Hart Health Strategies provides a comprehensive policy briefing on a weekly basis. This in-depth health policy briefing is sent out at the beginning of each week. The health policy briefing recaps the previous week and previews the week ahead. It alerts clients to upcoming congressional hearings, newly introduced bills, regulatory announcements, and implementation activity related to the Patient Protection and Affordable Care Act (PPACA) and other health laws.


Manchin Says He Will Not Back Build Back Better

Consideration of President Joe Biden’s $2 trillion tax and social spending package appears to be indefinitely delayed following stalled negotiations between the White House and Sen. Joe Manchin (D-W.Va.). During an interview on Fox News Sunday, Manchin stated “I cannot vote to continue with this piece of legislation. I just can’t. I’ve tried everything humanly possible. I can’t get there...This is a no on this legislation.” The White House later responded that Manchin’s remarks were “at odds with his discussions this week with the President” and that the administration will continue to press him to reverse his position. Democrats have spent months trying to achieve passage of the Build Back Better Act through the budget reconciliation process, which would allow them to bypass a Republican filibuster in the Senate, making Machin’s vote essential in the evenly divided chamber.

Debt Limit Raised through Early 2023

President Joe Biden has signed legislation (S.J.Res.33) to raise the U.S. debt limit by $2.5 trillion, averting a U.S. default on its obligations and extending the federal government’s borrowing authority into early 2023. The measure increases the national debt ceiling to $31.4 trillion. Lawmakers had previously secured an agreement requiring only a simple majority vote for passage of the bill, which was cleared by the Senate in a 50-49 vote and by the House of Representatives in a 221-209 vote. Rep. Adam Kinzinger (R-Ill.), who is not running for reelection, was the only Republican to vote in support of the bill. Congress has since adjourned for the year, with the Senate scheduled to reconvene for the second session of the 117th Congress on January 3 and the House of Representatives scheduled to return on January 10.

ACT For ALS Act Sent to President for Signature

The Senate passed legislation (H.R.3537) by voice vote last week directing the U.S. Department of Health and Human Services (HHS) to support research on and expanded access to investigational drugs for amyotrophic lateral sclerosis (ALS). The Accelerating Access to Critical Therapies (ACT) for ALS Act authorizes $100 million annually to fund early access to ALS investigational therapies, accelerate ALS and neurodegenerative disease therapy development, and increase research on and development of interventions for rare neurodegenerative diseases. The bill was previously passed by the House of Representatives and will now be sent to President Joe Biden to be signed into law.

Wyden Urges Administration to Address Part B Premium Increases

Senate Finance Committee Chair Ron Wyden (D-Ore.) is urging the Biden administration to cap the increase in Medicare Part B premiums stemming from the price of the new Alzheimer’s treatment Aduhelm. “Medicare beneficiaries cannot afford to be saddled with a record increase in monthly premium costs,” his letter to U.S. Department of Health and Human Services (HHS) Secretary Xavier Becerra states, “Especially when those premium costs are being driven up by uncertain expectations of sky-high Medicare costs for an outrageously expensive drug like Aduhelm that has presented limited clinical evidence of its effectiveness.”

Senate HELP Committee Questions FDA Nominee

Sens. Joe Manchin (D-W.Va.) and Bernie Sanders (I-Vt.) announced that they will join Sen. Richard Blumenthal (D-Conn.) in voting against the nomination of Robert Califf to serve as Commissioner of Food and Drugs. The lawmakers have been critical of Califf ’s ties to the pharmaceutical industry, with Manchin also underscoring Califf ’s prior failure to address the agency’s role in the opioid crisis. Nevertheless, Califf ’s confirmation hearing before the Senate Health, Education, Labor, and Pensions (HELP) Committee last week proceeded relatively smoothly, with the nominee stating that he is on the record in support of making drugs more affordable and defending his record on opioids. Califf also pledged to undertake an extensive review of opioid regulations including product labeling. While a committee vote, which would proceed a Senate floor vote, has not yet been scheduled, Califf is expected to be confirmed as FDA Commissioner for a second time. He has the support of both HELP Committee Chair Patty Murray (D-Wash.) and Ranking Member Richard Burr (R-N.C.), who urged his Republican colleagues to support the nomination. Califf was previously confirmed by the Senate in an 89-4 vote. More than sixty of the senators who voted for his confirmation continue to serve in the Senate today.

Former Sen. Johnny Isakson Dies at 76

Former Sen. Johnny Isakson (R-Ga.) passed away on Sunday at the age of 76. Isakson served in the House of Representatives between 1999 and 2004, and in the Senate from 2005 until his retirement in 2019. During his time in the Senate, he chaired the Ethics Committee, responsible for enforcing standards of behavior for senators and their staff, for five years. He also served on the Health, Education, Labor, and Pensions (HELP) Committee, championing the Over-the-Counter Monograph Safety, Innovation, and Reform Act. As chair of the Veterans’ Affairs Committee, Isakson was a longtime leader in veterans’ suicide prevention policy and successfully introduced and passed the MISSION ZERO Act. Last Congress, key veterans’ health legislation was named in honor of him and former Rep. Phil Roe - the Johnny Isakson and David P. Roe, M.D. Veterans Health Care and Benefits Improvement Act. Isakson also served on the Senate Finance Committee and co-chaired the Chronic Care Working Group, co-authoring the Creating High-Quality Results and Outcomes Necessary to Improve Chronic (CHRONIC) Care Act, a bipartisan bill to strengthen and improve health outcomes for Medicare beneficiaries living with chronic conditions.

Former WH Testing Coordinator to Serve as HRSA Administrator

Carole Johnson will be assuming the role of Administrator of the Health Resources and Services Administration (HRSA) after her time spent as the Testing Coordinator for the White House COVID-19 Response Team. Prior to joining the Biden administration, Johnson worked as Commissioner of the New Jersey Department of Human Services and previously served as the White House Domestic Policy Council’s public health lead in the Obama administration. Tom Inglesby will replace Johnson on the White House COVID-19 Response Team. Inglesby has been serving as senior advisor for COVID-Response in the Office of the Secretary of the U.S. Department of Health and Human Services (HHS).

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