services (HHS) will investigate regulatory and executive action that can be taken to stop hospitals and doctors from sending surprise medical bills. President Trump also unveiled a plan to provide seniors with $200 drug discount cards to help cover prescription drug co-pays. The drug discount cards would be sent to 33 million Medicare beneficiaries and would be carried out through a Medicare demonstration program. Costs of the $200 discount cards are expected to be paid for by savings from the administration’s”favored nations” program that has yet to be implemented.

The Food and Drug Administration (FDA) announced this week that drug makers seeking an emergency use authorization (EUA) for a COVID-19 vaccine will need to meet a higher standard of efficacy than would normally be required. FDA Commissioner Dr. Stephen Hahn said that the agency would be releasing guidelines for drug makers that aim to submit an EUA request for a COVID-19 vaccine. The move is expected to boost public confidence in the vaccine’s effectiveness. In a press conference, however, President Trump indicated that the new standards have to be approved by the White House and that they may or may not approve them.

The FDA also announced that the United States will allow states to import some medications from Canada. The final rule allows states, tribes, pharmacists, and wholesalers to submit two-year drug import plans that must be submitted and authorized by the FDA. The plan excludes certain drugs such as controlled substances, IV drugs and pricey biologics. The FDA said that it is unable to estimate the final cost savings.

This week, the Senate, Health, Education, Labor, and Pensions (HELP) Committee held a hearing on COVID-19. Both Centers for Disease Control and Prevention (CDC) Director Dr. Robert Redfield and National Institute of Allergy and Infectious Diseases Director Dr. Anthony Fauci said that they expect the coronavirus vaccine to be widely available by spring of 2021 with a timeline of 700 million doses by April. Dr. Fauci also said that he anticipated that we would know the effectiveness of drugs currently being developed by November or December. FDA Commissioner Dr. Stephen Hahn promised that the vaccine would not be determined by political actors and that he will fight for science and the integrity of the agency. HHS Assistant Secretary for Health Admiral Brett Grior touted the administrations purchase of point-of-care tests from Abbott to improve testing capabilities.

Johnson & Johnson COVID-19 vaccine candidate is entering its late-stage trial and has started dosing up to 60,000 volunteers in a study. Johnson & Johnson became the fourth vaccine maker to move a vaccine candidate into late-stage human trials. The trial could yield results as soon as the end of this year allowing them to seek an EUA by early next year if effective. Early human studies of the vaccine have shown a strong immune response in just fifteen days. The Johnson & Johnson COVID-19 vaccine is the first large U.S. trial of an inoculation that could work after just one shot and its vaccine also has an advantage in distribution as it can stored at refrigerator temperatures for three months which is far longer than other vaccines that require deep freezing for long-term storage.

We hope you enjoy a lobster roll tonight on National Lobster Day!

September 18, 2020

President Trump signed an executive order for prescription drugs last weekend that would include a “favored nations” rule. The rule will link Medicare drug payments to the lowest price they are charged in other nations that are members of the Organization for Economic Cooperation and Development with a similar per-capita gross domestic product. The order will direct the Department of Health and Human Services (HHS) to start demonstration projects for Medicare Part B and Part D. The pharmaceutical industry strongly opposed the plan claiming it was an overreach that would threaten American innovation. The Trump administration gave the industry one month to come up with a counter proposal, but White House spokesman Judd Deere said, “negotiations did not produce an acceptable alternative, so the President is moving forward.”

Centers for Medicare and Medicaid Services (CMS) Administrator Seema Verma announced on Monday that CMS would be withdrawing a proposed Medicaid Fiscal Accountability Rule (MFAR) due to the unintended consequences of the rule. The rule would have changed the complex payment arrangements that states use to raise money for Medicaid programs and hoped to increase transparency and accountability from state Medicaid programs. The proposal faced criticism from governors and state Medicaid directors who argued that the rule would have reduced the ability for states to obtain federal matching funds. Several groups opposed the rule including the National Governors Association, the American Hospital Association, and the National Association of Medicaid Directors.

This week, CMS released the final report from the independent Coronavirus Commission for Safety and Quality in Nursing Homes. The panel of academics, nursing home operators and administrators, and state health officials recommended additional funding for testing, staff salary increases, the careful resumption of family visits, additional funding for infection control training, and an increase in personal protective equipment. In a press release, CMS Administrator Seema Verma said that the report vindicated the administration’s approach to date and gave them an action plan for the future. Some patient advocate groups have pushed back on this claim and believe the report needs to make facilities more accountable.

The Food and Drug Administration (FDA) released performance data for over 55 COVID-19 diagnostic tests this week. The FDA began distributing reference panel samples in May and provided them to over 150 developers as a resource to validate accurate diagnostic tests. The performance data displays the Limit of Detection (LoD) of authorized molecular diagnostic COVID-19 tests against a standardized sample panel provided by the FDA. The data is expected to help labs, doctors, and patients evaluate and gain insight into the performance of different authorized tests.

CMS administrator Seema Verma announced that Accountable Care Organizations (ACOs) in the Medicare Shared Savings Program posted savings for the third straight year. Verma wrote that the Medicare Shared Savings Program saved the agency $1.19 billion as a result of 541 ACOs which is the largest savings yet for the program. The ACOs in the program generated net beneficiary savings of $169 compared to savings of $106 for legacy track ACOs. CMS will also allow certain ACOs to extend participation agreement in the shared savings program for an additional year and allow certain new ACOs to freeze their current risk level for 2021 to respond to the pandemic in their communities.

CMS finalized its End-Stage Renal Disease (ESRD) Treatment Choices (ETC) Model that seeks to improve or maintain the quality of care while reducing Medicare expenditures for patients with chronic kidney disease. The ETC model will impact 30 percent of kidney care providers and is estimated to save $23 million over five years. CMS also finalized a new innovation center model to improve the quality of care for cancer patients. The new Radiation Oncology (RO) Model is part of a final rule on specialty care models that is estimated to save Medicare $230 million over 5 years by creating simpler and more predictable payments.

Le shanah tovah to those who are celebrating Rosh Hashanah this weekend!

September 11, 2020

The House Energy and Commerce Committee marked-up and favorably reported 26 health bills to the full House of Representatives last week. Included in the 26 bills was H.R. 1379, the Ensuring Lasting Smiles Act, that would require all individual and group market health insurance plans to cover medically necessary treatment that was the result of birth defects or congenital abnormalities; H.R. 2564, the Medicare Enrollment Protection Act, that would create a Medicare Part B special enrollment period for individuals enrolled in coverage under the Consolidated Omnibus Budget Reconciliation Act (COBRA) and would exempt individuals enrolling through the special enrollment period from the Part B late enrollment penalty; and H.R. 8158, a bill that would amend title XVIII of the Social Security Act to specify that the budget neutrality requirement for establishing new payment classes of oxygen and oxygen equipment no longer applies and would make a technical correction to the placement of this provision in the statute. Energy and Commerce Chairman Frank Pallone (D-NJ) said at the beginning of the mark-up that he expects all the bills that were advanced by the committee on Wednesday to receive floor votes prior to the House adjourning to campaign.

This week, the Senate, Health, Education, Labor, and Pensions (HELP) Committee held a hearing on vaccines. The National Institutes of Health (NIH) Director Dr. Francis Collins said that there is no way of knowing when there will be a safe vaccine for COVID-19, but that he is hopeful a vaccine will be approved by the end of the year. He also said that studying the safety and effectiveness of a COVID-19 vaccine is the agency’s top priority. Democrats on the Committee voiced concerns that the vaccine would be issued prematurely to increase President Trump’s reelection chances, but both Surgeon General Dr. Jerome Adams and NIH Director Dr. Francis Collins assured Democrats on the Committee that they will not allow politicization in the vaccine process and that the vaccine will not be approved if it is not safe and effective.

AstraZeneca announced this week that global trials of its COVID-19 vaccine were paused due to an unexpected inflamed spine in one of its patients. AstraZeneca said that there wouldn’t be any more testing done until there was clarity on whether the spinal issue was the result of the vaccine. At the Senate HELP hearing this week, NIH Director Dr. Francis Collins noted that pausing global trials was an example of following sound scientific practices and proof of the lack of politicization in the vaccine process. AstraZeneca’s drug was considered one of the favorites to develop a vaccine quickly and were planning on enrolling as many as 50,000 participants in late-stage trials in the U.S., U.K., and other countries.

The CEOs of AstraZeneca, BioNTech, GlaxoSmithKline, Johnson & Johnson, Merck, Moderna, Novavax, Pfizer, and Sanofi all pledged this week they would not submit vaccine candidates to the Food and Drug Administration review before their safety and efficacy are shown in large clinical trials. The CEOs hope that the pledge will increase public confidence in the scientific and regulatory process that evaluate COVID-19 vaccines. A recent survey found a third of Americans were unsure if they would get the vaccine. The nine drug companies also vowed “to ensure a sufficient supply and range of vaccine options, including those suitable for global access.”

The NIH announced this week that they have started two of three late-stage clinical trials to examine the use of blood thinners to treat COVID-19 patients. Blood clotting in those patients has led to strokes, heart attacks, and organ failure. The NIH will launch these trials at over 100 sites around the world and involve patients in various clinical settings. Patients not hospitalized will receive either a placebo, aspirin, or a low or therapeutic dose of the blood thinner Eliquis, while hospitalized patients will receive varying doses of heparin to test the safety and effectiveness of the generic blood thinner.

We will always remember and honor on Patriot Day those who perished on this tragic day in 2001.

September 4, 2020

Earlier this week, the Centers for Medicare and Medicaid Services issued a proposed rule that would create a Medicare coverage pathway for innovative technology. The pathway, Medicare Coverage of Innovative Technology (MCIT), would create national coverage for breakthrough medical devices as designated by the Food and Drug Administration (FDA), provide services to implement and maintain them, and any treatments that resulted from device complications. MCIT would be authorized for four years from the date of FDA market authorization.

The Trump administration announced it had reached a deal with Abbott Laboratories to purchase 150 million rapid coronavirus tests for $750 million. The tests are expected to be deployed in nursing homes, schools and other places with high risk populations. This agreement swiftly follows the Food and Drug Administration (FDA) authorizing the emergency use of Abbott’s BinaxNOW test. The test gives results within 15 minutes and costs only $5. The test is designed for use within 7 days of the patient developing symptoms. Results appear on a card similar to over-the-counter pregnancy tests with two lines indicating an infection and one line indicating there is no infection.

The Centers for Disease Control (CDC) has notified public health officials in each of the 50 states and in five large cites (New York, Chicago, San Antonio, Houston and Philadelphia) that they should be prepared for coronavirus vaccination distribution in October or November of this year. The plan lays out technical specifications for two vaccines described as Vaccine A and Vaccine B. There is speculation that these correspond to the vaccines being developed by Moderna and Pfizer. Pfizer had indicated last month that their vaccine may be ready for government approval as early as October of this year. The documents CDC sent provide scenarios for distributing the vaccine with priority being given to healthcare and long-term care workers.

The pharmaceutical industry responded to President Trump’s challenge regarding his Executive Orders on drug pricing – that the industry should come up with a better plan if they don’t like his proposal. The Pharmaceutical Research and Manufacturers of America (PhRMA) submitted a plan to the White House to lower drug prices by $100 billion over the next ten years. The industry’s plan offers to trim the price of drugs administered by physicians in their offices or hospitals covered by Medicare Part B by ten percent. The second element of the plan would cap at five percent the cost-sharing for patients in the catastrophic phase of the Medicare Part D program. The plan calls for the Centers for Medicare and Medicaid Innovation (CMMI) to administer both demonstration programs.

On Wednesday, CMS announced the issuing of an inpatient hospital pay rule for FY2021. The rule would expand new technology add-on payments, increase Medicare spending on acute inpatient services by 2.7%. The rule also approves 13 technologies out of 15 submitted for technology add-on payments.

The Congressional Budget Office (CBO) announced its panel of outside advisors on health policy and the health care sector for the coming year. The panel includes experts from academia, teaching hospitals, hospital associations, insurance companies, public health officials, healthcare consulting and business interests. The full list of the panel can be found here. CBO also has a panel of economic advisors that convenes more frequently than their health advisors, which typically meet once a year.

Finally, CMS announced yesterday the launch of Care Compare, which redesigns and streamlines eight existing healthcare comparison tools available on Medicare.gov. CMS hopes that this redesign will make the user experience much easier to make informed decisions about how to choose coverage that best fits beneficiary needs and wants.

We hope everyone enjoys their long weekend as we pay tribute to and celebrate the accomplishments of American workers.

August 21, 2020

*Healthcare Today is going to take a brief summer vacation and will return on September 4th.*

The Trump administration announced that the Food and Drug Administration (FDA) will no longer regulate a large number of laboratory-developed tests including tests for the coronavirus. The Department of Health and Human Services (HHS) outlined its decision in a notice published this week. Supporters of the new policy have argued that this will allow additional and innovative tests to come to market quicker, but public health experts have warned that this decision could lead to an increase in unreliable coronavirus tests. According to the Washington Post, the decision is routed in a discrepancy between HHS and FDA about the legal authority to regulate these specific types of lab-developed tests.

In a call with governors this week, HHS Secretary Alex Azar announced that the Centers for Medicare and Medicaid Services (CMS) is planning to issue new regulations that will mandate hospitals to report additional data. On the call with governors, Azar noted that regular updates on hospitalizations and data are important to ensure the federal government properly allocates COVID-19 treatment. The rule will seek to improve the quality of data that is currently being reported and overhaul the current system that currently relies on faxes and paper records.

President Trump announced this week that he rejected a proposal that would cut military health services by $2.2 billion. The military health system is used by around 9.5 million active-duty personnel, military retirees and their dependents, and it operates hundreds of facilities around the world was going to be cut as part of an overall spending review. Trump tweeted that “A proposal by Pentagon officials to slash Military Healthcare by $2.2 billion dollars has been firmly and totally rejected by me.”

This week, Senate Republicans released a narrow coronavirus relief package. The legislation includes many of the proposals included in the Republicans initial $1 trillion package. The bill would provide an additional $45 billion to the HHS Public Health and Social Services Emergency Fund. The funding would provide $20 billion for the manufacturing, production, and purchase of vaccines, therapeutics, and diagnostics; $6 billion to prepare for, distribute, administer, and track coronavirus vaccines; and $16 billion that would go almost entirely to states, localities, health service providers, and other groups for testing, contact tracing, and surveillance. The bill will also provide additional funding for the postal service, liability protections for businesses, and a $300 weekly supplemental unemployment insurance payment for the rest of the year.

House Speaker Nancy Pelosi has called the House back into session this weekend to vote on a U.S. Postal Service bill that would reverse any revision to service standards, closure or consolidation of post offices or their hours and includes $25 billion in emergency funding, of which $15 million will go to the USPS OIG office. The cost-cutting measures taken by Postmaster General Louis DeJoy likely impacted millions of Americans who get their prescriptions by mail. Exactly how many people have been affected directly by any changes in postal service is unclear with many Americans prescriptions being delayed or not being delivered. An Axios-Ipsos poll released this week found nearly one in five Americans received prescriptions through the mail and the use of mail order for prescriptions have risen by 20 percent since the spread of the coronavirus in the United States.

We tip our cap to the greatest generation and others who are older than us on National Senior Citizen Day.

August 14, 2020

This week, the Centers for Medicare and Medicaid Services (CMS) announced the Community Health Access and Rural Transformation (CHART) model that is focused on improving health care in rural America. The CHART model was announced on August 3rd as part of an executive order and is a voluntary pilot payment model through CMS’ Centers for Medicare and Medicaid Innovation that seeks to provide hospitals in rural areas with more consistent Medicare payments. Providers can join the community transformation track or the Accountable Care Organization track. Under the Community Transformation track, CMS plans to invest up to $75 million in up to 15 rural communities and allows hospitals to waive cost-sharing for certain Part B services. The Accountable Care Organization track will offer upfront investments to rural healthcare providers to improve outcomes and quality for rural beneficiaries.

