Health Update (November 25)
Impeachment hearings continued on Capitol Hill this week on Capitol Hill. Despite not being atop the cable news headlines, there was quite a bit of movement on the healthcare front as well, with the Senate HELP confirmation hearing of Dr. Stephen Hahn as Commissioner of the FDA, a hearing on Alzheimer’s in the Senate Finance Committee, and a two-day markup in the House Energy & Commerce Committee on two maternal health bills, as well as a bill on youth vaping prevention. While no formal movement has occurred, talks continued behind the scenes on both House Speaker Nancy Pelosi’s drug pricing bill (HR 3) and the Grassley/Wyden (S.2543) drug pricing bills, with Pelosi promising to keep a key progressive amendment in the bill, and Senate Finance Chairman Chuck Grassley (R-IA) promising to help seniors with high Medicare Part D costs. Elsewhere, Congress passed its continuing resolution (CR) to keep the government open through Dec. 20. ACA enrollment is also down significantly compared to last year, and earlier this week, the House Ways & Means Committee announced a Request for Information (RFI) soliciting input that will inform the Rural and Underserved Communities Health Task Force as it works to develop bipartisan legislation to improve health care outcomes within under-served communities.
Hearings and Markups
Senate HELP Confirmation Hearing
The Senate HELP Committee held a hearing on Wednesday (Nov. 20) on the nomination of Stephen M. Hahn, MD, to serve as Commissioner of the Food and Drug Administration (FDA). Youth vaping and flavored e-cigarettes, prescription drug prices, opioids, and generic drugs headlined the Senate HELP Committee’s hearing for Dr. Hahn. Hahn currently serves as the Chief Medical Executive of the MD Anderson Cancer Center and was nominated by President Trump in September. Dr. Hahn said that he was committed to ending youth vaping but declined to promise to move forward with an e-cigarette flavor ban that the administration originally supported taking action on but has recently put on hold. Senate Finance Ranking Member Patty Murray (D-WA) and Sen. Mitt Romney (R-UT) pressed Hahn on the issue, asking whether he would cave to political pressure and White House opposition to the ban. Hahn responded that as a doctor, he always puts patients first. During the first set of questioning, Sen. Tim Scott (R-SC) pressed Hahn on generic drugs, specifically on Sec. 205 of the Lower Health Care Costs Act that was recently passed out of the committee. Scott mentioned that Sec. 205 could have unattended consequences by deterring generic drug development and discouraging manufacturers from filing early, leading to less competition and higher prices for consumers. Hahn said he believes nothing is more important than getting innovative products into the market for the American people and noted the generic pathway is a remarkable way to do so. An executive summary of this hearing can be found here.
House E&C Markup
The House Committee on Energy & Commerce Subcommittee on Health held a markup this week on bills H.R. 2339, the “Reversing the Youth Tobacco Epidemic Act of 2019”; H.R. 4995, the “Maternal Health Quality Improvement Act of 2019”; and H.R. 4996, the “Helping Medicaid Offer Maternity Services (MOMS) Act of 2019.” H.R. 2339, the “Reversing the Youth Tobacco Epidemic Act of 2019” The committee sent Chairman Frank Pallone’s (D-NJ) tobacco bill to the House floor on Tuesday (Nov. 19). The bill aims to curb youth e-cigarette use by raising the minimum tobacco purchase age to 21 and banning all characterizing flavors, among other policies. The bill passed with four amendments, including one that would exempt large, premium cigars from some of the prohibitions the bill places on tobacco products.
The bill would also:
- ban online sales of all tobacco products;
- extend advertising restrictions that currently apply to cigarettes and smokeless tobacco to other tobacco products;
- and mandate FDA issue a final rule requiring graphic warnings on cigarettes and in cigarette advertising by the court-ordered deadline of March 15, 2020.
Lawmakers debated whether to withhold a user fee funding increase from FDA’s tobacco center until the agency shares user fee financial and implementation reports with the committee, as it is required to do on a biannual basis, per the Tobacco Control Act. The amendment was ultimately voted down.
H.R. 4995, the “Maternal Health Quality Improvement Act of 2019”
The committee unanimously approved a bill that would create new maternal health programs focused on quality measures, rural areas, and tackling racial and ethnic disparities. The Maternal Health Quality Improvement Act, introduced by representatives Eliot Engel (D-NY), Larry Bucshon (R-IN), Xochitl Torres Small (D-NM), Bob Latta (R-OH), Alma Adams (D-NC) and Steve Stivers (R-OH), would:
- authorize grants for the Alliance for Innovation on Maternal Health program;
- authorize grants for medical and nursing school programs aimed at preventing discrimination in maternity care;
- direct HHS to study and make recommendations for best practices to reduce provider discrimination;
- authorize funding for perinatal quality collaboratives;
- and authorize a grant program to integrate services for pregnant and postpartum women to reduce adverse outcomes after a birth.
