October 19, 2018
The Centers for Medicare and Medicaid Services (CMS) released a proposed rule that will require drug companies to disclose the list price of the drug in any direct-to-consumer television advertising. The rule would apply to all therapies with a list price greater than $35 for a month’s supply of the drug which should cover virtually all drugs that are marketed on television. The announcement of the proposed rule came on the heels of an announcement by PhRMA, the trade association of drug companies, of a voluntary initiative where drug companies would steer consumers to a website to learn more about drug pricing. PhRMA has suggested it will challenge the proposed rule in the courts around First Amendment issues.
CMS also announced the hiring of Mary Mayhew as the new Deputy Administrator and Director of the Center for Medicaid and CHIP. Mayhew previously served as Commissioner of the state Department of Health and Human Services in Maine. Maine has submitted a waiver application to CMS to institute a work requirement in the state’s Medicaid program. Mayhew has stated that she will recuse herself from any Maine-related issues at CMS.
Kaiser Family Foundation released a study on Tuesday about the growth in Medicare Advantage plans. There will be 417 more plans available next year putting the total number of plans available to over 2,700 plans. There have not been that number of plans available since 2009. The Affordable Care Act pulled back significantly on reimbursements to Medicare Advantage plans so plans dropped starting in 2010. Devoted Health, a startup health insurance company, announced it has raised $300 million from investors. Devoted offers Medicare Advantage plans in 8 Florida counties and has plans to expand its coverage. Devoted has ties to Todd Park and Bob Kocher who were both senior officials in the Obama Administration.
We are hearing the President will sign the opioids bill passed by Congress very soon. There were lots of provisions in the bill Members of Congress are touting after its passage, so the signing ceremony will be welcome news.
“The Trump administration on Monday moved to require drug makers to disclose prices in consumer ads, just hours after branding a pharmaceutical industry transparency plan as inadequate. HHS said its proposed rule fulfilled another prong of the president’s blueprint to address pharmaceutical costs and would help Americans make more informed decisions that could lower out-of-pocket costs and those of government health programs like Medicare and Medicaid. The move came with polls showing significant voter outrage about drug costs, which also are comprising an ever larger share of the federal budget. The agency said research shows added price transparency will discourage manufacturers from raising prices. The proposed rule would require manufacturers to list a product’s monthly wholesale price or the cost for a typical course of treatment if it is greater than $35 for 30 days. The information would have to appear in text large enough for people to read. The ads also would have to include a statement that patients with health insurance may pay a different sum. The idea is meeting strong resistance from the drug lobby PhRMA, which argues disclosure of list prices without additional context is misleading to consumers, since most have insurance that negotiates lower costs and charges the consumer just a fraction of a drug’s list price. The industry worries disclosure of the higher list prices could discourage patients from seeking needed medical care.”
“Senate Majority Leader Mitch McConnell (R-Ky.) said Wednesday that Republicans may try again to repeal the Affordable Care Act after the November midterm elections, reviving an issue that polls show has swung sharply in the Democrats’ favor. In an interview with Reuters, McConnell said that his party’s failure last year to repeal the health-care law, also known as Obamacare, was “the one disappointment of this Congress from a Republican point of view.” “If we had the votes to completely start over, we’d do it. But that depends on what happens in a couple weeks. . . We’re not satisfied with the way Obamacare is working,” McConnell said. Republicans are optimistic about their chances of maintaining control of the Senate next month, while polls suggest that a Democratic takeover of the House is increasingly likely. Polls show that health care is a top issue for voters, and many GOP candidates have begun campaigning on a longtime Democratic theme — protecting people with preexisting medical conditions — despite the fact that congressional Republicans have voted time and again to repeal the Affordable Care Act, which provides those protections.”
“Virginia is set to start accepting enrollment applications from the roughly 400,000 low-income adults newly eligible for Medicaid. Gov. Ralph Northam announced Thursday that the state would begin accepting applications on Nov. 1 for new coverage that will begin at the start of 2019. State lawmakers voted to expand Medicaid earlier this year, joining a majority of other states that have already expanded publicly funded health care to low-income adults. Medicaid expansion is a key part of former President Barack Obama’s signature health care law. Northam said the federal government has recently signed off on Virginia’s request to expand its Medicaid program.”
“New York state officials are considering blocking parts of the $68 billion merger of drugstore store chain CVS Health Corp. and Aetna Inc., jeopardizing billions of dollars in insurance premiums for Aetna. CVS and Aetna won approval from the U.S. Justice Department on Oct. 10, contingent on Aetna divesting its Medicare Part D business, which covers prescription drugs for seniors. But the deal still needs to pass through state regulatory bodies. At a public hearing in Manhattan on Thursday, Maria Vullo, superintendent of the state Department of Financial Services, said her agency might block CVS’s merger with Aetna’s New York unit. She called U.S. approval of the overall deal “myopic” and repeatedly asked CVS and Aetna representatives for written evidence that they would deliver on promises to lower prices.”
October 12, 2018
The Trump Administration is considering taking bolder actions against e-cigarettes. Health and Human Services Secretary (HHS) Alex Azar and Food and Drug Administration (FDA) Commissioner Scott Gottlieb penned an op-ed in the Washington Post stating that they are “actively reconsidering our policy” on which devices can be on the market without submitting a new pre-market application to the FDA. This follows a visit by FDA inspectors to the headquarters of Juul Labs a leading manufacturer of e-cigarettes and took over 1,000 pages of documents about their sales and marketing. Juul offers e-cigarettes in flavors such as mango and cucumber which are appealing to underage users. Youth vaping jumped 75 percent last year. There is speculation that FDA may ban flavored e-cigarettes.
Even though the language seeking to overturn the privacy protections afforded from 42 CFR Part 2 did not make it into the final opioid package passed by Congress, there is speculation that Congress will revisit that issue soon. Congressman Markwayne Mullin (R-OK) has stated that he wants the House to pass his bill overturning the restriction on including addiction from a patient’s medical records. Senator Alexander (R-TN) who Chairs the Health, Education, Labor and Pensions (HELP) Committee has also expressed an interest in revisiting the issue.
FDA approved a new hearing aid from Bose that patients can fit, program and control on their own. Last year Congress approved a measure allowing FDA to approve over-the-counter hearing aids to be sold. FDA has not yet issued regulations implementing the law so this approval comes with the condition that the device must comply with federal and state laws regarding the sale of hearing aids, including state laws that require hearing aids be acquired from a licensed hearing aid dispenser.
The Senate rejected a Congressional Review Act (CRA) resolution that sought to overturn the Trump administration regulation on short-term health plans. The resolution failed on a vote of 50-50 with all Democratic Senators voting in favor as did Senator Collins (R-ME). The final regulation issued by the Trump administration defined short-term health plans that do not need to comply with the Affordable Care Act as being one year in duration and eligible for three renewals.
The merger between CVS and Aetna was cleared by the Justice Department this week. The approval comes with a condition that Aetna must sell off its Medicare Part D plans. Last month the Justice Department approved the sale of one of CVS’ biggest rivals Express Scripts to Cigna.
We hope our friends and family in the Green Mountain state enjoy their National Vermont Day today. After all, Vermont was the first state to join the country after the 13 original colonies.
“A long-shot bid to derail the Trump administration’s expansion of short-term health plans died in the Senate on Wednesday, even with Sen. Susan Collins providing the lone Republican vote for the resolution. The Senate vote ended in a 50-50 tie, falling short of the majority needed to pass the measure reversing new regulations allowing insurers to sell skimpy health plans outside the Obamacare markets for up to a year, rather than the previous limit of three months. The Trump administration has touted the expanded plans as a cheaper alternative to Obamacare, but Democrats and health groups have warned it would undermine the Obamacare market. In recent weeks, Democrats have tried to tie the short-term health plans to broader warnings about GOP efforts to gut protections for pre-existing conditions.”
“The Justice Department’s approval of the $69 billion merger between CVS Health and Aetna on Wednesday caps a wave of consolidation among giant health care players that could leave American consumers with less control over their medical care and prescription drugs. The approval marks the close of an era, during which powerful pharmacy benefit managers brokered drug prices among pharmaceutical companies, insurers and employers. But a combined CVS-Aetna may be even more formidable. As the last major free-standing pharmacy manager, CVS Health had revenues of about $185 billion last year, and provided prescription plans to roughly 94 million customers. Aetna, one of the nation’s largest insurers with about $60 billion in revenue last year, covers 22 million people in its health plans. The two companies say that they will be better able to coordinate care for consumers as the mergers help tighten cost controls. Larry J. Merlo, the chief executive of CVS Health, said in a statement that the approval “is an important step toward bringing together the strengths and capabilities of our two companies to improve the consumer health care experience.” But critics worry that consumers could end up with far fewer options and higher expenses. “This type of consolidation in a market already dominated by a few, powerful players present the very real possibility of reduced competition that harms consumer choice and quality,” George Slover, senior policy counsel for Consumers Union, an advocacy group, said in a statement. The consumer organization had opposed the Aetna-CVS merger, arguing that people enrolled in Aetna health plans could be forced to seek care at CVS retail clinics, and that those who were not insured by Aetna could pay higher prices for drugs than those who were.”
“President Donald Trump signed two bills at the White House on Wednesday aimed at lowering pharmaceutical drug prices by promoting greater disclosure in drug pricing. The two bills the president signed — the Know the Lowest Price Act and the Patients’ Right to Know Drug Prices Act — are meant to prevent “gag clauses” in agreements between pharmacies and pharmacy benefit managers, the middlemen who administer prescription drug programs for insurance companies, which pharmacists say kept them from disclosing cheaper drug options to consumers. Under the new legislation, pharmacists will be allowed, though not required, to tell patients about lower-cost options.”
“The average price tag for the most popular level of insurance sold in the Affordable Care Act’s federal marketplaces is dropping slightly, the first time the rates have stopped going up since the health plans were created a half-dozen years ago. In the 39 states that rely on HealthCare.gov, the monthly premium is dipping by 1.5 percent for 2019 in a tier of coverage that forms the basis for the ACA’s federal insurance subsidies, according to federal figures released Tuesday. The figures also show that, after several years of defections, some insurers are returning to sell ACA health plans, and fewer consumers around the country will have only one insurance company in their marketplace. In issuing this new portrait of the marketplaces on the cusp of the Nov. 1 yearly sign-up period, administration officials did an about-face from President Trump’s declarations since his campaign that the ACA was “dead” and its insurance exchanges were collapsing — a refrain popular among Republicans. Seema Verma, administrator of the Department of Health and Human Service’s Centers for Medicare and Medicaid Services, credited the administration for improving the affordability and supply of ACA coverage. She said the Trump administration’s recent policies have stabilized the marketplaces, and she focused on a rule change to make it easier to rely on short-term health plans with relatively low prices that lack popular consumer protections.”
October 5, 2018
We heard lots of cheers around the Capitol as the Senate passed the comprehensive opioid bill, H.R. 6, by an overwhelming vote of 99 to 1. The bill includes provisions from many individual bills introduced by Senators and Members of the House. Senator Portman (R-OH) touted a provision based upon a bill (S. 3057) he introduced to require the Postal Service to inspect international shipments to prevent the illegal importation of fentanyl. Another provision authored by Senators Klobuchar (D-MN) and Rubio (R-FL) creates an anti-kickback statute to prevent patient brokering where individuals receive compensation for referring patients to treatment facilities. We expect the President to sign this bill into law quickly.
The Substance Abuse and Mental Health Services Administration (SAMHSA) is seeing a shake-up in its leadership. Paolo del Vecchio who has run SAMHSA’s mental health center since 2012 is being reassigned to lead the office of management, technology and operations. Greg Goldstein who currently leads the office is departing the agency.
The Administrator of the Centers for Medicare and Medicaid Services (CMS) Seema Verma touted the fact that the insurance marketplaces under the Affordable Care Act (ACA) are looking healthier. Administrator Verma stated that many of the markets are seeing more choices of insurance providers and the prices of the policies sold in the exchanges are only expected to rise by less than 5 percent on average.
Memorial Sloan Kettering Cancer Center has come under scrutiny over some potential conflicts of interest of its executives. The Chief Executive, Dr. Craig Thompson, announced he was stepping down from two corporate boards of healthcare companies for which he received significant compensation. A Vice President, Dr. Gregory Raskin, is turning over $1.4 million in compensation he earned while serving on a board of a biotech company.
“The Senate passed the final version of a sweeping opioids package Wednesday afternoon and will send it to the White House just in time for lawmakers to campaign on the issue before the November midterm elections. The vote was 98 to 1, with only Utah Sen. Mike Lee (R) opposing it. The bill unites dozens of smaller proposals sponsored by hundreds of lawmakers, many of whom face tough reelection fights. It creates, expands and reauthorizes programs and policies across almost every federal agency, aiming to address different aspects of the opioid epidemic, including prevention, treatment and recovery. It is one of Congress’s most significant legislative achievements this year, a rare bipartisan response to a growing public health crisis that resulted in 72,000 drug-overdose deaths last year. It marks a moment of bipartisan accomplishment at an especially rancorous time on Capitol Hill as senators debate Brett M. Kavanaugh’s nomination to the Supreme Court.”
“If your employer is sticking you with a bigger share of the medical bill before health insurance kicks in, you may have to get used to it. More companies are making workers pay an annual deductible or increasing the amount they must spend before insurance starts covering most care, according to a survey released Wednesday by the Kaiser Family Foundation. Annual deductibles for single coverage have now climbed about eight times as fast as wages over the last decade. That means that those who use the health care system are pouring more of their take-home pay into medical bills even though they have coverage. Health benefits experts say they see few signs that these rising deductibles will level off anytime soon for employer-sponsored benefits. “At some point they have to come down to Earth, we just don’t know what point that is,” said Matthew Rae, a Kaiser senior health policy analyst. Employer-sponsored coverage is the most common form of health insurance in the United States, covering about 152 million people, according to Kaiser. The nonprofit found that the annual cost or premium for family coverage rose 5 percent this year to $19,616, on average, while single coverage premiums climbed 3 percent to $6,896. That continued a trend toward moderate increases over the past several years.”
“The Food and Drug Administration conducted a surprise inspection of the headquarters of the e-cigarette maker Juul Labs last Friday, carting away more than a thousand documents it said were related to the company’s sales and marketing practices. The move, announced on Tuesday, was seen as an attempt to ratchet up pressure on the company, which controls 72 percent of the e-cigarette market in the United States and whose products have become popular in high schools. The F.D.A. said it was particularly interested in whether Juul deliberately targeted minors as consumers. “The new and highly disturbing data we have on youth use demonstrates plainly that e-cigarettes are creating an epidemic of regular nicotine use among teens,” the F.D.A. said in a statement. “It is vital that we take action to understand and address the particular appeal of, and ease of access to, these products among kids.” F.D.A. officials described the surprise inspection as a follow-up to a request the agency made for Juul’s research and marketing data in April. Kevin Burns, Juul’s chief executive officer, said the company had already handed over more than 50,000 pages of internal documents to the F.D.A. in response to that request.”
“Rep. Pete Sessions (R-Texas) on Tuesday introduced a resolution intended to protect people with pre-existing conditions, illustrating the lengths vulnerable Republicans are going to try to show they favor those protections. The resolution from Sessions, who is facing a close reelection race against Democrat Colin Allred, is nonbinding, but expresses the opinion of the House that pre-existing conditions should be protected. In a statement, Sessions said that “Obamacare has failed the American people,” but he added that he does want to preserve pre-existing condition protections. “To cement these protections, I proudly introduced this resolution to ensure that patients with pre-existing conditions are protected from the erroneously high costs and the limited options they are experiencing now,” Sessions said. The resolution does not spell out the details of how pre-existing conditions would be protected in the absence of ObamaCare.”
House and Senate negotiators concluded a brisk negotiation over the final version of a legislative package to help in the fight against the opioid epidemic. On Tuesday night, the House filed an amendment to the Senate-passed version of H.R. 6 – the SUPPORT for Patients and Communities Act. The final version of the bill did not include the House-passed language that would have allowed health care providers to include information about addiction treatment in the patient’s health records without their consent. Nevertheless, the bill did include language directing the Secretary of Health and Human Services (HHS) to develop best practices for including information about a patient’s opioid use disorder in their medical record with their consent. The measure includes many consensus measures to improve Medicaid and Medicare coverage for opioid treatment services. The bill also allows the Food and Drug Administration (FDA) to require better safety protocols for packaging of opioids and to create expedited pathways for the creation of non-addictive pain treatment medications. State Targeted Response Grants are authorized at $500 million per year through 2021. The House passed the bill earlier today, and we expect the Senate to pass it next week.
The House passed two bills aimed at the so-called “gag clauses” in pharmacy contracts that prohibit pharmacists of informing patients about the cheapest available drugs. One bill, S. 2553, would prohibit Medicare Part D and Medicare Advantage plans from including provisions in their contracts prohibiting pharmacists from telling patients that the retail cost of the drug is lower than their copayment. The second bill, S. 2554, would include similar prohibitions in employer provided and individual market plans. The President is expected to sign both bills as he has called for these policies in his efforts to lower prescription drug costs.
The House also passed the reauthorization of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act. The measure authorizes $7.1 billion for Project Bioshield which is a fund used to buy medical countermeasures to respond to the outbreak of diseases such as Zika and Ebola. The Senate Committee on Health, Education, Labor and Pensions (HELP) reported a version of this legislation earlier this year. Given that the House bill passed on a voice vote, it is possible the Senate may call up the House-passed bill to move quickly on this reauthorization.
California Governor Jerry Brown signed legislation that bans the sale of short-term health insurance policies in the state. California is the first state to take such an action. This legislation is in reaction to the regulation finalized by the Trump Administration defining these short-term plans that do not need to comply with the Affordable Care Act (ACA) as being a year in duration and are eligible for three renewals. The Trump Administration has been touting this rule as a way to help lower healthcare costs. It will be interesting to see if more states follow California’s lead on these non-ACA compliant plans.
Today marks both the Hug a Vegetarian Day and the Drink Beer Day. We hope you enjoy your hugs and beers responsibly.
AP investigation: Drug prices going up despite Trump promise- Associated Press (September 24)
“President Donald Trump made reducing drug prices a key promise during his election campaign, repeatedly accusing drugmakers of “getting away with murder.” At the end of May, he promised that drug companies would be announcing “massive” voluntary drug price cuts within two weeks. That hasn’t happened, and an Associated Press analysis of brand-name prescription drug prices shows it’s been business as usual for drugmakers, with far more price hikes than cuts. The number of increases slowed somewhat and were not quite as steep as in past years, the AP found.”