House Energy and Commerce Committee Chairman Frank Pallone, Jr. (D-NJ), Health Subcommittee Chairwoman Anna G. Eshoo (D-CA) and Oversight and Investigations Subcommittee Chair Diana DeGette (D-CO) launched a probe into nine health and dental insurance companies business practices during the COVID-19 pandemic. The lawmakers sent a letter to Anthem, Cigna, CVS Health, Humana, UnitedHealth Group, Delta, Guardian, Metlife, and United Concordia seeking more information on their COVID-19 policies amid the pandemic. The letters ask if insurers are providing any financial assistance to providers as their industry is seeing record profits and inquires about consumer billing complaints.

Centers for Disease Control and Prevention Director (CDC) Dr. Robert Redfield warned this week that if Americans fail to follow public health guidance then the country could be facing “the worst fall, from a public health perspective, we’ve ever had.” Health officials are worried that a convergence of a bad flu season with the COVID-19 pandemic would strain our health system and impact millions of Americans. Redfield noted that the positive tests of COVID-19 need to be below 5% by flu season to avoid a convergence of influenza and the COVID-19 pandemic. According to data from John Hopkins University, more than 30 states have over 5% test positivity

Moderna Inc. has reached a deal with the Trump administration to supply 100 million doses of its experimental COVID-19 vaccine as the administration continues to try and acquire the most advanced vaccines in testing. The deal is expected to be valued at up to $1.5 billion with vaccine doses selling for roughly $15 a dose. Moderna joins Pfizer and Johnson & Johnson as companies that have reached the supply agreements with the Trump administration.

Vice President Joe Biden announced Sen. Kamala Harris (D-CA) as his running mate for the 2020 election. In her relatively brief time in the Senate Harris focused most of her attention on criminal justice, immigration, and social justice issues. Harris is a co-sponsor of Sen. Bernie Sanders Medicare for All bill, but while running for president she introduced her own health care plan that would give Americans a choice between choosing a public option or a highly regulated private health insurance plan. The Trump campaign has started and will likely continue attacking Harris for her support of Medicare for All.

We hope you set some time aside tomorrow to relax with your friends and family on National Relaxation Day!

August 7, 2020

This week, Missouri voters chose to approve Medicaid expansion. Missouri becomes the 38th state to expand, and is expected to cover over 200,000 additional low-income residents. Through the Affordable Care Act, the federal government will cover 90% of the expansion costs and will open eligibility in the program to families and individuals up to 138% of the federal poverty level. Medicaid expansion will now be added to the Missouri state constitution and the state will be required to expand Medicaid by next July. Missouri becomes the sixth Republican-led state to expand Medicaid and no state has chosen to vote down Medicaid expansion

President Trump signed an executive order this week aimed at encouraging manufacturing of certain drugs and medical supplies in the United States. The executive order loosens federal drug-safety and environmental regulations and urges purchasers to buy American made drugs. The drugs and medical supplies that the order will cover are expected to include medicines that are used in response to a biohazard attack or public health emergency. The Food and Drug Administration will come up with the list of essential medicines, but the White House has not said when they will release the list.  President Trump also signed an executive order that seeks to help health care providers in rural areas. The executive order directs the Department of Health and Human Services (HHS) to set up a new voluntary pilot payment model through CMS’ Centers for Medicare and Medicaid Innovation that seeks to provide hospitals in rural areas with more consistent Medicare payments. The executive order will allow doctors to be able to treat patients virtually for new services including eye exams and certain mental health visits after the pandemic subsides. The order also directs the Federal Communications Commission and Department of Agriculture to form a task force focusing on improving broadband infrastructure to support telehealth in rural communities.

The Senate passed by unanimous consent S. 3703, the Promoting Alzheimer’s Awareness to Prevent Elder Abuse Act, to improve the prevention of elder abuse and exploitation of individuals with Alzheimer’s disease and related dementias. The Senate also passed S. 785, the John Scott Hannon Veterans Mental Health Care Improvement Act of 2019. This bill seeks to connect more veterans with mental health care by bolstering the VA’s mental health workforce and increasing rural or hard-to-reach veterans’ access to VA care, while making sure veterans have access to alternative and local treatment options.

House Democrats are investigating the $765 million loan that was awarded to Eastman Kodak to produce drug ingredients. House Coronavirus Crisis Subcommittee Chair Jim Clyburn, Financial Services Committee Chair Maxine Waters and other committee leaders have sent letters to both the International Development Finance Corporation CEO and the Eastman Kodak CEO seeking information on how Kodak obtained the government support and why Kodak, given its past focus on photography, was given the loan. The committee chairs are also seeking documentation of stock trades by Kodak leadership.

The House Energy and Commerce Committee announced they will be launching a probe into health and dental insurance companies’ businesses practices during the COVID-19 pandemic. Some of the largest health insurance companies received record second quarter profits. Energy and Commerce Chairman Frank Pallone said in a statement that the Committee will be sending oversight letters to a series of health and dental insurance companies in the hopes of finding out if they are in compliance with existing statutes requiring COVID-19 testing be free of consumer cost-sharing for all patients.

The HHS Office of Inspector General (OIG) released a report on Thursday that called on Medicare to improve oversight of nursing homes. The OIG found hundreds of facilities that didn’t meet the staffing requirements required by Medicare for several weeks in 2018. The analysis of over 13,000 facilities found that close to 7% of facilities reported 30 or more days in which staffing levels failed to meet one standard. The Centers for Medicare and Medicaid Services has said that it will enhance oversight over nursing homes and explore ways to provide more information on staffing levels.

We will be enjoying responsibly a BRLO German IPA tonight on International Beer Day!

July 31, 2020

The nationwide distribution of a potential COVID-19 vaccine will be a “joint venture” between the Department of Defense and Centers for Disease Control and Prevention (CDC). The CDC will be in charge of tracking the side effects of the vaccine and communications with state public health organizations, while the Department of Defense will be in charge of distribution logistics, manufacturing, and the process of safely packing the vaccines. In the past, the CDC has served as the distribution center for state and local health officials in major outbreaks, but in a statement a Trump administration official said that this will allow them to more effectively distribute hundreds of millions of doses and that the two agencies will be working together as one team.

Eastman Kodak Co. has received a $765 million loan under the Defense Production Act to expedite the domestic manufacturing of drugs back to the U.S. Kodak is expected to manufacture essential ingredients that the Food and Drug Administration (FDA) defines as in short supply. This is another attempt by the Trump Administration to increase drug manufacturing in the United States as over 70 percent of the world’s drug ingredients are currently made outside of the U.S. Kodak was one of thirty companies the White House was considering for funding and will be required to repay the loan over twenty-five years.

This week, the Department of Health and Human Services (HHS) released a report on surprise medical bills. The report encourages Congress to enact legislation to protect patients from surprise bills as it is currently a market failure that will not correct itself. The report does not take a position on an approach Congress should take to address the problem, but it says legislation is an appropriate remedy to end surprise medical bills. Following the release of the report  the Senate Health, Education, Labor, and Pensions Chairman Lamar Alexander (R-TN) and Ranking Member Patty Murray (D-WA), the House Energy and Commerce Chairman Frank Pallone (D-NJ) and Ranking Member Greg Walden (R-OR),  and the House Education and Labor Chairman Bobby Scott (D-VA) and Ranking Member Virginia Foxx (R-NC) all released a joint statement in support of enacting legislation to end surprise billing. The leaders of the Ways and Means Committee who passed its own legislation to end surprise billing were not included in the statement.

The Senate GOP released a $1 trillion coronavirus relief package this week, the HEALS Act. The package would provide HHS with $118.4 billion in funding with $51 billion going towards COVID-19 testing and vaccine development. It also includes an additional $25 billion increase to a hospital bailout fund, allows the expansion of telehealth to remain until the end of 2021, increases liability protections for hospitals, gives doctors until January to pay back Medicare advance payments, and increases funds to the National Institutes of Health. The HEALS Act does not include additional funds for Medicaid. House and Senate leadership along with the Trump administration are currently negotiating on a relief package, but we are hearing they are currently far apart in negotiations.

House Speaker Nancy Pelosi has now instituted a mandate that all members and staff are required to wear masks on the floor. In a statement Pelosi said, “Members and staff will be required to wear masks at all times in the hall of the House. Members may remove their masks, temporarily, when recognized.” House leadership is also discussing the possibility of mandating testing after the positive test of Rep. Louie Gohmert (R-TX) who often refused to wear a mask in the Capitol.

We want to wish Harry Potter a happy birthday and we are planning to celebrate the occasion with a batch of guacamole with our pup on National Avocado and Mutt Day.

July 24, 2020

The Trump Administration announced additional resources will be provided to nursing homes in their fight against COVID-19. The Department of Health and Human Services (HHS) will provide $5 billion of the CARES Act Provider Relief Fund to nursing homes to increase testing capacity, hire additional staff, and buy new technology to enable residents to speak with family members who are unable to visit. This funding will be tied to completing a new infection control training program that the Centers for Disease Control and Prevention (CDC) and the Centers for Medicare and Medicaid Services (CMS) are developing. CMS will start requiring all nursing homes with a 5% positivity rate or greater test all nursing staff each week. CMS will be providing over 15,000 testing devices to nursing homes and hopes the new testing requirement will keep the virus from entering nursing homes and spreading through asymptomatic carriers.

HHS Secretary Alex Azar signed a renewal of the COVID-19 national Public Health Emergency deceleration that is expected to last for at least another 90 days. The extension of the Public Health Emergency allows a number of regulatory changes including the 6.2% increase to the federal share of Medicaid funding, the rollback of telehealth restrictions, and emergency approval of new tests and drugs to remain in place. This is a big win for cash-strapped State and Local governments that had been advocating the administration for an extension of the Public Health Emergency.

President Trump is expected to sign a number of executive orders later today that seek to lower drug prices. We are hearing that the proposals will include a “favored nations” rule that will link Medicare drug payments to the prices they are charged in other nations, include changes to the 340B drug program, and include a plan for Americans to buy lower-cost prescription medication imported from Canada.

A COVID-19 vaccine being developed by Oxford University and AstraZeneca has shown promising results according to new data published in the medical journal The Lancet. The data showed that the vaccine triggered an immune response against COVID-19 and participants only had minor side effects including muscle aches, chills and feeling feverish, but acetaminophen relieved those symptoms. The study had over 1,000 patients and triggered both an increase in antibodies and T-Cell response. One of the studies authors noted that the two-pronged immune response is ideal as it prevents healthy cells from being infected while killing cells that have already been infected. The researchers said that the results are promising but that more research is still needed to understand rarer reactions to the vaccine. 10,000 patients in the United Kingdom have already been administered as part of a follow-up study and a larger study in the United States is expected to take place with 30,000 patients. The Trump administration previously awarded the duo up to $1.2 billion from the Biomedical Advanced Research and Development Authority in the hopes of having a vaccine widely available by January.

In a victory for the Trump administration, the U.S. Court of Appeals for the District of Columbia Circuit ruled in a 2-1 decision that the departments of Health and Human Services, Treasury and Labor had the authority to let short-term insurance plans be sold for longer periods of time. The short-term insurance plans were initially limited to three months during the Obama administration, but the Trump administration introduced changes that would allow customers to purchase these plans for just under a year at a time and then renew them twice. Opponents of the Trump administration proposal argued that these short-term insurance plans could hurt patients that need health care, increase premiums on the Affordable Care Act marketplace, and that the plans were intended to be a stopgap but not someone’s main insurance.

The House is scheduled to vote on its first package of fiscal 2021 appropriations bills today that includes the Agriculture-FDA, Interior-Environment, Military Construction-Veterans Affairs, and State-Foreign Operations appropriations bills. This week, the House added a package of amendments to the bill including barring the U.S. from withdrawing from NATO or from the World Health Organization; emphasizing the need for a binational coronavirus testing strategy with Mexico; and barring the State Department from promoting the sale or export of e-cigarettes.

While Mother Nature had other ideas, we sure welcomed “opening day” for baseball as DC’s World Champion Washington Nationals begin their title defense.

July 17, 2020

The House Energy and Commerce Committee marked-up several health bills this week with the committee favorably reporting 17 bills to the full House of Representatives this week. Included in the 17 bills was H.R. 5201, the “Telemental Health Expansion Act of 2019,” that would permanently include a patient’s home as an eligible originating site for mental health services delivered via telehealth and remove Medicare’s geographic restrictions for such services; H.R. 3935, the “Protecting Patients Transportation to Care Act,” that would amend the Medicaid statute to include non-emergency medical transportation (NEMT) in the list of mandatory Medicaid benefits by codifying current Medicaid NEMT regulations and require state Medicaid programs to have in place a utilization management process for the benefit; H.R. 5534, the “Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act,” that permanently removes the 36-month limit for Medicare coverage of immunosuppressive drugs following a kidney transplant; H.R. 7539, the “Strengthening Behavioral Health Parity Act,” that would help improve and strengthen enforcement of existing mental health parity laws; and H.R. 7574, the “Strengthening America’s Strategic National Stockpile Act of 2020,” that seeks to make several improvements to the Strategic National Stockpile (SNS) and incorporates language from a number of bipartisan bills introduced in the 116th Congress.

The House Appropriations Committee approved a $196.5 billion Fiscal Year 2021 spending package for Labor, Health and Human Services, and Education on a party-line vote. The bill increases the Department of Health and Human Services (HHS) budget for Fiscal Year 2021 by a total of $96.4 billion and includes an additional $24.25 billion in emergency spending for state and local public health departments. Private equity-backed health care companies would also face new restrictions on receiving funds under the bill. The legislation would require the government to restrict Medicare advanced payments to private equity-owned organizations that furloughed or laid off workers. The legislation would also require federal government to report every 90 days on organizations that received early payments from Medicare this year and any group that seeks new advanced payments would have to disclose the amount of money going to providers owned by private equity firms and disclose if they are owned by a private equity firm. The bill is expected to move to the House floor as part of a “minibus” in the upcoming weeks where it is likely to pass.

The Robert Wood Johnson Foundation released a new study this week that estimates that more than 10 million people will lose employer-sponsored health insurance due to the coronavirus pandemic. The study used projection data on employment losses by industry, state, and demographic characteristics that are regularly published by the U.S. Department of Labor. The study projects that 2.8 million of these people will enroll in Medicaid, 600,000 people will enroll in the individual market, and 3.3 million of these people will regain employer-sponsored insurance by being added to a family member’s employer-sponsored insurance. The study projects that 3.5 million of these people will become uninsured and that a higher percentage of people will lose insurance in states that did not expand Medicaid.

HHS has told hospitals to stop reporting data on COVID-19 to the Centers for Disease Control and Prevention (CDC) National Healthcare Safety Network and instead report data only through two other systems, called HHS Protect or Teletracking. White House coronavirus coordinator Deborah Birx had expressed frustrations with the CDC reporting system and believes the HHS reporting system will track the virus’ spread faster and with more efficiency. In addition to the new reporting system, the CDC pulled its COVID-19 data dashboards off its website. These decisions have led to Democrats expressing fears that the Trump administration is politicizing the data and not being transparent to the American public. A spokesperson for HHS said that the agency will remain transparent and is working to make more of its data publicly available.