The committee also approved an amendment to the bill from Rep. Tony Cardenas (D-CA) that would require the Centers for Disease Control and Protection to improve data collection on race, ethnicity, and other demographic information related to maternal mortality and morbidity.
H.R. 4996, the “Helping Medicaid Offer Maternity Services (MOMS) Act of 2019”
HR 4996, the “Helping Medicaid Offer Maternity Services (MOMS) Act of 2019,” was also unanimously approved out of the committee. The bill would allow states to extend Medicaid for beneficiaries up to one year postpartum and give states that do so a higher federal match. Representative Joe Kennedy (D-MA) offered the only amendment on the bill which requires the Medicaid and CHIP Payment and Access Commission (MACPAC) to review the payment structure. Health Subcommittee Ranking Member Michael Burgess (R-TX) said committee Republicans won’t support the bill on the House floor without offsets for the increased federal match, but urged his colleagues to advance the bill to the full House. An executive summary of this markup can be found here.
Senate Finance Hearing
The Senate Finance Subcommittee on Health held a hearing on Wednesday (Nov. 20) entitled, “Alzheimer’s Awareness: Barriers to Diagnosis, Treatment and Care Coordination.” Long term care and better business models were the main topics discussed. One of the witnesses, Dr. Jason Karlawish, said “A better business model for the diagnosis and care of persons with Alzheimer’s disease needs to be created. The majority of people with Alzheimer’s disease are over 65 and so covered under Medicare, therefore, has a key role in shaping the business model for the care of persons with Alzheimer’s disease.” Karlawish also said that his preliminary research suggests that some Medicare Advantage plans are not paying for care planning; that primary care physicians need more instruction on how to spread the work out over several visits; that Medicare should study how to integrate the code into its Comprehensive Primary Care Plus initiative; that the code should recognize that many of the services for dementia care are delivered by nurses, social workers and community health. Another witness, Dr. Marc A. Cohen, told the subcommittee that the affordability and accessibility of private long-term care insurance could be improved. “Premium levels are now out of the financial reach of most middle-class Americans. …But affordability is not the only challenge,” he said. 
Ways & Means Rural and Underserved Communities Task Force
On Monday (Nov. 18), Ways and Means Committee Chairman Richard Neal (D-MA) and Ranking Member Kevin Brady (R-TX) announced a Request for Information (RFI) soliciting input that will inform the Rural and Underserved Communities Health Task Force as it works to develop bipartisan legislation to improve health care outcomes within underserved communities. “Severe inequity exists in our nation when it comes to the accessibility and affordability of healthcare,” the pair said. “Earlier this year, we formed a bipartisan task force to examine the delivery and financing of health services in urban and rural underserved areas. Now, we urge stakeholders from across the country to provide their input on priority topics that affect health status and outcomes for the Task Force to consider and discuss. The submissions we receive will support our members’ work identifying the causes of health care disparities and developing strategies to close gaps in care that exist between certain communities.” Representatives Danny Davis (D-IL), Terri Sewell (D-AL), Brad Wenstrup (R-OH), and Jodey Arrington (R-TX) serve as co-chairs of the Rural and Underserved Communities Health Task Force. The full RFI can be viewed here.
This week, representatives Diana DeGette (D-CO) and Fred Upton (R-MI) released their initial vision for their landmark Cures 2.0 legislation and are now calling on experts and stakeholders to submit their ideas and feedback on the plan. The first installment of 21st Century Cures was signed into law nearly three years ago, and already, there are better ways to prevent and screen cancer, an improved understanding of the human brain, and improvements in the field of regenerative medicine. A record number of new drugs have been approved – including new generics – which have helped lower health care costs for millions of Americans. Cures 2.0 will aim to improve care delivery and look at how it is possible to modernize coverage and access to life-saving cures. “We are so proud of what the first effort of 21st Century Cures has been able to achieve in such a short amount of time, but one thing we have heard from listening to folks across the nation is that we need to do more to promote access to these life-saving cures,” DeGette and Upton said. “There are still too many patients without a treatment, and we need to do everything we can to help them now.” DeGette and Upton requested input and feedback to be submitted by December 16, 2019. A link to the full document detailing the initial vision for Cures 2.0 can be found here.