Lawmakers unveil massive bipartisan bill aimed at fighting opioid crisis- The Hill (September 25)
“Bipartisan congressional leaders in both chambers on Tuesday night unveiled a massive bill aimed at fighting the epidemic of opioid abuse in the United States, capping months of work. Fighting the crisis has been an area of bipartisan cooperation this year amid many fierce partisan battles raging with more publicity. The 660-page bill takes a wide variety of actions aimed at fighting the crisis. It lifts some limits on Medicaid paying for care at treatment facilities, undoing part of a decades-old restriction that many lawmakers called outdated. It cracks down on illicit opioids being imported through the mail from other countries, fueling the epidemic. It encourages the development of nonaddictive painkillers as an alternative to opioids. “Once signed into law, this legislation sends help to our communities fighting on the front lines of the crisis and to the millions of families affected by opioid use disorders,” the chairs and ranking members in both chambers who worked on the measure said in a joint statement after unveiling the text late Tuesday night.”
Trump administration defends Medicaid work requirements- The Hill (September 27)
“A top health official in the Trump administration defended Medicaid work requirements Thursday, arguing that its intent isn’t to expel people from the program.”Community engagement requirements are not some subversive attempt to just kick people off of Medicaid,” Seema Verma, head of the Centers for Medicare and Medicaid Services, said in a speech in Washington, D.C. “Instead, their aim is to put beneficiaries in control with the right incentives to live healthier, independent lives.” More than 4,300 people lost their Medicaid coverage in Arkansas this month for not adhering to the new rules. Verma’s comments come as the administration defends itself against a lawsuit targeting its approval of the Arkansas work requirements. Hearings for the case, filed by the National Health Law Program, have not yet been scheduled. Verma referenced the Arkansas program in her remarks, repeating an assertion from the state’s governor that it helped 1,000 people gain employment. “Imagine the impact that this has had on the lives of those individuals and their families,” Verma said. Arkansas became the first state, in Medicaid’s 53-year history, to strip coverage from beneficiaries for not meeting work requirements. The Trump administration has also approved work requirements in Indiana and New Hampshire that are slated to take effect next year. A similar program in Kentucky was struck down this summer by a federal judge.”
Obamacare is about to get a bit cheaper for lots of people- CNN (September 28)
“It will likely cost a little less to buy the benchmark Obamacare plan next year. The rate could drop for the first time since the Affordable Care Act exchanges opened in 2014. The premium for the benchmark silver policy on the federal exchange is expected to decline by 2% for 2019, Health Secretary Alex Azar said Thursday. The predicted decline for next year comes after a 37% spike for this year’s benchmark silver plan, upon which premium subsidies are based. The number of insurers on the federal exchange also will grow for the first time since 2015, Azar said. Over the past two years, 44% of carriers have dropped out of the program. The Centers for Medicare & Medicaid Services, which administers Obamacare, typically releases a more detailed look at the upcoming year’s premiums and insurer participation in late October. Open enrollment begins November 1 and runs through December 15 in most states. Obamacare’s fortunes have taken a notable turn for the better this year. In 2017, insurers were fleeing the marketplace or hiking rates to combat the GOP-fueled uncertainty surrounding the Affordable Care Act. The new stability isn’t that surprising to those who watch the industry closely. Many insurers are breaking even or have started making a profit in the individual market, and the threat of Congress repealing the law has waned.”
This was a big week in fight against the opioid epidemic. The Senate passed their version of comprehensive legislation in the fight against opioid abuse by a vote of 99 to 1. If you drew a Venn diagram of the House and Senate passed bills there would be a fair amount of overlap. Nevertheless, there are some policy divides the two chambers will need to resolve. Perhaps the most significant is one that deals with privacy as the House tackles the prohibition in 42 USC Part 2 to allow substance abuse records to be part of a patient’s medical records. The rationale for lifting the ban is that medical records are now protected by the Health Insurance Portability and Accountability Act (HIPAA) which was not in place when 42 USC Part 2 was put in place. Privacy and other advocates are concerned about the vulnerability of patients if the protections in 42 USC Part 2 are lifted. We are expecting House and Senate negotiators to resolve their differences quickly and possibly file a conference report next week.
Another development this week was the announcement by the Trump Administration that they were awarding nearly $1.5 billion in funding to combat the opioid crisis. The Substance Abuse and Mental Health Services Administration (SAMHSA) announced the awarding of $930 million in State Opioid Response (SOR) grants. The Centers for Disease Control (CDC) announced the awarding of $194 million to support states and territories to assist with the collection of data. The Health Resources and Services Administration (HRSA) awarded $396 million which will be used to fund community health centers in their fight against opioid abuse. $50 million of those funds is being reserved for rural organizations that can assist in this fight.
The Senate passed the second “minibus” appropriations bill which includes the Labor, Health and Human Services, and Education (Labor-HHS) appropriations bill by a vote of 93 to 7. This bill also includes the Department of Defense appropriations bill and a continuing resolution (CR). While President Trump has made some noise on social media about the appropriations bill and the lack of funding for the border wall, we still expect the House to pass the bill next week and the President to sign it into law. It is interesting to note that this bill includes the rescission of $7 billion in unspent Children’s Health Insurance Program (CHIP) funding that the White House proposed in its rescission package this spring.
The Senate also passed this week a bill that would ban the so-called “gag clauses” placed on pharmacists that prohibit them from informing consumers when it is cheaper to buy a drug without their insurance coverage. This bill also passed on an overwhelming majority of 98 to 2. If the House is also able to pass this bill next week, it will mark a big victory for President Trump who has been pushing this policy in his fight against prescription drug costs.
The Justice Department cleared the merger of Cigna and Express Scripts this week. The expectation is the deal will be finalized before the end of the year even though there are still some state approvals necessary before the deal can be finalized.
The Chief Actuary for the Center for Medicare and Medicaid Services (CMS) released their report on Medicaid spending this week projecting total Medicaid spending to be close to $600 billion in 2017. The report projects Medicaid spending to top $1 trillion by 2026 with the growth in spending exceeding the rate of economic growth. This program has roughly doubled in size since 2008.
Senate passes bipartisan opioid package- CNN September 17
“In a rare bipartisan move, the Senate on Monday passed legislation aimed at combating the opioid epidemic that had overwhelming support from both sides of the aisle. The package is made up of provisions from five Senate committees and more than 70 lawmakers, and comes after the House passed a similar bill in June. This legislation was sponsored by Tennessee Republican Sen. Lamar Alexander, chairman of the Senate Health Committee, and includes several initiatives that work to curb the opioid crisis. In a statement Monday, Alexander said he is “already working to combine the Senate and House-passed bills into an even stronger law to fight the nation’s worst public health crisis, and there is a bipartisan sense of urgency to send the bill to the President quickly.” The package has provisions that would give the US Food and Drug Administration the authority to require specific packaging for opioids, as well as a push for research on non-addictive pain killers, according to a previous statement from Alexander. In 2016, more than 63,600 people died from an overdose in the United States — and 42,249 of those deaths involved an opioid, according to the Centers for Disease Control and Prevention. The legislation also includes the “STOP Act,” which would attempt to help stop the flow of illegal drugs coming into the United States.”
“Federal regulators on Monday have approved health insurer Cigna’s $52 billion acquisition of drug benefits manager Express Scripts, a mega deal that’s the latest evidence of health care giants bulking up, the companies said in an announcement Monday. The combination represents a major reshuffling of the health care industry as companies try to constrain costs and gird for the long-expected entrance of Amazon into the sector. The Justice Department reportedly is also close to approving CVS Health’s blockbuster acquisition of Aetna, which would create one of the country’s biggest health care companies. The looming approval of the deals comes two years after Obama administration regulators blocked a major proposed consolidation in the health insurance industry over concerns about diminished competition. DOJ successfully sued in 2016 to halt Anthem’s proposed acquisition of Cigna and Aetna’s merger with Humana”
“A bipartisan group of senators is unveiling a draft measure to crack down on surprise medical bills, which they say have plagued patients with massive unexpected charges for care. The measure would prevent a health care provider that is outside of a patient’s insurance network from charging additional costs for emergency services to patients beyond the amount usually allowed under their insurance plan. The insurer, not the patient, would have to pay additional charges, which are limited under the proposal. The bill targets situations like one that received a flood of national attention last month, when NPR and Kaiser Health News reported on a high school teacher who was charged $109,000 by the hospital that cared for his heart attack, even after his insurance had already paid $56,000.”
“The Trump administration is awarding more than $1 billion in grants to help states confront the opioid epidemic, with most of the money going to expand access to treatment and recovery services. Officials say more than $900 million comes from a grant program Congress approved this spring as part of a budget bill. Lawmakers are working on another bipartisan bill to address the opioid problem and hope to have final legislation to President Donald Trump by year’s end.”
“Lawmakers are considering adding a provision easing costs on drug companies to an opioid package currently being negotiated. The powerful pharmaceutical industry has been pushing for months to roll back a provision from February’s budget deal that shifted more costs onto drug companies, and they sense they have a chance to attach the change to the bipartisan opioid package currently moving through Congress. Democratic aides said Republicans are pushing to add the change at the behest of drug companies. Senate Democrats have not taken a clear position. Henry Connelly, a spokesman for House Democratic Leader Nancy Pelosi (Calif.) said Thursday evening, though, that Pelosi opposes the move. “The way Republicans are writing this, Big Pharma will get two or three times more money than the opioids crisis,” Connelly said. “Leader Pelosi opposes this Republican attempt to hijack a bipartisan effort on opioids funding to ram through a multi-billion dollar handout to Big Pharma.” Drug pricing advocates are up in arms at the possibility of a change favorable to pharmaceutical companies making it into a package aimed at fighting the opioid epidemic.”
September 14, 2018
The Labor-Health and Human Services-Education (Labor-HHS) appropriations bill conference report was filed last night. The bill also includes the Defense Appropriations bill and a continuing resolution (CR) that funds the portions of the federal government not covered by a regular appropriations bill until December 7th. Some healthcare highlights in the bill include: $2 billion increase for the National Institutes of Health (NIH); $3.8 billion to combat the opioid crisis including $1.5 in funding for states; and a $584 million increase for the Substance Abuse and Mental Health Services Administration (SAMHSA). Of note the bill does not include the bipartisan amendment offered by Senators Grassley (R-IA) and Durbin (D-IL) to provide funding for the Secretary of HHS to develop regulations to require pharmaceutical companies to disclose their price in direct-to-consumer advertising. The amendment had passed the Senate on a voice vote. With the passage of this bill, 75% of the government will be funded by regular appropriations bill and only 25% will be funded by the CR.
The Census Bureau released their community survey this week. The survey revealed that the number of uninsured in the country remained static in 2017 at 8.8% or 28.5 million individuals. Those numbers are not statistically different from the figures for 2016. The uninsured rate dipped in three states and rose in fourteen states but overall the numbers remained static on a national basis.
The House took the first step towards taking another swipe at the Affordable Care Act (ACA). The House passed a rule on Thursday to provide for consideration of a bill that will increase the definition of “full-time employee” from 30 to 40 hours, suspend the penalty for the employer mandate from 2015-2018, repeal the tanning tax, and delay the so-called Cadillac tax for an additional year. The House did not begin debate on the measure before departing for the week and is expected to consider it during the last week in September.
Apple announced this week that its new Apple Watch 4 includes an App that monitors your heart rhythm and notify you if you have an irregular heartbeat. This App is the first ever over-the-counter electrocardiogram (ECG). There are other products in the market, but this is the first one that consumers can use with a doctor’s review.
Former Veterans Affairs (VA) Secretary Shulkin has landed at Sanford Health the largest non-profit rural health system in the country. Shulkin will be serving as Sanford’s Chief Innovation Officer but he will not be relocating to the company’s headquarters in Sioux Falls, SD.
The Senate delayed consideration of the House passed opioid bill (H.R. 6) until Monday. We are hearing that House and Senate negotiators have already begun to try and iron out the differences between the House-passed version and Senator Alexander’s (R-TN) substitute amendment with hopes of sending something to the President before the election.
“America’s uninsured rate held essentially steady from 2016 to 2017, according to U.S. Census Bureau figures published on Wednesday, the first year this decade that the nation did not make progress in reducing the ranks of those without health insurance. The finding suggests America’s recent success in lowering its uninsured population has plateaued, with potential implications for policymaking and the fate of the U.S. health care system. “There has been a stall in the progress of reducing the number of uninsured Americans,” said Laura Skopec, a health care expert at the Urban Institute, a centrist think-tank. In 2016, 8.8 percent of the American population — or 28.1 million people — did not have health insurance. In 2017, the number of those without health care rose by about 400,000 people to 28.5 million while the rate of the uninsured did not change, according to Census Bureau figures. The increase was not statistically significant. The reversal comes after nearly a decade of progress in bolstering the number of Americans with health care. The number of uninsured Americans fell steadily from 2010 until 2016, decreasing by at least 0.3 percentage points every year over that period. From 2010 to 2016, the uninsured rate fell dramatically — nearly in half — as tens of millions of more people were signed up for health insurance under the Affordable Care Act signed by President Obama in 2010.”
“House Republicans on Thursday blocked a drug pricing amendment supported by President Trump from inclusion in a health-care spending bill. The provision, which passed the Senate on a bipartisan basis last month, would require drug prices to be disclosed in television advertisements for drugs in an effort to increase transparency and bring down prices. Lawmakers and aides said that House Republicans objected to including the provision in the final version of the funding bill, which was finished by House and Senate negotiators on Thursday. Sen. Dick Durbin (D-Ill.), one of the sponsors of the provision, blamed pharmaceutical companies for exercising their influence to block the measure. “When are we going to stand up to Big Pharma?” Durbin asked. He noted that Trump supported the measure, reading aloud a tweet from the president last month praising the measure as a move “to end the secrecy around ridiculously high drug prices.” The proposal is part of Trump’s plan to lower drug prices, something the president has been vocal about. Republican Sen. Chuck Grassley (Iowa), who co-sponsored the measure with Durbin, tweeted Thursday that it is “EMBARRASSING to bow to BIG PHARMA at expense of consumers” and not include the provision. Asked about the objections, Rep. Tom Cole (R-Okla.), the top health appropriator in the House, said he did not want to get into the details, but said that some House Republicans opposed the provision.”
“The thousands of people who lost Medicaid coverage this month in Arkansas for not following newly implemented work requirements may be a sign of what’s to come in other GOP-led states. Indiana and New Hampshire are slated to implement their Medicaid work requirements next year, and a slew of other states are awaiting approval from the Trump administration. Arkansas has served as a test case of sorts since it was the first state to implement work requirements, and this month it became the first state to kick off beneficiaries for not following them. The state removed more than 4,000 people from the Medicaid rolls, with some estimates saying that number could climb to 50,000 when the requirements are fully implemented in 2019.”
“Opening yet another legal battle over the Affordable Care Act, a coalition of patient advocates and other healthcare groups is going to court to try to block the Trump administration from expanding the availability of short-term health plans that don’t offer a full set of benefits. The lawsuit, filed Friday in federal court in Washington, seeks to blunt one of the signature moves by the administration to weaken patient protections enacted through the 2010 healthcare law, often called Obamacare. It accuses Trump’s Treasury, Labor and Health and Human Services secretaries of jeopardizing access to life-saving medical care for millions of Americans with serious medical conditions, including mental illness, cancer and HIV/AIDS. “It will be more expensive, and perhaps impossible, for some individuals with preexisting conditions to obtain healthcare and health insurance coverage — undermining the purpose of, and congressional plan embodied in, the ACA,” the lawsuit argues. The administration finalized new regulations last month designed to allow insurance companies to sell more short-term plans. That fulfilled a pledge by the president to loosen insurance rules that Republicans say have driven up premiums for consumers who don’t get health coverage through an employer or a government health program such as Medicare or Medicaid. The controversial move — which came on the heels of the unsuccessful campaign last year by congressional Republicans to repeal the healthcare law — will allow people who buy skimpier short-term plans to keep them for as long as three years, up from the previous limit of three months.”
September 7, 2018
The Senate was able to reach an agreement to proceed to the House passed opioid bill (H.R. 6) and consider a substitute amendment offered by Senator Alexander (R-TN). Amendments to the Alexander amendment will not be made in order. The amendment includes additional funding for states to combat the opioid crisis. The bill also gives more authority to the National Institutes of Health to develop non-opioid pain therapies. The amendment does not address the issues in 42 CFR Part 2 regarding sharing substance abuse patients’ records as the House bill does. We are expecting the House and Senate will need to convene a conference committee to resolve the differences between the two bills.
Oral arguments began this week on Texas v. Azar which is the challenge to the Affordable Care Act (ACA) brought by 20 conservative states. The states are arguing that since Congress repealed the individual mandate of the ACA as part of the tax bill last year that the rest of the law must be scrapped as well. Many legal scholars think the states may have a high hurdle to climb with their case, but many of us have been surprised before with ACA cases. While ACA cases have delivered surprising outcomes in the past, many legal scholars believe the states have a high hurdle to climb – and, notably, during his confirmation hearing in front of the Senate Judiciary Committee this week, Supreme Court nominee Brett Kavanaugh also appeared to cast some doubt on the states’ challenge.
Telemedicine got a boost this week with the American Medical Association (AMA) releasing new billing codes that include codes for reimbursement for remote patient monitoring and internet consultations. AMA is urging the Centers for Medicare and Medicaid Services (CMS) to adopt these codes as part of next year’s physician fee schedule rule. Reimbursement has long been seen as a barrier for expanding telemedicine and these codes certainly seem to help lower that barrier.
The Department of Justice appears to be moving closer to the approval of the two big health care mergers with CVS Health acquiring Aetna and Cigna acquiring Express Scripts. Justice has expressed some competition concerns with the CVS-Aetna deal which may mean the disposition of some Medicare Part D related assets.
The New York Times reviewed Bose’s Sleepbuds this week. The Centers for Disease Control (CDC) has identified sleep deprivation as a health epidemic. And we all know too well how our devices can keep us up at night responding to texts and emails, checking scores or standings in fantasy leagues, or how many likes your cute kid pictures are getting on Instagram. But now we have a device to help with your sleep by blocking out distracting noises and replacing them with calming sounds like ocean waves or breezes. Brian Chen gave the device a mixed review so you will have to check them out for yourselves (although it will not be a cheap exploration at $250 per pair).