In some positive news, a preliminary report from the New England Journal of Medicine found that the ongoing phase 1 clinical trial of the Moderna’s COVID-19 vaccine showed positive vaccine results. That vaccine showed that it generated an immune response in healthy adults and was generally well tolerated. Patients did feel some side effects, including fatigue, chills, headache, muscle pain, and pain at the site of injection, but these were all considered mild or moderate. Researchers have said that all participants in the study developed neutralizing antibodies to the virus at levels similar to those seen in people who’ve naturally recovered from COVID-19. More research on the vaccine is still needed to be done and the vaccine is expected to begin a large phase three trial later this month. In a press releases, Moderna has said the company is on track to produce at least 500 million doses per year and possibly up to 1 billion doses beginning in 2021.

😊 to you on World Emoji Day!

July 10, 2020

Coronavirus cases in the United States have now passed 3 million and public health experts predict that America is on pace for 200,000 deaths by election day. Texas, California, and Florida have all recorded a record number of daily deaths this week and as of Thursday the Harvard Global Health Institute estimated 15 states were in an “accelerated spread” of the virus. The virus continues to impact minorities at a higher rate. New Federal data shows Black and Latino communities have been disproportionately affected by the coronavirus in rural, suburban, and urban areas.

The House Appropriations Committee approved its fiscal year 2021 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies bill by voice vote this week. The bill provides $23.98 billion in discretionary funding which is an increase of $487 million from the previous year. The bill invests over $3.2 billion in discretionary funding for the Food and Drug Administration, over $25 billion for child nutrition programs, and over $1 billion for food safety and inspection programs. The House Appropriations Labor-HHS-Education bill advanced through the Subcommittee this week. The bill passed by a vote of 9-6 and it would increase funding for HHS by $1.5 billion bringing funding for the department to $96.4 billion. The Biomedical Advanced Research and Development Authority would receive $4.5 billion in funding to make and develop vaccines and therapeutics during public health emergencies. The bill also provides $9 billion in emergency funding for the Centers for Disease Control and Prevention that would go towards improving state and local public health responses and modernize public health data collection. The full Appropriations Committee will mark-up the Labor-HHS-Education appropriations bill on Monday.

The Centers for Disease Control and Prevention and an advisory committee of outside health experts are working on a ranking system to decide who will get coronavirus vaccines first. A preliminary plan would prioritize distribution of approved vaccines to medical and national security officers. Essential workers and people considered to be high risk such as the elderly would receive the vaccine next. Agency officials have also considered providing Black and Latino people with the vaccine ahead of others as these communities have been disproportionately impacted by the virus. This option would likely face court challenges and medical experts have noted that there may not be scientific basis for this approach. To increase distribution of the eventual vaccine, the committee plans on making the most promising vaccines before they have cleared the final stages of the clinical trial.

The Trump administration formally notified the United Nations that the United States will withdraw from the World Health Organization (WHO) effective July 6, 2021. President Trump has said that the WHO has severely mismanaged the handling of the coronavirus crisis and that reforms are needed. The United States is by far the largest contributor to the WHO contributing 22% of the total members’ assessed contributions. President Trump’s decision faced criticism from the international health community and congressional Democrats who argued that withdrawing from the organization in the middle of a pandemic doesn’t make sense and that the organization needs additional support right now.

Novavax, Inc. received $1.6 billion from the Operation Warp Speed Program for development of its vaccine. This is the largest amount of funding that has been provided from the program and the company said in a statement that the funding will allow the company to conduct advanced human studies and establish manufacturing to deliver 100 million doses as soon as late 2020. Novavax is expected to begin its final-stage study of its vaccine candidate as soon as early fall with as many as 30,000 subjects. Moderna announced that they have partnered with Spain’s Laboratorios Farmacéuticos Rovi for fill-finish duties on “hundreds of millions” of the Massachusetts-based vaccine maker’s mRNA COVID-19 shot candidate. This is the second agreement Moderna has made after signing a fill-finish agreement with major contract development manufacturing organization Catalent last month.

Bipartisan legislation introduced by Sen. Dianne Feinstein (D-CA) and Sen. John Cornyn (R-TX) that seeks to prevent online sales of electronic cigarettes to minors passed through the Senate by unanimous consent last week. The bill requires e-cigarette online retailers to verify the age of all customers for all purchases, require an adult with an ID to be present for delivery, label shipping packages to show they contain tobacco products, and comply with all state and local tobacco tax requirements.

Last week, the House passed legislation that seeks to strengthen the Affordable Care Act. The bill would provide more federal funds for states that expand Medicaid, expand the Affordable Care Act tax credits, and cap the amount a person can pay for coverage premiums at 8.5% of income. The bill also allows immigrants that are living in the United States under the Deferred Action for Childhood Arrivals program to qualify for subsidized insurance plans.

Today is Chronic Disease Day and we’d like to raise additional awareness for the issues that impact the chronic disease community and acknowledge that 7 out of 10 people in the U.S. have a chronic disease.

June 26, 2020

With the July 4th holiday coming up next week, Healthcare Today is going to take a brief summer vacation so we can celebrate our nation’s founding.  Healthcare Today will return on July 10th.

The Centers for Medicare and Medicaid Services (CMS) issued a proposed rule that would make the current expansion of telehealth in home health permanent. The proposed rule would allow home health agencies to continue reporting the costs of telehealth technology as allowable beyond the COVID-19 public health emergency in the hopes of ensuring patient access to the latest technology and care. CMS also announced the creation of the Office of Burden Reduction and Health Informatics. The new office will build on agency’s Patients over Paperwork (PoP) Initiative and it will seek to reduce regulatory and administrative burden. The new office is tasked with engaging with healthcare stakeholders to gain a better understanding of the regulatory burdens that impact care delivery.

The House Energy and Commerce Committee held a hearing on “Oversight of the Trump administration’s response to the COVID-19 Pandemic” with the Director of the National Institute for Allergy and Infectious Diseases Dr. Anthony Fauci, Department of Health and Human Services (HHS) Assistant Secretary for Health Dr. Brett Giroir, Food and Drug Administration Commissioner Dr. Stephen Hahn, and Centers for Disease Control and Prevention Director (CDC) Dr. Robert Redfield. Fauci told the committee that we are still in the pandemic’s first wave and that he was concerned about the surge of new cases in southern and western states including Texas, Arizona, and Florida. Fauci also expressed optimism that a vaccine for Covid-19 could be done by the end of the year or early 2021. Grior noted that that the administration is continuing to work to increase testing and that HHS selected the Morehouse School of Medicine to develop and implement a $40 million initiative to mitigate the impact of Covid-19 within racial and ethnic minority communities. CDC Director Robert Redfield said that Americans needed to get a flu vaccine as the impact of the coronavirus and seasonal flu could place a tremendous burden on our hospital system.

We are hearing that the Trump administration is looking to reform the CDC and is launching an evaluation into its early response to the Covid-19 pandemic. On the hill, Sen. Bill Cassidy (R-LA) has called for the CDC to reform and has said he won’t give them more funds until they do. Changes are likely to come to the agency with Democrats on the hill calling for better oversight of the CDC, while Republicans have said they hope to fund improvements to the disease and technology reporting tools to create a biosurvelliance system that would be capable of detecting emerging infectious diseases.

The Trump administration urged the Supreme Court to strike down all of the Affordable Care Act. In a legal brief filed Thursday night, the Justice Department argued that the entirety of the Affordable Care Act was unconstitutional when the individual mandate penalty for uninsured people was removed by Congress as “the individual mandate is not severable from the rest of the Act.” If the Supreme Court were to rule in favor of the Trump administration an estimated 20 million Americans would lose insurance coverage and protections for pre-existing conditions. Beginning in October, the Supreme Court will review the Texas vs. United States Affordable Care Act court decision that ruled the entire law was invalid due to the individual mandate’s lack of constitutionality.

This week, Judge Carl Nichols of the U.S. District Court for the District of Columbia ruled that the Trump Administration can proceed with its proposed hospital price transparency requirements. The 2019 final rule that is scheduled to go into effect January 2021 would require hospitals to make its standard charges public for all items and services, meaning a hospital’s gross charges and payer-specific negotiated charges would be revealed to the public. The American Hospital Association (AHA) argued the administration did not have legal authority to require the publication of negotiated prices. In his decision Judge Nichols sided with the Trump administration finding that hospitals were attempting to limit transparency and patients’ insight into medical prices. The AHA has said that they will appeal this decision.

With people largely working from home, it was a bit easier this year to enjoy National Take Your Dog to Work Day!

June 19, 2020

The Department of Health and Human Services (HHS) issued a final rule that revises a rule that implemented nondiscrimination protections for patients under the Affordable Care Act. The new rule focuses on Section 1557 and would remove nondiscrimination protections for LGBTQ people for healthcare and health insurance. Supporters of the rule believe the rule is a necessary reversal of executive overreach in the Obama administration, will help insurers and hospitals save money and will minimize confusion over the legal meaning of “sex discrimination”. Critics of the rule believe this could harm vulnerable groups such as transgender patients especially during a pandemic. The final rule is expected to go into effect by mid-August. HHS also awarded $107.2 million through the CARES ACT Provider Relief Fund that will be dispersed to 310 recipients that seeks to increase the health workforce in rural and underserved communities.

The Senate Health Education Labor and Pensions (HELP) Committee held a hearing this week on telehealth. HELP Committee Chairman Lamar Alexander (R-TN) called on Medicare to permanently lift restrictions that limit coverage of telehealth in rural areas. Of the 31 temporary federal policy changes that were made, members on the committee voiced the greatest support for expanding the reimbursement to a larger number of providers and permanently changing the originating site rule. Witnesses warned members of the Committee that without making permanent changes to expand telehealth, patients would lose access to care. The HELP Committee is still deciding which of the temporary policy changes to make permanent, but we could find some of the temporary changes included in the next coronavirus relief package. In other telehealth news, Sen. Brian Schatz (D-HI) led a bipartisan letter to Senate leadership asking them to make the provisions from the bipartisan CONNECT for Health Act that were included in previous COVID-19 legislation permanent to provide expanded telehealth access for Medicare beneficiaries.

This week, the Centers for Medicare and Medicaid Services released a proposed rule that would support Value-Based Purchasing (VBP) for Drugs Covered in Medicaid and establish minimum standards in Medicaid State Drug Utilization Review (DUR). The rule seeks to increase state flexibility in entering innovative value-based purchase agreements with drug manufacturers while providing manufacturers with regulatory flexibility. The proposed rule would also create new opioid-related standards for state Medicaid DUR programs that are required for states under the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act.

COVID-19 has disproportionately impacted minorities, with African Americans and Latinos being impacted heavily. Current federal data has shown African Americans dying at double the death rate of whites while making up 33 percent of the nationwide cases, despite only being 13 percent of the population. Black Americans have also been consistently underrepresented in clinical trials for diseases ranging from cancers to diabetes and heart disease. New data has also seen a surge in coronavirus cases in the Latino community with research showing Latinos are dying at much higher rates than white patients in the same age group with more Latinos over the past two months than any other racial or ethnic minority group. Congress is working on these issues, with Senate Finance Committee Chairman Chuck Grassley (R-IA) asking Committee members for input on policies to reduce these ongoing health disparities. House Energy and Commerce Chairman Frank Pallone (D-NJ) said at a hearing this week on racial disparities that CMS needed to release specific data categorized by race, ethnicity, and gender as the agency has promised to. Ranking Member of the Energy and Commerce Health Subcommittee Michael Burgess (R-TX) agreed that lawmakers needed to address the racial inequities and work on legislation that can become law.

We’d like to wish everyone a happy Juneteenth and hope you are celebrating the oldest nationally celebrated commemoration of the ending of slavery in the United States, while continuing to pursue equal justice for all.

June 12, 2020

The Department of Health and Human Services (HHS) announced this week the distribution of additional relief funds from the Provider Relief Fund to eligible Medicaid and Children’s Health Insurance Program (CHIP) providers. HHS announced its plans to distribute approximately $15 billion to eligible providers that participate in state Medicaid and CHIP programs and have not received a payment from the Provider Relief Fund General Allocation. Some assisted living facilities will be eligible for funding for the first time after failing to receive aid previously. Providers will report their annual revenue to a payment portal and will be provided at least 2 percent of gross revenue from patient care. HHS also announced they will be distributing $10 billion in provider relief funds to safety net hospitals and that hospitals will have to apply by June 15.

Senate Finance Committee Chairman Chuck Grassley (R-IA) and Ranking Member Ron Wyden (D-OR) asked HHS to create a comprehensive database of funds distributed from the Coronavirus Aid, Relief, and Economic Security (CARES) Act and the Paycheck Protection Program Health Care Enhancement Act to health care providers in a letter to Secretary Azar. The bipartisan letter calls on HHS to increase transparency by releasing data on the allocation of over $200 billion in federal funds and “establish a single, comprehensive and publicly available data source that easily shows the amount of funding received by each provider.” The letter also seeks details on the terms and conditions requirement for providers that receive more than $150,000 in funding from HHS administered COVID-19 funding sources.

On Thursday, the Centers for Medicare and Medicaid Services (CMS) warned nursing homes that seizing economic relief payments could lead to being blocked from participation in the Medicare and Medicaid programs and be subject to federal enforcement. CMS issued these guidelines after committee leaders in the House and Senate engaged both CMS and the HHS Inspector General. House Energy and Commerce Committee Chairman Frank Pallone (D-NJ) and House Ways and Means Committee Chairman Richard Neal (D-MA) wrote to CMS Administrator Seema Verma raising concerns about this practice, while Senate Finance Committee Chairman Chuck Grassley (R-IA) and Ranking Member Ron Wyden (D-OR) wrote to acting HHS Inspector General Christi Grimm urging her office to alert the public and facility operators.

Moderna announced this week that its COVID-19 vaccine final-stage clinical trial should start in July. The trial will include 30,000 people and is being done in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID). In its statement, Moderna said it hopes that the clinical trial will show the vaccine prevents people from developing symptoms of COVID-19 and keeps people from getting severe cases of the virus that would require hospitalization. Moderna also announced that if the vaccine is successful, they could possibly manufacture 1 billion doses of the vaccine per year starting in 2021 that would allow 500 million people to be vaccinated. Separately, Johnson & Johnson also announced the acceleration of the Phase 1/2a human clinical trial of its investigational SARS-CoV-2 vaccine, expected to now be moved up to the second half of July from its initial expected start in September.

Speaking at a webcast to the Biotechnology Innovation Organization, NIAID Director Anthony Fauci warned that the coronavirus is far from over. Fauci noted that the only way to defeat the virus is through a vaccine with billions and billions of doses for the whole world. In some good news for pharmaceutical companies, Fauci said that he does not support drug price controls and that the government should instead encourage companies to fairly price products developed with taxpayer backing that impact public health.

Please enjoy your dessert tonight on National Peanut Butter Cookie Day and on Sunday enjoy some Heaven Hill Brands bourbon for National Bourbon Day!

June 5, 2020

Centers for Disease Control and Prevention Director Robert Redfield testified this week before the House Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies. Redfield told the committee that the United States remains unprepared for future major pandemic health threats noting shortcomings in local, state, and federal authorities’ ability to track and spot diseases and develop countermeasures. Redfield also apologized to the committee for his agency’s inadequate reporting on racial disparities in coronavirus patients. The CARES Act that was passed in March required the CDC to report on racial disparities among coronavirus deaths, cases, and hospitalizations. On Thursday, the Department of Health and Human Services (HHS) announced testing labs will now be required to collect demographic data including race, ethnicity, sex, and age in addition to collecting zip code data.

