Ohio Clock

Home | Ohio Clock

<img class="alignright size-full wp-image-5645" src="https://ohioclockblog.bakerhostetlerblogs.com/wp-content/uploads/sites/27/2018/11/1200x630Washington-DC-iStock_000074771283_Blog-image_lt-blue-e1549910644100.jpg" alt="" width="438" height="230">
HEALTH PROVISIONS FACE UNCERTAINTY AS CONGRESS RETURNS FOR BUSY DECEMBER
Congress returns to Washington this week after the Thanksgiving holiday with only 18 days before the government runs out of money – and that’s not even the most important issue lawmakers will face in what is shaping up as a cramped year-end calendar.
In addition to <a href="https://www.washingtonpost.com/business/2019/11/23/lawmakers-reach-deal-spending-levels-skirting-now-fight-over-trumps-border-wall-demand/">scrambling to fund the government</a>, the Democrat-controlled House is likely to vote this month to impeach President Donald Trump.
With lawmakers pushing other key items, such as tax provisions, renewing Pentagon programs and the U.S. trade agreement with Mexico and Canada, what’s the likelihood that healthcare provisions will see congressional action?
House leaders say they will schedule a <a href="https://www.majorityleader.gov/content/dear-colleague-house-vote-lowering-prescription-drug-costs-voting-rights-funding-government">vote</a> in the coming weeks on <a href="https://www.congress.gov/bill/116th-congress/house-bill/3?r=1">legislation</a> that addresses prescription drug prices. Among other things, it would require pharmaceutical manufacturers to negotiate prices with the government on 250 drugs; it also would apply those negotiated prices to private health plans nationwide.
It will likely be a party line vote, with few if any Republicans supporting the House bill.
The Senate Finance Committee is separately backing its own <a href="https://www.finance.senate.gov/chairmans-news/grassley-wyden-release-legislative-text-of-finance-committee-passed-prescription-drug-pricing-reduction-act">drug pricing bill</a> with support from the White House. But that effort has largely stalled as rank-and-file Republicans object to government-imposed limits on drug price increases. Even committee Chairman <a href="https://www.grassley.senate.gov/">Chuck Grassley</a>, R-Iowa, said recently he thinks it’s <a href="https://www.politico.com/news/2019/12/01/prescription-drugs-bill-trump-074077">unlikely his bill receives a Senate vote this year</a>.
If comprehensive drug pricing bills don’t pass, it’s possible that discrete, bipartisan provisions can be plucked out of each chamber’s bills and used in other legislation, including renewing a series of Medicare and other health programs.
Medical device manufacturers also are making a final push to further suspend the 2.3 percent excise tax on their industry that renews in January. They hope to piggyback on other legislation, potentially as part of horse-trading with other tax provisions. While suspending the device tax enjoys bipartisan support in both chambers, Congress is not certain to block the tax from going back into effect. 
When it comes to year-end provisions, even senior lawmakers are unclear on a path forward and how much of anything other than the bare minimum to keep the government open can win congressional approval, mostly because of the highly charged partisan environment fueled by impeachment proceedings.
FDA NOMINEE TO RECEIVE COMMITTEE VOTE

The Senate HELP Committee is scheduled to <a href="https://www.help.senate.gov/hearings/nominations09">vote</a> Tuesday on the nomination of Dr. Stephen Hahn to lead the Food and Drug Administration (FDA).

Hahn, an oncologist and chief medical executive at MD Anderson Cancer Center in Houston, faced the committee for questions in November. Senators from both parties pressed him on regulation of vaping and flavored tobacco products and their hopes to stop youth exposure to these products. Hahn relied on his experience as a clinician to answer but was hesitant to speak about the administration’s plans before he is included in their development.

It’s not clear whether Hahn’s nomination can be voted on by the full Senate before the end of the year.

HEALTH BILLS SLATED FOR HOUSE VOTES THIS WEEK

The House is scheduled to vote this week on bipartisan bills that would support overseas AIDS and tropical disease efforts.

House Foreign Affairs Committee Chairman <a href="https://engel.house.gov/">Elliot Engel</a>, D-N.Y., introduced a <a href="https://www.congress.gov/bill/116th-congress/house-resolution/517/text">resolution</a> calling on donor countries to increase their pledges to the Global Fund to Fight AIDS, Tuberculosis and Malaria.

