Below is this week’s “Capitol Hill Healthcare Update,” which is posted on Mondays when Congress is in session. Highlights this week: With the shutdown over (for now), the FDA is back in business; two hearings spotlight drug prices; House GOP questions CMS on Medicaid managed care; and more.
SHUTDOWN OVER, FOR NOW
Congress on Friday approved a stopgap-funding bill that reopens the FDA and other government departments and agencies that had been shuttered for more than a month, but the reprieve is only temporary as a new shutdown showdown could be rekindled in mid-February.
The funding not only reopens the government but also provides back pay for the 800,000 federal employees affected by the shutdown. FDA Commissioner Scott Gottlieb said FDA employees could see the money deposited into their bank accounts as soon as Wednesday.
In addition to receiving appropriated funds from Congress, the FDA now will be able to accept industry user fees to process drug and medical device applications. The FDA could work on reviews funded by user fees that were received before the shutdown began in December but was prohibited from accepting new industry payments or work on new applications once the government closed.
The funding approved by Congress is temporary, lasting only until Feb. 15. Beginning this week, congressional leaders will begin discussions on approving border security and other funding through the rest of the fiscal year.
It’s not immediately clear how the new discussions could reach a different conclusion than the stalemate that led to the 35-day partial shutdown, the longest in U.S. history. But there’s little appetite on Capitol Hill for another shutdown, and there’s even bipartisan discussions about outlawing future shutdowns.
HOUSE, SENATE HEARINGS PUT PRESCRIPTION DRUG PRICES IN SPOTLIGHT
House and Senate committees on Tuesday will begin a series of hearings on prescription drug prices, with academic and think-tank witnesses discussing the issue and potential policy solutions.
The Senate Finance Committee will kick off what the panel announced was “Part I” of hearings that focus on drug prices. Witnesses include Dr. Peter Back of the Memorial Sloan Kettering Center for Health Policy and Outcomes, Douglas Holtz-Eakin of the American Action Forum, Mark Miller of the Laura and John Arnold Foundation, and Kathy Sego of Madison, Ind., a mother of a child with insulin-dependent diabetes.
In the first hearing under Democrat control, the House Oversight and Reform Committee will be “examining the actions of drug companies in raising prescription drug prices.” Witnesses include Alicia Georges of AARP; Dr. Aaron Kesselheim, a professor at Harvard Medical School; Dr. Gerard Anderson, a professor of health policy and management at Johns Hopkins University; and Avik Roy of Foundation for Research on Equal Opportunity.
The House committee, which is led by pharma industry critic Rep. Elijah Cummings, D-Md., earlier this month sent letters to 12 pharmaceutical manufacturers asking for pricing information on an array of Medicare Part D prescription medicines – from oncology to those that control cholesterol. The inquiries begin what’s expected to be an aggressive investigation into industry pricing practices that likely will include the public testimony of company executives.
Cummings said the letters are just the first step in what he described as one of Congress’ “most wide-ranging investigations in decades into the prescription drug industry’s pricing practices.”
HOUSE REPUBLICANS PRESS CMS ON MEDICAID MANAGED CARE
Top Republicans on the House Oversight and Reform Committee last week questioned CMS on its oversight of Medicaid managed care organizations after government watchdog agencies identified integrity issues that could allow for fraud and abuse.
Reps. Jim Jordan, R-Ohio, the ranking member on the committee, and Mark Meadows, R-N.C., in a letter pressed CMS Administrator Seema Verma for information on how the agency oversees Medicaid managed care organizations. Meadows is the ranking member on the panel’s Government Operations Subcommittee.
A 2018 Government Accountability Office report called for “improvements [to] better oversee payment risks.” A 2018 HHS inspector general report found that “weaknesses exist” in Medicaid managed care organizations’ efforts to identify and address fraud and abuse.
SENATORS REINTRODUCE BILL ON MISCLASSIFIED PRESCRIPTION DRUGS
The top lawmakers on the Senate Finance Committee last week reintroduced legislation to “crack down on big pharma games,” permitting HHS to fine pharmaceutical manufacturers that overcharge Medicaid by misclassifying their prescription drugs as generics.
Introduced by committee Chairman Chuck Grassley, R-Iowa, and Sen. Ron Wyden, D-Ore., the ranking Democrat on the panel, the legislation was prompted by Mylan’s $465 million settlement in 2017 with the Justice Department over misclassification of the allergy injection EpiPen. By knowingly misclassifying EpiPen as a generic drug in the Medicaid Drug Rebate Program, Mylan paid lower rebates to the government.
The senators’ bill would allow HHS to reclassify drugs, impose penalties and recover improper rebate payments.
An HHS inspector general report in 2017 found the overwhelming majority of the 30,000 drugs in the Medicaid rebate program were correctly classified. But as many as 3 percent – or 885 drugs – may have been misclassified, and Medicaid was overcharged $1.3 billion for just 10 of those drugs in 2016, the report found.
Originally introduced in the 115th Congress in December and approved by the House, the bill stalled in waning days of the lame duck session, requiring it to be reintroduced this year.
HOUSE PANEL TO FOCUS ON ACA’S PRE-EXISTING CONDITIONS
The House Ways and Means Committee on Tuesday will hold a hearing focusing on the Affordable Care Act’s protections for individuals with pre-existing conditions.
Scheduled witnesses include Karen Pollitz of the Kaiser Family Foundation, Andrew Stolfi of the Oregon Division of Financial Regulation, Keysha Brooks-Coley of the American Cancer Society, Andrew Blackshear of the American Heart Association, and Rob Robertson of the Nebraska Farm Bureau.
This is the committee’s first hearing after Democrats won the House majority last November to focus on the 2010 health law.
HEALTH CENTERS, RURAL PROVIDERS SUBJECT OF SENATE HEARING
The Senate HELP Committee on Tuesday will hold a hearing on health centers and providers in underserved communities, after the committee’s leaders proposed renewing center funding.
Scheduled witnesses include Dennis Freeman, CEO of Cherokee Health Systems in Knoxville, Tenn.; Dr. John Waits, CEO of Cahaba Medical Care in Centreville, Ala.; Dr. Andrea Anderson, director of family medicine at Unity Health Care, Inc., in Washington; and Thomas Trompeter, CEO of HealthPoint in Renton, Wash.
Committee Chairman Lamar Alexander, R-Tenn., and Sen. Patty Murray, D-Wash., the panel’s top Democrat, earlier this month introduced legislation to reauthorize federal funding for community health centers and four other federal health programs that are set to expire this fall.
Alexander said 1,400 centers nationwide provide healthcare services to 27 million Americans, many of whom live in rural areas.
In addition to community health centers, the senators’ bill also would reauthorize the National Health Service Corps, the Teaching Health Center Graduate Medical Education program, the Special Diabetes Program at the National Institutes of Health and the Special Diabetes Program for Indians.
SENATORS SEEK INFORMATION ON LIVER-TRANSPLANT POLICIES
A group of 20 bipartisan senators wrote to HHS last week that a new policy governing organ transplants could force patients in rural and low-income areas to wait longer for a liver match.
The changes last month by the Organ Procurement and Transplantation Network to the national liver distribution policy failed to account for regional variations in liver donation rates, the senators wrote. The letter seeks information on how the network’s policy change will impact Midwestern and Southern states as well as low-income patients.