A bipartisan letter from Senate Financial Services Chairman Chuck Grassley (R-IA), Senate Financial Services Ranking Member Ron Wyden (D-OR), Energy and Commerce Chairman Frank Pallone (D-NJ) and Energy and Commerce Ranking Member Greg Walden (R-OR) was sent to HHS Secretary Alex Azar telling him that the HHS isn’t giving enough money from the Public Health and Social Services Emergency Fund (PHSSEF) to doctors and hospitals that rely heavily on Medicaid funds. The lawmakers told Azar that they have “serious concerns with the ongoing delay of funding” to Medicaid-dependent providers and that the delay could hurt these doctors and hospitals. Rural doctors and hospitals have voiced frustrations for months that when doling out the emergency funds HHS has favored wealthy hospitals and doctors.

Brian Miller, a White House lawyer, was confirmed by the Senate this week to serve as the Treasury Department special inspector general for pandemic recovery. Miller will oversee the trillions of dollars in federal loans and grants that have been provided by Congress during the coronavirus pandemic. In a confirmation hearing, Miller promised to not seek President Trump’s approval before reporting to lawmakers and that he has served both Republican and Democratic administrations. Miller has worked for close to a decade as the inspector general of the General Services Administration, but most recently worked in Trump’s White House Counsel’s office.

The Centers for Medicare and Medicaid Services (CMS) announced this week that the number of nursing home deaths that are attributed to COVID-19 has reached nearly 32,000 residents and more than 600 employees, with both numbers likely to rise as around 12% of nursing homes have yet to report data. Over 250 nursing homes said they lack any surgical masks and 800 more said they were going to run out within a week. Nursing homes are also dealing with staff shortages with nearly 2,000 facilities reporting staff shortages and an additional 2,200 stating they lacked enough aides. CMS did issue enhanced enforcement of nursing homes earlier in the week to ensure nursing home safety. The enforcement increases civil monetary penalties for facilities with persistent infection control violations and imposes enforcement actions on lower level infection control deficiencies.

We are hearing that Johnson & Johnson; Merck & Co.; Pfizer Inc.; Moderna Inc.; and the University of Oxford in collaboration with AstraZeneca Plc; as well as two other firms are working with the White House as part of its “Warp Speed” coronavirus vaccine program. Operation Warp Speed’s goal is to have 300 million doses of a shot available by the end of the year. National Institute of Health Director Dr. Francis Collins said this week that some vaccine candidates could be ready for large scale testing that would involve 30,000 volunteers as soon as July.

We urge you to go to your local Dunkin’ franchise for a sweet treat on this National Donut Day!

May 29, 2020

In grim news, the death toll from the coronavirus in the United States has now passed 100,000 deaths. In just over four months from the first known case, coronavirus deaths in the United States are now greater than every single U.S. military conflict dating back to the Korean War. New York and New Jersey have been the hardest hit states with over 40,000 deaths and African-Americans have been disproportionately impacted by the virus. As states begin phased reopening plans, health experts believe that increased testing and contact tracing are needed to ensure we do not see a spike in coronavirus cases and deaths.

The coronavirus health side effects are growing. According to new polling by the Kaiser Family Foundation 48 percent of adults say they or someone in their household have skipped or delayed medical care due to the coronavirus outbreak. A survey done by the American Cancer Society found that 79 percent of cancer patients in active treatment reported care delays including seventeen percent of patients undergoing chemotherapy, hormone therapy, or radiation. New York and New Jersey vaccination rates have also plunged during the pandemic. New Jersey has experienced a 40 percent decline in vaccines ordered and administered with the same period last year for children under the age of 2 and a 60 percent decline among those ages 2 and above. In New York City, the number of vaccines administered to kids in the city dropped 63 percent in the six-week period from March 23 to May 9, compared to the same period last year. For children older than two, the decline was 91 percent and for children age two and under, vaccines dropped by 42 percent.

The White House is making another attempt at achieving a surprise medical bill fix and hope to include it in the next coronavirus relief package. We are hearing that the White House plan would outlaw health care providers from charging patients for thousands of dollars in surprise medical bills but would not mandate how hospitals and doctors recover costs from insurers. Under this plan, billing disputes would have to be worked out on a case-by-case basis that would likely raise premiums and provider rates. Doctors fear that this proposal could give health insurers too much leverage, while insurers and employers worry about a possible wave of lawsuits to resolve billing disputes. An aide to Senate Health, Education, Labor, and Pensions (HELP) Committee Ranking Member Patty Murray (D-WA) has already raised Murray’s concerns with the proposal and the White House proposal may fail to garner traction on Capitol Hill.

The Centers for Medicare and Medicaid Services (CMS) announced this week an agreement with insurers to cap Medicare insulin prices. Over 1,750 standalone Medicare Part D prescription drug plans and Medicare Advantage plans with prescription drug coverage have applied to offer lower insulin costs through the Part D Senior Savings Model for the 2021 plan year. Close to half of all eligible Medicare Part D and Medicare Advantage plans will offer this and seniors that apply for the program won’t have to pay more than $35 a month for insulin. CMS projects the model will save the federal government $250 million over five years and save beneficiaries an average of $446 per year.

Merck announced plans for two vaccines to prevent the coronavirus and a pill to treat the virus. Merck purchased an antiviral discovered at Emory University and advanced two candidate vaccines that are based on the Ebola and measles immunizations technology. Merck received $38 million from the Biomedical Advanced Research and Development Authority (BARDA) and will work with BARDA and nonprofit IAVI to develop a vaccine using technology behind Merck’s Ebola vaccine. A Merck executive noted that while the vaccine candidates look promising that it likely will take longer to develop and deploy the vaccine.

The House Ways and Means Committee held a hearing this week on ways to mitigate the disproportionate impact of COVID-19 on communities of color. Ways and Means Committee Chairman Richard Neal (D-MA) focused on the longstanding issues of inequality that have contributed to the disproportionate impact on people of color. Ways and Means Health Subcommittee Chairman Lloyd Doggett (D-TX) criticized the Trump administration for not appointing an official that spoke Spanish to help on COVID-19 efforts and asked Texas state leaders to expand Medicaid. Fellow Texan and Ways and Means Ranking Member Kevin Brady (R-TX) argued that Medicaid expansion is not needed as it shifts money away from those who need it most to the healthy. Other members cited current limitations with telehealth, with Rep. Adrian Smith (R-NE) calling for Medicare to reimburse for telehealth services to allow the transfer of nursing home patients to emergency rooms and the update of reimbursement policies to allow for these services to be paid for.

The Centers for Disease Control and Prevention (CDC) issued new recommendations for employers bringing workers back to office buildings. The recommendations include conducting daily in-person or virtual health checks; spacing workers apart; staggering shifts; reducing shared objects like communal coffee pots; improve ventilation and air filtration; and encourage employees that have symptoms or a sick family member to stay at home. As employees go back to work, many can expect to wear masks, have daily health checks, and open office plans having staggered shifts to minimize exposure.

With DC and Virginia starting with Phase 1 reopening, we hope you can enjoy a nice cocktail at the outdoor seating area of your local restaurant on National Mint Julep Day tomorrow.

May 22, 2020

The Centers for Medicare and Medicaid Services (CMS) announced changes to Medicare Advantage (MA) and Part D plans. The final rule issued by CMS today seeks to expand MA for End Stage Renal Disease (ESRD) Patients, increases telehealth access for seniors with MA plans, expand the supplemental benefits available for beneficiaries with an MA plan with chronic diseases and provide additional support for MA beneficiaries in rural communities. This rule provides beneficiaries with ESRD more coverage options in the Medicare program including extra benefits such as transportation, home-delivered meals, or a health and wellness program. CMS will also now allow MA plans to allow telehealth providers in certain specialty areas to count towards meeting CMS network adequacy standards.

Apple and Google have released their exposure notification technology that will help detect when a user has spent any time near another user that has tested positive for the coronavirus. The partnership between Apple and Google will create a new system that will use a smartphone’s Bluetooth system to share data and establish a contact tracing network with people you have been in contact with. Alabama, North Dakota, and South Carolina are the first U.S. states along with 22 countries to commit to use the technology. Public health experts have noted that the app will be helpful in isolating and identifying people with coronavirus and who they have been in contact with but that human contact tracers will still be needed.

Moderna announced positive results from its phase one trial for its coronavirus vaccine. The phase one clinical trial, led by the National Institute of Allergy and Infectious Diseases (NIAID), involved 45 people and resulted in eight participants developing neutralizing antibodies for COVID-19. On a phone call with investors, Moderna CEO Stéphane Bancel said that the results indicate the vaccine has a high probability to provide protection from COVID-19 disease in humans. It is important to note that phase one trials are intended to evaluate the safety, not the effectiveness, of new vaccines, so Moderna will now conduct a phase two study to test the drug’s effectiveness. Health experts have warned that while initially results are encouraging, it is still too early to draw any conclusions.  If all the trials go well, however, the Food and Drug Administration could grant emergency-use authorization for the vaccine by the fall.

CMS has issued new guidance for nursing homes to ensure the safe reopening of homes across the nation. The guidance calls for coronavirus tests of all residents and nursing home staff and for coronavirus infections at the state or local level to be declining before facilities are reopened or visitation rules are relaxed. CMS wants states to inspect nursing homes that have had previous COVID-19 cases before allowing visitors and all nursing home staff to be screened daily for symptoms and tested weekly. Other factors that nursing homes will need to consider before relaxing restrictions include local hospital capacity, access to personal protective equipment, and adequate staffing levels. Nursing home facilities have struggled with COVID-19 and according to data from the Kaiser Family Foundation coronavirus nursing home deaths account for at least one-third of U.S. COVID-19 deaths.

The U.S. Biomedical Advanced Research and Development Authority (BARDA) has provided over $1 billion in funding to British drug maker AstraZeneca to manufacture a coronavirus vaccine. AstraZeneca announced this week that they have the capacity to produce one billion doses of the vaccine that is currently being developed at the University of Oxford. AstraZeneca’s CEO, Pascal Soriot, said that if the vaccine is successful, they will have substantial doses by September or October and many people vaccinated by the end of the year. BARDA also announced a four-year $354 million contract with Phlow to manufacture the supplies for medicines for patients hospitalized with COVID-19. Phlow will be expected to produce the active pharmaceutical ingredients and chemical compounds to prevent and alleviate domestic drug shortages.

The Association of American Medical Colleges (AAMC) submitted a letter to CMS Administrator Seema Verma urging the administration and Congress to extend and make permanent some of the telehealth waivers and flexibilities that have been implemented in the COVID-19 public health emergency. AAMC noted it is imperative to maintain the progress and make certain that reimbursement remains at a level that will support the infrastructure needed to provide telehealth services. This is likely going to be the first of many calls from industry groups to make these changes permanent.

The Government Accountability Office announced the appointment of three new members to the Medicare Payment Advisory Commission (MedPAC), as well as the reappointment of two current members. Michael Chernew, PhD,Leonard D. Schaeffer Professor of Health Care Policy, Department of Health Care Policy at Harvard Medical School in Boston, MA is the newly appointed chair. GAO also appointed Betty Rambur, PhD, RN, FAAN, Routhier Endowed Chair for Practice and Professor of Nursing, College of Nursing at the University of Rhode Island in Kingston, RI; and Wayne J. Riley, MD, President and Professor of Internal Medicine and Health Policy and Management at the State University of New York Downstate Health Sciences University in Brooklyn, NY. David Grabowski, PhD, Professor, Department of Health Care Policy at Harvard Medical School in Boston, MA; and Dana Gelb Safran, ScD, Head of Measurement at Haven and Assistant Professor, Department of Medicine at Tufts University in Boston, MA terms were both reappointed to the commission.

On this Memorial Day weekend, we thank all of those men and women in uniform who made the ultimate sacrifice for our country to give us all the freedoms we enjoy.

May 15, 2020

The House is expected to pass a $3 trillion coronavirus relief bill this evening. H.R. 6800, the Heroes Act, would provide aid to local and state governments, direct cash payments to individuals, expand unemployment insurance, and institute a nationwide testing and contact tracing system. The bill includes a 14 percentage point increase of the Federal Medical Assistance Percentage payments to state Medicaid programs that would begin July 1 through June 30, 2021; $75 billion in funding to workforce agencies and public health departments to expand COVID 19 testing and create a contact tracing and surveillance system that could be used nationwide; $100 billion to the federal fund for healthcare providers; a provision lowering interest rates to 1% for providers who take Medicare advance payments; an elimination of cost sharing for COVID 19 treatments for patients in private, Medicaid, Medicare, TRICARE, and Veterans Affairs facilities; full subsidies for COBRA premiums for furloughed workers; special enrollment periods for the Affordable Care Act (ACA) exchanges and Medicare; a requirement for drug manufacturers to report foreign drug manufacturing sites; provides a temporary increase of 2.5 percentage points for Medicaid disproportionate share hospital allotments; and a requirement of regular reporting to Congress on states requests to the Strategic National Stockpile. The Administration and Senate Republicans have already voiced their opposition to the legislation, and the bill is likely only to be used as a marker in future bipartisan negotiations.

This week the Centers for Disease Control and Prevention (CDC) published reopening guidance for schools, workplaces, camps, child care programs, mass transit systems, and bars and restaurants. The CDC provides decision-making tools for these groups in separate one-page documents. The decision tool documents use graphics and traffic signs to tell organizations what they need to consider before reopening. The guidance is not as detailed as a leaked 63-page draft report that was reported to have been “shelved” by the White House, but the CDC has said it hopes its released tools give local and state officials more control over their reopening process.

This week, NIAID Director Anthony Fauci, FDA Commissioner Stephen Hahn, HHS Assistant Secretary for Health Brett Giror and CDC Director Robert Redfield testified in front of the Senate Committee on Health, Education, Labor, and Pensions on the federal plan for workers and students to return after the crisis. Fauci emphasized the need for increased testing and contact-tracing and that he believes a return to normalcy would require 40-50 million tests each month by the end of 2020. Fauci also indicated that it was unlikely a vaccine would be ready by the beginning of the school year.

Dr. Rick Bright, a top public health official who claims he was removed from his post after pushing back on the drug hydroxychloroquine as a treatment for COVID-19, testified in front of the House Energy and Commerce Committee’s Subcommittee on Health this week. Dr. Bright warned Congress that without clear planning and implementation, 2020 could be the “darkest winter in modern history.” Bright also noted that he believes that it will take longer than the estimated 12-18 months to develop a coronavirus vaccine.

Early data from a small-scale study suggests that the popular Abbott ID NOW point-of-care test that is used to diagnose COVID-19 has produced potential inaccurate results and that the test may return false negative results. The Food and Drug Administration (FDA) has warned the public of the potential for inaccurate results after the study released this week found the test could be missing as many as forty-eight percent of infections. Abbot has continued to defend the accuracy of tests and has pointed to studies that show it is as accurate as any other test currently being used. It is notable that the White House has been using this test to screen its staff.

Moncef Slaoui, a former chairman of vaccines at GlaxoSmithKline, will serve as the chief adviser on the “Operation Warp Speed” project to produce a coronavirus vaccine to Americans by the end of 2020. Slaoui will lead the project that will pull together private pharmaceutical companies along with the military and government agencies with the goal of decreasing the development time for a vaccine by as much as eight months.

As unemployment numbers climb and millions of Americans are expected to use the ACA exchanges, insurers are deciding if they should reenter the ACA marketplace. United Healthcare, the nation’s largest insurer, announced this week that they will be re-entering Maryland’s marketplace and that they are planning other expansions. This follows the company’s 2016 decision to leave 34 states’ ACA exchanges. We can expect to see more insurance companies consider rejoining ACA marketplaces as the pandemic decreases industry revenue coming from the employer-based market.

A study released by the Tufts Center for the Study of Drug Development found that women, blacks, and Hispanics participate in clinical trials at rates below their share of the U.S. population. The study highlights an existing problem of underrepresenting minorities in clinical trials, but is even more important during the COVID-19 pandemic as it appears to harm blacks disproportionately. NIAID Director Anthony Fauci has promised that NIAID trials will be very representative of minority populations.

