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<img class="alignright size-medium wp-image-3460" src="https://healthlawupdate.bakerhostetlerblogs.com/wp-content/uploads/sites/19/2016/01/Washington-DC-iStock_000074771283_Full-300x200.jpg" alt="Washington DC iStock_000074771283_Full" width="300" height="200" />New Bill Targets Drug Prices

Bipartisan legislation introduced in the Senate last week would require pharmaceutical manufacturers to alert the U.S. Department of Health and Human Services (HHS) before increasing prices more than 10 percent, continuing congressional pressure on the industry over drug pricing. The bill’s authors – including Sen. John McCain, (R-AZ) – say it would bring needed transparency to the industry’s pricing practices. The legislation also would require companies to certify to HHS the drug’s manufacturing, research, and marketing costs, and net profits. The McCain <a href="https://www.baldwin.senate.gov/imo/media/doc/Text%20-%20FAIR%20Drug%20Pricing%20Act.pdf">legislation</a> will not become law and likely won’t receive even a committee hearing in Congress this year. Still, it’s another indication of the bipartisan political sensitivity around drug prices; McCain is seeking re-election in November.

House to Vote on Long-Term Care Hospital Payments 

The House this week is scheduled to consider <a href="https://www.congress.gov/114/bills/hr5713/BILLS-114hr5713ih.pdf">legislation</a> that would provide regulatory relief to several categories of long-term care hospitals, including easing the so-called “25 percent rule” that prohibits full reimbursement if 25 percent of a hospital’s annual Medicare patient population comes from only one acute-care hospital. The legislation would temporarily reinstate the 50 percent threshold that was in place before July 1. It would also provide targeted relief from the site-neutral payment policy enacted as part of a 2013 law for four specific long-term hospital groups.

House Bill to Aid Critical Access Hospitals

The House on Monday is scheduled to vote on <a href="https://www.congress.gov/114/bills/hr5613/BILLS-114hr5613ih.pdf">legislation</a> that would provide regulatory relief for critical access hospitals by temporarily barring HHS from enforcing the physician supervision requirement. Although a rule by the Centers for Medicare and Medicaid Services (CMS) – twice blocked by Congress – requires that outpatient services be provided under the direct supervision of a physician, some rural and critical access hospitals say it reduces beneficiary access to services in areas where the number of physicians is limited. The legislation was introduced by Rep. Lynn Jenkins, (R-KS).

‘Cures’ Vote Not Expected This Week

House Energy and Commerce Committee Chairman Fred Upton, (R-MI) has been frenetically working to bring even a slimmed-down version of his legislation to the House floor this month for a vote. But disagreements over policy, new funding levels for the National Institutes of Health and corresponding offsets targeted at the pharmaceutical industry continue to stymie the “<a href="https://www.congress.gov/114/bills/hr6/BILLS-114hr6rfs.pdf">21st Century Cures</a>” bill. The committee has been pushing offsets, including prohibiting drug patent settlements (pay-for-delay), potentially with some clawback features; lowering payments for home infusion drugs under the Medicare Part B durable medical equipment (DME) benefit to average sales price; and providing a generic drug applicant a new right to sue in federal court to secure a branded sample subject to a REMS (Risk Evaluation and Management Strategy) to conduct bioequivalence studies. Even if the House were to act this week, the Senate won’t consider the bill until after the November elections.

Woodcock to Testify Before Senate Panel

Dr. Janet Woodcock, the director of the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research, will testify this week before the Senate Appropriations’ FDA Subcommittee, which is continuing Congress’ focus on drug prices. The subcommittee, which is chaired by Sen. Pat Roberts, (R-KS), wants to examine the FDA’s role in promoting generic drug applications. Woodcock is expected to be criticized over the EpiPen and the agency’s failure to approve multiple generics to ensure one company doesn’t monopolize a market.

Mylan CEO to Testify

Mylan CEO Heather Bresch will testify Wednesday before the House Oversight and Government Reform Committee about her company’s decision to raise prices for EpiPen. Republicans and Democrats on the committee have criticized the price increases. Reps. Jason Chaffetz, (R-UT) and Elijah Cummings, (D-MD) also said they will examine how to establish more competition for EpiPen as well as speeding the FDA’s approval of generics. Also testifying is Douglas Throckmorton, deputy director of the FDA’s Center for Drug Evaluation and Research. Meanwhile, Chairman Upton wrote to the HHS inspector general demanding an investigation into whether CMS is properly overseeing the program that requires drug makers to pay rebates in exchange for having their products covered by Medicaid. Upton singled out Mylan and asked whether the company had paid required rebates for EpiPen.

