Health Law Update

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<img class="alignright wp-image-3460 size-medium" 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" />With Congress reconvening after a seven-week summer recess, we wanted to provide you with a quick topline of key healthcare issues lawmakers are expected to consider this week.

Zika Funding

The Senate voted September 6 – and as expected – failed to overcome a Democratic filibuster of new funding to combat the Zika virus. Congress earlier this summer failed to approve funding after Senate Democrats twice blocked consideration of legislation that would have provided $1.1 billion. Democrats object to the GOP Zika bill in part because it’s offset by cuts in the Affordable Care Act. Congressional leaders are expected to include Zika funding in a must-pass spending bill later this month to keep the government operating after fiscal 2016 expires on September 30.

21st Century Cures

On September 7, House Energy and Commerce Chairman Fred Upton (R-MI) acknowledged publicly what had been widely suspected on Capitol Hill – his “21st Century Cures” medical innovation legislation will not pass Congress before the November elections.

Key lawmakers and committee staff had been working during Congress’ summer recess to find a resolution to the popular bill (<a href="https://www.congress.gov/bill/114th-congress/house-bill/6">H.R. 6</a>). Upton had hoped to push through a scaled-down version in September with small-bore regulatory changes designed to speed the discovery and approval of new drugs and medical technology. Upton proposed adding $4 billion for the National Institutes of Health (NIH), $1 billion for the Cancer Moonshot initiative and $1 billion to combat opioid abuse.

But the bill had been blocked by Senate Democrats, who were pressing for billions of dollars more in automatic funding for NIH. Lawmakers also couldn’t resolve partisan disputes as Democrats didn’t want to streamline regulatory approval for pharmaceutical manufacturers without also addressing drug prices, which lawmakers are highlighting in their political campaigns.

Upton still hopes Cures can win congressional approval in December when Congress will reconvene for a post-election lame duck session.

Medicare Part A

The House Ways and Means Health Subcommittee held a hearing on September 7 to examine the evolution of quality in Medicare Part A, specifically whether existing Medicare policies are giving hospitals enough incentives to deliver high-quality, cost-efficient care. “Breaking down barriers to innovation in Medicare will improve the program for beneficiaries and ensure limited taxpayer dollars are being spent efficiently,” subcommittee Chairman Pat Tiberi (R-OH) said. Witnesses included Barbara Gage of George Washington University’s Center for Healthcare Innovation and Policy Research; Elisabeth Wynn of the Greater New York Hospital Association; and Dr. Gregory Worsowicz, president of the American Academy of Physical Medicine Rehabilitation.

Medicare Part B

On September 7, the House Budget Committee held a hearing on the Centers for Medicare and Medicaid Services’ (CMS) <a href="https://innovation.cms.gov/">CMMI demonstration projects</a>, including the controversial pilots for provider-administered drugs under Medicare Part B and a bundled payment model for joint replacement. Opponents of the Part B demo, which include both Republicans and Democrats, learned they will face a significant procedural hurdle if they hope to overturn the plan – the demo could save taxpayers more than $30 billion over 10 years. That means, under congressional budget rules, lawmakers would need to find corresponding savings elsewhere to kill the pilot program. Congress isn’t likely to act to block the demo until December at the earliest. CMS hasn’t finalized the Part B drug plan, and the agency hasn’t forwarded a draft to the White House’s Office of Management and Budget for review.

Mental Health Parity

The House Energy and Commerce Health Subcommittee will hold a hearing on September 9 examining federal mental health parity laws and regulations. Lawmakers will examine a section of <a href="https://www.congress.gov/bill/114th-congress/house-bill/2646">H.R. 2646</a>, the “Helping Families in Mental Health Crisis Act,” as well as additional mental health and substance use disorder parity laws.

Cancer Moonshot

Vice President Joe Biden’s Cancer Moonshot initiative recently released the <a class="js-autopdflink" href="http://f.datasrvr.com/fr1/116/73724/blue-ribbon-panel-report-2016.pdf" target="_blank" rel="noopener">first</a> of three major reports, calling for the creation of a national clinical trials network for immunotherapy research and a national cancer data “ecosystem.” It also advocated increased support for the development of new technologies to monitor cancer cells and the impact of cancer treatments, including radiologic imaging, nuclear medicine and PET imaging. Radiation therapy is also referenced as a potential means of overcoming drug-resistant cancerous tumors.

EpiPen

Mylan Pharmaceuticals remains in the congressional crosshairs as lawmakers in both parties criticize price increases for the company’s emergency allergy treatment. Mylan has agreed to meet privately this week with staff for the Senate Aging Committee and the House Oversight and Government Reform Committee, as well as respond this week to written questions from the Senate Judiciary Committee. Congressional hearings – and even subpoenas – could target Mylan in coming weeks.

Congress is Back in Session – So What Now for Healthcare?