We hope you enjoy your favorite pizza pie and chocolate chip cookies for dessert tonight on this National Pizza Party Day and National Chocolate Chip Day!

May 8, 2020

House Speaker Nancy Pelosi (D-CA) has indicated that the House could vote as early as next week on a new coronavirus relief package. It is expected that the proposal will include relief for state and local governments, funding for increased testing and contact tracing, and proposals that would seek to “put money in the pockets of the American people.” House Minority Leader Kevin McCarthy (R-CA) has indicated that a slower process with congressional hearings is needed. Additionally, Senate Majority Leader McConnell has expressed reservations overfunding for state and local governments and has made clear he will not agree to any bill that does not include a liability shield for businesses. It is expected that the earliest the House would vote on its version of the bill would be late next week as House leadership has promised members a 72-hour notice before votes.

A bipartisan group of House Appropriation Committee members have indicated they support exempting critical health-care funds from budget caps that have been set under the Budget Control Act. This would allow Congress to appropriate large increases in biomedical spending next year without cutting funding for other health care programs. Ranking Member of the House Appropriations Labor-HHS-Education Subcommittee Tom Cole (R-OK) said at a hearing this week that he supports the measure and has talked to Appropriations Chairwoman Nita Lowey (D-NY) and House Appropriations Labor-HHS-Education Subcommittee Chairwoman Rosa DeLauro (D-CT) about the issue. Former Centers for Disease Control and Prevention Director Tom Frieden and former Senate Majority Leaders Bill Frist (R-TN) and Tom Daschle (D-SD) proposed the ideas to Congressional leaders in a letter.

The Senate Health Education Labor and Pensions (HELP) Committee held a hearing this week on new testing technology and deployment for the coronavirus by the National Institutes of Health (NIH) and the Biomedical Advance Research and Development Authority (BARDA). NIH Director Francis Collins discussed the public-private partnership called Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) that has multiple working groups targeting many aspects of the COVID-19 response. The NIH and ACTIV have also launched a COVID-19 initiative, Rapid Acceleration of Diagnostics (RADx), to expand the range of technologies and increase access to testing through a $1.5 billion program that aims to fast-track new technologies to rapid deployment by the end of summer or fall 2020. Both HELP Committee Chairman Lamar Alexander (R-TN) and Ranking Member Patty Murray (D-WA) said in the hearing that an increase in coronavirus testing was needed to safely reopen the country with Alexander calling for millions of additional coronavirus tests.

The Food and Drug Administration (FDA) is facing scrutiny over its emergency use authorization (EUA) process. In a letter to FDA Commissioner Stephen Hahn, Senate HELP Ranking Member Patty Murray (D-WA) and Sen. Elizabeth Warren (D-MA) asked the FDA to explain how it is tracking the safety and effectiveness of products that have received an EUA during the coronavirus pandemic. There are concerns that the EUA process has been politicized after Hydroxychloroquine, a drug that was touted by President Trump, received an EUA despite little evidence that the drug would be effective in treating the coronavirus. The Senators said that over the past three months the FDA has issued over 110 EUAs for coronavirus related products and that is an unprecedented expansion after 77 EUAs were issued between 2005 and 2018.

The Department of Health and Human Services (HHS) announced Thursday that Community Health Centers were awarded $583 million. The funding will be divided among 1,385Health Resources and Services Administration (HRSA) health centers in all 50 states. The funding will be used to help the centers buy personal protective equipment, buy and administer tests, train staff, expand walk-up or drive-up testing, and notification of identified contacts of their exposure to COVID-19. This and previous investments brings the total investments in health centers to nearly $2 billion.

LeadingAge, a senior living industry group has called on Congress and the administration to place aging-service providers on par with hospitals in terms of personal protective equipment (PPE) and include $100 billion in funding in the next coronavirus relief package for senior living providers. LeadingAge argued that PPE and rapid testing kits were necessary to ensure the safety of caretakers and residents. The funding would be used to cover costs associated with COVID-19, increase hazard pay to frontline workers, increase access to telehealth; and support low-income housing assistance. The group has said that senior living communities have been left out of coronavirus relief packages that targeted nursing homes and hospitals.

We want to wish a happy Mother’s Day to all our Moms and expectant Moms. We hope you enjoy your day with your family!

May 1, 2020

In an interim final rule released yesterday, the Centers for Medicare and Medicaid Services (CMS) announced a new set of waivers of Medicare requirements to increase coronavirus testing and new flexibilities for Medicare and Medicaid providers. CMS announced they will allow more coronavirus testing at pharmacy parking lots by allowing pharmacists to test individuals while partnering with practitioners to bill the program. Medicare and Medicaid will also cover certain antibody tests. Other changes to make it easier for providers to respond to the coronavirus include letting hospitals charge typical outpatient rates for Medicare services that are delivered at temporary expansion sites; allowing rural health clinics to expand bed counts without triggering limits on per-visit payment rates; allowing teaching hospitals to claim credit for residents that are deployed to other hospitals in response to an emergency; delaying reporting and compliance for a number of CMS programs; further expansion of telehealth in Medicare; and the cancellation of next year’s application process and limitation of pandemic-related costs for accountable care organizations that are participating in the Medicare Shared Savings Program.

Dr. Anthony Fauci expressed optimism about Gilead’s experimental drug remdesivir, after results from a clinical trial conducted by the National Institute of Health found “remdesivir has a clear-cut, significant positive effect in diminishing the time to recover.” Preliminary results from the 1,063-patient study found that those who received remdesivir had a 31 percent faster recovery time than those who received a placebo. Additionally, the group receiving remdesivir had a mortality rate of eight percent, which is a statistically significant, lower rate than the control group, which had a 11.6 percent mortality rate. Former FDA Commissioner Scott Gottlieb tweeted that he believes Gilead’s data is strong enough to meet or exceed the standards required for an Emergency Use Authorization. Gilead’s CEO Daniel Day has said the company already is up to 100,000 treatment courses of remdesivir and hopes to have multiple millions of treatment courses by the end of the year. Day has promised to make remdesivir accessible and affordable and they are exploring ways of administering it through an injection or an oral inhaler. While not yet a cure or a vaccine, this is certainly a step towards helping treat COVID-19.

The Trump administration has announced it is organizing a Manhattan Project style project to accelerate the development and deployment of a coronavirus vaccine. The project that will be called “Operation Warp Speed” and it will seek to bring together private pharmaceutical companies along with the military and government agencies to decrease the development time for a vaccine by as much as eight months. Taxpayers will be shouldering the majority of financial risk should vaccine candidates fail, and the project will likely cost billions of dollars. President Trump has publicly said he’s in charge of the project and that the goal is to have 300 million doses of a vaccine available by January. Many public health officials believe this is an optimistic timeline and that it will take at least 12-18 months in a best-case scenario.

Last month, Apple and Google have announced a partnership in creating a new system that they hope will track the spread of the coronavirus. The system will use a smartphone’s Bluetooth system to share data and establish a contact tracing network with people you have been in contact with. The system would hope to maintain privacy and security by creating encrypted and privacy-safe keys with each process in the app being voluntary. Apple and Google delivered an initial version of the Application Program Interface to a small number of developers to test this week and over the next few weeks are expected to release it more broadly in mid-May. A planned Senate Republican bill is expected to be released next week would require tech companies to obtain consent to collect people’s location or health.

Doctors’ offices, medical equipment suppliers, and clinicians will now be receiving relief through grant programs instead of a loan program that required repayment within a year. The Centers for Medicare and Medicaid Services announced on Sunday that they won’t be accepting additional applications for its Advance Payment Program. Providers that have used the Advanced Payment Program to help with cash flow issues will now be expected to use grant funding that has been made available. CMS has made additional direct grant payments available through the agency’s Provider Relief Funding and Congress has appropriated an additional $175 billion to health care providers in the last two coronavirus relief packages.

The Centers for Disease Control and Prevention (CDC) released new guidance on coronavirus testing. The guidance recommends that states further develop and implement their own testing plans as they begin to reopen. The guidance is designed to facilitate the state development and implementation of robust testing plans.

The Department of Health and Human Services and the CDC will be piloting antibody studies in Detroit and New York City. Michigan is working with the CDC to bring additional testing to Southeast Michigan and New York City Mayor Bill De Blasio said that 150,000 antibody tests would be made available. The antibody tests are used to detect if people have been exposed to the virus, and these studies will increase understanding of how the coronavirus is impacting frontline workers. Participants of the study will be required to fill out a questionnaire to inform serological analysis in the United States.

We tip our hat to former Health PAD at OMB and current Director of the Domestic Policy Council Joe Grogan as he plans his departure from the White House later this month.  Good luck in your future endeavors Joe!

April 24, 2020

President Trump signed additional funding for the Paycheck Protection Program into law. The Paycheck Protection Program and Healthcare Enhancement Act provides an additional $75 billion for the Public Health and Social Services Emergency Fund but plans for spending this additional funding have not yet been announced. The bill also includes an additional $25 billion in funding for coronavirus testing with $11 billion of that going towards states. The Department of Health and Human Services (HHS) also announced their plans for distributing additional funding from the Public Health and Social Services Emergency Fund that was created in the CARES Act. Providers will receive $20 billion from the fund based on cost reports, $10 billion in funding will go to rural hospitals and health clinics, and the Indian Health Service will receive $400 million that will be distributed based on operating expenses, and additional provisions will go to providers that only treat Medicaid patients.
The Health Resources and Services Administration (HRSA) announced this week that they were awarding close to $165 million in funding to combat the COVID-19 pandemic in rural communities. This investment will provide funding to 1,779 small rural hospitals and for 14 HRSA-funded Telehealth Resource Centers that provide telehealth assistance to rural areas. The funding seeks to assist hospitals in increasing the amount of personal protective equipment, expanding telehealth capabilities, and increasing coronavirus testing capacity.
President Trump announced that he will invoke the Defense Production Act (DPA) to manufacture more swabs for testing. Puritan Medical Products, a manufacturing company based in Maine, will be producing a minimum of 20 million, and potentially as many as 50 million, swabs per month. Medical labs and state officials throughout the country have struggled to get the swabs that are used for testing and have said the shortages are prolonging the pandemic. The decision to invoke the DPA comes as the administration looks to ramp up coronavirus testing and reopen the economy.
As thousands of Americans have died from the coronavirus in nursing homes, the Centers for Medicare and Medicaid Services (CMS) announced this week that nursing homes will now be required to report coronavirus cases directly to the CDC as well as to patients and their families. Nursing homes are now required to report communicable diseases, healthcare-associated infections, and potential outbreaks to State and Local health departments. CMS will also require these facilities to report the data to the Centers for Disease Control and Prevention in a standardized format that will be released.
Leaked draft documents, since removed from the World Health Organization’s website, suggest Gilead’s drug remdesivir showed no benefits when treating coronavirus patients in a randomized clinical trial. While COVID-19 patients who received remdesivir died at higher rates than the control group, researchers concluded the differences were not statistically significant. The company is responding that the data is preliminary and incomplete since the study ended early due to low enrollment. This comes after a University of Chicago trial last week found initial success in its trial.
The FDA announced that they were warning against the use of hydroxychloroquine outside of a hospital or clinical trial setting, due to life threatening side effects including increased risks of heart rhythm problems. Earlier in the week a panel of medical experts convened by the U.S. National Institutes of Health (NIH) recommend against the use of hydroxychloroquine and azithromycin for the treatment of COVID-19. Their findings show the combination of hydroxychloroquine and azithromycin can be associated with QT prolongation, which increases the risk of sudden cardiac death. The panel also said that they could not make a recommendation for or against taking hydroxychloroquine by itself, however.
This week marked the 50th anniversary of Earth Day, so we encourage you to plant a tree in your yard this weekend on this National Arbor Day.

April 17, 2020

President Trump and the coronavirus task force issued guidelines that could allow some states and employers to ease social distancing practices designed to curb the coronavirus outbreak, and begin to re-open the economy. The guidelines recommend states have a two-week downward trend in coronavirus symptoms and cases before they start to ease social distancing practices. The guidelines laid out a three-stage easing of social distance restrictions that would start with a phase one that would allow restaurants and gyms to open with social distancing measures. Phase two would allow schools, youth activities, and nonessential travel to resume while avoiding gatherings of more than 50 people. Phase three would allow employers to start going back to work and people would be allowed to visit senior care facilities and hospitals. The guidelines also outline “core state preparedness responsibilities” that comprise of adequate testing and screening, adequate personal protective equipment, and plans to surge hospital beds if needed.

Governors have full authority to choose when they should open their states, and more than a dozen states and the District of Columbia have already decided to extend stay-at-home rules into May or June. The governors of Delaware, New York, New Jersey, Connecticut, Pennsylvania, and Rhode Island announced the creation of a multi-state council to restore the regional economy once the COVID-19 pandemic is over. Similarly in the Midwest, the governors of Illinois, Michigan, Ohio, Wisconsin, Minnesota, Indiana, and Kentucky announced plans to work together on the reopening of their regional economy. On the west coast, the governors of California, Oregon, and Washington, announced that their states would coordinate together to end their shelter in place orders once the crisis has subsided.

On Tuesday, President Trump announced that that he will be halting American funding for the World Health Organization (WHO) while they hold a review of their handling of the coronavirus crisis. President Trump said the WHO severely mismanaged and covered up the spread of the coronavirus. The review is expected to take around 60 or 90 days and President Trump said that a “very thorough investigation” is currently underway. The United States is by far the largest contributor to the WHO contributing 22% of the total members’ assessed contributions. President Trump’s decision faced criticism from the international health community and congressional Democrats who argued that withholding funding in the middle of a pandemic doesn’t make sense and that the organization needs support right now.

New data from the Center for Disease Control and Prevention (CDC) showed Americans have followed the social distancing practices and they are working. CDC Director Robert Redfield said that compliance of the social distancing measures has been in excess of 90% and that new models show that fewer than 70,000 Americans will die from the coronavirus. The CDC said original estimates for compliance were around 50% and the high compliance has led to a decline in expected deaths.

President Trump announced a national ventilator exchange program this week. The program was developed with the American Hospital Association and it allows hospitals to lend ventilators to other hospitals that are facing large coronavirus outbreaks. The program seeks to use the more than 60,000 ventilators that are currently unused by sending them to areas that have been coronavirus hotspots. More than twenty health systems have already signed up to participate in the voluntary effort.
New York City hospitals are running out of dialysis fluids and machines as many coronavirus patients have developed kidney failure. Twenty percent of coronavirus patients in intensive care have developed kidney failure and need dialysis treatment often for weeks. The city is facing shortages of dialysis machines and trained nurses to administer dialysis. Without dialysis, these patients’ damaged kidneys can’t remove enough fluid and toxins from their body.

New data released by the CDC has found African-Americans are more likely to get the coronavirus, underscoring existing racial disparities in our nation’s social and health systems and the hurdles that exist for social distancing. The data found African-Americans have 30 percent of the nationwide cases despite only being 13 percent of the population. African-Americans have higher rates of pre-existing conditions such as asthma, diabetes, and heart disease making them more susceptible to the coronavirus. The Federal government has yet to release widespread data on who is getting sick and this data only provides a limited look at who is being impacted by the coronavirus as race has only been identified in around a quarter of coronavirus cases. The Centers for Medicare and Medicaid Services (CMS) Administrator Seema Verma has promised to release CMS demographic data on how the coronavirus impacts certain race, ethnicity, and gender, but that has yet to be released.

Enjoy your cheddar tonight before dinner on National Cheese Ball Day!

