CONGRESS RECONVENES, WITH A FOCUS ON OPIOIDS

Lawmakers return today to Capitol Hill after a two-week recess, and multiple committees in both the House and Senate are poised to examine the opioid crisis and potential legislative solutions.

The Senate HELP Committee will hold a hearing Wednesday on bipartisan legislation that, among other things, would give the Food and Drug Administration (FDA) and National Institutes of Health (NIH) flexibility to promote alternative pain treatments, allow nurse practitioners and physician assistants to prescribe medication-assisted treatments, and establish uniform guidelines for local opioid recovery centers.

Other opioid-related hearings Wednesday include a Senate Judiciary subcommittee hearing on fentanyl and a House Oversight and Government Reform healthcare subcommittee hearing on local responses to the epidemic. Separately, leaders on the Senate Finance Committee are soliciting their members for opioid-related legislative proposals to include in a potential bill.

The House Energy and Commerce health subcommittee will also hold a hearing Wednesday on a series of opioid bills. Among the legislation under consideration are measures requiring state Medicaid programs to use prescription drug-monitoring programs, mandating e-prescribing for Medicare coverage of controlled substances under Part D and standardizing electronic prior authorizations for controlled substances under Part D.

Congressional attention on opioids isn’t expected to dissipate anytime soon. The House Energy and Commerce investigations subcommittee will hold a hearing in early May that will include the CEOs of the nation’s largest pharmaceutical distributors.

PRESCRIPTION DRUGS, MEDICAL DEVICES CAUGHT UP IN CHINA TARIFF DEBATE

The House Ways and Means Committee will hold a hearing Thursday to examine the impact of the Trump administration’s proposed tariffs on Chinese imports, which would impact the pharmaceutical and medical technology industries.

Raw drug ingredients and technologies used in medical devices are among the 1,300 products on which Trump is proposing to levy a new 25 percent tariff. Of the $50 billion in Chinese imports the White House targeted for tariffs, more than 10 percent include pharmaceutical and medical device products.

The proposed tariffs target pacemakers, artificial joints, MRI machines and sterile equipment used in surgeries. The FDA said 80 percent of the raw ingredients in the prescription drugs used by U.S. patients are imported from either China or India.

Industry representatives for both the drug and device sectors will lobby lawmakers and the Office of the U.S. Trade Representative to try to remove key healthcare-related imports from the list of proposed tariffs.

JOHNSON WANTS HOUSE TO VOTE ON HIS ‘RIGHT TO TRY’ LEGISLATION

The author of Senate-passed legislation that would give terminally ill patients wider access to unapproved prescription drugs is calling on House leaders to schedule a vote on his bill.

Sen. Ron Johnson (R-Wis.) last week said the easiest path to enact his so-called right-to-try legislation is for the House to approve his bill rather than pushing an alternative measure. House leaders have so far been noncommittal on next steps on the issue.

Last month, House leaders negotiated a compromise bill that differed slightly from Johnson’s legislation, which the Senate approved on a voice vote last year. That House bill, which won approval 267-149, would create a pathway for terminally ill patients to request access to unapproved treatments directly from pharmaceutical manufacturers.

Although only two House Republicans voted against the House bill in March, GOP leaders have been cool to the underlying idea, saying the FDA’s existing compassionate-use program provides patients with access to treatments that have yet to win agency approval.

Both Johnson’s bill and the House-approved measure would apply only to prescription drugs, not medical devices.

LAWMAKERS TO QUESTION COLLINS ON NIH BUDGET

A House appropriations subcommittee on Wednesday will hear testimony from NIH Director Francis Collins on his agency’s fiscal 2019 budget.

President Trump earlier this year proposed NIH receive $35.5 billion, a $500 million increase after proposing cutting its budget the year before. But lawmakers last month already boosted NIH spending to $37.1 billion for the current fiscal year, with the added money targeting Alzheimer’s disease research, opioids and a universal flu vaccine.

Fiscal 2019 begins Oct. 1.

KEY DEMOCRAT CRITICIZES CMS FOR NOT UPDATING DRUG PAYMENTS DATABASE

The top Democrat on the House Energy and Commerce Committee last week criticized Center for Medicare and Medicaid Services (CMS) for not updating a database that tracks Medicare and Medicaid spending on prescription drugs.

In a letter to CMS administrator Seema Verma, Rep. Frank Pallone (D-N.J.) said the agency’s prescription drug dashboard is a key tool to track taxpayer spending on drugs, but that CMS hasn’t added new data since the Trump administration came into office last year. Not updating the database “raises questions about this administration’s supposed commitment to lowering the price of prescription drugs for the American people,” Pallone wrote.

He asked Verma to respond to a series of questions, including justifying why the database hasn’t been updated and whether CMS staffers were instructed not to update it.

GAO CALLS ON CMS TO STRENGTHEN MEDICARE DATA SECURITY 

The House Energy and Commerce Committee last week released a report from Congress’ watchdog agency that called for greater oversight by CMS over Medicare data security.

The report by the Government Accountability Office (GAO) noted that CMS had created an oversight program for data obtained by Medicare administrative contractors, but the agency hadn’t established a similar program to monitor security implementation by other entities, including researchers.

The GAO recommended CMS provide additional guidance on required security controls and that CMS more routinely track oversight efforts.

The committee’s oversight panel has held several hearings in recent months to examine policy solutions to strengthen cybersecurity efforts in the healthcare sector.