HR 3 Update
A key progressive amendment to Pelosi’s drug pricing plan will remain in the package when the bill heads to the floor. The amendment, added in the House Education and Labor Committee’s markup of H.R. 3, would require the government to examine the possibility of rebates for employer-sponsored health plans when a drug company raises the price of a medicine faster than inflation. The policy would require HHS and the Treasury Department to submit a feasibility report to Congress by the end of 2021 on a system for having drugmakers refund the portion of price hikes that exceed the inflation rate. The agencies, and the Labor Department, would be required to issue regulations based on the report’s findings by the end of 2022. The Congressional Progressive Caucus is pushing three other amendments to the final bill including proposals to increase the number of drugs eligible for government price negotiations and makes those prices available to uninsured Americans. They also want to fully repeal the ban on government drug price negotiations in Medicare Part D. But House leadership has expressed concern about losing moderate Democrats if the bill moves further left. Democratic leaders are hoping to bring the bill to a floor vote as early as the first week of December. They’re awaiting a final score from the Congressional Budget Office, which has taken longer than expected. After it receives a score, Democrats must decide how to spend the anticipated hundreds of billions of dollars in savings, a politically tricky process that could fracture the caucus and further delay a final vote. The Senate won’t consider the legislation, Majority Leader Mitch McConnell (R-KY) says. 
Grassley said he is updating his committee’s drug pricing legislation to help seniors pay Part D catastrophic costs, and Ranking Member Ron Wyden (D-OR) said he is keen on changes that would lower insulin costs. Grassley said the updated bill will be filed in the coming weeks. The Senate bill (S. 2543) would cap beneficiary annual Part D spending at $3,100, and Grassley and Wyden are updating the bill to put beneficiaries on a year-long installment-payment plan when they hit that cap early in the year. Drug makers back the policy, but insurers oppose it because they would have to pay seniors’ up-front costs. Wyden and Grassley stressed that their bill is bipartisan, and Grassley again beckoned fellow Republicans to support S. 2543. “This bill may not have 60 votes today but when Republicans wake up to the fact that 22 of them are up for re-election and in every state it’s an issue in their state as it is in my state and I’m not up for re-election, they’re going to soon realize that this is the road to doing something responsible for the taxpayer and also exercising good judgement for the health of Americans,” Grassley said. 
Congress Passes Spending Bill
The Senate passed a continuing resolution (CR) Thursday afternoon (Nov. 21) by a vote of 74-20. President Trump signed the short-term spending bill, which funds the government through Dec. 20. The House approved the CR earlier in the week by a vote of 231-192. While Congress has nearly sidestepped yet another debilitating shutdown, congressional leaders still lack a clear fiscal 2020 funding plan beyond Dec. 20, with protracted fights over the president’s border wall impeding progress on full-year appropriations bills and impeachment proceedings threatening to consume Congress through January. 
More than 737,000 people signed up for Obamacare coverage through HealthCare.gov during the second full week of open enrollment, slightly behind last year’s pace, CMS said this week. Through the first 16 days of open enrollment, nearly 1.7 million people enrolled in 2020 coverage, according to updated figures. That’s about 255,000 fewer people than at this point in 2018, though last year’s figure included one additional day of enrollment. During the previous week, enrollment was down about 1.5 percent compared to the same sign-up period for 2019 coverage. But for the second consecutive week, the number of new consumers selecting a health plan — 186,646 — is slightly higher than during the same period last year. Open enrollment on the federal site runs through Dec. 15. 
 Bowers, Lois. “Better business model needed for dementia care, Senate Committee hears.” McKnight’s Senior Living. 21 Nov. 2019. https://www.mcknightsseniorliving.com/home/news/better-business-model-needed-for-dementia-care-senate-committee-hears/
 “Ways and Means Leaders Announce Rural and Underserved Communities Health Task Force Request For Information.” Ways & Means. 15 Nov. 2019. https://waysandmeans.house.gov/media-center/press-releases/ways-and-means-leaders-announce-rural-and-underserved-communities-health
 Karlin-Smith, Sarah. “Pelosi to keep progressive amendment in drug pricing bill.” Politico Pro. 21 Nov. 2019. https://subscriber.politicopro.com/article/2019/11/pelosi-to-keep-progressive-amendment-in-drug-pricing-bill-3974378
 Wilkerson, John. “Grassley Updating Rx Pricing Bill To Help Seniors With Catastrophic Cap.” Inside Health Policy. 21 Nov. 2019. https://insidehealthpolicy.com/inside-drug-pricing-daily-news/grassley-updating-rx-pricing-bill-help-seniors-catastrophic-cap
 Politico Pro Staff. “House passes stopgap spending bill, averts shutdown.” Politico Pro. 19 Nov. 2019. https://subscriber.politicopro.com/article/2019/11/house-passes-stopgap-spending-bill-averts-shutdown-3974232
 Goldberg, Dan. “Obamacare signups continue to lag last year’s pace.” Politico Pro. 20 Nov. 2019. https://subscriber.politicopro.com/article/2019/11/obamacare-signups-continue-to-lag-last-years-pace-3974303
[i] “DeGette, Upton call for ideas on Cures 2.0.” DeGette. 22 Nov. 2019. https://degette.house.gov/media-center/press-releases/degette-upton-call-for-ideas-on-cures-20