“Senate Majority Leader Mitch McConnell (R-Ky.) signaled to reporters on Wednesday that he doesn’t have any plans to move again this year to repeal ObamaCare, even though Republicans might now have a better chance of success after Sen. Jon Kyl (R-Ariz.) was sworn in. Senate Republicans view Kyl as someone more likely to vote with GOP leaders on health care reform legislation than was late Sen. John McCain(R-Ariz.), the maverick whom Kyl replaced after his death. McCain’s vote ultimately axed the 2017 GOP effort to repeal ObamaCare. Moderate Republican Sens. Susan Collins (Maine) and Lisa Murkowski(Alaska) also voted no. But taking another stab at an ObamaCare repeal before the end of the year would be a herculean task as Senate Republicans would have to first pass a budget to set up a special process allowing such a bill to pass with a simple majority. “The agenda for the month is already set. We have our plate full through the end of the fiscal year,” McConnell told reporters Wednesday when asked about moving legislation in the next few months to repeal ObamaCare.”
“The Department of Justice is close to approving CVS Health’s acquisition of Aetna and Cigna’s acquisition of Express Scripts, The Wall Street Journal reported Wednesday, citing people familiar with the matter. Both deals could receive formal antitrust approval as soon as the next few weeks, the people told the Journal. Regulators will require CVS and Aetna to sell off assets related to its Medicare drug coverage in order to appease competitive concerns surrounding the nearly $70 billion deal, people familiar with the deliberations told The Wall Street Journal. One potential buyer in talks for the assets is WellCare Health Plans, though discussions between CVS, Aetna and the Justice Department are still ongoing, people told the paper.”
“Lawyers from 20 mostly conservative states on Wednesday demanded a federal judge scrap the “hollow shell” of Obamacare. The judge didn’t immediately rule on their request for an injunction but at times sounded sympathetic to their argument. The oral arguments opened the latest legal bid to kill the 2010 health care law, which has survived two major Supreme Court rulings and months of repeal efforts in Congress. While numerous legal experts have deemed the argument outlined in this case a stretch, Attorney General Jeff Sessions has thrown the Trump administration’s weight behind key parts of the legal assault, notably calling on the court to toss out the law’s popular protection for people with pre-existing conditions. The red states’ lawsuit has already become grist for campaign attacks ahead of the midterm elections, with Democrats pillorying Republicans for putting at risk protections for sick individuals. More than 7 in 10 Americans – including a majority of Republicans – said maintaining that protection is “very important,” according to the latest survey from the Kaiser Family Foundation. Two of the attorneys general pressing the lawsuit – Josh Hawley in Missouri and Patrick Morrisey in West Virginia – are running for Senate, challenging incumbent Democrats in states that Trump carried. U.S. District Court Judge Reed O’Connor, a George W. Bush appointee, vigorously questioned attorneys during the three-hour hearing but gave no indication of when he would rule. “
“The Senate has reached an agreement on an opioids package aimed at addressing the national epidemic that killed 72,000 Americans last year. The deal was first announced in a tweet Thursday night by Majority Leader Mitch McConnell’s (R-Ky.) spokesman, Don Stewart, who wrote that Democrats lifted a hold placed on the bill and that a floor vote was likely next week. Soon after, Sen. Rob Portman (R-Ohio) — who has several bills that are part of the package including an effort to combat synthetic drugs like fentanyl — released a statement saying that the bill would be voted on next week. The House passed another package of opioid measures in June, and the two sets of bills would need to be reconciled before becoming law. President Trump has declared the opioid crisis a public health emergency and on Aug. 20 urged the Senate to pass legislation that tackled the fentanyl problem specifically. The Senate bill had stalled over Democratic objections to a grant program they said was written too narrowly to benefit only one addiction advocacy group, the Addiction Policy Forum. The organization was closely connected to PhRMA and Democrats wanted the language broadened to cover more groups. This hold up was first reported Wednesday by Politico. Senators had been working all summer to reach a deal on opioid legislation, which has emerged as a rare bipartisan priority ahead of November’s midterm elections. Trump increased the pressure by tweeting that they must pass the Portman-sponsored bill on shipments of illicit fentanyl through the international postal system.”
“Millions of people covered under the Affordable Care Act will see only modest premium increases next year, and some will get price cuts. That’s the conclusion from an exclusive analysis of the besieged but resilient program, which still sparks deep divisions heading into this year’s midterm elections. The Associated Press and the consulting firm Avalere Health crunched available state data and found that “Obamacare’s” health insurance marketplaces seem to be stabilizing after two years of sharp premium hikes. And the exodus of insurers from the program has halted, even reversed somewhat, with more consumer choices for 2019.The analysis found a 3.6 percent average increase in proposed or approved premiums across 47 states and Washington, D.C., for next year. This year the average increase nationally was about 30 percent. The average total premium for an individual covered under the health law is now close to $600 a month before subsidies. For next year, premiums are expected either to drop or increase by less than 10 percent in 41 states with about 9 million customers. Eleven of those states are expected to see a drop in average premiums. In six other states, plus Washington, D.C., premiums are projected to rise between 10 percent and 18 percent. Insurers also are starting to come back. Nineteen states will either see new insurers enter or current ones expand into more areas. There are no bare counties lacking a willing insurer.”
August 24, 2018
*Healthcare Today is taking a small summer vacation. There will be no Healthcare Today update next week. Healthcare Today will return on September 7th. Have a good Labor Day weekend! *
The Senate passed the Labor-Health and Human Services-Education (Labor-HHS) Appropriations bill combined with the Defense Appropriations bill this week on a strong vote of 85 to 7. The Senate has not considered and passed a Labor-HHS appropriations bill since 2003. In 2003 Arnold Schwarzenegger was elected Governor of California and Finding Nemo was a hit at the box office to put things in perspective.
The bill includes a $2 billion increase in funding for the National Institutes of Health (NIH) matching a similar increase in funding. NIH faced flat funding for 12 years, but its budget has jumped from $30 billion to $39 billion in four years. The bill also includes significant resources to fight the opioid crisis. $3.7 billion is included for treatment and prevention measures. And $10 billion is included to fund research at the Department of Defense for non-addictive treatments for chronic pain. Also, of note the Senate included an amendment from Senators Grassley (R-IA) and Durbin (D-IL) to include funding for the Secretary of HHS to develop regulations to require pharmaceutical companies to disclose their price in direct-to-consumer advertising.
Speaking of the Senate, we are hearing the upper chamber is poised to consider a package of legislation in response to the opioid epidemic. We are hearing it will likely be on the floor after Labor Day. Insurance companies are lobbying hard to make sure the provision in the House passed bill (H.R. 6) to extend insurance coverage for people with end-stage renal disease (ESRD) to 33 months from 30 months in current law is kept out of the Senate package.
The Centers for Medicare and Medicaid Services (CMS) approved a waiver this week for the state of Maryland to implement a reinsurance program to help lower the cost of insurance plans sold on the Affordable Care Act (ACA) exchanges. The Maryland legislature approved two bills to create a reinsurance program for the individual market in the state. A tax is being imposed on insurance companies to subsidize the insurance plans with the most expensive patient population.
Tuesday marked the 100th day since the President rolled out his plan to combat the high cost of prescription drugs. HHS touted the fact that 15 drug companies have either “reduced list prices, rolled back planned price increases, or committed to price freezes for the rest of 2018.” Keep in mind that some of these pricing decisions came before the President made his announcement, but many companies have also reacted to the President’s messaging around drug pricing.
Google is exploring new fitness goals beyond the 10,000 steps a day goal as they are finding many people are intimidated by that goal. For us shoe-leather lobbyists, we often exceed that goal in just the morning of a client’s fly-in, but we understand the need to do more to encourage healthy lifestyles across the board. Google is looking at giving credit for activities like taking the stairs over using an elevator and creating rings on the Apple Watch for other goals beside 10,000 steps.
“U.S. Health and Human Services Secretary Alex Azar said it was within his agency’s power to eliminate rebates on prescription drug purchases, a key element of the Trump administration’s plan to lower prescription medicine costs. Such rebates are negotiated in the United States by pharmacy benefits managers (PBMs) to lower the cost of medicines for their clients, including large employers and health plans that cover tens of millions of Americans. Drugmakers say they are under pressure to provide rebates to the few PBMs that dominate the market, which include CVS (CVS.N), Express Scripts (ESRX.O) and UnitedHealth’s Optum (UNH.N), and that those payers do not pass on enough of those savings to patients – a contention the PBMs dispute. The drugmakers say the rebates force them to raise the price of their therapies over time to preserve their business. The Trump administration has been receptive to that argument. Azar, in an interview with Reuters on Friday, said rebates created a perverse incentive to continuously raise drug prices. Azar, a former top executive at drugmaker Eli Lilly & Co, is trying to deliver on President Donald Trump’s promises to lower the cost of prescription drugs for Americans, which Trump made a major priority during his 2016 presidential campaign.”
“The Justice Department has arrested one of the biggest sellers of drugs on the dark web and moved to bar two Ohio doctors from prescribing medications, part of a sprawling effort to prosecute drug cases amid the nation’s opioid epidemic. It is one of several arrests, charges and guilty pleas involving illicit and prescription drugs announced in Cleveland on Wednesday, as Attorney General Jeff Sessions is moving aggressively against those who distribute illicit drugs and illegally prescribe legal ones.“ Today’s announcements are a warning to every trafficker, every crooked doctor or pharmacist, and every drug company, every chairman and foreign national and company that puts greed before the lives and health of the American people: this Justice Department will use civil and criminal penalties alike, and we will find you, put you in jail, or make you pay,” Sessions said. Federal prosecutors allege that Matthew and Holly Roberts of San Antonio were two of the biggest drug dealers on the dark web, completing nearly 3,000 verified transactions on various underground marketplaces between 2011 and 2018 — including the largest number of verified fentanyl transactions on the dark web. Prosecutors said they operated under the name “MH4Life.” They could not be reached for comment Wednesday. In addition to the powerful synthetic opioid fentanyl, which has caused the number of overdose deaths nationwide to skyrocket, authorities allege the couple possessed and distributed fentanyl analogues, heroin, cocaine, methamphetamine, Xanax and other drugs.”
“The Senate on Thursday overwhelmingly passed an $857 billion spending package that Republican leaders are counting on to convince President Donald Trump to back down from threats of a government shutdown in September. The package, an uncommon bipartisan truce to fund two-thirds of government operations, was strategically crafted to ward off a presidential veto. But the odds remain long that the legislation will even make it to the White House, with just 11 working days left for House and Senate lawmakers to merge opposing versions of the bills — and get Trump’s approval — before funding runs out on Sept. 30. The Senate passed the fiscal 2019 package 85-7 during its rare mid-August session, after spending leaders brokered a temporary detente on including partisan policy language that has traditionally hindered the chamber’s ability to pass funding bills. The two bills in the package, which Senate Majority Leader Mitch McConnell called “hugely important,” would fund the departments of Defense, Labor, Education and HHS. The legislation includes victories for both parties, like the largest military pay raise in nearly a decade and an expansion of programs to counter opioid addiction. At the same time, McConnell and Minority Leader Chuck Schumer sidestepped political flash points like efforts to include provisions on abortion funding and the Trump administration’s policies for separating families that cross the border illegally.”
“The Senate on Thursday passed a measure to provide funding to require drug advertisements to disclose the price of the drug after a last-minute push. The passage came as part of the massive health-care spending bill that the Senate passed on Thursday, which included the amendment from Sens. Chuck Grassley (R-Iowa) and Dick Durbin (D-Ill.). The move marks a rare moment where Congress took some action aimed at high drug prices, a contentious issue that has been a recent target of Democrats and the Trump administration. “More information gives transparency to the transaction and will help give American consumers a break and start to slow down the skyrocketing cost of prescription drugs,” Durbin said in a statement. The Senate’s health spending bill still needs to be reconciled with the House’s before it goes to the president’s desk. Grassley and Durbin worked up until Thursday to get their amendment included, warning that powerful pharmaceutical companies were working against them.”
“The Trump administration needs to take more steps to better manage ObamaCare after enrollment dropped by 5 percent in 2018, the nonpartisan Government Accountability Office (GAO) said in a critical report released Thursday. The GAO recommended that the Department of Health and Human Services (HHS) set enrollment targets for 2019, a practice taken by the Obama administration but abandoned by the Trump administration, and better manage local groups responsible for signing people up for ObamaCare. Congressional Democrats who requested the report said its conclusions are proof the administration purposely set the Affordable Care Act (ACA) up for failure. “This independent and nonpartisan GAO report confirms that the Trump Administration’s sabotage of our health care system is driving up costs for consumers and leaving more Americans without health insurance,” Rep. Frank Pallone Jr. (D-N.J.) and Sens. Patty Murray (D-Wash.), Ron Wyden (D-Ore.) and Bob Casey (D-Pa.) said in a statement. “It’s not surprising that consumers were confused about the status of the ACA at the end of last year, which made the extreme cuts to consumer outreach and advertising that much more egregious.” Most of the stakeholders interviewed by the GAO said consumer confusion about ObamaCare likely played a major role in the decline in enrollment. While 9.2 million people signed up for ObamaCare plans in 2017, 8.7 million people enrolled in 2018. Stakeholders also blamed the administration’s decision to cut funds for outreach and advertising.”
The House Ways and Means Committee released its report on their red tape initiative aimed at seeking to remove regulatory barriers to improved health care outcomes. The report summarizes the efforts by the committee to work with stakeholders to identify these regulatory burdens. The report states the committee work is not done in this area and highlights the committee’s efforts to work with the administration on rulemaking but it is not clear from the report whether there will be further legislative action taken in this Congress on this issue.
The Senate Republican leadership released the text of a new opioid bill that combines the work of the Senate Finance; Health, Education, Labor and Pensions (HELP); and Judiciary Committees. The text was filed as a substitute amendment to the House passed opioid bill H.R. 6. The Senate is expected to turn to this bill after the passage of its next minibus comprised of the Defense and Labor, Health and Human Services, and Education appropriations bills.
Speaking of which, the Senate is expected to sort through numerous amendments that will be filed to the next minibus starting next week. Given the breadth of the bills, there is expected to be numerous controversial amendments ranging from abortion to migrant children to Department of Defense policies filed to the bill. The Senate Appropriations Committee is hoping the Senate can pass the bill without any so-called poison pill amendments included.
The Food and Drug Administration (FDA) announced on Thursday the approval of the first generic version of Mylan’s EpiPen. FDA touted this approval as another way the administration is helping to lower the cost of prescription medications. Similarly, Senate Judiciary Committee Chairman Chuck Grassley (R-IA) praised the approval as “great news for millions of Americans who depend on life-saving anti-allergy devices.” Mylan had widely criticized over price increases for their EpiPen. It is yet to be seen, however, how the new generic version will be priced.
Senator Grassley also made news this week when he called for anti-trust reviews of the two pending large healthcare mergers between CVS Health and Aetna and Cigna and Express Scripts. Grassley wrote a letter to the Assistant Attorney General for Antitrust to urge a careful examination of the pending mergers to ensure that these transactions do not lead to less competition and consumer access in the pharmaceutical supply chain.
“Google parent Alphabet has invested $375 million in next-gen health insurance company, Oscar Health. Google has been a longtime supporter of the six-year-old New York company, having previously invested in Oscar through its Capital G investment wing and Verily health and life sciences research wing. “Alphabethas invested in Oscar over many years and has seen the company and its team up close. We’re thrilled to invest further to help Oscar in its next phase of growth,” an Alphabet spokesperson told TechCrunch. That $165 million round raised back in March valued the health startup at around $3 billion. The new round maintains a similar valuation, while giving Alphabet a 10 percent share in Oscar. The deal also has longtime Google employee and former CEO Salar Kamangar joining Oscar’s board.”
“Three consumer groups are suing the Trump administration in an effort to halt the implementation of work requirements in Arkansas’ Medicaid program. The administration earlier this year approved Arkansas’ request to require certain Medicaid recipients to work 80 hours a month or lose their benefits. The mandate went into effect on June 1 for enrolleeswho are between the ages of 30 and 49, not disabled and don’t have dependent children at home. It will expand to those age 19 to 29 next year. The National Health Law Program, along with Legal Aid of Arkansas and the Southern Poverty Law Center, filed the suit in U.S. District Court in Washington D.C. on Tuesday. The suit charges that approval of Arkansas’ waiver runs counter to Medicaid’s objective of providing the poor with access to health care. It comes about six weeks after consumer groups successfully stopped the implementation of work requirements in Kentucky. A district court judge slammed the Department of Health and Human Services for not considering the waiver’s detrimental impact on enrollees. The administration is seeking to address the court’s concerns andhas reopened the application for evaluation. In Arkansas, thousands are already having trouble meeting the new rules. Nearly 30% of eligible enrollees did not satisfy the requirement in June. They have two more months to get back on track or get kicked out of the program. The rest worked, went to school, volunteered, searched for jobs or qualified for exemptions.”
“Drug overdose deaths surpassed 72,000 in 2017, according to provisional estimates recently released by the Centers for Disease Control and Prevention. That represents an increase of more than 6,000 deaths, or 9.5 percent, over the estimate for the previous 12-month period. That staggering sum works out to about 200 drug overdose deaths every single day, or one every eight minutes. The increase was driven primarily by a continued surge in deaths involving synthetic opioids, a category that includes fentanyl. There were nearly 30,000 deaths involving those drugs in 2017, according to the preliminary data, an increase of more than 9,000 over the prior year. Deaths involving cocaine also shot up significantly, putting the stimulant on par with drugs such as heroin and the category of natural opiates that includes painkillers such as oxycodone and hydrocodone. One potential spot of good news is that deaths involving those latter two drug categories appear to have flattened out, suggesting the possibility that opiate mortality may be at or nearing its peak.”
