United States: Capitol Hill Healthcare Update February 27, 2018

CONGRESS RECONVENES WITH FOCUS ON OPIOID LEGISLATION

Congress reconvenes today after a weeklong recess, and a House subcommittee is scheduled to begin a series of hearings focusing on bipartisan efforts to combat the opioid epidemic, while a Senate committee plans to discuss how technology can curb opioid abuse.

The House Energy and Commerce Health Subcommittee on Wednesday will consider eight bills related to law enforcement and patient safety, including legislation that would authorize new funding for opioid education, loosen restrictions on prescriptions via telemedicine of controlled substances used to treat addiction, and crack down on synthetic opioids. Another bill would call on the Drug Enforcement Administration to develop guidelines to train pharmacists and other healthcare providers on fraudulent or forged prescriptions.

Committee Chairman Greg Walden, R-Ore., said earlier this month that his panel will hold two additional opioid-related hearings in March. He said he hopes the House can approve before Memorial Day a package of bipartisan legislation designed to curb opioid misuse.

In addition to the legislation, the committee's oversight and investigations subcommittee is continuing its investigation into wholesale distributors of opioids. That panel has focused on rural communities that received more painkillers than their populations would appear to warrant, and whether those opioids were diverted.

The Senate HELP Committee on Tuesday is scheduled to hold a hearing on opioid monitoring and how to leverage technology to curb abuse. Scheduled witnesses include Snezana Mahon of Express Scripts, Sherry Green of the National Alliance for Model State Drug Laws, Dr. H. Westley Clark of Santa Clara University, and Sanket Shah of the University of Illinois.

HOUSE ANTITRUST PANEL TO PROBE CVS-AETNA SALE AMID SKEPTICISM FROM LAWMAKERS

A House panel on Tuesday is scheduled to examine CVS Health Corp.'s $69 billion acquisition of Aetna Inc.

The Judiciary Subcommittee on Regulatory Reform, Commercial and Antitrust Law will examine the sale amid questions from lawmakers about what impact the consolidation would have on prescription drug prices and whether it could undermine new market players, like Amazon's rumored entry into the pharmacy business.

Although CVS is a retail pharmacy and Aetna is an insurer, both companies have significant overlap in the Medicare Part D prescription drug program. Some lawmakers have expressed concern the combined company may violate antitrust laws by using its pharmacy benefit management services to give Aetna an advantage over the competition.

Scheduled witnesses at the hearing include Tom Moriarty, CVS' general counsel, and Thomas Sabatino, Aetna's general counsel. Other witnesses include Dr. Craig Garthwaite of the Kellogg School of Management at Northwestern University; Dr. Lawrence Wu, an economics consultant; George Slover of Consumers Union; and Geoffrey Manne of the International Center for Law and Economics.

LEGISLATION AIMS TO ENSURE MEDICARE PAYMENT COVERAGE, CHANGES TO NTAP

Bipartisan legislation that could be introduced in the House as soon as this week would create accelerated Centers for Medicare and Medicaid Services (CMS) transitional and payment coverage for new technologies that offer treatment or diagnostic breakthroughs for patients.

Reps. Suzan DelBene, D-Wash., and Jackie Walorski, R-Ind., have been circulating draft legislation for several weeks. The bill could be introduced this week, though introduction could slip into March.

The Food and Drug Administration (FDA) usually quickly approves new medical technology, but coverage and reimbursement can be a bottleneck at CMS, where the process to receive a payment code can take three years or longer. The new legislation is expected to provide for transitional coverage for a designated breakthrough product beginning when FDA approves it, and the product would also be eligible for new technology add-on payments (NTAP) and outpatient pass-through payments.

The bill is expected to make other NTAP changes, including increasing the add-on payment to 80 percent, up from the current 50 percent. It also would create an appeals process that would allow CMS to make a product NTAP-eligible beginning in the next quarter after a successful appeal by a manufacturer, rather than requiring manufacturers to reapply the following fiscal year.

Although there's bipartisan support in Congress for CMS to be more aggressive with its NTAP approvals, it's not clear that there's sufficient support for this legislation to gain traction on Capitol Hill. Mandating coverage and boosting add-on payments would increase Medicare costs, requiring offsetting spending reductions.

BIPARTISAN HEALTH BILLS ON TAP THIS WEEK

The House will kick off votes today with a series of noncontroversial healthcare bills, while a Senate committee later this week is expected to advance legislation on pediatric cancer research.

The bipartisan bills scheduled for House action today include legislation by Rep. Gus Bilirakis, R-Fla., that would call on Health and Human Services (HHS) to expand research and surveillance infrastructure for congenital heart disease; legislation by Rep. Danny Davis, D-Ill., that would reauthorize a sickle cell disease prevention and treatment demonstration program; legislation by Rep. Michael Burgess, R-Texas, that would help place military trauma care providers in civilian trauma centers; and legislation by Rep. Robin Kelly, D-Ill., that would renew a Centers for Disease Control and Prevention (CDC) dental health grant program for low-income populations.

The Senate HELP Committee on Wednesday is scheduled to vote on legislation by Sen. Jack Reed, D-R.I., that would authorize the National Institutes of Health (NIH) to support efforts to catalog data about children, adolescents and young adults with certain cancers in order to establish a national childhood cancer registry. The bill also would authorize CDC to award grants to state oncology registries to improve tracking of childhood cancers.

The Senate panel also is scheduled to vote to renew the FDA animal drug user fee program.

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