House Panel to Vote on Health Bills

The House Energy and Commerce Committee on Tuesday will vote on a series of mostly bipartisan <a href="https://energycommerce.house.gov/news-center/press-releases/subhealth-passes-5-bipartisan-public-health-bills">healthcare bills</a>, including legislation that would extend the authority of paramedics and other emergency medical services professionals to administer controlled substances to patients.

Other bills include:
<ul>
 	<li>Establishing a National Clinical Care Commission to evaluate and recommend solutions for better coordination and use of federal programs for people with diabetes and related metabolic syndromes and disorders;</li>
 	<li>Increasing data collection by HHS to help place maternal health professionals in more appropriate geographic regions and address health professional shortages through their existing participation in the National Health Service Corps;</li>
 	<li>Awarding grants to initiate and sustain mental health awareness training programs; and</li>
 	<li>Reauthorizing grants and scholarships for graduate and undergraduate nursing education.</li>
</ul>
Meanwhile, the committee’s Oversight and Investigations Subcommittee will hold a hearing Friday on bioresearch labs. The panel has held hearings on shipments of live anthrax from federal labs at the Centers for Disease Control and an Army lab.

Senate Panel to Focus Diagnostic Tests

The Senate Committee on Health, Education, Labor and Pensions (HELP) will hold a hearing on Tuesday to address the regulation of laboratory-developed tests. Witnesses include Dr. David Klimstra of Memorial Sloan Kettering Cancer Center; Brad Spring of BD Life Sciences; Jeff Allen of Friends of Cancer Research; and Karen Kaul, chairwoman of the Pathology and Laboratory Medicine Department at NorthShore University HealthSystem. The committee also will discuss <a href="https://www.congress.gov/114/bills/s2873/BILLS-114s2873is.pdf">legislation</a> introduced by Sen. Orrin Hatch, (R-UT) that would promote collaboration among doctors through technology designed to improve health outcomes.

CMS Likely to Meet MACRA Deadline

CMS last week submitted to the White House for final review its proposal to implement a new Medicare reimbursement system for physicians and other Part B clinicians, signaling the agency is likely to meet a Nov. 1 statutory deadline to publicly release a final rule. Congressional leaders in both parties have called on CMS to allow for flexibility for physician offices to meet the expected Jan. 1 reporting deadline for the Merit-Based Incentive Payment System. CMS did <a href="https://blog.cms.gov/2016/09/08/qualitypaymentprogram-pickyourpace/">announce</a> earlier this month that it would offer some flexibility in how doctors submit data for the quality reporting program. Congress is likely to hold hearings next year to evaluate how CMS is implementing the payment system and how well doctors are meeting reporting requirements and deadlines.

Lawmaker Pushes Bill to Overturn Device Preemption

Rep. Mike Fitzpatrick, (R-PA) last week advocated for his <a href="https://www.congress.gov/114/bills/hr5403/BILLS-114hr5403ih.pdf">legislation</a> that would overturn a 2008 Supreme Court decision affirming preemption protections for medical technology that undergoes the FDA’s most-stringent review process. Fitzpatrick met last week with several Pennsylvania constituents and touted his legislation, which was introduced in June. The bill, which has only one co-sponsor, is not expected to receive serious consideration in Congress. Fitzpatrick has long been an industry critic and champion of legislation backed by trial lawyers against device manufacturers. Fitzpatrick is not seeking re-election in November.

Democrats Push Back on Part B Demo

Nine House Democrats last week urged CMS to scale back its controversial five-year Medicare Part B prescription <a href="https://www.gpo.gov/fdsys/pkg/FR-2016-03-11/pdf/2016-05459.pdf">drug pilot</a> program. As the Obama administration enters its final months, it is expected to release the rule to authorize the demonstration testing competing approaches for physician payments for office-administered drugs. Lawmakers in both parties have criticized the pilot’s scope and lack of input from stakeholders. Some in Congress want to approve legislation in the post-election lame duck voting session to block the Part B rule, which some lawmakers and stakeholders fear is a precursor to a similar far-reaching demonstration for Part D drugs.

Drug Industry Reaches Biosimilars Agreement 

The new Congress sworn in next January will begin review of a series of user fee agreements after the pharmaceutical industry and FDA reached an agreement over agency user fees for biosimilars. The agreement for alternatives to branded biologics will be packaged with other user fee renewals for branded and generic drugs and medical technology into comprehensive legislation that Congress will consider in 2017, before the current user fees expire next September. Lawmakers are unlikely to change the industry-FDA deals but could add other policies related to regulatory approvals.

Capitol Hill Healthcare Update