“President Donald Trump said Thursday he wants the U.S. government to sue pharmaceutical companies that manufacture opioids as part of his efforts to halt an epidemic of drug addiction. Trump said he’d like to bring a federal lawsuit, rather than just join existing litigation against the drugmakers. “Some states have done it,” Trump said during a Cabinet meeting at the White House. “But I’d like a lawsuit to be brought against these companies that are really sending opioids at a level — it shouldn’t be happening. So highly addictive. People go into a hospital with a broken arm, they come out, they’re a drug addict.” Drugmakers such as Purdue Pharma LP and Johnson & Johnson that sell opioid painkillers face hundreds of lawsuits filed by states, cities, counties, Native American tribes and labor unions as the epidemic of addiction continues to rage in the U.S. The Centers for Disease Control and Prevention said preliminary estimates indicate that almost 72,000 Americans died from opioid overdoses last year, a figure that has been rising for years.”
The Trump administration continued with its push to help lower prescription drug prices. On Tuesday, August 7th, the Centers for Medicare and Medicaid Services (CMS) announced that Medicare Advantage plans can now begin to use step therapy for physician-administered drugs. That means patients have to start with the least costly therapies and insurance companies would have to give prior approval before more costly drugs can be used. Physician-administered drugs are covered under Medicare Part B currently and represent about $12 billion in spending under Medicare Advantage plans. The Department of Health and Human Services (HHS) estimates that this policy will save between 15 to 20 percent.
The Office of the National Coordinator of Health Information Technology (ONC) held a three-day conference on interoperability this week. CMS Administrator Seema Verma vowed to make health-care providers “fax-free” by 2020. ONC’s Steve Posnack declared that there will be a new holiday coming up. October 12, 2018 will be “No Fax Friday.” Pretty amazing that with all of the technical advances we are still discussing fax machines. There were many other important issues discussed at the forum in terms of patient matching, interoperability infrastructure, and many more.
CMS released a proposed rule on Thursday to revamp the Medicare Shared Savings Program where Accountable Care Organizations (ACOs) are eligible for shared savings payments if they are able to deliver savings in Medicare Part A and Part B using coordinated care models. Under the current Shared Savings Program, ACOs can opt for different tracks with different levels of risks and possible rewards. CMS Administrator Verma stated that she wants to see ACOs taking on more risk as most of the ACOs are participating in track 1 of the Medicare Shared Savings program where there is no risk of losing money if they do not meet key goals and the cost of care is greater than in a traditional care setting. The trade association for ACOs expressed some disappointment with this proposal.
Many states are reacting to the short-term plans regulation issued by the Trump administration last week. Sixteen states have vowed to regulate these plans more rigorously than the federal government will under this rule. Since insurance is still regulated at the state level, there is not much the federal government can do about those reactions. The White House has been touting the savings that individuals can achieve by buying a short-term plan versus buying a Silver plan (one of the least expensive) on the Affordable Care Act exchanges.
The Food and Drug Administration on Monday announced a shift in the way it evaluates drugs to treat opioid addiction that the agency says will give it more flexibility to approve new treatments. Now, rather than merely examining whether a potential treatment reduces opioid use, the agency will consider factors like whether a drug could reduce overdose rates or the transmission of infectious diseases. “We must consider new ways to gauge success beyond simply whether a patient in recovery has stopped using opioids, such as reducing relapse overdoses and infectious disease transmission,” FDA Commissioner Scott Gottlieb said in a statement. The announcement is the latest in a string of efforts to improve the federal government’s response to the growing opioid crisis, which also includes legislation on Capitol Hill that aims to ensure treatment is evidence-based and, separately, to ensure more federal programs will pay for methadone treatment. MAT, coupled with psychosocial counseling, is widely acknowledged to be the standard of care in treating opioid addiction. Currently, just three drugs exist to treat opioid use disorder: buprenorphine, methadone, and naltrexone. Adherence to the drugs is typically low, and addiction treatment experts have long said MAT is vastly underutilized, calling for expanded access to existing options and the development of more drugs beyond the existing three.”
“Pharmaceutical companies will soon have to negotiate prices for more drugs. The Centers for Medicare & Medicaid Services will allow Medicare Advantage plans to negotiate prices of medicines covered under Medicare Part B, which covers drugs typically administered by a physician. These tend to be more expensive treatments like rheumatoid arthritis drugs and some cancer drugs. Medicare Advantageplans, which are offered by private companies, will also be able to use step therapy, or starting patients on less expensive options before moving them up to more expensive drugs. CMS Administrator Seema Verma told reporters Tuesday this practice is already “widely used” across the private sector. Verma said she expects lower drug prices to come from insurers and pharmacy benefit managers negotiating better discounts and passing those savings on to patients. They’ll be required to pass on more than half of these savings. “For too long, Medicare Advantage plans have not had the tools to negotiate a better deal for patients,” Verma said in a statement. “Today we begin lifting those barriers so plans can use private-sector tools to drive down the cost of expensive drugs while also offering new care coordination and drug adherence programs, to ensure that patients are getting high quality care at lower cost.” Plans can implement the changes starting Jan. 1, 2019. In a statement, Health and Human Services Secretary Alex Azar said drug prices “can start coming down for many of the 20 million seniors” enrolled in Medicare Advantage plans “as soon as next year.” Spending on drugs covered under Part B totaled $27.5 billion in 2015, according to a report from The Medicare Payment Advisory Commission. A handful of treatments covered under Medicare Part B cost more than $1 billion in one year alone, according to government data from 2016.”
U.S. President Donald Trump said he would make an announcement next week that would bring down prescription drug prices “really, really substantially.” Trump didn’t further explain the action he would take in comments to reporters at the beginning of a dinner Tuesday with corporate leaders at his golf club in Bedminster, New Jersey. Trump said the prices of prescription drugs made by Pfizer, Novartis and other pharmaceutical companies were “too high.” He added, “We are announcing something next week which is going to get them down really, really substantially.”
“Two top Republicans are urging the White House to complete a thorough economic analysis before releasing a new policy that could completely upend the way prescription drugs are purchased. In a letter to Office of Management and Budget (OMB) Director Mick Mulvaney, House Energy and Commerce Committee Chairman Greg Walden (R-Ore.) and Senate Finance Committee Chairman Orrin Hatch (R-Utah) said they want a full analysis of a pending proposed rule regarding prescription drug rebates. “The publicly available title of the rule indicates that the action contemplated could be significant in scope, with the potential to dramatically change the process by which prescription drugs are purchased within the supply chain,” Walden and Hatch wrote. Even without knowing the full details of the proposal, the chairmen said the changes “could ripple across the health care sector.” The proposed rule is part of the administration’s efforts to bring down the costs of prescription drugs. The rule, which is currently under review by the OMB, could remove the legal protection of rebates paid by drug companies to insurers and pharmacy benefit managers. Generally, a pharmaceutical company pays a rebate so a pharmacy benefit manager – the third-party administrators of prescription drug programs – will make its product the only one of its kind on the list approved for reimbursement or so that the co-pay for its product is less than the co-pay of competing products.”
“Health and Human Services Secretary Alex Azar on Thursday urged states to cooperate with the Trump administration’s expansion of “short-term” health plans outside of ObamaCare. Several state regulators have moved to restrict the sales of these plans in their states, arguing that, despite being less expensive than ObamaCare plans, they’re bad for consumers and aren’t an adequate substitute for comprehensive insurance. Unlike plans sold under ObamaCare, the administration’s short-term health plans do not have to cover services like maternity care or prescription services, and they can deny coverage to people with pre-existing conditions. Speaking at the American Legislative Exchange Council in Louisiana, Azar said the short-term plans are a viable option for people who can’t afford ObamaCare, arguing that states should not restrict access to them. “This affordable option will only be as available as state legislators and insurance commissioners allow it to be,” Azar said. The administration issued a rule last week extending the maximum duration of short-term plans from three months to up to three years.”
August 3, 2018
The Departments of Health and Human Services (HHS), Labor, and Treasury released a final rule on Wednesday defining short-term healthcare plans that do not need to comply with the Essential Health Benefits requirements of the Affordable Care Act (ACA). These plans also do not have to comply with the requirement that 80 percent of the plans revenues be spent on medical care or quality improvement. Nor do these plans have to comply with the pre-existing condition ban in the ACA.
Under the Obama Administration, these plans were limited to 3 months to be used for sudden and unforeseen circumstances such as a disruption in work. Under the Trump Administration’s rule, these plans are 12 months in duration and may be renewed by the insurer providing coverage three times (for a total of three years). The Trump Administration is touting this rule as a way to help drive down the cost of health insurance. Critics of this rule believe this will further undermine the ACA marketplaces. This rule is likely to be challenged in the courts and Congress. Senate Democrats are planning to introduce a Congressional Review Act resolution to repeal this regulation.
The Federal Communications Commission voted unanimously to advance the $100 million telehealth pilot program. The program would fund broadband deployment to connect Medicaid beneficiaries and veterans to at-home telehealth services such as monitoring for chronic conditions. FCC has previously supported broadband deployment to connect healthcare facilities but this is the first time they will be connecting with patients.
The Centers for Medicare and Medicaid Services (CMS) released a trove of Medicare Advantage (MA) data to CareSet, the health data NGO. CareSet will aggregate the data and release it for studies and analysis. This is the first time MA data has been released from CMS which is significant as about one third of seniors are enrolled in MA plans.
The Senate Committee on Health, Education, Labor, and Pensions held their third hearing in a series on healthcare costs. The focus of this hearing was on administrative costs. Each of the three witnesses, of course, pointed to different drivers of administrative costs. This was also the hearing where a Senator made a quip about dropping acid.
We are expecting the Senate to consider the Labor-HHS appropriations bill when it returns on August 15th. This bill will be paired with the Department of Defense appropriations bill to create another minibus. If the Senate can manage to get 60 votes to cut off debate and amendments to the bill, they will likely push the House to pass it as written by the Senate.
“Hoping to head off a full expansion of Medicaid under the Affordable Care Act, some senior officials in the Trump administration and Republican governors have been pushing hard for a smaller expansion to satisfy a growing political demand in their states. But President Trump decided on Friday to shut down the debate until after the midterm elections, administration officials said. The debate has divided the Trump administration between top officials at the Department of Health and Human Services and hard-liners, mainly at the White House, more determined to snuff out the Affordable Care Act. And it gained steam as states pressed forward with Medicaid expansions that could leave more people with health coverage under the Affordable Care Act next year than when Mr. Trump took office. This year, Virginia expanded Medicaid through the Affordable Care Act. Maine voters approved an expansion that is likely to begin after the current governor, Paul R. LePage, leaves office next year. And ballot measures in Utah, Idaho and Nebraska could expand Medicaid in deep red states.”
“Enrollment in the individual health insurance market — the market for people who don’t get coverage through work — has declined 12 percent in the first quarter of 2018, compared to the same period last year, according to a new analysis released Tuesday. The analysis from the Kaiser Family Foundation showed enrollment in the individual market grew substantially after the implementation of the Affordable Care Act (ACA) and remained steady in 2016, before dropping by 12 percent in 2017. There were 17.4 million people enrolled in the individual market in 2015, compared to 15.2 million in 2017 and 14.4 million in the first quarter of 2018. The study notes that much of the decline is concentrated in the off-exchange market, where a number of enrollees are not eligible for ObamaCare subsidies and therefore not protected from significant premium increases in 2017 and 2018. In this market, enrollment numbers dropped by 38 percent from the first quarter of 2017 to the first quarter of 2018. The Trump administration last year canceled key ObamaCare subsidies for insurers, leading insurers to increase premiums substantially.”
“Pfizer Chief Executive Ian Read said on Tuesday he believes the Trump administration intends to stop the practice of allowing rebates on prescription drug purchases, suggesting that U.S. drug pricing reforms may focus on middlemen rather than drugmakers. “I believe the administration does want to remove rebates, and they consider it a priority,” he said in an interview, following similar comments made on Pfizer’s conference call to discuss second quarter earnings. The administration has already proposed a rule that would scale back protections currently in place that allow rebates between drug manufacturers and insurers and pharmacy benefits managers (PBMs). Read said he believes the administration wants to get rid of them entirely.”
“The Trump administration took another whack at the Affordable Care Act on Wednesday. Officials unveiled a final rule that will make it easier to obtain coverage through short-term health insurance plans, which don’t have to adhere to the law’s consumer protections. The move would reverse an Obama administration decision to limit the duration of short-term plans to no more than 90 days in order to make them less attractive. Insurers will soon be allowed to sell these policies for just under a year. They can be renewed for up to 36 months, though that renewal isn’t guaranteed. Administration officials say the short-term plans will provide a cheaper health insurance alternative for those who can’t afford to buy coverage on the Obamacare exchanges. “We fully recognize that these products are not necessarily for everyone, but we do think they will provide an affordable option to many, many people who’ve been priced out of the current market under the Obamacare regulations,” said Randy Pate, a deputy administrator at the Centers for Medicare & Medicaid Services. But patient advocates and health policy experts argue that these policies provide only skimpy coverage and will undermine the Affordable Care Act. Other actions the administration has taken this year include making it easier for small businesses to band together to buy coverage and slashing support for a program that helps people sign up for Obamacare.”
“Top Senate Democrats said they are planning to force a vote on a measure that would overturn the Trump administration’s rule expanding access to cheap, controversial insurance plans. The resolution of disapproval will be introduced by Sen. Tammy Baldwin(D-Wis.). During a call with reporters Thursday, Senate Minority Leader Charles Schumer (D-N.Y.) said he thinks there will be unanimous support among Democrats once the resolution is introduced. The measure will only require 51 votes to pass, which would mean that in Sen. John McCain’s (R-Ariz.) absence the backers need to recruit one Republican to their cause. “All it takes is one or two Republicans who claim to support preexisting condition protections,” Schumer said. The resolution aims to overturn the Trump administration’s new rule that expands access to non-ObamaCare insurance plans. The administration touts these plans because they offer lower premiums for healthy people, but the plans don’t need to follow ObamaCare rules, meaning they can charge people with preexisting conditions higher premiums and leave out coverage of certain health services. Democrats attack the plans as “junk” insurance and say the move is part of the administration’s efforts to “sabotage” ObamaCare.”
July 27, 2018
The House had three healthcare bills on the floor this week. Two of the bills (H.R. 6199 and H.R. 6311) expanded the use of health savings accounts (HSAs) to allow more uses for HSAs for preventive care and over-the-counter medications and to increase contributions respectively. The third bill (H.R. 184) permanently repeals the medical device tax imposed by the Affordable Care Act (ACA). Earlier this year Congress approved and the President signed into law a two-year delay of the tax as part of a continuing resolution.
The Centers for Medicare and Medicaid Services (CMS) released the hospital outpatient prospective payment system (OPPS) proposed rule this week. The rule contains a controversial site-neutral payment proposal where hospital reimbursements are lowered to the levels provided for similar treatments in a physician office. The rule also expands the number of services that can be preformed in ambulatory surgical centers. CMS is touting these provisions as increasing competition in healthcare. However, hospitals will likely strongly oppose these proposals and the proposed reductions in reimbursements for drugs purchased under the 340B program.
CMS also released a rule this week to authorize the risk adjustment program under the ACA. This is the program that allows insurance companies with low-risk patient populations to compensate the insurance companies that have high-risk patient populations. The Trump administration had previously suspended these payments, but this final rule re-establishes the program.
Attorney generals from 11 states and the District of Columbia filed suit against the Trump administration over their association health plan final rule. The lawsuit claims that the Department of Labor did not follow the Administrative Procedures Act in crafting the rule to redefine “employer” to allow for businesses to pool together to offer health insurance that does not need to comply with the essential health benefits requirement of the ACA.
It seems like we are always hearing “there is an app for that?” these days. But this one caught our attention. The California medical board developed an app to allow patients to check on the licensure status of their physician to see if they have moved, added a new specialty, or have been subject to disciplinary actions for transgressions.
“Robert Wilkie, a Pentagon under secretary, was confirmed Monday by the Senate as secretary of the Department of Veterans Affairs, giving the sprawling agency its first permanent leader in months. The vote, which was 86-9, came the day before the President will address the Veterans of Foreign Wars national convention in Kansas City. Nominees to lead the VA are typically confirmed unanimously by the Senate. While Wilkie was confirmed overwhelmingly, the vote was the first time since the VA secretary became a Cabinet position that any senators voted against confirmation. In a statement, President Donald Trump praised Wilkie as someone who has “dedicated his life to serving his country with honor and pride,” and said Wilkie has displayed “great patriotism and a commitment to supporting and empowering America’s armed forces and veterans.” The nine lawmakers who voted against Wilkie’s nomination were mostly Democrats, joined by Bernie Sanders, a Vermont independent, who cast the lone dissenting vote against advancing Wilkie’s nomination in committee. Sanders said then that he voted no because he was concerned that the Trump administration would privatize the VA’s health care.”
“The House on Tuesday voted to repeal ObamaCare’s medical device tax, a provision that members of both parties have criticized as harming innovation. The House voted 283 to 132 to repeal the 2.3 percent tax on sales of medical devices, with some Democrats joining Republicans to approve the measure. 57 Democrats voted for the measure. The vote comes during a week of health-care measures put forward by the GOP as they try to blunt Democratic attacks over rising premiums, a key midterm message. The vote could help Rep. Erik Paulsen (R-Minn.), the sponsor of the bill, who faces a tough reelection fight this year. “This bill reverses a harmful tax that is hurting job growth and innovation across the country,” Paulsen said. There is no clear path forward for the measure in the Senate this year, however.”
“The Centers for Medicare and Medicaid Services is proposing to move toward site neutral payments for clinic visits and to close a loophole through which providers are billing patients more for visits in hospital outpatient departments when they create new service lines. In a proposed rule for the 2019 Medicare hospital outpatient prospective payment system and ambulatory surgical center payment system, CMS has proposed site neutral payments for clinic visits, the most common service billed under the OPPS. Currently, CMS often pays more for the same type of clinic visit in the hospital outpatient setting than in the physician office setting. If finalized, the proposal is projected to save patients about $150 million in lower copayments for clinic visits provided at an off-campus hospital outpatient department, CMS said. The proposed rule aims to address other payment differences between sites of service. For 2019, CMS is proposing to expand the number of procedures payable at ambulatory surgical centers to ensure the payment for procedures involving certain high-cost devices parallels the amount provided to hospital outpatient departments.”
“The House on Wednesday passed a measure to delay ObamaCare’s health insurance tax for two years and expand Health Savings Accounts, part of a GOP effort to try to lower premiums. The bill, which passed 242-176, is part of a Republican effort to blunt Democratic attacks on the GOP for rising premiums – a key argument in the midterm elections this year. The health insurance tax has been criticized by Republicans and some Democrats for driving up premiums. “This is a flawed tax that gets passed onto American families,” Rep. Peter Roskam (R-Ill.) said on the House floor. Democrats, though, said the measures would have no substantial impact on premiums, and instead pointed to Republican efforts to protect themselves in the midterms.”