April 10, 2020

Today, the Department of Health and Human Services (HHS) announced that it would be releasing an initial $30 billion of the $100 billion Public Health and Social Services Emergency Fund  was created in the CARES Act. The $100 billion will be given to providers starting today and the funds will be used to ensure uninsured Americans can get testing and treatment without a surprise medical bill and support healthcare related expenses and lost revenue that can be attributed to the coronavirus. Providers and facilities will be allotted a portion of the $30 billion based on their share of the 2019 Medicare fee-for-service (FFS) reimbursements. The $30 billion are grants and will not need to be repaid. HHS is partnering with the UnitedHealth Group to help deliver the initial $30 billion distribution as quickly as possible.

The Center for Disease Control formally announced last week recommendations to wear cloth face coverings in public settings where social distancing measures are difficult to maintain. The recommendation noted that it was still important to maintain the social distancing measures that are currently in place, but that the face coverings were recommended for trips to grocery stores or pharmacies especiallyin areas of significant community-based transmission.

Dr. Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases, said that the United States may begin to turn around the fight against coronavirus next week, citing a decrease in new death projections. In proof that social distancing measures throughout the country are working Fauci said that the estimated death toll is looking more like 60,000 than the originally estimated 100,000-200,000. Dr. Fauci reiterated that social distancing must continue, but that the Administration has begun discussing the best steps to reopen the economy.

The Center for Medicare and Medicaid Services (CMS) issued guidance this week that issues further  relaxation of guidelines in attempts to best address the coronavirus patient surge. CMS hopes that the relaxed guidance will help rural hospitals, patients in hospice care, and skilled nursing facilities that have been vulnerable during the coronavirus outbreak. The relaxed guidance expands earlier changes to guidance and now lets doctors’ practice across state lines for telehealth and relaxes a number of guidelines for physicians, nurse practitioners and occupational therapists to better do their jobs.

President Trump, Vice-President Pence, First Lady Melania Trump, and Second Lad Karen Pence spoke with behavioral health advocates this week. The four leaders spoke with hundreds of American Mental Health advocates who thanked the President for the $425 million for mental health and substance abuse services funding that was included in the CARES Act. Mental health issues will continue to be as the coronavirus takes a mental toll on Americans who have been impacted by social distancing guidelines and job loss.

A National Institute of Health clinical trial of hydroxychloroquine has begun with the first participants currently enrolled in Tennessee. Hydroxychloroquine is an anti-malarial drug, sometimes used to treat autoimmune diseases like Lupus, that has often been touted by President Trump for its potential to treat COVID-19 patients. The clinical trial will evaluate and study the effectiveness of the drug and will enroll more than 500 adults that are currently hospitalized with COVID-19. Hydroxychloroquine has shown promise in a lab setting against SARS-CoV-2, the virus that causes COVID-19, but scientists believe clinical trial data is needed to determine whether it is effective and safe in treating COVID-19.

President Trump ended a feud with 3M when he announced that his administration had reached an agreement with the company to produce 166.5 million masks over the next three months. 3M has promised to produce N95 and KN95 masks and they will be importing the masks from China. The masks will be going to frontline workers and the agreement allows 3M to continue to ship products to Canada and Latin America.

We wish everyone a happy Passover and Easter! Let’s hope the Easter Bunny leaves the eggs at least 6 feet apart.

April 3, 2020

As the coronavirus pandemic continues to spread throughout the country, President Trump announced this week that he is extending the suggested federal guidelines that Americans should avoid all nonessential travel until at least April 30. President Trump said Thursday that the administration is also formalizing new guidance that would recommend that Americans wear face coverings to slow the spread of the virus. The administration is likely to recommend that people who live in areas that have been hit hard by the coronavirus wear a bandana or t-shirt over their mouth and nose when outside the home.

The Centers for Medicare and Medicaid Services (CMS) issued an interim final rule around a broad package of temporary regulatory waivers to help the health care system address the coronavirus patient surge. The rule hopes to increase hospital capacity by taking a number of measures including allowing communities to take advantage of local ambulatory surgery centers that have canceled elective surgeries, temporarily permitting non-hospital spaces and buildings to be used for quarantine and patient care sites if they have state approval, allowing hospitals and laboratories to perform coronavirus tests at home, allowing coronavirus testing and screening at drive-through and off-campus test sites, permitting ambulances to transport patients to more facilities, authorizing hospitals to temporarily bill for services outside of their four walls, and increasing the number of licensed beds, operating rooms, and procedure rooms in physician-owned hospitals.

The interim final rule also allows more than 80 additional services to be furnished through telehealth. CMS is allowing telehealth to fulfill many face-to- face visit requirements, providers can now evaluate patients who only have audio phones, and providers will be able to bill telehealth visits the same rate as in-person visits. CMS seeks to expand the healthcare workforce by temporarily removing barriers for physicians, nurses, and other clinicians. The rule will issue waivers to allow hospitals to let physician assistants and nurse practitioners to perform and order tests and medications, lets hospitals provide benefits and support to medical staff, and allows CMS to waive the physician supervision requirements for certified registered nurse anesthetists. Finally, CMS has temporarily eliminated paperwork requirements to give clinicians more time with their patients.

Dr. Anthony Fauci, the director of National Institute of Allergy and Infectious Diseases, and Dr. Deborah Brix, who is coordinating the coronavirus response, estimated that there will be as many as 100,000 to 240,000 American deaths from the coronavirus in a best-case scenario and that in the next few weeks we can expect those numbers to rise. Fauci and Brix did say that the social distancing measures are working and that the deaths could have been as many as 2.2 million deaths if nothing was done.

President Trump has issued a statement that he has invoked the Defense Production Act to increase the production of ventilators. The President has ordered that “the Secretary of Health and Human Services and the Secretary of Homeland Security will help domestic manufacturers like General Electric, Hill-Rom, Medtronic, ResMed, Royal Philips, and Vyaire Medical secure the supplies they need to build ventilators needed to defeat the virus.”

Glen Fine, the acting inspector general of the Department of Defense has been appointed as the chair of the Pandemic Response Accountability Committee. The Committee was created to oversee the $2 trillion stimulus deal that was signed into law by President Trump. Fine will oversee a board of inspectors general that will be monitoring their own respective federal departments and he’ll be working to prevent waste, fraud, and, abuse of the $2 trillion coronavirus relief bill. Fine has worked for eleven years as an inspector general under both Democrats and Republicans.

House Speaker Nancy Pelosi (D-CA) has begun planning a Phase IV coronavirus relief package. Initially the package was expected to include new money for health centers, clean water, broadband access, and public transportation, but Speaker Pelosi said today that a Phase IV bill needs to be focused and address the immediate needs of the coronavirus pandemic. We can now expect the next package to include more money for small businesses, direct cash payments to Americans, and more money to aid city and states. Trump has indicated that he is interested in pursuing a $2 trillion dollar infrastructure bill, while Senate Majority Leader Mitch McConnell (R-KY) has said that any additional coronavirus relief package would likely take longer to implement and that Speaker Pelosi is moving prematurely.

With all of these stay at home orders, we hope you consider a virtual happy hour with your friends this weekend using Zoom or other technologies. Be safe!

March 27, 2020

We are continuing to dedicate all of our coverage to COVID-19 as the country continues to fight this pandemic.

Congress passed H.R. 748, the Coronavirus Aid, Relief, and Economic Security (CARES) Act, to respond to the epidemic in our country. H.R. 748 is intended as an economic stimulus to help our economy rebound and to provide some relief to dislocated workers, but it also includes a number of provisions to assist communities who are confronting this virus and a number of other health policies. The Senate voted unanimously 96 to 0 to approve the bill and the House voted by voice vote to approve it. The Senators who missed the vote were either infected with the disease or on a self-quarantine. You can read our daily posting about developments related to COVID-19 here and our summary of the health provisions contained in the CARES Act here.

The United States is now leading the world in confirmed cases of the coronavirus. According to Johns Hopkins University, there are now more than 86,000 confirmed cases, surpassing the number of cases in China and Italy.  Even though the U.K. lags behind the United States in terms of the outbreak, some significant figures in that country have contracted the disease. We learned this week that Prince Charles, Prime Minister Boris Johnson, and his Health Secretary Matt Hancock have all tested positive for the disease.

The Director of the National Institute of Allergy and Infectious Diseases at the National Institutes of Health (NIH), Dr. Anthony Fauci, is pushing an aggressive plan to begin production of a vaccine for the coronavirus while it is still being evaluated. The vaccine candidate entered a phase I clinical trial earlier this month.  Dr. Fauci is hopeful that when they enter phase II that a manufacturer will be willing to take the risk and begin production. The concern is that if you wait until the conclusion of the trials, it will take another six months to deliver the product.

The U.S. Army Corps of Engineers is seeking to convert hotels into acute alternate care facility for patients infected with the coronavirus. The agency is drafting a request for proposals for companies to step forward to offer their space for conversion into new care settings for patients. The hope is to convert 10,000 rooms in New York to help with the overcrowding in hospitals. The United States Navy is also planning to land a hospital ship in New York by Monday.

The Food and Drug Administration (FDA) has warned consumers that it has not approved any home test kits for the coronavirus. Several manufacturers have been producing tests and advertising them to consumers. The House Oversight and Reform Committee’s Subcommittee on Economic and Consumer Policy sent letters to the company manufacturing those kits asking how many tests have been sold and what they charged for them.

Yesterday was supposed to mark Opening Day for Major League Baseball.  Alas, we were not able to go to the ballparks to enjoy, but we are able to re-watch last fall’s playoffs on MASN here locally. And the Nationals are still the champs!

March 20, 2020

As coronavirus cases in the United States have surpassed 15,000 President Trump announced at a press briefing this week that he is invoking the Defense Production Act of 1950. The Defense Production Act of 1950 allows the President to mobilize and enlist American businesses to help in times of national crisis. Under the Defense Production Act of 1950, companies are required to accept and prioritize contracts from the government, the government must provide financial measures to companies including loans, loan guarantees, and purchase commitments to increase the production speed of materials, and it allows business competitors to work together to increase supply production. It is expected that the President will use the Defense Production Act to streamline and increase the development of ventilators, medical masks, hospital beds, and other health care equipment as the United States continues its battle against the coronavirus outbreak.

President Trump said at his coronavirus press briefing on Thursday that the Food and Drug Administration (FDA) would accelerate the testing of therapeutic drugs to treat the coronavirus by eliminating out-of-date rules and bureaucracy. President Trump announced that Chloroquinea drug used to treat malaria, is showing promise and that the review of the drug would be fast-tracked. Doctors in China, South Korea, and France have all reported that treatments using Chloroquine have helped, but FDA Commissioner Stephen Hahn emphasized the importance of safety in finding a vaccine and that Chloroquine needs to be first looked at in a clinical trial. Hahn also said that a vaccine would not be ready for another 12 months.

The Federal Emergency Management Agency (FEMA) is working to help coordinate the response to the coronavirus. President Trump’s emergency declaration on March 13th freed up $40 billion in funding that was reserved for supplies and personal. The agency will now be coordinating the crisis and FEMA Administrator Peter Gaynor has said he has every single federal agency and commercial partner at his disposal. Gaynor has said that the agency is working on improving supply chain management and testing availability for patients.

On the legislative front, earlier in the week, H.R. 6201 or the “Phase II” coronavirus bill passed the Senate and was signed into law. This bill responds to the coronavirus outbreak by providing paid sick leave and free coronavirus testing, expanding food assistance and unemployment benefits, and requiring employers to provide additional protections for health care workers. The Senate immediately began work on “Phase 3” with republicans releasing text of legislation (see these health care provision summaries from Senate HELP and Senate Finance committees). Democrats are now entering negotiations with republicans on what could be a final package to be voted on next week.

Reps. Mario Diaz-Balart (R-FL) and Ben McAdams (D-UT) became the first two members of congress to test positive for the coronavirus. Both members are in good condition and are in self-quarantine for the time being. At least fourteen other members of congress announced they would also self-quarantine after they were in close contact with the lawmakers including Minority Whip Steve Scalise (R-LA).

The U.S. Navy is activating two hospital ships, the USNS Mercy and the USNS Comfort, to the Bay Area and to New York to help combat the coronavirus and alleviate hospitals. At full strength both ships can provide up to 1,200 doctors, nurses, and other medical specialists. The ships will be boarded by U.S. Navy medical personnel and be filled with medical supplies and equipment. The USNS Mercy is based in San Diego and is ready for activation immediately while the USNS Comfort which will be going to New York is currently in a maintenance period that will delay its activation.

It is International Day of Happiness, so we hope you enjoy your “quarantini” to help celebrate!

March 17, 2020

*In the wake of the ongoing coronavirus activities we are writing a special edition of Healthcare Today to keep you up-to-date on the ongoing news*

At the White House Coronavirus Task Force briefing yesterday, President Trump laid out new guidelines for all Americans to slow the spread of the coronavirus. The president said that even if you are young and healthy, Americans should work from home when possible, avoid gathering in groups of 10 or more people, avoid eating/drinking in bars and restaurants, and avoid non-essential travel and social visits. These guidelines are in place for the next fifteen days, at that point the administration will reassess if these guidelines need to be in place. These additional guidelines came after the Centers for Disease Control (CDC) recommended Sunday night against any gathering greater than 50 people for the next eight weeks. In Washington DC, Mayor Muriel Browser announced as of 10 pm Monday all bars and restaurants will become grab-and-go, takeout, or delivery-only and no eating inside bars or restaurants will be allowed.

After Republican opposition, the House passed a revised coronavirus bill by unanimous consent that clears the bill for Senate action. The revised coronavirus package included some amendments to the small business tax credit sections and amended language regarding Medicaid reimbursement. We are hearing that the House is unlikely to return to Washington until the next Coronavirus stimulus package is ready for a vote.

Senate Minority Leader Chuck Schumer spoke on the Senate floor today outlining what he and Senate Democrats believe should be included in the next package to address the Coronavirus. They are proposing at least $750 billion in federal funding to combat coronavirus and the current economic crisis. Federal funds would work to fix hospital and treatment capacity issues; expand unemployment insurance and increase Medicaid funding; guarantee everyone can afford coronavirus testing; address public health and economic needs for Native Americans; provide Immediate loan payment forbearance for all Federal loans, student loans, mortgages, small business loans and others, and moratoriums on evictions and foreclosures; and deliver immediate help to small businesses. On the Republican side, it is being reported that Senate Majority Whip John Thune was asking members to submit ideas to leadership for the additional stimulus package, and Senator Mitt Romney (R-UT) has put together a proposal of direct payments to American families and student debt relief. In other Senate news, the Senate Health, Education, Labor, and Pensions Committee postponed a hearing on the Coronavirus that was scheduled for Wednesday per public health officials’ recommendations.

The first human trial to prevent against the Coronavirus began today. The first test will take place at the Kaiser Permanente Washington Health Research Institute in Seattle and the trialists will receive shots that were co-developed by the National Institutes of Health and Moderna Inc. testing for side effects of the shots. Public health officials expect it to take at least a year to a year and half before a vaccine is ready for widespread public use, but this is seen as an important step in pursuing that goal.

As you can see, while much of Washington is working remotely, they are still working. We will continue to see considerable actions taken by the Federal government to address this crisis.

