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RYAN SAYS POTENTIAL COMPROMISE COMING ON RISK EVALUATION AND MITIGATION STRATEGY DRUGS

House Speaker Paul Ryan, R-Wis., last week said congressional leaders are trying to hammer out compromise legislation that would make it easier for generic manufacturers to obtain branded drugs that are protected under a Food and Drug Administration (FDA) safety program.

Ryan made the comment about the FDA’s Risk Evaluation and Mitigation Strategies (REMS) safety program during BakerHostetler’s 29th annual Legislative Seminar last week. Ryan didn’t offer specifics but said leaders on the House Energy and Commerce and Judiciary committees were working on compromise language that would speed generic manufacturers’ access to those drugs for bioequivalence testing.



Most Republican leaders on Capitol Hill have opposed the legislation, known as the CREATES Act, saying it would empower trial lawyers by making it easier to bring lawsuits and levy financial penalties against branded manufacturers. But FDA has recently stepped up attention on REMS drugs, and lawmakers are looking to generate savings for taxpayers and beneficiaries.

Meanwhile, the pharmaceutical industry is seeking to roll back a change Congress made in March to Medicare Part D plans and include it with any compromise REMS bill. Lawmakers earlier this year voted to require manufacturers to contribute more toward closing the Part D donut hole, but that change effectively increases out-of-pocket costs for beneficiaries in 2020.

Depending on how individual provisions are scored by the Congressional Budget Office, the REMS drug language could be paired with rebalancing pharmaceutical manufacturers’ and insurers’ contributions toward closing the donut hole.

HOUSE TO VOTE ON ‘RIGHT-TO-TRY’ DRUG BILL

The House is slated to give final congressional approval this week to legislation that would give terminally ill patients wider access to unapproved prescription drugs.

The House in March passed its own “right-to-try” legislation, but it never gained traction in the Senate, which has been pushing its own bill by Sen. Ron Johnson, R-Wis.. Rather than develop compromise legislation, the House as soon as Tuesday is expected to take up Johnson’s bill and send it to the White House for President Trump’s signature.

House Majority Leader Kevin McCarthy, R-Calif., announced the move last week. Trump gave the effort a boost earlier this year when he singled out right-to-try legislation in his State of the Union address.

The bill would not apply to medical devices.

HOUSE, SENATE COMMITTEES CONTINUE TO MOVE ON OPIOID BILLS

Congressional committees remain in legislative overdrive on opioid-related bills, as House and Senate panels approved more than three dozen separate measures last week.

The House Energy and Commerce Committee approved 32 opioid bills, including making it easier for Medicaid beneficiaries to gain access to treatment. The Ways and Means Committee last week passed seven bills, including one sponsored by health subcommittee Chairman Peter Roskam, R-Ill., that would include electronic prior authorization for opioids reimbursed under Medicare.

The Senate Commerce Committee on Tuesday will consider opioid legislation within its jurisdiction, including on drug testing by the Transportation Department. The Senate Judiciary Committee on Thursday is scheduled to vote on six opioid bills, including a measure renewing the Office of National Drug Control Policy.

House leaders next month are expected to merge their individual bills into one package with a vote before the end of June. The Senate is similarly working to wrap its opioid provisions into one bill and schedule a vote before August. Opioid legislation could be one of the few bipartisan measures that gains traction in Congress before the midterm elections in November.

NO HEARINGS YET ON TRUMP’S DRUG PRICING PLAN

It’s been nearly two weeks since President Trump and Health and Human Services (HHS) Secretary Alex Azar announced a sweeping series of steps to reduce prescription drug prices, but so far few in Congress seem interested in knowing more.

The White House’s plan mostly focuses on regulatory actions and demonstration projects that HHS, FDA or Center for Medicare and Medicaid Services (CMS) could do on its own. House Speaker Paul Ryan said last week at BakerHostetler’s 29th annual Legislative Seminar that Congress should exercise its legislative role and not acquiesce to the Trump administration’s rulemaking authority.