“Department of Health and Human Services Secretary Alex Azar said the agency is “undeterred” by a judge’s ruling overturning work requirements in Kentucky. Addressing the Heritage Foundation on Thursday morning, Azar said the agency’s goal is to make “sensible reforms” that address the Medicaid program’s growth and changing demographics, as Medicaid expansion led to far more single, “able-bodied” enrollees. “I’ve told the team as we work on this that the mantra should be common sense,” Azar said. “Anything a state does here, people should look at it, ‘Oh yeah. That’s not some unreasonable, crazy thing.” A judge in the U.S. District Court for the District of Columbia ruled that HHS did not consider whether adding the work requirements would allow Kentucky’s Medicaid program to provide medical assistance to people in the state. In approving Kentucky’s work requirements waiver, HHS failed to note that the changes could lead to 95,000 people losing coverage—a “glaring” oversight, the judge ruled.”
July 20, 2018
Despite the challenging environment of a charged election year, Congress did approve two bipartisan health bills this week. The Energy and Commerce Committee approved H.R. 6378 to reauthorize the programs in the Pandemic and All-Hazards Preparedness Act. The bill authorizes additional funding to respond to pandemic influenza and emerging infectious diseases. The Energy and Commerce Committee also approved H.R. 5333 to revamp the approval process for over-the-counter drugs. The bill creates a $134 million Food and Drug Administration (FDA) user fee program to approve these medications.
A federal appeals court upheld a decision from a lower court to allow the Trump Administration to move forward on their plan to cut $1.6 billion in reimbursements under the 340B program. In a unanimous decision, the court found that the hospital associations lawsuit was premature because the cuts had not yet taken effect. The American Hospital Association has already stated it plans to refile their suit in district court.
FDA Commissioner Scott Gottlieb outlined an 11-point biosimilar action plan at speech before the Brookings Institution as part of the administration’s efforts to tackle high drug prices. The plan is seeking to spark competition in the biosimilar market. While only 2 percent of patients use biosimilar treatments, they account for 40 percent of total spending on drugs.
FDA is also tackling the controversial issue of drug importation. FDA is convening a working group to explore the issue of importing single source drugs with no patents or exclusivities associated with it for instances when there is a price spike or there are patient access issues.
During the last week, we saw our country celebrate national daiquiri day, national hot dog day and national ice cream day. Let’s hope our fruit and vegetables get national recognition in the coming weeks to get our diets back on track.
“House Ways and Means Committee Chairman Kevin Brady (R-Texas) said Monday that he is in talks with the Trump administration about ways to restart key ObamaCare payments that the administration abruptly suspended this month. The administration’s surprise suspension of $10.4 billion in payments to insurers this month set off a round of warnings of rising premiums and condemnation from Democrats who said it was further GOP “sabotage” of the health-care law. Brady, a key congressional Republican on health-care issues, told reporters Monday that he is talking with Health and Human Services Secretary Alex Azar and others about how to restart the payments. “The administration wants to restore those payments, so we’re looking at ways that we can help them do that,” Brady said. He left open the possibility of legislative action to help address the situation. The House is planning to vote next week on a range of health-care bills, including expanding health savings accounts and delaying or repealing certain ObamaCare taxes, Brady said.”
“An appeals court on Tuesday rejected an attempt by hospitals to challenge the Trump administration’s changes to the controversial federal drug discount program known as 340B, sticking them with a $1.6 billion cut in federal payments. The decision is the latest in a series of blows to hospitals trying to preserve the program, which increasingly pits them against the drug makers who must offer steep discounts on medicines under its rules. Participating hospitals get higher reimbursement for the drugs from the federal government, and use the difference to cover charity care and other costs. Last July, the Trump administration proposed slashing its higher reimbursement for the drugs by about 27 percent — amounting to a roughly $1.6 billion cut for the industry in 2019. Hospitals, led by the American Hospital Association, America’s Essential Hospitals, and the Association of American Medical Colleges along with three of their individual members, lost their initial lawsuit over the cuts when a federal judge ruled they had contested the change prematurely, before any of the cuts had actually taken effect. The appellate judges, from the U.S. Court of Appeals for the District of Columbia Circuit, affirmed that decision Tuesday.”
“Novartis, the Swiss drugmaker, said Wednesday that it would not raise prices on its products in the United States for the rest of 2018, joining Pfizer, which delayed its increases last week after President Trump singled out the company for criticism. Novartis’s chief executive, Vas Narasimhan, said during an earnings call with investors that the company had made the decision in June, amid escalating outrage over high drug prices. “We thought that was prudent, given the dynamic environment we’re currently in,” he said. A spokesman for Novartis said the company notified the state of California, which has a new drug-price transparency law, of its decision in June, but the news was not widely known. Pharmaceutical companies are scrambling to stem the groundswell of criticism over steep drug pricing, as elected officials and the Trump administration have taken up the issue.”
“The health department has quietly dipped into tens of millions of dollars to pay for the consequences of President Donald Trump’s border policy, angering advocates who want the money spent on medical research, rural health programs and other priorities. The Department of Health and Human Services has burned through at least $40 million in the past two months for the care and reunification of migrant children separated from their families at the border — withhousing costs recently estimated at about $1.5 million per day. The ballooning costs have also prompted officials to prepare to shift more than $200 million from other HHSaccounts, even as the White House weighs a request for additional funding for the Department of Homeland Security — a politically explosive move almost certain to antagonize fiscal hawks in the run-up to the midterm elections.”
“CVS Health Corp.’s proposed acquisition of insurer Aetna Inc. could attract the attention of the Justice Department because it appears likely to reduce competition in at least some of the Medicare prescription drug plan markets in which the two companies currently compete. It would not only be a merger between the nation’s largest health insurer and its second largest pharmacy benefit manager and pharmacy chain, it would also be a merger between two major Medicare prescription drug plan administrators. As the Justice Department weighs the deal, antitrust enforcers could be concerned that both companies sell Medicare Part D prescription drug plans to seniors. According to Bloomberg Intelligence analysts, a merged CVS-Aetna would account for 33 percent of the Medicare Part D market. The accompanying graphics show the merger could have a big impact on Middle America. In many counties, a merger would mean that more than half of the Medicare beneficiaries enrolled in a Part D plan would be the conglomerate’s customers. In McPherson County, Neb., 100 percent of people enrolled in Medicare prescription plans would have coverage through CVS-Aetna.”
July 13, 2018
Two big much anticipated Medicare payment regulations were released this week by the Centers for Medicare and Medicaid Services (CMS). The physician fee schedule proposed rule is attempting to scale back the amount of documentation physicians need to provide for payment in an effort to streamline the Medicare program to allow doctors to spend less time on compliance and more time with patients. The proposal was met by cautious optimism from physician stakeholders. The End-Stage Renal Disease (ESRD) proposed rule contained some changes for reimbursement for durable medical equipment. The competitive bidding for durable medical equipment was put on hold for 2019 while CMS contemplates reforms to the program.
The Ways and Means Committee reported out four bills this week to expand the use of health savings accounts (HSAs). The measures allow Medicare beneficiaries to continue to contribute to their accounts. Other provisions of these bills allow more services, treatments and over-the-counter drugs to be covered by HSAs. These proposals met sharp criticism from committee Democratic Members who charge that these policies will encourage the sale of more high-deductible low-value plans and create incentives for insurance companies to pull back from the Affordable Care Act (ACA) marketplaces. The committee also approved bills to postpone the ACA employer mandate and delay the so-called Cadillac tax the ACA imposed on high cost plans.
One of the Federal Communications Commission (FCC) Commissioners floated the idea of creating a $100 million pilot program to fund telehealth services for low-income Americans after they are discharged from hospitals or clinics. The FCC will consider this proposal at their next meeting in early August.
The House Appropriations Committee approved the Labor-HHS appropriations bill this week. The committee approved several amendments aimed at how HHS is handling the situation with the migrant children separated from their parents. Republicans on the committee were successful in defeating amendments offered by Democratic Members seeking to restore funding for the Title X program and to authorize the Centers for Disease Control (CDC) to study gun violence. Earlier this year the committee had clarified that CDC is permitted to conduct this kind of research but there currently lacks any funding or authorization for them to conduct those studies.
There is new attention around the so-called Stark law which is the anti-kickback law enacted by Congress in 1989. Critics of the law believe it is serving as an impediment to innovative ways to better coordinate care. CMS is convening an inter-agency panel to review the law to see if it is presenting unnecessary regulatory barriers to better more coordinated care. The Ways and Means Committee’s Health Subcommittee also announced a hearing next week to review the laws as well.
We are sure there will continue to be scrutiny over the healthcare cases that came before President Trump’s nominee for Associate Justice on the Supreme Court Brett Kavanaugh. Judge Kavanaugh has had cases involving abortion, contraception and the ACA’s individual mandate come before him on the D.C. Circuit Court of Appeals.
“The Trump administration’s latest blow to Obamacare is rattling health insurers as they draw up rate proposals, sparking new worries about huge premium increases just before midterm elections. The administration’s decision to freeze a $10 billion program designed to protect insurers from big losses in Obamacare injected more volatility into insurance marketplaces, which President Donald Trump’s health department has sought to undermine. And the move swiftly drew new warnings from insurers that higher premium increases could soon follow when enrollment reopens in November. This decision really does add uncertainty in the marketplace and could impact rates,” said Kris Haltmeyer, vice president of legislative and regulatory policy at the Blue Cross Blue Shield Association, who urged the administration to quickly reinstate the program. Obamacare insurers again have already proposed double-digit rates hikes on average for the 2019 enrollment season starting in November. Many insurers have said the administration’s attacks on the law, from killing the individual mandate to boosting skimpier health plan alternatives, are contributing to higher prices.”
“Spooking House conservatives and risking a presidential veto, Senate spending leaders are proposing to blow past budget limits to fund a popular private health care program for military veterans. Minutes before they were to meet on Thursday, congressional appropriators canceled their first public conference talk that had been intended to settle differences in three of the 12 annual spending bills President Donald Trump must sign by Sept. 30 to avert a government shutdown. One of the three provides for spending on veterans. The 11th-hour cancellation came amid a cross-Congress showdown over how to pay for a program that allows some veterans to spend taxpayer money on private doctors and hospitals. The question is whether to break budget limits, known as caps, to come up with the cash.”
“The liberal base is fired up about abortion rights, but Senate Democratic Leader Charles Schumer (N.Y.) will seek to emphasize access to affordable health care as much as Roe v. Wade in the battle over the Supreme Court. In sharp contrast to the Obama era, Schumer thinks health care is the Democrats’ best weapon. By putting the charged issue of women’s reproductive rights within the broader framework of access to health care, the matter is likely to be less polarizing in red states. Ten Democrats face reelection this year in states that President Trump won in 2016, and four of those battlegrounds lean against abortion rights, according to a state-by-state survey by the Pew Research Center. Another Democratic senator, who is not up for reelection until 2020, Sen. Doug Jones (Ala.), also hails from a majority anti-abortion state. Trump announced Monday night that he would nominate Brett Kavanaugh, a judge on the influential U.S. Court of Appeals for the District of Columbia Circuit, to the nation’s highest court. By emphasizing access to affordable health care, Schumer is also making a bid for two Republican swing votes, Sens. Susan Collins (Maine) and Lisa Murkowski (Alaska), who voted against the Republican plan to repeal ObamaCare in 2017.”
“Pfizer announced on Tuesday it would postpone drug price hikes after an “extensive” conversation between the company’s CEO and President Donald Trump. “Pfizer shares the President’s concern for patients and commitment to providing affordable access to the medicines they need,” Pfizer CEO Ian Read said in a statement. The company said it would defer price increases, effective July 1, to give Trump “an opportunity to work on his blueprint to strengthen the healthcare system and provide more access for patients.” Drug prices will return to the levels they were prior to July 1 as soon as possible, according to Pfizer. The prices will remain at those lower levels until the end of the year, or until Trump’s health-care plan goes into effect — whichever comes sooner.”
“The Trump administration is once again slashing funding for a program that helps Americans sign up for Obamacare. The Centers for Medicare & Medicaid Services announced Tuesday that it would provide only $10 million for the navigator program for this fall’s open enrollment season. The move is the latest effort by the Trump administration to undermine the Affordable Care Act. This past year, navigators only received $36 million in funding, down from $63 million in 2016. The reduction was paired with a 90% cut in Obamacare’s advertising budget. The agency once again defended the decrease by saying that navigators, which usually hail from non-profit and community organizations, are not effective. They enrolled less than 1% of consumers who signed up for 2018 coverage in 34 states using the federal exchange, according to CMS. Navigators say they don’t get credit for all the consumers they help guide through the process but don’t actually sign up. Also, navigators assist people with enrolling in Medicaid, which is not reflected in the numbers. The Trump administration broadened the opportunity for private sector agents and brokers to assist consumers in signing up last fall. They assisted 42% of enrollees, the agency said.”
“The Centers for Medicare and Medicaid Services on Wednesday released proposed payment changes for durable medical equipment prosthetics, orthotics and supplies and the end-stage renal disease programs. Payments for 2019 to end-stage renal disease facilities are expected to increase by 1.7 percent compared to this year. For hospital-based ESRD facilities, CMS projects an increase in total payments of 1.8 percent, while for freestanding facilities, the projected increase in total payments is 1.7 percent. For 2019, Medicare expects to pay approximately $10.6 billion to approximately 7,000 ESRD facilities for the cost associated with furnishing chronic maintenance dialysis services.”
July 6, 2018
The Inspector General (IG) of the Department of Health and Human Services (HHS) released a report this week on opioid use in the Medicare Part D program. The study finds that nearly one third of Medicare Part D beneficiaries – 14.1 million out of 45.2 million enrolled in the program – received an opioid prescription last year. Of particular concern, 4.9 million beneficiaries received opioid prescriptions for three or more months. The IG is concerned about these numbers and whether opioids are being properly prescribed and used. Alabama, Mississippi, Arkansas and Oklahoma were the states with the highest opioid usage. The study did find examples of patients who appear to be “doctor shopping” where they received multiple prescriptions for many different providers and were having their prescriptions filled at different pharmacies. The study concludes that multiple efforts by the federal and state governments must be taken to curb overuse of opioids and mentioned that the Centers for Medicare and Medicaid Services (CMS) will be putting in place new policies next year to address overutilization in Part D.
Everyone is anxiously awaiting the release of several Medicare payment proposed rules this week. While there is no hard deadline for their release, CMS typically tries to have the rules published no later than early July to allow enough time for a 60-day comment period and their ability to respond to the comments and finalize the rule in time for the new payment systems to take effect in January. The physician fee schedule is expected to contain new quality pay provisions and the end stage renal disease rule is expected to include medical equipment bidding provisions.
The Senate Committee on Veterans Affairs announced this week it will hold a confirmation vote for Robert Wilkie on July 10th. Wilkie’s confirmation is expected to sail through the Senate as he has the backing of the Chairman and Ranking Member of the committee.
Next week, the House Energy and Commerce Health Subcommittee will be holding a hearing on the 340B Drug Pricing Program. The Health Subcommittee will learn more about a recent report by the nonpartisan Government Accountability Office (GAO) regarding lax oversight of contract pharmacies within the 340B Drug Pricing Program. The subcommittee will also get feedback on several bills and discussion drafts that would strengthen the 340B Program.
Apple is picking up its entry into the electronic health records (EHR) space. Several big health networks are signing up for a feature that allows patients to download their health records directly onto their Apple product. The Cleveland Clinic has its own health records app known as MyChart. MyChart allows patients to see upcoming and past appointments, physician notes, schedule appointments and request prescription renewals.
“As health insurers across the country begin filing their proposed rates for 2019, one thing is clear: The market created by the Affordable Care Act shows no signs of imminent collapse in spite of the continuing threats by Republicans to destroy it. In fact, while President Trump may insist that the law has been “essentially gutted,” the A.C.A. market appears to be more robust than ever, according to insurance executives and analysts. A few states are likely to see a steep spike in prices next year, but many are reporting much more modest increases. Insurers don’t appear to be abandoning markets altogether. In contrast to last year, regulators are not grappling with the prospect of so-called “bare” counties, where no carrier is willing to sell A.C.A. policies in a given area. “The market is in a better position now than it has ever been since the exchanges have opened,” said Deep Banerjee, who follows insurers for S & P Global Ratings. The companies first began selling policies in the state exchanges, or marketplaces, five years ago. After years of losses, the insurers are now generally making money.”
“Supporters of Medicaid expansion in Nebraska say they have reached their goal to become the third Republican-leaning state this year to put an initiative on the November general election ballot. The group Insure The Good Life said Thursday that more than 133,000 signatures – shattering the required 85,000 needed — will be submitted Thursday to the Nebraska Secretary of State’s office to bring healthcare to 90,000 Nebraskans via ballot measure. The Secretary of State and county clerks then have 40 days to certify the signatures, supporters said Thursday. “Nebraska has left more than $1 billion of Nebraskans’ tax dollars on the table – dollars that we send to Washington D.C. and don’t see again.” former Nebraska Senator Kathy Campbell said Thursday. “Let’s bring that money home – money that is already going to states like Arkansas, Iowa, and California.” Nebraska, Utah and Idaho could follow the lead of voters in Maine who last November voted to expand Medicaid under the Affordable Care Act via ballot initiative. These states are seeking ballot initiatives because their Republican-leaning legislatures or governors have been roadblocks to the idea.”
“Gov. Matt Bevin’s administration is cutting dental and vision coverage for nearly a half-million Kentuckians after his Medicaid overhaul plan was rejected in court. The state Cabinet for Health and Family Services calls the cuts an “unfortunate consequence” of Friday’s ruling by a federal judge who said Kentucky can’t require poor people to get jobs to keep their Medicaid benefits. U.S. District Judge James E. Boasberg’s rejection of the Republican governor’s plan to overhaul the state’s Medicaid program is a setback for President Donald Trump’s administration, which has been encouraging states to impose work requirements and other changes on the joint state and federal health insurance program for the poor and disabled. Cabinet spokesman Doug Hogan sought in a weekend statement to place the blame squarely on the judge. The ruling means there is no longer a “legal mechanism” in place to pay for dental and vision coverage for about 460,000 Medicaid beneficiaries, his statement said.”
