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
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 especially in 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 Chloroquine, a 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
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!