Lawmakers also are expected to pass <a href="https://www.congress.gov/bill/116th-congress/house-bill/3460/text?q=%7B%22search%22%3A%5B%22hr3460%22%5D%7D&amp;r=1&amp;s=2">legislation</a> by Rep. <a href="https://chrissmith.house.gov/">Chris Smith</a>, R-N.J., that seeks to coordinate international efforts to facilitate effective research on and treatment of neglected tropical diseases.

SENATORS INTRODUCE LONG-TERM PCORI REAUTHORIZATION

A bipartisan group of senators last month introduced legislation reauthorizing the Patient-Centered Outcomes Research Institute (PCORI), a nonprofit created in 2010 by the Affordable Care Act, to study the comparative effectiveness of different medical treatments.

Sens. <a href="https://www.warner.senate.gov/public/">Mark Warner</a>, D-Va., <a href="https://www.cassidy.senate.gov/">Bill Cassidy</a>, R-La., <a href="https://www.vanhollen.senate.gov/">Chris Van Hollen</a>, D-Md., and <a href="https://www.capito.senate.gov/">Shelley Moore Capito</a>, R-W.Va., introduced the bill to reauthorize PCORI through fiscal year 2029.

PCORI has awarded more than $2.3 billion in grants to study patient outcomes from different medical treatments. Its findings are publicly available for patients and providers, and although they are not used by the government to determine coverage and payment decisions, the Centers for Medicare &amp; Medicaid Services can take the institute’s research into consideration along with other factors.

Cassidy, a former practicing gastroenterologist, said healthcare costs are lowered when patients have information and can choose what is right for them.

Both the House Ways and Means Committee and House Energy and Commerce Committee have approved legislation to reauthorize PCORI, but stakeholders expect the Senate bill to be the one that ultimately reauthorizes the research for the long term.

OVERSIGHT PANEL TO REVIEW SEASONAL FLU PREPAREDNESS

The House Energy and Commerce Oversight and Investigations Subcommittee will hold a <a href="https://energycommerce.house.gov/committee-activity/hearings/hearing-on-flu-season-us-public-health-preparedness-and-response">hearing</a> Wednesday to examine public health preparedness for influenza season.

Witnesses include Dr. Nancy Messonnier, director of the National Center for Immunization and Respiratory Diseases at the Centers for Disease Control and Prevention; Dr. Anthony Fauci, director of the National Institute for Allergy and Infectious Diseases; Dr. Robert Kadlec, assistant health and human services secretary for preparedness and response; and Dr. Peter Marks, director of the Center for Biologics Evaluation and Research at the FDA.

The 2018-19 flu season was the longest in a decade. While the 2017-18 season was shorter in duration, it was more severe, with nearly 80,000 deaths from the flu. Committee leaders said they want to “discuss efforts underway to develop a more effective vaccine, improve vaccination rates and enhance diagnosis and treatment for those who come down with the flu.”

‘CURES’ AUTHORS SEEKING INPUT ON FUNDING NEW TREATMENTS 

Reps. <a href="https://upton.house.gov/">Fred Upton</a>, R-Mich., and <a href="https://degette.house.gov/">Diana DeGette</a>, D-Colo., are moving forward with an effort to build on the <a href="https://www.fda.gov/regulatory-information/selected-amendments-fdc-act/21st-century-cures-act">21st Century Cures Act</a> they shepherded into law in 2016 to accelerate new medical treatments and technologies.

While the original Cures Act aimed to improve regulatory processes, <a href="https://upton.house.gov/news/documentsingle.aspx?DocumentID=401299">Cures 2.0</a> as it’s being dubbed would focus on ensuring coverage and reimbursement for innovative drugs and devices. Policymakers have been flummoxed by challenges presented by the most promising new treatments that provide immense value to patients, but at a high cost often to a narrowly tailored patient population. Current payment systems are designed around the opposite: low-cost treatments provided to many patients.

The Cures Act became Upton’s legacy-defining achievement as chairman of the Energy and Commerce Committee when it was signed into law by President Barack Obama. But in an environment in which drugmakers are vilified by many lawmakers, legislation that would likely benefit them is expected to have a challenging time gaining traction in Congress.

Upton and DeGette are seeking feedback on a potential bill by Dec. 16.