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.

CONGRESS WORKS TO PASS BUDGET BEFORE FRIDAY’S SHUTDOWN DEADLINE

House leaders are pushing to schedule a vote this week on a $1.3 trillion budget agreement that would give the Senate enough time to pass it before a Friday deadline when government funding expires.

Without action this week by Congress, the government would shut down for the third time this fiscal year. A series of unresolved policy disagreements – including about healthcare – has prevented lawmakers from reaching an agreement to fund the government through fiscal 2018, which ends Sept. 30.

House leaders say they hope to wrap up discussions today and release legislative text of the budget agreement tonight, setting up a House vote Wednesday. The Senate would follow suit, likely Friday.

Over the weekend, leaders were still haggling over thorny policy disputes, including authorizing billions of dollars to fund the Affordable Care Act’s cost-sharing payments to lower individuals’ insurance premiums. But a flash point remains concerning whether the underlying bill also would prohibit taxpayer-subsidized plans from covering abortions.

Other healthcare provisions still being debated include efforts by pharmaceutical manufacturers to reduce their required contributions to close the Medicare Part D prescription drug donut hole and funding a new reinsurance program to reduce insurance plan premiums. Potential changes to Medicare’s outpatient transitional pass-through rules and reimbursements for generic biologic drugs also are candidates for inclusion in the budget bill.

HOUSE TO TRY AGAIN ON ‘RIGHT-TO-TRY’ LEGISLATION

After failing last week to approve legislation that would give terminally ill patients wider access to prescription drugs that are still being studied in clinical trials, House leaders said they will vote again this week.

Last week’s vote was just short of the supermajority needed to approve the legislation under special fast-track procedures. This week’s vote would require only a simple majority, virtually ensuring the bill’s passage in the House.

Only two House Republicans opposed the bill last week. Democrats – largely echoing the position of the pharmaceutical industry – say the Food and Drug Administration’s (FDA) existing compassionate-use program is sufficient to provide terminally ill patients with access to treatments that have yet to win agency approval. Both the House bill and separate Senate legislation would apply only to prescription drugs, not to medical devices.

PHYSICIANS’ PAY, NOMINATIONS AND OPIOID POLICIES TO DOMINATE HILL HEARINGS THIS WEEK

The House Energy and Commerce Committee will hold a series of hearings this week on the opioid crisis, including examining the role of the Drug Enforcement Administration (DEA).

Acting DEA chief Robert Patterson will testify Tuesday at an Oversight and Investigations Subcommittee hearing that will focus on the panel’s yearlong investigation into alleged pill dumping in West Virginia.

Separately, the committee’s Health Subcommittee will hold a two-day hearing beginning Wednesday to examine prevention policies and the public health sector’s role in curbing the crisis. The subcommittee will review two dozen opioid-related bills, including modifying the FDA breakthrough pathway designation to spur approval of abuse-deterrent opioids.

The House Education and the Workforce Health Subcommittee will hold a hearing Tuesday on a recent Labor Department rule on association health plans. The panel has legislative jurisdiction over ERISA-based health policies.

The Senate Finance Committee is scheduled to hold a hearing Tuesday on two Health and Human Services (HHS) nominees. John Bartrum, who is a former senior congressional and White House budget aide, is currently a partner and lobbyist at the Squire Patton Boggs law firm. He was nominated by President Donald Trump last summer to serve as HHS assistant secretary for financial resources.

The committee also will consider Lynn Johnson’s nomination to serve as an HHS assistant secretary for family support. Johnson currently is the executive director of a county health department in Colorado.

Senior Centers for Medicare & Medicaid Services (CMS) leaders are expected to participate in the House Ways and Means Health Subcommittee hearing Wednesday examining implementation of the 2015 Medicare Access and CHIP Reauthorization Act physician payment policy.

ALEXANDER: TRANSPARENCY NEEDED IN 340B DRUG PROGRAM

Senate HELP Committee Chairman Lamar Alexander (R-Tenn.) said last week that hospitals participating in the 340B prescription drug discount program need to disclose how they use the $6 billion they have saved since 2015. During a hearing by Alexander’s committee, one hospital official testified that 340B entities are worried that increased record keeping would be burdensome and that the data could be used to restrict the program, which was designed to underwrite increased hospital services to low-income populations.

Senate Democrats on the committee said the real issue is the cost of prescription drugs, while committee Republicans questioned the explosive growth of the 340B program.

Witnesses included Dr. Bruce Siegel of America’s Essential Hospitals; Lori Reilly of Pharmaceutical Research and Manufacturers of America; Sue Veer, representing the National Association of Community Health Centers; and Joseph Hill for the American Society of Health System Pharmacists.

Alexander didn’t say whether he would support legislation to increase hospital reporting requirements or limit hospitals’ participation in the program. But he did pledge to hold another hearing on the 340B program later this year.

CONGRESSIONAL LEADERS CALL ON CMS TO IMPROVE MEDICAID DATA

Key healthcare leaders in Congress last week called on CMS to take steps to strengthen data acquisition and analysis to identify improper Medicaid payments.

Congress’ watchdog arm, the Government Accountability Office, last year found that CMS lacks a plan to use data generated by the Transformed Medicaid Statistical Information System (T-MSIS). That program tracks information about beneficiary eligibility, enrollment and service utilization as well as claims data for Medicaid and the Children’s Health Insurance Program.

The bipartisan leaders of the Senate Finance Committee and the House Energy and Commerce Committee sent a letter to CMS administrator Seema Verma asking a series of questions, including the status of the agency’s ability to leverage the T-MSIS data to reduce states’ reporting burden and enhance program integrity.

Energy and Commerce Committee Chairman Greg Walden (R-Ore.); the panel’s top Democrat, Rep. Frank Pallone (D-N.J.); Senate Finance Committee Chairman Orrin Hatch (R-Utah); and the committee’s ranking member, Sen. Ron Wyden (D-Ore.) signed the letter.

HOUSE LAWMAKERS ESTABLISH HEALTHCARE INNOVATION CAUCUS

Bipartisan lawmakers in the House last week created the Healthcare Innovation Caucus, which they said was designed to spur legislation that encourages innovative policy ideas that lead to improved quality of care and lower costs.

Reps. Mike Kelly (R-Pa.), Ron Kind (D-Wisc.), Markwayne Mullin (R-Okla.) and Ami Bera (D-Calif.) formed the caucus.

Kelly said the group would focus on accelerating the shift from volume-based care to rewarding value and patient outcomes by advancing successful, innovative payment models and the technologies needed to support them.

Kelly and Kind serve on the Ways and Means Committee, which has jurisdiction over CMS and Medicare Part A and Part B. Mullin serves on the Energy and Commerce Committee, which has jurisdiction over FDA and Medicare Part B and Part D. Bera is a former physician.