March 13, 2020

President Trump has announced a 30-day travel ban on individuals traveling from the 26 European countries of the Schengen Area. The President subsequently issued a Presidential Proclamation on the travel ban. The travel ban is effective beginning March 13th at 11:59 pm, the United Kingdom and Ireland are exempt from the ban, and American citizens and permanent residents abroad are not impacted. The Trump administration has also announced a number of measures that they hope will increase testing for the coronavirus. The Food and Drug Administration (FDA) will authorize New York state to authorize public and private labs to start testing, authorize labs to run tests using Roche’s high-volume platform, and create a new hotline for labs if they have problems validating a test, can’t receive authorized tests, or have issues validating a test. The Department of Health and Human Services (HHS) has put Assistant Secretary for Health Brett Giroir in charge of coordinating testing efforts within HHS’ agencies. It is also expected that President Trump will declare a national emergency today that will invoke the Stafford Act and allow more federal aid for states and municipalities.
As of this morning, both House Speaker Nancy Pelosi and Treasury Secretary Steve Mnuchin were close to a deal on a coronavirus bill. It is expected that the bill will include: free coronavirus testing for everyone including the uninsured that needs a test, increased unemployment insurance, paid emergency leave, increased federal funds for Medicaid, provide clarification for Medicare telehealth services, and enhance food security initiatives for student meals, the Supplemental Nutrition Assistance Program, and seniors’ nutrition and food banks. A vote in the House of Representatives is expected on the bill today. The Senate will be in session next week to consider the bill.
The Centers for Disease Control Director (CDC) Robert Redfield and Director of the National Institute of Allergy and Infectious Diseases Director Dr. Anthony Fauci both testified on Capitol Hill this week. Redfield faced criticism for lawmakers for the lack of availability of tests and the missteps in the area of testing. Under tough questioning from Rep. Katie Porter (D-CA), Redfield promised that the CDC would pay for coronavirus testing. Dr. Fauci admitted in hearings that the current testing system for the coronavirus was failing and that improvements needed to be made.
The World Health Organization has declared the coronavirus a global pandemic. There are now more than 118,000 cases in 114 countries and more than 4,300 people have lost their lives. D.C. Public schools will close beginning Monday through April 1st and Maryland public schools will be closed from March 16th-27th. The NCAA has officially cancelled the men’s and women’s basketball tournament, and the NBA, NHL, MLB, PGA, and MLS have all suspended play due to the spread of the coronavirus.
In other news, CMS and the HHS Office of the National Coordinator for Health Information Technology issued rules this week that would implement interoperability and patient access provisions of the 21st Century Cures Act. These rules will allow patients to download their health records using third-party apps and hope to give patients more control of their healthcare.
The Energy and Commerce Health Subcommittee marked-up several health bills this week. Thirteen bills that were approved through the committee including H.R. 5534, the Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act of 2019, that seeks to provide extended months of Medicare coverage of immunosuppressive drugs for kidney transplant patients; H.R. 3935, The  Protecting Patients Transportation to Care Act, that seeks to provide for the continuing requirement of Medicaid coverage of nonemergency transportation to medically necessary services; and H.R. 4801, the Healthy Start Reauthorization Act of 2019, that would reauthorize the Healthy Start Program.
The Centers for Medicare and Medicaid Services launched a new model this week that seeks to lower the out-of-pocket expenses for insulin. This is a voluntary model that – if insurers and insulin manufacturers agreed to participate – would allow participating Part D enhanced plans to lower Medicare beneficiaries’ out-of-pocket costs for insulin to a maximum $35 copay per thirty-day supply throughout the benefit year. Sanofi and Eli Lily have both announced they will participate, while Novo Nordisk is currently reviewing the model.
We will have a full moon tonight on Friday the 13th. That won’t happen again until 2049. This week also brought us the weird combination of changing clocks, full moon, and Friday the 13th all in the same week!

March 6, 2020

There are now at least 200 known cases of the coronavirus in the United States across twenty states. President Trump has signed an $8.3 billion emergency funding package earlier today that would provide $7.76 billion to federal, state and local agencies to combat the coronavirus and authorizes an additional $500 million in waivers for Medicare telehealth restrictions.

Telehealth advocates praised the waiver of Medicare’s geographical restrictions on telehealth during a public health emergency.  The bill also loosens restrictions on the use of a telephone to deliver care, as long as that phone has audio-visual capabilities.  The waiver is limited to seniors and providers who have established an existing relationship within the past three years. Also, the provision would not apply to seniors who became Medicare-eligible within the last three years.

The package provides $826 million for vaccines and treatments for the National Institute of Allergy and Infectious Diseases, $300 million to purchase vaccines from the drug industry once they’ve been approved, $950 million in grants to states that seeks to limit the stress on state health departments, another $100 million to community health centers, $300 million for the Center for Disease Control (CDC) to respond to international disease outbreaks, $435 million to the State Department for global health programs, and $3.1 billion to purchase medical supplies.

America’s Health Insurance Plans, a major health insurance trade group, made a commitment to cover testing for the coronavirus. They said they would begin relaxing policies and they could also potentially waive co-pays. The CDC has also updated its guidance on testing for the virus allowing clinicians to use their judgement to determine if a patient should be tested or not.

In other news, the Supreme Court agreed on Monday to hear a challenge to the Affordable Care Act that will likely occur this fall. The Justices will review the Texas vs. United States Affordable Care Act court decision that ruled the entire law was invalid, however that ruling allowed the law to remain in place as the appeals process continues. It is likely that they will hear the arguments beginning in October of 2020 and a decision on the case won’t be made until the spring or summer of 2021. The Supreme Court’s decision is a win for Democrats who hope a focus on health care will help them in the 2020 election as it did in the 2018 midterm elections.

The Food and Drug Administration (FDA) has provided an update on the agencies evaluation of the regulatory pathways for cannabidiol (CBD) products this week in a report to Congress. The report said that the FDA still needs more data, more safety information, and is worried about the number of people that are using multiple CBD products. The FDA also expressed concerns that widespread use of CBD could lead to less clinical research. CBD businesses were upset with the report as they were hoping the report would provide more regulatory clarity.

This week, Representatives Diana DeGette (D-CO) and Larry Bucshon (R-IN) along with Senators Michael Bennet and Richard Burr (R-NC) introduced the Verifying Accurate Leading-Edge IVCT Development (VALID) Act. This bicameral, bipartisan legislation seeks to expand our countries diagnostic testing capabilities and help our response to public health threats. The bill would propose a major revamp of the FDA proposal for a precertification program, create a new product category for diagnostic and lab tests that would be under FDA review and approval, and create a new system for labs and hospitals to submit their tests electronically to the FDA for approval.

It is National Oreo Cookie Day today, so we hope you enjoy some Oreos for dessert!

February 28, 2020

President Trump has placed Vice President Mike Pence in charge of the federal government’s response to the Coronavirus. Department of Health and Human Services (HHS) Secretary Alex Azar was initially tasked with leading the response, but Pence will lead the task force and has added the State Department’s top AIDS official, Deborah Birx, who has run that office since 2014 to join the team. Congressional leadership began discussions around supplemental funding to address the outbreak this week. We are hearing negotiators are seeking anywhere from $4 billion to $8.5 billion. This is a much higher number then the initial $1.25 billion in new funds that the administration requested, but President Trump has said he is willing to increase his budget request if lawmakers were willing to allocate more money. The Centers for Disease Control and Prevention announced this week that they had identified the first coronavirus case in the United States of unknown origin. In previous cases, patients had either travelled to China or had contact with other patients that had the disease.

Energy and Commerce Chairman Frank Pallone’s (D-NJ) bill that seeks to curb youth use of e-cigarettes passed in the House of Representatives today. The bill would ban all flavored tobacco products and impose a tax on e-cigarettes that seeks to reduce youth use of e-cigarettes. The bill ultimately passed despite opposition from 17 Democrats and the majority of Republicans over concerns of banning menthol cigarettes and that the legislation could lead towards a black market for vaping products.

HHS Secretary Alex Azar had a busy week on the hill this week testifying before for committees on both President Trump’s fiscal year 2021 budget and the Coronavirus. Much of the hearings centered around the administration’s response to the spread of the coronavirus and the amount of supplemental funding the administration will seek to deal with the virus. Secretary Azar did promise to work with congressional committees to find a solution end surprise medical bills, noted increased investments to deal with the opioid crisis, highlighted the decline in drug overdose deaths for the first time in decades, and touted the administration’s approach to transform rural health care.

Walmart has decided to expand and increase its investments in low-cost health care centers. Traditionally Walmart stores have had vision and pharmacy centers, but its new health care centers will also allow patients to receive a $30 medical checkup, a $25 teeth cleaning, or talk with a counselor for $1 a minute. They currently have two health care centers with plans to open a third center this summer. These centers could allow Walmart to compete with CVS and Walgreens that have moved into the clinic space and allow patients in rural areas more access to care.

We hope you enjoy your fried fish for dinner on this National Tartar Sauce Day and your tagalongs, samosas, thin mints, and do-si-dos for dessert on this Girl Scout Cookie Weekend!

February 21, 2020

The outbreak of coronavirus (COVID-19) continues to dominate the news. The number of new cases appears to be slowing, although there is concern whether new cases are slowing or if it is a matter of how cases are being confirmed by health officials in China. Health officials in Japan are exploring how the disease is being spread after a cruise ship docked in Yokohama was quarantined with over 600 passengers testing positively for the disease.

Congress is also digging in deeper over the outbreak; Representatives John Garamendi (D-CA) and Vicky Hartzler (R-MO) have introduced a bill (H.R. 4710) to require the Department of Defense (DoD) to only purchase American-made raw materials, medicines, and vaccines for U.S. troops. There is a growing concern about the fact that China manufactures most of the therapies Americans consume. The bipartisan duo plans to advance their bill as part of the Defense Authorization bill. There is also a hearing scheduled March 3rdin the Senate Health, Education, Labor, and Pensions (HELP) Committee featuring officials from the Centers for Disease Control (CDC), National Institutes of Health (NIH), Food and Drug Administration (FDA) about steps the federal, state and local governments are taking to prevent the spread of this disease.

Sanofi Pasteur is getting in the game to develop a vaccine for coronavirus, joining Johnson & Johnson, Inovio, and Moderna in the race to develop a preventative measure to combat the disease. Reynolds American is infecting fast growing tobacco plants with coronavirus to see if they can unlock some clues about how to develop a vaccine.

The Trump administration’s plans to impose work requirements in the Medicaid program took a step back at the end of last week. A federal appeals court in Washington upheld a lower court’s ruling in March that voided the Department of Health and Human Services (HHS) approval of the state of Arkansas plan to impose work requirements in their state’s Medicaid program. The decision is likely to be appealed to the Supreme Court although HHS did not immediately comment on the decision.

The Medicare Advantage program is proving to be more popular with senior citizens. The plan experienced a 9.4% spike in enrollees this year, making the total covered population by the program 24.4 million seniors. Seven states (California, Minnesota, Florida, Hawaii, Oregon, Pennsylvania, and Rhode Island) have over 40% of their seniors enrolled in the program. Minnesota is the leading the pace with nearly 60% of their seniors covered by Medicare Advantage. The Congressional Budget Office (CBO) attributes Medicare Advantage to the growing Medicare spending. CBO noted that Medicare spending is going to be $22 billion higher than originally projected with most of that growth coming from the Medicare Advantage program.

Senator Grassley is more optimistic about the chances of his drug pricing bill passing the Senate. In fact, the senator tweeted a classic missive about his bill on Valentine’s Day. The latest Republican senator to support the bill is his fellow Iowan Senator Joni Ernst (R-IA) becoming the 12th Republican senator to publicly back the bill. Senator Grassley believes he needs at least 25 Republican senators for Majority Leader Mitch McConnell (R-KY) to feel comfortable with the bill on the Senate floor.

As Washington continues to grapple with the cost of insulin as part of the drug pricing debate, FDA finalized its definition of “biological product” clarifying a protein as a polypeptide with a specific sequence, ultimately allowing for the transition of applications for insulin, human growth factor, fertility treatments and other products to licensed biologics starting March 23. This will in turn open up possible biosimilar and interchangeable competition for insulin.

We want to give a big thanks to all the hospital employees, nurses, doctors, and other healthcare professionals on this National Caregivers Day.

February 14, 2020

The World Health Organization has officially named the Coronavirus Disease announcing it will be called COVID-19.  The “co” stands for “corona”, “vi” for “virus” and “d” for “disease”, while “19” was for the year, as the outbreak was first identified on December 31st, 2019. Coronavirus cases in the United States have risen to 15 and an American in Wuhan, China died from the virus. At least twenty-five public health laboratories in the United States announced they’ve been unable to test for cases of the coronavirus originating in Wuhan because the test kits that have been distributed by the Centers for Disease and Control (CDC) are delivering inconclusive results. The CDC is currently working with the labs to fix the issue and labs are sending all clinical specimens to the CDC as a backup measure.

Both the House Education and Labor Committee and the House Ways and Means Committee marked up legislation this week seeking to fix the issue of surprise billing. The House Education and Labor Committee legislation passed through the committee with bipartisan support but had members of the committee oppose the legislation due to its use of a benchmark rate and the legislation’s impacts on doctors. The House Education and Labor Committee’s legislation would limit cost-sharing for patients to their insurance plan’s in-network rate and prohibit doctors outside their patients’ networks from billing them directly for more than the same in-network rate. Under this plan, doctors would need to accept a benchmark rate for bills under $750 and go through arbitration in disputes over bills higher than $750. Some of the Education and Labor Committee members favored the House Ways and Means legislation that passed through committee this week with bipartisan support.

The Ways and Means Committee legislation has the support of doctors’ groups and it would ask payers and providers to settle their disputes privately or go to third-party mediators for settlements. The leaders of the House Energy and Commerce, House Education and Labor, and House Ways and Means Committees are expected to try to work out their differences and come up with final legislation soon.

President Trump also weighed in on surprise billing this week. Trump thanked the House Ways and Means and Education and Labor Committees for their work and asked them to work with the House Energy and Commerce Committee and Senate Health Education Labor and Pension Committees to send a bipartisan bill to his desk.

Senate Finance Chairman Chuck Grassley (R-IA), Ranking Member Ron Wyden (D-OR), Sen. Todd Young (R-IN), and Sen. Ben Cardin (D-MD) have started to probe the U.S. Organ Procurement and Transplantation Network (OPTN). A number of inspector general audits and news reports have raised questions about the agencies abilities with reports indicating thousands of available organs were not used and questioning of whether patient safety standards were met. The group of senators sent a letter to the United Network for Organ Sharing (UNOS) that oversees the OPTN requesting an expansive amount of data.

A bipartisan bill led by Sen. Bill Cassidy (R-LA), Sen. Jeanne Shaheen (D-NH), and Sen. Tammy Baldwin (D-WI) was introduced this week that seeks to close the orphan drug loophole that currently gives certain profitable drugs shelter from competition. Currently, drug companies are allowed to get seven years of market exclusivity if they can prove to the Food and Drug Administration (FDA) that the new drug they developed needs exclusivity to be economically viable. The bill will allow the FDA to remove this market exclusivity if the company fails to prove that the drug would be economically unviable when facing competition encouraging more market competition and allowing cheaper options to come on the market sooner.

We wish you all a Happy Valentine’s day and hope you enjoy your time with your loved ones!

February 7, 2020

Last Friday, President Trump announced a travel ban on immigrants who pose a risk of transmitting the coronavirus. The executive order bans entry into the United States for all foreign nationals who were physically present within China during the 14-day period immediately preceding their entry to the United States unless they’re immediate relatives of U.S. citizens or permanent residents. The executive order seeks to stop the virus from spreading, but Ron Klain, who led the Obama Administration’s Ebola response efforts, told a House Foreign Affairs subcommittee that the travel ban won’t stop the spread of the virus. Jennifer Nuzzo, an associate professor and senior scholar at the Johns Hopkins Center for Health Security, agreed and said at the hearing that the virus is spreading too quickly for the travel ban to be effective. Klain believes the focus needs to be on people who have visited the Hubei province in the past 14 days. The White House declined to send administration officials to testify.