June 29, 2018
The Senate Appropriations Committee reported out the Labor-HHS appropriations bill this week. The committee has been moving at a brisk pace and has reported out all of the appropriations bills before the July 4th recess. There is talk of pairing the Labor-HHS bill with the Defense Appropriations bill to create the next “minibus” appropriations vehicle. The House Appropriations Committee had to postpone its full committee markup of the Labor-HHS over a scheduling conflict and will consider the bill in committee after the July 4th recess.
Robert Wilkie had a smooth confirmation hearing in the Senate Veterans Affairs (VA) Committee this week. Senator Tester (D MT) who serves as the ranking Member on the committee stated that he thought Wilkie will be confirmed and that he has the “tools to do the job.” Not that there are not challenges waiting for him at the VA, but we expect his confirmation to sail through the Senate.
Senate Democrats will emphasize healthcare as they talk about the upcoming Supreme Court vacancy with the retirement of Justice Anthony Kennedy. Look for them to focus on the impact of another conservative justice on issues such as pre-existing conditions and abortion rights.
The Centers for Medicare and Medicaid Services (CMS) denied a waiver application from the state of Massachusetts to limit drug coverage in its Medicaid program. Drug manufacturers had protested the waiver application and cheered the CMS rejection of the waiver.
The newly named CEO Atul Gawande of the new healthcare joint venture between Amazon, Berkshire Hathaway, and JP Morgan Chase spoke at the Aspen Institute over last weekend and share some insights into the approach the new company will take. Gawande stated that the three biggest drivers of healthcare costs are the “middlemen”, inflated pricing and misallocated care. There is still a lot of anticipation about how this company takes shape and what new innovations it will bring.
“Online retail giant Amazon is entering the pharmacy business after months of speculation that the company could disrupt how prescription drugs are sold the same way it upended bricks-and-mortar retail. Amazon announced Thursday that it would acquire PillPack, an online pharmacy that seeks to simplify medication for people who take multiple drugs, by delivering packets with presorted doses. A person who takes five different medications each morning, for example, could receive a packet with all the pills in a single pouch, instead of having to manually sort the doses into pill boxes for each day. “I think this is a fundamental step for Amazon, to begin to attack the pharmacy industry,” said Adam Fein, president of Pembroke Consulting and an expert on the drug supply chain. “This is the beginning of the pharmacy industry shakeout. I think everyone right now is scrambling to figure out what this means for their business model.” Stock prices for major pharmacies and other companies that help deliver drugs to consumers tumbled. CVS Health, Walgreens and Express Scripts Holding opened down on the news.”
“The Trump administration on Wednesday rejected a request from Massachusetts that state officials argued would have given them more flexibility over its Medicaid program and greater negotiating power over drug companies. The state’s Health and Human Services department asked the administration to approve a plan that would have allowed the state to limit what drugs would be covered in its Medicaid program. Currently, states are required to cover almost all drugs approved by the Food and Drug Administration, but states are looking for new ways to cut down drug prices as Medicaid costs continue to eat up state budgets. While drug manufacturers provide deep discounts to states and the federal government in exchange for having their drugs covered by Medicaid, states argue these rebates, which are a set percentage of a drug’s list price, are no longer enough sufficient as drug costs keep rising. In an effort to reduce what the state is spending on prescription drugs through Medicaid, the state asked the administration if it could exclude coverage of drugs that aren’t cost effective and have little evidence of actually working. But the administration ruled that the proposal goes against federal law. The Trump administration told the state that if it wanted to pick and choose what drugs its Medicaid program covered, it would have to forgo those rebates and negotiate directly with drug companies.”
“Health insurers are finding success in ObamaCare this year and are planning to expand their offerings in many states, defying expert’s predictions. Insurance startup Oscar Health filed to sell ObamaCare plans in Florida, Arizona and Michigan for the first time, and will enter new markets in Ohio, Tennessee and Texas. Smaller insurers are also making moves, such as Bright Health in Tennessee and Presbyterian Healthcare in New Mexico. It will be the first time Bright Health is selling plans in Tennessee, while Presbyterian is returning to the state exchange after leaving in 2016. Experts have been hailing these developments, saying that insurers have finally figured out how to become profitable in the ObamaCare marketplace. But the success is also coming in the face of persistent GOP hostility toward the health-care law and brings the risk of double-digit premium hikes for customers.”
FDA approves first cannabis-based drug- CNN (June 25th)
“The US Food and Drug Administration approved a cannabis-based drug for the first time, the agency said Monday. Epidiolex was recommended for approval by an advisory committee in April, and the agency had until this week to make a decision. The twice-daily oral solution is approved for use in patients 2 and older to treat two types of epileptic syndromes: Dravet syndrome, a rare genetic dysfunction of the brain that begins in the first year of life, and Lennox-Gastaut syndrome, a form of epilepsy with multiple types of seizures that begin in early childhood, usually between 3 and 5. “This is an important medical advance,” FDA Commissioner Dr. Scott Gottlieb said in a statement Monday. “Because of the adequate and well-controlled clinical studies that supported this approval, prescribers can have confidence in the drug’s uniform strength and consistent delivery.” The drug is the “first pharmaceutical formulation of highly-purified, plant-based cannabidiol (CBD), a cannabinoid lacking the high associated with marijuana, and the first in a new category of anti-epileptic drugs,” according to a statement Monday from GW Pharmaceuticals, the UK-based biopharmaceutical company that makes Epidiolex.”
June 22, 2018
On Tuesday the Department of Labor (DOL) issued the final rule for association health plans. President Trump issued an executive order on October calling on his administration to make it easier to form association health plans to help lower health care costs. Under previous guidance from DOL small businesses had to demonstrate a much greater “commonality of interest” to pool together to offer their employees group health plans. The new regulation makes it much easier for small businesses and sole proprietors to come together to form a group health insurance plan. For example, the rule allows for small businesses can join together to form a group health plan if they are located in the same metropolitan area. The rule allows plans formed under the previous the guidance to continue to operate under that guidance and not comply with the new regulation.
Under the regulation, small businesses can either purchase group health plans or self-insure their group health plan. Since these plans are group plans they do not have to comply with the essential health benefits requirement of the Affordable Care Act (ACA). At least two state Attorney Generals have stated they plan to challenge the new rule in court as they are concerned about healthier individuals being drawn out of the ACA marketplaces for lower cost non-ACA compliant plans. Avalere Health projected that 3 million people would leave the ACA exchanges based upon the proposed rule.
Dr. Atul Gawande was named as the new chief executive of the new healthcare venture being formed by Amazon, Berkshire Hathaway, and JP Morgan Chase. It is an interesting choice as Dr. Gawande is an accomplished Harvard surgeon and prolific writer on healthcare but has no experience managing a large organization. The new organization will be based in Boston and Dr. Gawande has no plans to leave Harvard or stop writing for the New Yorker magazine.
The House continues its push on the opioid epidemic. The House approved more than 15 bills this week including H.R. 6 which is a more comprehensive bill made up of a number of other outstanding House bills. The rule the House passed for H.R. 6 also instructs the Clerk of the House to add the legislative text of three previously passed House bills to the text of H.R. 6.
The Office of Management and Budget (OMB) released a plan to reorganize the federal government. As we speculated earlier, the OMB plan calls for consolidating the Supplemental Nutrition Assistance Program (SNAP) and the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) into the Department of Health and Human Services and renaming the agency the Department of Health and Public Welfare. Other notable reforms include merging the Departments of Education and Labor into a new agency entitled the Department of Education and the Workforce. These proposed changes will require congressional approval. Given the limited amount of time on the legislative calendar before the election, we are not anticipating congressional action on this plan in the immediate future.
“The Trump administrationtook the final step Tuesday in its plan aimed at making health insurance policies cheaper for some small businesses. The administration released its final rule governing association health plans, which allow small businessesand the self-employed to band together based on their industry or location and buy health insurance. The rule stems from an executive order that Trump signed in October aimed at providing alternatives to the Affordable Care Act, which it is bent on dismantling. But the move is expected to weaken some of the Affordable Care Act’s consumer protections for those buying these plans and make coverage more expensive for those who remain on the Obamacare exchanges. The rule allows association health plans to be regulated in the same way as large employer policies. That would free them from having to adhere to some of Obamacare’s rules, particularly the one requiring insurers to offer comprehensive coverage. Plans can start being offered as soon as September 1.”
“Republicans on Capitol Hill are giving up on what might be their last best chance to overhaul Medicare, just as they’re losing their leading champion on the issue, House Speaker Paul Ryan. The quiet surrender on a subject that’s energized GOP fiscal hawks for the better part of a decade comes as new projections show Medicare’s trust fund in its worst shape since the recession, partly because of Republicans’ other chief obsession: their sweeping tax cuts. That’s left conservatives unsure how to agitate for a politically unpopular Medicare overhaul — one that President Donald Trump detests — and raises new questions about who will take up the entitlement reform mantle as Ryan heads for the exits.”
“Amazon, Berkshire Hathaway and JPMorgan Chase announced the leader of their new health care company. Dr. Atul Gawande, a renowned surgeon and writer, has been named CEO of the new health care venture. Gawande practices general and endocrine surgery at Brigham and Women’s Hospital in Boston and is a professor at Harvard Medical School. He’s a staff writer for The New Yorker and has written four New York Times bestsellers. The companies’ executives, Amazon’s (AMZN) Jeff Bezos, Berkshire’s (BERK) Warren Buffett and JPMorgan’s (JPM) Jamie Dimon said in January that their companies would work together to give their combined 840,000 employees better health care choices. The CEOs hope to bring down costs, both for their workers and their companies.”
“The White House on Thursday unveiled a sweeping plan to reorganize how the federal government is structured, including controversial proposals to impose work requirements on assistance programs. “Businesses change all the time,” said White House Office of Management and Budget Director Mick Mulvaney. “Government doesn’t, and one of the things you get when you hire a businessman to become president is you bring this attitude from the private sector.” The plan touches a wide range of agencies, but one of its main proposals is to move the food stamp program, officially known as SNAP, out of the Department of Agriculture and into the Department of Health and Human Services. That department would then be renamed the Department of Health and Public Welfare. A new Council on Public Assistance would then oversee programs gathered in one place, including food stamps and Medicaid, and have the power to impose uniform work requirements in those programs, a move strongly opposed by Democrats. The reorganization plan faces tough odds in Congress, where even aside from the dispute over work requirements, any reorganization faces opposition from congressional committees that could lose power if their jurisdictions change.”
“A key Republican is touting efforts by the House to combat the national opioid epidemic, calling recent actions “rifle shots” at tackling targeted problems associated with the growing crisis. Rep. Tom MacArthur (R-N.J.), a co-chair of the House Bipartisan Heroin Task Force, said Wednesday that the more than 50 bills passed by the House in the past two weeks are key to helping stem the epidemic. “These are not funding bills,” MacArthur said at an event hosted by The Hill and sponsored by the Pharmaceutical Care Management Association. “They are policy changes, for the most part, and they deal with a range of things that all point to that prevention, treatment and recovery––there’s a number of focus just on the fentanyl crisis, which is growing.” The effort has largely been bipartisan and comes after Congress passed $6 billion over two years for mental health and to combat the opioid crisis. Democrats have sponsored and cosponsored opioid legislation, and only opposed a handful of the bills. Rep. Tim Ryan (D-Ohio) said that he’s worked with Republican Rep. Evan Jenkins (W.Va.) on legislation to tackle opioids. The crisis is hitting both red and blue areas of the country hard and has led to bipartisan work in a hyperpartisan Congress.”
The nation’s largest doctors group and an influential science paneltoday called on the Trump administration to halt its policy of separating migrant children from their families, saying it exacerbates emotional and physical stress and could create long-lasting health effects on children. The American Medical Association became the latest medical professional group to weigh in on the family separation controversy. The American Academy of Pediatrics, American Psychological Association and American College of Physicians have urged the administration to back away from its “zero-tolerance” policy, citing long-term consequences. “It is well known that childhood trauma and adverse childhood experiences created by inhumane treatment often create negative health impacts that can last an individual’s entire lifespan,” James Madara, the CEO of the physicians group, said in a letter to Attorney General Jeff Sessions, Homeland Security Secretary Kirstjen Nielsen and HHS Secretary Alex Azar. “The AMA believes strongly that, in the absence of immediate physical or emotional threats to the child’s well-being, migrating children should not be separated from their parents or caregivers.”
June 15, 2018
The opioid epidemic continues to be front and center for Congress. The House passed over 30 bills on the suspension calendar and 3 more that were a bit more contentious. The more contentious included a measure to create a demonstration program in the Section 8 housing program to set aside vouchers for people with substance abuse disorders. Another more contentious bill – the Stop the Importation and Trafficking of Synthetic Analogues Act (SITSA) – empowers the Department of Justice for setting penalties for synthetic drugs like fentanyl. While SITSA had support from the bipartisan Problem Solvers Caucus, it also had some critics on both the right and left. We are hearing that the House Leadership was planning to enroll all of these opioid bills into a single House bill before sending it to the Senate. It is possible that the Leadership will have more than one legislative vehicle to separate out the more controversial bills from the ones that easily passed the House.
A federal judge approved the acquisition of Time-Warner by AT&T this week and the expectation is this could have ripple effects in the healthcare world. The current thinking is that the approval makes it more likely the CVS’s acquisition of Aetna and Cigna’s acquisition of Express Scripts will also be approved.
The Centers for Medicare and Medicaid Services (CMS) had decided not to update the hospital quality star ratings system. Concerns were raised when a preview of the ratings had shown a big shift since December. The star ratings programs have also been rolled out to health plans in Medicare Advantage and Part D plans as well as for care settings including nursing homes and dialysis clinics.
There are some interesting developments at the intersection of technology and healthcare. Apple Watch plans to release a software update that can track tremors associated with Parkinson’s Disease. Researchers believe this can provide better insights into the disease’s progression as well as alerts about when medications have worn off. Additionally, CMS is now providing reimbursement for continuous glucose monitoring (CGMs) devices that interface with smart phones.
We are hearing the release of the final rule on association health plans is imminent. The Office of Management and Budget finished their review this week, so it should be published in the Federal Register any day now.
“Kentucky has sued Walgreens for its role in the state’s opioid epidemic. Attorney General Andy Beshear filed the suit against Walgreens for its dual role as a distributor and a pharmacy, saying it allegedly failed to monitor its own operations and shipped and dispensed large amounts of opioids. Beshear said Walgreens flooded Kentucky with opioid prescriptions at its more than 70 locations across the state, “directly contributing to the state’s drug epidemic.” The lawsuit alleges “unfair, misleading and deceptive business practices by Walgreens for excessively distributing and dispensing opioids in Kentucky and for failing to legally report to state and federal authorities the suspiciously large orders it received for prescription opioids.” A spokesman for Walgreens Boots Alliance declined to comment on pending litigation.”
“Increases in health-care costs and policy changes are driving ObamaCare premium increases for the 2019 plan year, according to a new report released Wednesday. The American Academy of Actuaries says that the elimination of the individual mandate penalty and the expansion of cheaper health plans with fewer benefits will contribute to premium increases next year. “The individual market, which had shown signs of stabilizing, now faces a potential deterioration of the risk pool due to policy changes that reduce incentives for healthy individuals to enroll in [ObamaCare] marketplace plans. This deterioration and other factors could drive premiums higher for 2019,” said senior health fellow Cori Uccello. Several insurers seeking rate increases for next year have cited the repeal of the mandate penalty as a primary reason for the request. “Eliminating the penalty is expected to increase premiums as unsubsidized lower-cost healthy individuals will be more likely to forgo coverage,” the brief says. The Trump administration is expected to roll out changes this summer that would expand access to short-term, limited-duration plans and association health plans.”
“New York doctors who received payments from pharmaceutical companies that make opioids were more likely to prescribe the drugs to their patients, according to a new report from the New York State Health Foundation. The findings — similar to the results of a national investigation done by CNN in March — increase concern that money from pharmaceutical companies influences doctors’ prescribing habits. “It’s a systemic issue that is troubling and needs to be addressed,” said David Sandman, chief executive of the New York State Health Foundation, which issued the report. “It’s financial relationships that really raise eyebrows.” Doctors’ groups have denied that payments from pharmaceutical companies — which are legal — influence their prescribing habits.”
“President Donald Trump’s top health care official is lowering expectations that drug companies will soon announce huge price cuts, undercutting Trump’s recent claims that his drug pricing plan would produce immediate results. Trump on May 30 said some of the largest pharmaceutical companies would announce “voluntary massive drops in prices” within two weeks in response to his drug pricing plan released in mid-May. Wednesday will mark two weeks since Trump’s remarks, which drugmakers at the time said caught them by surprise. HHS Secretary Alex Azar told the Senate HELP Committee Tuesday morning that there are “several drug companies that are looking at substantial, material decreases in drug prices,” but he indicated it could take time for the cuts to happen. Azar did not say which companies were considering cuts or how deeply they would slash prices.”
“Health plans intent on driving down costs are zeroing in on emergency room visits – one of the biggest drivers of medical inflation but a category of care that’s seldom been subject to denials. Anthem, the country’s largest Blue Cross Blue Shield plan, shook the market last year by refusing to pay for some ER visits it deemed unnecessary, triggering heated battles with hospitals and doctors and fueling a broader debate over whether patients can find less expensive settings without putting their health at risk. Since then, Blue Cross Blue Shield of Texas has adopted a similar policy limited to patients with HMO plans at out-of-network hospitals. And UnitedHealth Group, the country’s largest insurer, is using its own methodology to scrutinize if hospitals are charging too much for emergency care. If it concludes they are, UnitedHealth won’t cover the full amount of the claim.”
June 8, 2018
The Department of Justice (DOJ) filed a brief in the lawsuit being brought by the state of Texas and 19 other Republican led states to challenge the constitutionality of the Affordable Care Act (ACA) now that the tax penalty for the individual mandate has been repealed. The brief argues that when the tax penalty is taken off the books on January 1, 2019 the individual mandate will be unconstitutional. Further, DOJ believes the guaranteed issue and community rating are inseverable from the mandate and should also be ruled unconstitutional. California and 16 other states have sought to intervene in the case and protect the law. It is not clear how far this court case will advance at this point.