Still, no House or Senate committee with jurisdiction over healthcare policy has announced hearings to examine the White House plan. House Ways and Means Committee Chairman Kevin Brady, R-Texas, told reporters last week that he does “expect some congressional hearings,” but committee staff said Brady’s panel wasn’t planning any near-term review of the White House initiative.

ANESTHESIOLOGISTS PRESS LAWMAKERS ON DRUG SHORTAGES

Physician anesthesiologists warned lawmakers last week that unprecedented drug shortages for local anesthetics and intravenous pain medications could trigger a healthcare crisis.

More than 600 members of the American Society of Anesthesiologists visited Capitol Hill last week to warn about severe shortages of injectable medications and the need for Congress to act. The physicians said anesthetics are an important tool in the fight against opioid abuse because they can be a substitute for opioids after surgery.

The society, in a separate letter to HHS Secretary Alex Azar, said drug shortages are mostly caused by quality-control problems during the manufacturing process. Because the drugs are typically off-patent, they sometimes have only one approved U.S. manufacturer, magnifying the crisis if one manufacturer is forced to halt production, the anesthesiologists said.

HOUSE PANEL TO REVIEW CHILDREN’S HOSPITAL GRADUATE MEDICAL EDUCATION PROGRAM

The House Energy and Commerce health subcommittee on Wednesday will review legislation that would renew funding for the Children’s Hospital Graduate Medical Education program.

The Senate Committee on Health, Education, Labor and Pensions (HELP) earlier this month approved its version of the bill, which would authorize $330 million in federal funding over five years. Under the Children’s Hospital GME program, more than 50 free-standing children’s hospitals nationwide train general pediatricians and pediatric specialists, including more than 7,000 individual physicians.

Scheduled witnesses at the House hearing include Dr. Gordon Schutze of the Baylor College of Medicine and Texas Children’s Hospital, and Dr. Susan Guralnick, associate dean for graduate medical education for the UC Davis Health System.

HOUSE SPENDING PANEL OKs BUDGET BOOST FOR FDA

The House Appropriations Committee last week approved a 10 percent increase in funding for FDA.

The fiscal 2019 spending bill includes a $308 million spending boost. FDA would receive $3.1 billion in discretionary funding, and when adding industry user fees, the budget would grow to $5.57 billion.

Meanwhile, the Senate appropriations subcommittee is set to vote Tuesday on FDA’s budget, followed by a full committee vote Thursday.

Congressional Republicans are racing to approve the underlying spending bill – which also includes funding for agriculture programs – before it gets caught up in election-year politics. A delay could force lawmakers to again enact stopgap FDA funding before the new fiscal year begins Oct. 1.

SENATE SET TO ADVANCE VETERANS’ HEALTH MEASURE

In advance of Memorial Day, the Senate is scheduled to give final congressional approval this week to legislation that would allow veterans to seek healthcare services outside of Department of Veterans Affairs (VA) facilities.

The House-amended bill provides $5.2 billion in mandatory funding to extend the existing Veterans Choice Program. Without those funds, VA officials warned that the program would run out of money this month.

Meanwhile, House leaders have scheduled a series of votes this week on veterans’ healthcare bills, including establishing oversight of VA electronic medical records and medical product purchasing, and cracking down on opioid abuse.

SENATE HEARING FOCUSES ON CHALLENGES FOR RURAL HEALTHCARE

The Senate Finance Committee will hold a hearing on Thursday regarding the challenges rural and frontier hospitals and providers face in delivering high-quality medical care.

Witnesses include George Pink, professor and deputy director for rural health at the University of North Carolina; Keith Mueller, interim dean at the University of Iowa’s College of Public Health; Konnie Martin, CEO of San Luis Valley Health in Colorado; Susan Thompson, CEO of UnityPoint Accountable Care in Iowa; and Karen Murphy, executive vice president of the Glenn Steele Institute of Health Innovation in Pennsylvania.

Meanwhile, the Senate HELP Committee on Wednesday will vote on legislation to renew a 10-year-old Pandemics and All-Hazards Preparedness Act, which is designed to ensure federal capabilities during a public health emergency. The committee on Tuesday holds a separate hearing on healthcare workforce shortages.

Capitol Hill Healthcare Update