It was a busy week in surprise billing. House Ways and Means Committee Chairman Richard Neal (D-MA) and Ranking Member Kevin Brady (R-TX) released text of the Committee’s bipartisan plan to stop surprise medical bills. The Ways and Means Committee plan centers on a pseudo-mediation model to fix the issue of surprise medical bills and for the first time seeks to require patients to receive a true and honest bill in advance of scheduled procedures. The committee plans to hold a mark-up of the legislation next week. House Energy and Commerce Committee Chairman Frank Pallone (D-NJ) and Ranking Member Greg Walden (R-OR) and Senate Health, Education, Labor and Pensions Committee Chairman Lamar Alexander (R-TN) and Ranking Member Patty Murray (D-WA) released a statement today in support of the bipartisan legislation that they released last year. Their legislation would allow health plans and providers to submit billing disputes over $750 to outside arbiters and bar air ambulances from billing patients the difference between the charged and the allowed amount. The House Education and Labor Committee is also expected to release new bipartisan legislation today and hold a mark-up on that bill next week.

The House of Representatives agreed to a resolution that disapproves of a recent Trump Administration policy that seeks to allow states to set limits on Medicaid benefits and drug lists. The new program will allow states to seek Section 1115 waivers to receive defined payments for adults that are covered by the Affordable Care Act’s Medicaid expansion. The vote was mostly along party lines with one Democrat voting with Republicans. Democrats refer to this policy as block-granting the Medicaid program and argued that they oppose any plan to weaken the Affordable Care Act’s expansion of Medicaid, while Republicans support the President’s proposal and believed this resolution was partisan and political.

The Centers for Medicare and Medicaid Services (CMS) issued proposed changes to Medicare Advantage and Medicare Part D that seek to modernize and strengthen the two programs. The proposed rule would implement the 21st Century Cures Act requirement to give all beneficiaries with End Stage Renal Disease the option to enroll in a Medicare Advantage plan starting in 2021. The changes also seek to lower beneficiary cost sharing on the most expensive prescription drugs by allowing beneficiaries to compare their out-of-pocket payments for different prescription drugs under Part D plans. CMS is also proposing updates to methodologies used to pay Medicare Advantage plans and Part D sponsors that are expected to increase revenue by 0.93%.

President Trump focused much of his State of the Union speech on health care, spending close to 15 minutes on health-related issues. The President mentioned a number of priorities including a push for bipartisan legislation to reduce drug costs, praise for his administration’s introduction of association health plans, and bipartisan support for investments in fighting kidney disease, HIV, and improvements in the opioid epidemic. The President also attacked Democrats on legislation that would give free health care to illegal immigrants and promised to never let socialism destroy American healthcare, giving us a possible preview of his reelection strategy.


It is National Wear Red Day, so we hope you enjoy sporting your Santa Claus costume!

January 31, 2020

The World Health Organization declared the Coronavirus a public health emergency of international concern. The organization hopes that this will allow the agency to give more help to countries to stop the spread of the virus. The White House announced the formation of a Coronavirus Task Force that will be led by Health and Human Services Secretary Alex Azar. The Task Force will seek to monitor, contain, and mitigate the spread of the virus. Senators have stated that there could be a potential need for supplemental funding to deal with spread of the virus, and the House Energy & Commerce Committee is planning a hearing on the virus next week

This week, the Centers for Medicare and Medicaid Services introduced the Healthy Adult Opportunity program. This initiative allows states to set limits on Medicaid benefits and drug lists. The new program will allow states to seek Section 1115 waivers to receive defined payments for adults that are covered by the Affordable Care Act’s Medicaid expansion. The capping of Medicaid spending is a major change from how the program is currently financed with a shift from open-ended matching to states to a capped amount of federal dollars to states for the program. This proposed change will likely face legal challenges from opponents who view this as executive overreach.

In surprise billing news this week, House Majority Leader Steny Hoyer (D-MD) said that he hopes a surprise billing deal can be moved as early as mid-February if committee leaders are able to come up with a consensus on the final bill. House Education and Labor Committee Chairman Bobby Scott (D-VA), who chairs one of the committees with jurisdiction over the matter, said this week that he plans to mark-up new surprise billing legislation in the next two weeks. House Ways and Means Committee Chairman Richard Neal (D-MA) announced that his committee will lay out language for legislation to tackle surprise medical bills next week and plan to have a mark-up on the legislation on February 12th. The Ways and Mean plan centers on a mediation model to fix the issue and has the support of Ranking Member Kevin Brady.

Yesterday, a bill passed in the House that would extend the government’s ability to categorize new, illicit types of fentanyl as illegal until 2021. The bill would extend the Justice Department’s temporary power to place fentanyl-like substances on the list of the most-strictly controlled drugs for fifteen months. The Senate version of the bill has already passed paving the way for President Trump to sign the bill into law.

Whether you are a 49’ers fan, a Chiefs fan, or neither, we hope you enjoy the Super Bowl this weekend.

January 24, 2020

The Supreme Court this week denied a motion to fast-track a review of the Texas vs. United States Affordable Care Act court decision. A group of attorneys general filed a petition asking the Supreme Court to fast-track a review of Texas vs. United States so that it could be considered this term. The Supreme Courts decision is a loss for Democrats who hoped that the decision could be heard before the election. Democrats remain hopeful that the Supreme Court will review the case by next term which begins in October, but it is likely that the case will not be heard until after the 2020 election.

The World Health Organization declared that the Wuhan coronavirus outbreak is not yet a global health emergency. The outbreak has now spread from China to at least five other countries and at least seventeen people have passed away due to the respiratory disease. The Centers for Disease Control (CDC) has begun screening travelers at major U.S. airports and has placed staff overseas to work alongside the ministers of health in China and Thailand. The CDC has also asked the Food and Drug Administration (FDA) to authorize emergency use of a newly developed diagnostic test to detect the Wuhan coronavirus. The FDA has authorized emergency use in past outbreaks of Zika and Ebola and the authorization allows the CDC to share this test with local and state health officials. The Senate Health, Education, Labor, and Pensions and Foreign Relations Committee hosted a briefing today for all senators with top administration health officials from the CDC, the State Department, and Centers for Medicaid and Medicare Services (CMS) around the coronavirus situation.

We are hearing that the CMS is planning to issue a letter next week regarding Medicaid block-grant guidance. CMS Administrator Verma is expected to issue a letter that will explain how states can seek 1115 waivers to receive defined payments for adults that are covered by Obamacare’s Medicaid expansion. Capping Medicaid spending will likely face legal challenges from opponents who view this as executive overreach.

There is a bipartisan push in the Senate to hold e-cigarette companies accountable for the youth vaping crisis. There was bipartisan legislation introduced this week by Senators Jeanne Shaheen (D-NH), Lisa Murkowski (R-AK), Richard Durbin (D-IL), Mitt Romney (R-UT), Tammy Baldwin (D-WI) and Susan Collins (R-ME) that would require e-cigarette manufactures to pay higher user fees to the FDA to help fund the agencies oversight of the e-cigarette industry. Under this bill the tobacco industry’s yearly fees to the FDA would increase from $712 million to $812 million. Companion legislation will be introduced in the House by Representative Cheri Bustos (D-IL). In other vaping news, over fifty lawmakers led by House Energy and Commerce Oversight Subcommittee Chairwoman Diana DeGette (D-CO) sent a letter to Human Health and Services Secretary Alex Azar calling on the agency to revise its guidance and issue new rules that would ban the sale of flavored nicotine products.

The Environmental Protection Agency (EPA) weakened its request to find out more about companies use of ethylene oxide in sterilizing medical equipment after pushback from the FDA. The FDA claimed jurisdiction over the use of the cancer-causing chemical and requested deletion of the entire discussion around ethylene oxide. The EPA removed the entire section dealing with low ethylene oxide volumes from the final version of its advanced notice of proposed rulemaking but did include a more general question regarding the cost and feasibility of the practice that could result in lower emissions of the toxic chemical.

It is National Beer Can Appreciation Day and National Peanut Butter Day so enjoy your peanut butter and jelly sandwich for dinner with your cold beer (in moderation).

January 17, 2020

Thousands of healthcare leaders and executives convened in San Francisco for the annual J.P. Morgan Health Care Summit this week. Centers for Medicare Services (CMS) Administrator Seema Verma was the keynote speaker for the event and spoke to attendees in a moderated question and answer session. Verma expressed her continued support to realign financial incentives and provide innovation in states to ensure costs are under control, the administrative burdens in providing value-based care, and the need to look at technology and innovation to solve our healthcare problems.

Kate Goodrich, the Chief Medical Officer at CMS, is resigning from her role at CMS to take a position at health insurer Humana. Goodrich played a central role at CMS and has led the quality measurement and value-based incentives group since 2012. Goodrich will now be working on improving outcomes for patients at Humana. Goodrich isn’t the only Administration official headed to Humana, as Mona Siddiqui is leaving her post as the Chief Data Officer at HHS to focus on initiatives at Humana to improve patient safety and quality of care.

House Speaker Nancy Pelosi said this week that the House will address the surprise billing issue once they return from the recess break. The leaders of the House Energy and Commerce Committee and the House Ways and Means Committee are both working on legislation to fix the surprise billing issue.  The Energy and Commerce plan has the support of Senate Health, Education, Labor, and Pensions Committee Chairman Lamar Alexander (R-TN) and Energy and Commerce Ranking Member Greg Walden (R-OR), and would allow health plans and providers to submit billing disputes over $750 to outside arbiters and bar air ambulances from billing patients the difference between the charge and the allowed amount. The Ways and Means plan has the support of Chairman Richard Neal and Ranking Member Kevin Brady (R-TX) and centers on a mediation model to fix the issue.

The House Energy and Commerce Health Subcommittee held a hearing this week on the future of cannabis policy for the new decade. Currently, researchers that want to study marijuana need to get approval from the Drug Enforcement Agency and can only use marijuana grown at the University of Mississippi. There was bipartisan support from the Subcommittee that an expansion of these research opportunities was needed. Critics of the current process noted that this system doesn’t reflect the diversity of marijuana strains currently on the market.

There is a bipartisan push for the Food and Drug Administration to allow hemp-derived cannabidiol (CBD) to be lawfully marketed as a dietary supplement. House Agriculture Chairman Colin Peterson (D-MN), Rep. James Comer (R-KY), and Rep. Brett Guthrie (R-KY) introduced legislation this week that would amend the Federal Food, Drug, and Cosmetic Act to change the way the FDA regulates hemp-derived CBD. The bill calls for flexibility in allowing hemp-derived CBD to be marketed in dietary supplements and require a study and report from the U.S. Department of Agriculture.

We hope you all enjoy the long weekend and take some time to remember Dr. Martin Luther King Jr’s legacy and lasting impact on our country.

January 10, 2020

The Supreme Court ordered the Trump Administration and the states challenging the Affordable Care Act to respond by today at 4:00 pm to an appeal filed to the Supreme Court. The appeal was filed by a group of Attorneys General who asked the Supreme Court to review a December decision by a federal appeals court that ruled the Affordable Care Act’s (ACA) individual mandate penalty unconstitutional.

The House Energy and Commerce Committee’s Health Subcommittee discussed a number of healthcare measures this week. The Subcommittee hearing focused on H.R. 5534, a bill that would remove the 36-month limit on Medicare coverage for transplant recipients. Medicare covers dialysis for all people who need it, but not all people who have received a kidney transplant are eligible to stay covered for the immunosuppressant drugs on which they rely to prevent their new kidney from being rejected. Also discussed in the hearing were H.R. 3935, a bill that would require Medicaid to cover non-emergency – but medically necessary – transportation like public transit, taxis, and van services, and H.R. 2477, a bill that directs the federal government to provide advance notice to individuals approaching Medicare eligibility about basic Medicare enrollment rules, filling a long-standing gap in education for older adults and people with disabilities.

The Bipartisan Policy Center released a poll this week that indicated healthcare will remain a top issue heading into the 2020 elections. Healthcare was polled as the most important issue overall for Democrats and Independent voters and the third most important for Republican voters. Among those polled there was a preference for improving the current system over repealing the Affordable Care Act or adopting a Medicare-for-all single-payer system.

The New England Journal of Medicine released a study that found the “hotspotting” program created by the Camden Coalition of Healthcare Providers did not live up to the promise of its potential. The model hoped to reduce spending and improve health care services for the sickest and most expensive patients. The program focused on health care workers identifying those patients and invested resources to coordinate their care. The program gained national recognition and interest from Federal officials. The study concluded that hospital readmission rates were no lower among patients randomly assigned to the Coalition’s program than among those who received usual care.

The Department of Health and Human Services (HHS) and the Centers for Medicare and Medicaid Services (CMS) announced that Brad Smith will replace Adam Boehler as the Director of the Center for Medicare & Medicaid Innovation (CMMI) at CMS and Senior Advisor to HHS Secretary Azar for Value-Based Transformation. Smith previously served as CEO of Aspire Health that he founded with former U.S. Senate Majority Leader Bill Frist (R-TN) and worked for Tennessee Gov. Bill Haslam and Sen. Bob Corker (R-TN).

For those of you like the one of us that has yet to take down their Christmas tree, we want to remind all of you to take care of your indoor foliage on this National Houseplant Appreciation Day.

January 3, 2020

The Food and Drug Administration (FDA) finalized its enforcement policy on unauthorized flavored cartridge-based e-cigarettes. Manufacturers will have 30 days to take flavored vape cartridges with the exception of menthol off the market. Open tank systems that are used more by adults will still be allowed to be sold in vape shops as long as steps to prevent youth access are taken by manufacturers. The Administration believes this guidance will both prevent teen use and allow e-cigarette use for adults who want to reduce or quit the use of combustible cigarettes. The guidance has faced criticism from lawmakers and public health organizations who believe that the partial ban doesn’t go far enough and that there are still loopholes that will allow teenagers to still buy products from vape shops.

The nursing home industry believes that an expected recommendation from the Medicare Payment Advisory Commission (MedPAC) will harm providers. At its December meeting, MedPAC recommended the elimination of the base payment rate update for fiscal year 2021 in skilled nursing facilities as they believe this would lower spending and not impact access to services. Mark Parkinson, President and CEO of the American Health Care Association, said in a statement that these recommendations are not the answer and that skilled nursing facilities are currently struggling to keep their doors open.

The Centers for Medicare and Medicaid Services (CMS) announced the Affordable Care Act (ACA) enrollment numbers remained stable in 2019. 8.3 million people enrolled dropping from around 8.5 million enrollees a year ago. CMS noted that the decline is due to a number of factors including a strong economy, the expansion of Medicaid in Maine, and Nevada switching to a state-based exchange.

A federal appeals court upheld the Department of Health and Human Services (HHS) methodology to administer the ACA risk-adjustment program reversing a lower court decision on the matter. The use of statewide average premiums was previously deemed “arbitrary and capricious” by a district court in New Mexico. The Tenth Circuit ruled that the program must be budget neutral and that using the statewide average was allowed. New Mexico Health Connections who brought the challenge could appeal the case directly to the Supreme Court, but it is unclear if they would hear the case.

House Energy and Commerce Chairman Frank Pallone (D-NJ) and Ranking Member Greg Walden (R-OR) along with Senate Health Education Labor and Pension Committee Chairman Lamar Alexander (R-TN) and Ranking Member Patty Murray (D-WA) expanded its bipartisan investigation into physician staffing companies and insurers role in surprise billing legislation. The leaders of the two committees sent letters to companies including Anthem Inc., Cigna Corp., UnitedHealth Group Inc., and CVS Health Corp. as part of its probe into the practice of surprise billing. The leaders are asking for assistance from the companies understand why surprise billing occurs and the policies and practices that help protect individuals from surprise billing.

It is JRR Tolkien’s birthday so enjoy re-reading the Hobbit or Lord of the Rings this weekend in his honor!