Congress continues to make fighting the opioid epidemic a big priority. The House is scheduled to take up more than 20 bills on the floor next week. Some of these bills will easily pass the House and will likely be placed on the suspension calendar while a few others will require a Rule for consideration. And the Senate Finance Committee will be marking up a package of 22 bills.
The Trump Administration is considering changing the name of the Department of Health and Human Services (HHS). They are also considering consolidating some other income support programs in the agency like the Supplemental Nutrition Assistance Program (formerly known as Food Stamps). HHS had previously had the word “welfare” in its title when it was the Department of Health, Education, and Welfare. It is not clear at this point what the new name will be. Many of us remember the shock waves that were sent when Tom Scully changed the name of the Health Care Financing Administration to the Centers for Medicare and Medicaid Services (CMS).
Accountable Care Organizations (ACOs) are under scrutiny from the Trump Administration. In rare public comments, a senior official from the Office of Management and Budget (OMB) Joe Grogan stated that ACOs need to take more risk sooner. There is a pending regulation altering the Medicare ACOs under review at OMB.
CMS rolled out a new scorecard for the Medicaid and CHIP programs. The scorecard will rate each state based upon their performance on a series of quality measures. The National Association of Medicaid Directors (NAMD) has concerns about the comparability, timeliness and accuracy of the data that is being reported. NAMD wants to work with CMS to refine the measures.
- House set to vote on more than 20 bills to combat opioid addiction- CNN (June 8)
“House is set to vote on more than two dozen bills next week aimed at fighting the opioid crisis, including policy changes to educate pharmacists, coordinate a national response and empowering the federal government to create a program to test alternative treatments. The House will vote individually on dozens of bills over the weeks of June 11 and June 18, a Republican aide on the House committee on Energy and Commerce told CNN. It’s the latest effort to tackle the crisis following the Comprehensive Addiction and Recovery Act and the 21st Century Cures Act, as well as the $4 billion appropriated in the omnibus this year. While the final details are still being worked out, the House will combine most of the bills into a more streamlined package before sending it over to the Senate for consideration, the aide said.”
- Trump admin tells court it won’t defend key provisions of the Affordable Care Act – CNN (June 8)
“The Trump administration won’t defend central provisions of the Affordable Care Act, saying in a legal filing Thursday night that key parts of the Affordable Care Act should be invalidated and that the individual mandate is unconstitutional. The filing came in a lawsuit brought by the state of Texas and a coalition of other Republican-led states who have filed suit in the United States District Court for the Northern District of Texas challenging the constitutionally of the Affordable Care Act. The states argue that after Congress eliminated the penalty for the individual mandate last year, effective in 2019, it destabilized other sections of the law. “In its filing the DOJ said that it agrees with Texas that the individual mandate is now unconstitutional and therefore it will not defend key provisions of the law in the suit,” said Timothy Jost, of Washington and Lee University School of Law. The provisions DOJ says should be invalidated are central to the ACA and would gut protections for those with pre-existing conditions.”
- Poll: Health care a top issue for voters ahead of midterms – The Hill (June 7)
“More than 1 in 5 voters, 22 percent, said in a new NBC News–Wall Street Journal poll that health care is their top issue in the November midterm elections. The economy and jobs followed at 19 percent, with guns at 13 percent, taxes, and spending at 11 percent and immigration at 10 percent. The poll found Democrats are more likely to consider health care a top issue. Thirty-two percent of Democrats said health care was a top issue for them, while 17 percent said guns. Twenty-six percent of Republicans said the economy and jobs are top issues for them in November, while 15 percent pointed to taxes and spending.”
June 1, 2018
The state of New Jersey also acted on a big health initiative with the Governor signing into law an individual mandate for health insurance coverage. The tax bill signed into law last year repealed the tax penalty to enforce the individual mandate from the Affordable Care Act so states are looking to state law for ways to continue or boost insurance coverage levels.
- Virginia General Assembly approves Medicaid expansion to 400,000 low-income residents- Washington Post (May 30)
“The Virginia legislature voted Wednesday to make government health insurance available to 400,000 low-income residents, overcoming five years of GOP resistance. The decision marks a leftward shift in the legislature and an enormous win for Gov. Ralph Northam (D), the pediatrician who ran on expanding access to health care.”
- Healthcare price transparency in U.S. not improved in recent years- Reuters(May 31)
“Although government measures and healthcare industry initiatives have tried to make prices more accessible to U.S. patients recently, researchers say there has been little improvement. In a follow-up to a 2011 study, researchers canvassed hospitals and surgeons trying to get price quotes for a full hip-replacement surgery. In less than half of cases, they got a complete or partial price for the procedure – and the number of hospitals that could provide any price information dropped from 48 percent to 21 percent from the first study to the second one.”
- Trump signs ‘Right to Try Act’ aimed at helping terminally ill patients seek drug treatments- CNN (May 30)
“President Donald Trump signed the “Right to Try Act” Wednesday, a measure aimed at helping terminally ill patients access drug treatments that are yet to be fully approved by the Food and Drug Administration. Trump, at a White House ceremony surrounded by patients and families who will be affected by the legislation, said his administration ‘worked hard on this’ but said repeatedly he didn’t understand why it hadn’t been done before.”
- Trump taps O’Rourke as acting VA secretary ahead of Wilkie confirmation – Politico (May 30)
“President Donald Trump has tapped longtime Veterans Affairs official Peter O’Rourke as the agency’s acting secretary, the White House announced Wednesday, a move that comes ahead of the confirmation hearing of VA secretary-designate Robert Wilkie.”
- New Jersey governor signs health-care mandate into law after federal repeal- The Hill (May 31)
“New Jersey Gov. Phil Murphy (D) on Wednesday night signed into law a bill imposing an individual mandate for health insurance to replace a federal requirement that Congress repealed. The move makes New Jersey the second state to require health-care coverage and impose a penalty on residents without it. Massachusetts imposed the requirement as part of its health reform law in 2006.”
- Democratic governors threaten to sue over Trump abortion rule- NBC News(May 31)
“Democratic governors are threatening to sue the Trump administration over a proposed rule that would force Planned Parenthood to give up its federal grants or keep family-planning and abortion-related services under different roofs. ‘If this reckless policy is finalized as written, we will have no choice but to explore all possible avenues, including legal options, to block it from harming the women in our states,’ Washington Gov. Jay Inslee and 13 fellow members of the Democratic Governors Association wrote in a letter to Health and Human Services Secretary Alex Azar. ‘Our voices will be heard on this damaging proposal, and we are prepared to match our words with action.'”
- Number of opioid prescriptions falls for fifth year in a row (May 31)
“The number of opioid prescriptions issued nationwide has dropped by 22 percent between 2013 and 2017, which a doctors group touted as progress in fighting the epidemic of opioid addiction. The report from the American Medical Association (AMA) finds there were 55 million fewer prescriptions over that time period and the number of prescriptions has dropped for five years in a row.”
May 25, 2018
This week the Senate passed the VA Maintaining Internal Systems and Strengthening Integrated Outside Networks (VA MISSION Act) and sent the bill to the President for his signature. This legislation provides the funding necessary to continue to fund the Choice Program to continue until the new community care program authorized by the MISSION Act is put in place. The bill also creates a presidential commission to review underperforming VA facilities for closure. It also expands the VA caregivers program so veterans from all eras can benefit from the program not just those from the post 9-11 era.
The House passed and sent to the President the so-called “Right to Try” legislation that will allow patients with terminal diseases the right to try experimental drugs not yet approved by the Food and Drug Administration. The President is expected to sign the bill next week and given how much he has promoted this policy we will likely see a significant signing ceremony event at the White House.
Congress continues its diligent work on the opioid epidemic with additional committees taking action. The Senate Judiciary Committee approved five bills to address the problem with solutions ranging from granting greater authority to the Drug Enforcement Administration (DEA), to reauthorizing the Office of Drug Control Policy, to closing a legal loophole around synthetic drugs. The Senate Finance Committee also announced plans to take action soon on 22 opioid related bills.
The Congressional Budget Office (CBO) released a report on Wednesday review the federal programs that provide subsidies for health insurance for individuals below the age of 65. One finding popped out is that CBO lowered its estimate for the number of uninsured because of the repeal of the individual mandate in last year’s tax bill. CBO lowered their projection by about 5 million people however also projects the number of uninsured will raise by about 5 million by the year 2027.
The House Energy and Commerce Committee’s Health Subcommittee held a hearing on legislation to reauthorize the Children’s Hospital Graduate Medical Education program. Former Energy and Commerce Committee Fred Upton noted at the hearing that only a few years ago there was bicameral and bipartisan support to scale back graduate medical education programs as this was one of the areas of agreement the on which the so-called Super Committee found agreement. However, we expect this reauthorization to be approved by Congress this year.
“HHS 340B rule delay would put hospitals at risk for high drug prices” – Modern Healthcare (May 24)
“Safety-net hospitals urged HHS not to postpone a rule setting new ceiling prices for the 340B drug discount program, saying the delay would leave them defenseless against rising costs. Although HHS was supposed to set ceiling prices starting July 1, the agency wants to hold off on the rule for a year. The request is the fifth time the rule has been postponed, and providers had until Tuesday to comment on the proposal. Hospitals that provide a significant amount of care to low-income patients or serve rural communities are eligible for 340B drug discounts. These hospitals also tend to have high amounts of uncompensated care and an increased chance of negative operating margins, according to Michael Rodgers, senior vice president at the Catholic Health Association.”
HHS Sec. Azar will testify at the June 12 Senate HELP Committee hearing” – The Hill (May 24)
“President Trump’s top health official will testify at a Senate hearing next month about the president’s proposal to reduce prescription drug costs. Health and Human Services Secretary Alex Azar will testify at the June 12 Senate Health, Education, Labor and Pensions Committee hearing, the first time lawmakers will publicly examine Trump’s plan, which was unveiled earlier this month. Committee Chairman Lamar Alexander (R-Tenn.) did not indicate whether the hearing will result in legislation.”
“House passes Trump-backed drug bill, letting sick patients bypass FDA” – Politico (May 22)
“House lawmakers on Wednesday overwhelmingly passed legislation expanding veterans’ access to private care at taxpayer expense, a campaign promise of President Donald Trump, and adding more money to the “Choice program” weeks before VA officials said it could run out of money. The $51 billion plan that passed 347-70 Wednesday includes $5.2 billion for the VA Choice program that funds private care. VA officials have warned that the program could run out of money as early as the end of the month, disrupting care for patients.”
May 18, 2018
The House Ways and Means Committee reported 7 bills in the continued legislative effort to address the opioid epidemic. While some of the Members expressed frustration that the committee was not doing enough to really tackle the crisis, all the measures were reported out on voice votes. Six of the measures sought to make improvements in the Medicare program to better handle the problem with solutions ranging from better coverage of opioid treatment programs, to requiring electronic prior authorizations for opioid subscriptions covered under Medicare Part D, to requiring the Department of Health and Human Services (HHS) to develop guidance for pain management and opioid abuse prevention.
The Energy and Commerce Committee reported 33 additional opioid bills. Most of the bills were reported unanimously but two bills proved to be more contentious. There was some division on the committee over the bills to allow Medicaid reimbursement for inpatient drug treatment and the bill to ease the current restrictions on sharing substance abuse records among physicians and hospitals.
The House is expected to consider all the reported opioid bills in early June. It is not yet clear whether some of these bills will be packaged before consideration on the House floor.
The Trump administration was busy this week moving forward with the plans the President laid out last Friday to help lower prescription drug prices. The Centers for Medicare and Medicaid Services (CMS) updated its drug pricing dashboard to include year-over-year pricing data on pharmaceuticals. CMS Administrator Seema Verma also issued a letter to all Part D plans stating that the administration finds any “gag orders” that some insurance plans and pharmacy benefit managers include in their contracts with pharmacies to be unacceptable.
HHS Secretary Azar announced during a speech on Monday morning that the agency will be issuing a request for proposals on a new pricing mechanism for drugs covered under Medicare Part B known as a Competitive Acquisition Program. Secretary Azar also revealed plans to review drugs they will seek to cover under Medicare Part D rather than Part B and eventually merging the two programs.
The House is also expected to consider next week the so-called “Right to Try” legislation that passed the Senate last year. The bill sponsored by Senator Johnson (R WI) allows patients to use medications not yet approved by the Food and Drug Administration. The House had try to narrow the scope of the bill by passing a measure to allow for unapproved drugs to be used by terminal patients but that bill did not gain any traction in the Senate. The President strongly supports the Johnson bill including a shout out during his State of the Union address and during his press conference on drug pricing last week.
- “Trump nominates Robert Wilkie as VA secretary” – CNN (May 18)
“President Donald Trump announced Friday that he is nominating Robert Wilkie to lead the Department of Veterans Affairs, three weeks after his previous nominee withdrew from the confirmation process amid controversy. Wilkie is currently the undersecretary of defense for personnel and readiness but has been serving as the VA’s acting secretary since the President fired VA Secretary David Shulkin in late March. But Trump said the announcement came as a surprise even to Wilkie.”
- “Trump to target Planned Parenthood with new abortion curbs” – Politico (May 18)
“The Trump administration is expected to announce as soon as Friday that it will dramatically change the federal family planning program to prohibit health care providers who accept the funds from making referrals for abortion — a step that could effectively cut off millions of dollars to Planned Parenthood. The changes to the Title X program, which are expected to be announced in new regulations, would mark the Trump administration’s latest win for social conservatives who are looking to prohibit access to abortion.”
- “House votes to expand veterans’ access to private care” – CNN (May 17)
“House lawmakers on Wednesday overwhelmingly passed legislation expanding veterans’ access to private care at taxpayer expense, a campaign promise of President Donald Trump, and adding more money to the “Choice program” weeks before VA officials said it could run out of money. The $51 billion plan that passed 347-70 Wednesday includes $5.2 billion for the VA Choice program that funds private care. VA officials have warned that the program could run out of money as early as the end of the month, disrupting care for patients.”
- “House to vote to send ‘right to try’ bill to Trump’s desk next week” – The Hill (May 17)
“The House will vote next week on Senate-passed legislation aimed at making it easier for sick patients to access experimental drugs — a big priority for President Trump, Vice President Pence and groups backed by conservative mega-donors Charles and David Koch. ‘This will not only offer a chance for the patient to possibly find treatment but could open possibilities to help others do the same,’ House Majority Leader Kevin McCarthy (R-Calif.) said in a statement. In August, the Senate passed Right to Try by unanimous consent. The bill, which Sen. Ron Johnson (R-Wis.) championed, lets sick patients request access to treatments the Food and Drug Administration (FDA) hasn’t yet approved.”
- “Stack of opioid bills advance out of key panel” – Washington Examiner (May 17)
“The House Energy and Commerce Committee on Thursday advanced 32 bills targeting the opioid crisis to the full House for a vote. The bills advanced after a marathon markup that lasted seven hours. Another package of 25 bills advanced out of committee earlier this month. ‘We have a unique opportunity to save lives, and we can’t lose sight of the real-world impact of our actions throughout this process,” said committee Chairman Greg Walden, R-Ore. “We owe it to the families of the more than 115 Americans who die from opioids every single day to come together and advance legislation that can help stem this tide.’”
May 11, 2018
President Trump just delivered his much anticipated speech on drug prices. Joined by Health and Human Services Secretary Alex Azar, the President talked about more negotiation, more competition and eliminating the middle men. Secretary Azar said there would be 50 actions HHS will take as part of their blueprint for lowering drug prices (for the full text of the blueprint click here). One action Azar mentioned was having the Food and Drug Administration (FDA) require pharmaceutical companies to include prices in their direct to consumer advertising.
The House Energy and Commerce Committee reported out 25 bipartisan opioid bills on Wednesday. Each bill cleared the committee on a voice vote. The committee plans to mark up more opioid bills next week as the Health Subcommittee had reported 63 bills during the last week in April. The expectation is these bills will be voted on in the House in early June.
Senator Alexander (R-TN) has stated that the Senate will wait for the House to act before calling up their opioid bill. While the Senate bill had broad bipartisan support in the Senate Health, Education, Labor, and Pensions (HELP) Committee, the committee did not take up some of the more contentious issues such as assessing fees to the manufacturers of opioids. It is not yet clear whether the Senate will reach an agreement on limitations for debate and amendments on the Senate floor to pass a bill.
The largest distributors of prescription drugs faced a difficult hearing this week as well. Representatives from McKesson, Cardinal Health, and AmerisourceBergen faced some difficult questions and statements from Members on the Energy and Commerce Committee.
The President sent to Capitol Hill the largest rescission package ever totaling $15.4 billion. Prime Policy Group published their analysis of the package on Tuesday which you can read here. There are a few notable rescissions in healthcare. The President proposed rescinded unspent monies from the Childrens’ Health Insurance Program (CHIP). What is interesting to note is that CHIP is a mandatory spending program. Rescission authority written into the Congressional Budget and Impoundment Control Act was intended for Presidents to be able to rescind discretionary funding appropriated by the Congress.
However, our reading of the law suggests that the letter of the law is silent on whether the funds are mandatory of discretionary. Senators will likely appeal to the Senate Parliamentarian arguing that the mandatory spending rescissions are not privileged and she will be listening to Senators on both sides. Also of note the President proposed rescinding funding from the Centers for Medicare and Medicaid Innovation (CMMI). While created by the Affordable Care Act, CMMI was exploring payment options supported by both parties.
The Centers for Medicare and Medicaid Services (CMS) released an interim final rule on Wednesday providing some targeted additional payments for suppliers of durable medical equipment such as oxygen for a six-month period. The rule had been pending at the Office of Management and Budget since September of last year. Secretary Azar testifying before the Senate Appropriations Committee was pressed about what the administration will do about reimbursement beyond the six months.
“Health care stocks whipsawed on Friday as President Trump unveiled his long-awaited plan to lower prescription drug prices, dubbed “American Patients First.” The sector briefly turned negative before trading 1.6 percent higher. Shares of Express Scripts and CVS both hit session lows before rising 3.7 percent and 3.8 percent. Dow Jones industrial average components Merck and UnitedHealth also dipped before trading higher upon the announcement. The proposal seeks to boost competition, improve negotiation and create incentives to lower list prices of prescription drugs and lower out-of-pocket costs for consumers. It stopped short of allowing Medicare to directly work with manufacturers on prices.”
“President Donald Trump wants Americans to get lower prices for medicines — and the rest of the world may pay for it. His “America First” message on drugs at home, coupled with pro-pharmaceutical industry policies abroad, could lead to higher costs for patients around the world — without making drugs more affordable for those in the U.S. Trump on Friday plans to deliver his long-promised speech on how to lower drug costs, addressing an industry he has in the past accused of “getting away with murder.” Global health officials worry he will also target practices that keep medicines affordable in other countries. Amid rising trade tensions between the U.S. and key trading partners, Trump and top administration officials have repeatedly blamed high U.S. prices in part on foreign countries that take advantage of the significant U.S. investment in medical research without paying their fair share. Many nations, including wealthy European ones, negotiate or regulate drug prices to keep them lower than what Americans typically pay.”
“President Donald Trump is looking to cut $15.4 billion out of the $1.3 trillion federal spending bill approved in March, using a process called rescission. Rescission withdraws spending authority for funds appropriated but not spent. Appropriated funds to the Centers for Medicare and Medicaid Innovation, or CMMI, and the Children’s Health Insurance Program would be cut. The Department of Health and Human ServicesCHIP program is targeted to lose $7 billion and the proposal would rescind $800 million to the innovation center.”
May 4, 2018
The President is going to give his much anticipated speech on drug pricing on Tuesday. Food and Drug Administration (FDA) Commissioner Scott Gottlieb may have given an indication of where the President will go on Tuesday when he remarked at a speech this week that it may be worth examining the safe harbor drug rebates have under anti-kickback laws. Drug makers have long pushed for having pharmacy benefit managers and insurance companies to pass along more of the negotiated rebates to consumers.
The three federal agencies declined to make significant changes in the rule for health insurance coverage of out-of-network emergency services. The final rule states that the plan satisfies the Affordable Care Act’s (ACA’s) copayment and coinsurance limitations if it pays the provider the greater of three amounts – 1. the same as the negotiated price for in-network providers; 2. the Medicare payment amount; or 3. the same amount as calculated for other out-of-network providers. This “greatest of three” or “GOT” method was originally put in place in 2015.
Centers for Medicare and Medicaid Services (CMS) Administrator Seema Verma defended the actions of the Trump administration around the ACA. In a speech before the World Health Care Congress, Administrator Verma claimed the law was broken before he took office. Verma also pointed to the administration’s proposed rule on short-term insurance plans that are not ACA-compliant saying extending the plans duration to one year will help to lower the cost of plans available to consumers.
“U.S. Food and Drug Administration chief Scott Gottlieb on Thursday questioned whether rebates that drugmakers provide to health insurers should remain protected by federal law, sparking new concerns on Wall Street over efforts to curb drug pricing. Gottlieb was referring to the common practice of pharmaceutical companies setting a high “list price” for a drug, and then lowering the cost for health plans through hefty rebates in exchange for the broadest access to patients. In recent weeks, he has criticized these practices for keeping drug prices high and locking out competitors. “What if we took on this system directly, by having the federal government reexamine the current safe harbor for drug rebates under the Anti-Kickback Statute?” Gottlieb said in remarks prepared for a Food and Drug Law Institute conference and posted on the FDA’s website.”
“President Trump on Thursday promised he would “immediately” sign revamped legislation expanding veterans’ access to private medical care at taxpayer expense, if Congress passes a new plan being considered just weeks before the “Choice Program” runs out of money. In a tweet Thursday, the president noted that it has been four years since the wait-times scandal at a Veterans Affairs hospital in Phoenix. That controversy showed that hospital employees were lying about the amount of time veterans waited for urgent health care, including cancer treatment and mental-health counseling.”
“President Donald Trump says he’ll quickly sign legislation expanding veterans’ access to private medical care if Congress clears the plan by Memorial Day. Trump noted in a tweet Thursday that it’s been four years since a scandal at a VA hospital in Phoenix, in which some veterans died while waiting for appointments. Congress has been working on overhauling the existing “choice” program, which is running out of money. Proposals have stalled over disagreements about cost and how much access veterans should have to private doctors.”
April 27, 2018
It was a busy week for healthcare in Washington with lots of new developments and a cancelled event – the President’s postponement of his speech on drug pricing.
The opioid epidemic is clearly the largest public health threat facing the country with 42,000 lives lost in 2016 alone. The Senate Health, Education, Labor, and Pensions (HELP) Committee reported S. 2680 – the Opioid Crisis Response Act by voice vote. The bill is comprised of over 40 initiatives largely from HELP Committee Senators. Although this bill sailed through committee, there was discussion of more controversial amendments being offered on the Senate floor should Leader McConnell allocate floor time. One notable proposal is from Senator Sanders (I-VT) to impose significant fines on drug manufacturers for their role in the opioid crisis.
The Energy and Commerce Committee’s Health Subcommittee also reported 63 opioid-related bills to the full committee. While some of these proposals were non-controversial and passed with bipartisan support, Ranking Member Frank Pallone (D-NJ) expressed his frustration about the committee acting too quickly without sufficient input from the federal agencies the bills are charging with new tasks to fight the epidemic. Pallone is fearful the quick actions could end up doing more harm than good. Democrats on the committee tried to block a few of the bills but did not have the votes to stop them from moving forward.
The Centers for Medicare and Medicaid Innovation (CMMI) released a Request for Information (RFI) about a possible new payment model. The new payment model, known as direct provider contracting, would attempt to put the patient at the center of this new care model. Unlike an accountable care organization or medical home where health care providers are coordinating the care, this would rely on the patient to determine the best providers and services needed for their own care. Interested parties have until May 25 to submit responses to the questions posed in the RFI.
The President’s nominee for Secretary of Veteran Affairs (VA) Real Admiral Ronny Jackson withdrew his name from consideration. Reports surfaced about alleged activities conducted while serving as the White House Attending Physician that were giving Senators on both sides of the aisle pause about Dr. Jackson’s candidacy. There is speculation that the President will look at other healthcare leaders for the next nominee to lead the VA.
Centers for Medicare and Medicaid Services (CMS) Administrator Seema Verma made a big splash at the Health Datapalooza conference this week. Administrator Verma announced that CMS will make public data from Medicare Advantage (MA) plans. The agency will release preliminary data from 2015 plans this year. Next year CMS will also release data from the Childrens’ Health Insurance Program (CHIP) and Medicaid. It is a big day for more data transparency and health research opportunities.
- HHS proposes Medicare payment rules to encourage hospitals to be clearer about prices – Washington Post (Apr 27)
“The Trump administration is proposing to rewrite rules on federal payments to hospitals treating older Americans on Medicare, making it easier for patients to see the prices of procedures and care. As part of annual updates to Medicare payment rules, federal health officials also want to add $1.5 billion for the coming year to the funds for so-called disproportionate share payments that help buffer hospitals from the expense of treating patients who cannot pay their bills.”
- Medicare may require hospitals to share electronic records – Axios (Apr 25)
“Even though electronic health records have become ubiquitous, hospitals and doctors still have not been able to easily share medical information with each other or with patients. Tying Medicare payments to an open exchange of medical records could force the industry to solve the practice known as information blocking.”
- Drug Pricing Proposal Should Revamp Medicare, GOP Experts Say – Roll Call (Apr 25)
“The administration’s proposal is a request for comment on strategies to lower drug prices and out-of-pocket costs. It was originally expected to be released in tandem with a speech by President Donald Trump on Thursday, but the speech was delayed as Health and Human Services Secretary Alex Azar recovers from an infection.”
- Frustration grows in health care industry over costs – Axios (Apr 27)
“The next big battle in health care will almost certainly be about costs, and right now it’s largely confined to industry infighting and finger-pointing. But mounting frustration from employers and employees could put cost controls on the table faster than you might think. Frustration over health care costs is one thing. But the greater threat to the health care industry is one that’s just starting to percolate — concern that we’ve already maxed out the existing tools to control those costs.”
April 20, 2018
Next week is shaping up to be a big week for healthcare in Washington. The Senate Committee on Health, Education, Labor, and Pensions (HELP) is scheduled to markup S. 2680, the Opioid Crisis Response Act of 2018, next Wednesday. This bill is comprised of 40 different proposals mostly from Senators serving on the HELP Committee. The legislation will make changes at 5 federal health agencies: Food and Drug Administration (FDA); Centers for Disease Control (CDC); Health Resources and Services Administration (HRSA); the National Institutes of Health (NIH); and the Substance Abuse and Mental Health Services Administration (SAMHSA). However, it does not propose any changes to the Medicare and Medicaid programs which both lie in the Senate Finance Committee’s jurisdiction.
The House Energy and Commerce Committee is also marking up a legislative package of proposals next Thursday. The committee is looking to package 34 separate proposals from Members of Congress serving on the panel. The bill which has not yet been introduced is expected to – at least – temporarily repeal the restriction on using Medicaid funds for inpatient treatment of addiction. The bill is also expected to make it easier to treat opioid abuse with telehealth under the Medicare program.
The President is planning to make a speech on drug pricing next Thursday. It is also expected that we will see the release of a Notice from the Department of Health and Human Services (HHS) on a strategy to lower drug prices and reduce out-of-pocket costs. HHS submitted the draft Notice to the Office of Management and Budget this past Tuesday. The Notice is expected to be a Request for Information on how to lower drug prices and the administration is expected to take more specific actions on drug pricing this summer.
HHS Secretary Azar announced this week that James Parker will serve as his Senior Advisor for transforming our health care system to a value-based system rather than a fee-for-service system. Parker most recently served as the Chief Executive Officer of an Indiana based managed care organization MDwise, Inc.
- Trump plans first major speech on drug prices next week – Politico (Apr 16)
“President Donald Trump is set to deliver his first major speech on drug prices on April 26, revisiting an issue he campaigned on but that is unlikely to yield major legislative changes. The strategy is unlikely to call for actions of the sort Trump touted on the campaign trail like allowing the government to negotiate the cost of drugs for Medicare, but based on the president’s fiscal 2019 budget request could advocate for Medicare and Medicaid demonstrations to test new ways of paying for drugs on a smaller scale, like allowing some states to try negotiating drug costs in Medicaid.”
- NIH abruptly changes course on industry opioids partnership after ethics flags raised – Stat (April 19)
“Dozens of drug companies were on the verge of teaming up with [NIH], which researchers hope will lead to the discovery of new medicines to treat addiction or serve as alternatives to opioids. But in an abrupt shift, the agency announced late last week that it won’t accept funds from drug makers after all. Citing recommendationsissued earlier this month by an NIH advisory panel, Collins said the agency will exclusively use taxpayer money to fund a comprehensive research initiative on pain and substance use disorder treatment.
- GOP in retreat on ObamaCare – The Hill (Apr 20)
Republicans are retreating from calls to repeal ObamaCare ahead of this year’s midterm elections. Less than a year after the GOP gave up on its legislative effort to repeal the law, Democrats are going on offense on this issue, attacking Republicans for their votes as they hope to retake the House majority.
April 13, 2018
A big focus this past week was the opioid epidemic. The Energy and Commerce Committee’s Health Subcommittee held a hearing examining 34 bills that the committee hopes will shape a comprehensive legislative package the Majority is hoping to bring to the floor before the Memorial Day recess. Democratic members on the committee are concerned about the committee moving too quickly and the possibility of a partisan opioid bill if they are not earnestly engaged in the drafting of the legislation. There are a number of issues on the table including allowing Medicaid to pay for inpatient addiction treatments and tracking prescriptions electronically in the Medicare program to help prevent abuse.
The Senate Committee on Health, Education, Labor, and Pensions (HELP) released a bipartisan draft bill to address the crisis. The bill is a product of 29 proposals put forward by nearly every member of the HELP Committee. The bill seeks to give the National Institutes of Health the flexibility necessary to develop non-addictive pain killers a move that Chairman Alexander (R-TN) dubbed the “Holy Grail” of tackling the opioid epidemic. Other provisions would give the Food and Drug Administration (FDA) greater authority to require drug manufacturers to package opioids in packaging for a set duration of time like a 3 or 7-day packet and to give consumers safe ways to dispose of unused opioids.
FDA Commissioner Scott Gottlieb had some strong words about drug pricing at the Community Oncology Alliance’s meeting held in Maryland. Commissioner Gottlieb took issue with raising co-pays and co-insurance requirements that are putting patients in precarious financial situations as they are seeking treatment for their lethal diseases. The cost of pharmaceuticals is one of the top priorities for Health and Human Services (HHS) Secretary Azar and we are likely to see administrative actions to address pricing.
We are also hearing the final rule on Association Health Plans may emerge from the Department of Labor in the next month or two. It will be interesting to see how aggressive the Department of Labor will be with the final rule. It is likely that the final rule will be challenged in the courts.
- Top House, Senate Dems warn administration on short-term insurance – The Hill (April 13)
“The ranking Democrats of five House and Senate committees are calling on the Trump administration to withdraw a proposal that would expand access to plans that don’t meet ObamaCare’s consumer protection rules. Led by House Energy and Commerce Committee ranking member Frank Pallone Jr.(N.J.), the Democrats warned Health and Human Services Secretary Alex Azar and other administration officials in a Thursday letter that the rule would “encourage the sale of junk health plans that will undermine consumer protections, sabotage the Affordable Care Act (ACA) marketplaces, and expose consumers to great financial risk.””
- NIH director: Agency is looking at alcohol industry influence ‘in a very aggressive way’ – STAT (April 11)
“The controversy over research conducted by the National Institutes of Health on the health impacts of moderate drinking has reached Capitol Hill, where a lawmaker on Wednesday stridently questioned the agency’s director, Francis Collins, over the NIH’s reportedly cozy relationship with the alcohol industry. In response to a question about reports that the NIH had allowed industry partnerships to influence research into alcohol use and the impact of alcohol marketing, Collins told Rep. Lucille Roybal-Allard (D-Calif.) that the NIH is “looking into this in a very aggressive way.””
- About half of Americans support single-payer health care – Washington Post (April 12)
“As President Trump’s administration tries to chip away at the Affordable Care Act by giving more authority to states to regulate private insurance, a new poll finds a slight majority of Americans support a move in the opposite direction, with everyone getting health insurance from a national government-run program. A Washington Post-Kaiser Family Foundation poll finds a 51 percent majority of Americans support a national health plan, also known as a single-payer plan, while 43 percent oppose it.”
April 6, 2018
This week an internal memo issued by the Secretary of Health and Human Services (HHS) Alex Azar surfaced outlining how the Secretary plans to run the department. The main takeaway from this appears to be that power and influence is being consolidated under Azar’s Deputy Secretary and close confidant Eric Hargan. The two served together at HHS during President George W. Bush’s administration and are known to have a strong rapport. Under this reorganization, Deputy Secretary Hargan will be the lead on all regulatory matters and will be the primary liaison between the Office of Management and Budget (OMB) and the White House. The memo also addresses the consolidation of staff and the removal of up to 40 percent of policy staff to streamline decision making.
Secretary Azar identified his top four priorities for the department: combating the opioid crisis; bringing down the cost of prescription drugs; addressing the cost and availability of health insurance; and transforming our health care system to a value-based system. Azar is creating several “Senior Advisors” – a new position – to help guide action on each of these priorities. Two of those advisors were named (Daniel Best for drug pricing and Dr. Brett Giroir for opioids); the other two will be named soon.
If you would like a copy of the memo, please email firstname.lastname@example.org.
Elsewhere in healthcare, Surgeon General Jerome Adams issued a rare public health advisory this week urging friends and family of people who are at risk of opioid overdose to carry with them naloxone which is used to treat overdoses. While first responders and many police officers carry naloxone, they often arrive too late in cases of overdoses. The last public health advisory from the Surgeon General’s office came in 2005 to warn against the dangers of drinking during pregnancy. This action by the Surgeon General indicates how severe the opioid epidemic has become.
- Senate Panel Unveils Draft Bill to Combat Opioid Addiction – Roll Call (Apr 5)
“The Senate health panel on Wednesday released a discussion draft intended to curb opioid addiction. The development comes as other House and Senate committees also prepare legislation. The Senate Health, Education, Labor and Pensions Committee plans to discuss this legislation at an upcoming hearing on April 11. The panel has already held six hearings on the opioid crisis so far this Congress featuring representatives from agencies including the Food and Drug Administration, the National Institutes of Health, and the Centers for Disease Control and Prevention, as well as governors from states affected by the crisis.”
- Heller promised Obamacare repeal in Las Vegas speech to GOP club – Las Vegas Review Journal (Apr 5)
“…Heller predicted that Republicans will pick up a handful of Senate seats in the midterm elections, and that would be the path to fulfilling that long-held promise of a repeal. “I think at the end of the day we end up with 53, 54 seats,” Heller said. “If we can do that, then we can repeal and replace and change the ACA as we know it today.” Heller was not among the original supporters of Trump, and was especially critical of then-candidate Trump during the 2016 campaign season.”
- In rare advisory, surgeon general urges public to carry overdose-reversal medication – STAT (Apr 5)
“Surgeon General Jerome Adamsis issuing a rare public health advisory on Thursday, calling for friends and family of people at risk for opioid overdoses to carry the OD-reversal medication naloxone. He likened the treatment to other livesaving interventions, such as knowing how to perform CPR or use an EpiPen.”
Rich Meade, a Vice Chairman at Prime Policy Group and Chair of the firm’s Healthcare Practice has over 25 years of experience in legislative, regulatory, political and public relations strategy. He previously served as Chief of Staff to the House Budget Committee. Rich has helped his clients navigate many complex regulatory and legislative landscapes to achieve many public policy successes including transitioning to a new Medicare payment and quality system, and developing, with the Centers for Medicare and Medicaid Services (CMS) and Office of the National Coordinator for Health Information Technology (ONC), a health information exchange (HIE) on the Nationwide Health Information Network (NwHIN).
Elizabeth Hart Thompson has nearly two decades of experience as a senior staff member on Capitol Hill and a lobbyist. She joined Prime from Crossroads Strategies, where she focused on health care, financial services and technology. Building on her extensive knowledge of the political and legislative processes, as well as, her dedication to team work, Elizabeth is particularly adept at developing and executing advocacy strategies that deliver meaningful results to clients.
Mitchell has been delivering trusted counsel across a diverse practice of legislative, policy and political issues for more than a decade. During his long-standing tenure both in Congress and throughout the political and policy sphere of Washington, he has tackled some of the largest healthcare, energy and regulatory issues presented before the federal government. He has a massive range of relationships and strategic congressional partnerships has paid dividends for consecutive congressional sessions. Mitch is a member of Prime Policy Group’s healthcare practice.