POLICY BRIEFINGS

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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.

• Biden Administration Key Policy Personnel
• Guide to the 118th Congress

THIS WEEK'S BRIEFING - OCTOBER 11, 2021

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• Senate Passes Short-Term Increase to Debt Limit
• Democrats Weigh Changes to Reconciliation Bill
• ARPA-H Out of Reconciliation Bill
• Ways and Means Leadership Criticizes Surprise Billing Regulation
• MA Prior Authorization Bill Continues to Gain Support
• Democrats Urge Review of Contraception Coverage
• NIH Director Collins to Retire
• FDA Commissioner Nomination Expected in Coming Weeks
• Senate Confirms DHS General Counsel
• DoD Sets Deadline for Civilian Vaccination
• Upcoming Congressional Hearings and Markups
• Recently Introduced Health Legislation

Senate Passes Short-Term Increase to Debt Limit

Congress has temporarily averted a default on U.S. debt obligations, reaching an agreement to increase the debt limit by $480 billion, which is estimated to allow the nation to meet its obligations through December 3, the same day the current continuing resolution (CR) funding the federal government is set to expire. Senate Majority Leader Chuck Schumer (D-N.Y.) and Minority Leader Mitch McConnell (R-Ky.) struck a deal that provided the 60 votes necessary to advance the bill. Republicans had previously refused to vote for a clean debt limit increase or suspension, insisting that Democrats address the debt limit through reconciliation, which would have necessitated a time-consuming process – time Democrats have argued they lacked before breaching the debt limit - and required Democrats to increase the cap to a specific number, rather than using a simple suspension through a certain date. McConnell has stated that Republicans will not provide assistance on the debt limit again. The House of Representatives is expected to pass the bill on Tuesday and send it to the President’s desk for his signature.

Democrats Weigh Changes to Reconciliation Bill

While Democrats continue to iron out a path to passage of the Build Back Better Act reconciliation package, White House representatives have stated that there is no time frame for the bill. Negotiations involving progressive and moderate Democrats and President Joe Biden himself are ongoing, with lawmakers exploring the possibility of including more short-term spending in the domestic policy package. This would reduce the overall size of the legislation without having to choose specific cuts to the bill, leaving the opportunity to extend the programs to the future. Progressives appear to be in favor of maintaining as many programs as possible in the bill for a shorter time, while others in the party have argued in favor of funding a smaller number of programs for the long-term – to reduce the number of political votes that would be required when programs must be extended and to avoid the risk of letting programs lapse.

Sen. Joe Manchin (D-W. Va.) continues to insist that the total size of the package not exceed $1.5 trillion, a figure many progressives have characterized as unacceptably low. The House version of the bill is estimated to cost at least $3.5 trillion. While Manchin is standing by his concerns regarding the expansion of health and social welfare programs, he supports the inclusion of drug pricing reform and additional funding for home health care. Senate Budget Committee Chairman Bernie Sanders (I-Vt.) has criticized Machin’s calls for means testing new or expanded safety net programs, including the addition of dental, vision, and hearing care benefits to the Medicare program. President Biden has reportedly told progressives that he is open to setting income limits for some social programs in the bill, but it remains unclear just how much the lawmakers will be willing to scale back the size and scope of their priorities. Machin has also stated that he will not support the package without the inclusion of the Hyde Amendment, which restricts federal funding for most abortions; the President has said he will sign a bill with or without the amendment. Sanders is requesting that Sens. Manchin and Kyrsten Sinema (D-Ariz.), who has also expressed opposition to the total size of the package, detail exactly what provisions they want to remove.

Progressives are standing by their demand that the stalled bipartisan infrastructure framework (BIF) and reconciliation bill be passed in tandem. Democrats are now targeting October 31 by which to pass the physical infrastructure legislation, in alignment with the 30-day extension of the Surface Transportation Authorization recently passed by Congress.

ARPA-H Out of Reconciliation Bill

The Advanced Research Projects Agency for Health (ARPA-H) will no longer be included in the Democratic reconciliation package currently under negotiation in Congress. The social spending and tax bill as drafted by the House of Representatives included $3 billion for President Joe Biden’s proposed research initiative to be housed within the National Institutes of Health (NIH). Senate Democrats confirmed last week that this funding is unlikely to be include in the final domestic policy legislation because it would not pass the chamber’s rules for budget reconciliation. Reps. Diana DeGette (D-Colo.) and Fred Upton (R-Mich.) have confirmed that they will include ARPA-H authorizing language in their Cures 2.0 bill, an update to their biomedical innovation law the 21st Century Cures Act (Public Law No. 114-255), and that they will release Cures 2.0 in the coming weeks. ARPA-H was proposed as a part of the President’s fiscal year (FY) 2022 budget proposal, and the House’s FY22 Labor, Health and Human Services, Education, and Related Agencies spending bill included appropriations funding, contingent on authorization of the new research agency. The outlook for the annual appropriations process, however, remains unclear as Congress is currently operating under a continuing resolution (CR) funding the federal government through December 3

Ways and Means Leadership Criticizes Surprise Billing Regulation

House Ways and Means Committee Chair Richard Neal (D-Mass.) and Ranking Member Kevin Brady (R-Texas) have sent a letter to the Biden administration criticizing the latest regulation to implement the No Surprises Act, which aims to avoid patient receipt of surprise medical bills and provide an independent dispute resolution (IDR) process for disputes between plans and providers over payment. The lawmakers argue that the recent rule outlining how the (IDR) process will work to resolve billing disputes between providers and insurers does not “reflect the law that Congress passed.” Neal and Brady state that the rule “biases the IDR entity toward one factor (a median rate) as opposed to evaluating all factors equally as Congress intended.” They ask the administration to provide additional justification for how the proposed implementation of the IDR process is in line with the No Surprises Act statute. House Energy and Commerce Chair Frank Pallone (D-N.J.) and Senate Health, Education, Labor, and Pensions (HELP) Committee Chair Patty Murray (D-Wash.) applauded the rule for establishing “a fair payment resolution process between providers and insurers while finally taking patients out of the middle.”

MA Prior Authorization Bill Continues to Gain Support

Amajority of members in the House of Representatives have signed on as cosponsors of the Improving Seniors’ Timely Access to Care Act (H.R. 3173). The bill would make changes to prior authorization in the Medicare Advantage (MA) program by establishing an electronic prior authorization process, minimizing the use of prior authorization for services that are routinely approved, requiring plans to report on the extent of their use of prior authorization and the rate of delays and denials, ensuring prior authorization requests are reviewed by qualified medical personnel, and ensuring that plans adhere to evidence-based medicine guidelines. H.R. 3173 currently has 227 cosponsors, with 129 Democrats and 98 Republicans in support of the bill introduced by Rep. Suzan DelBene (D-Wash.).

Democrats Urge Review of Contraception Coverage

House Energy and Commerce Committee Chair Frank Pallone (D-N.J.) and House Ways and Means Committee Chair Richard Neal (D-Mass.) have sent a letter to the Biden administration urging them to ensure the Affordable Care Act’s (ACA) requirements to provide health insurance coverage for contraceptives approved by the Food and Drug Administration (FDA) continue to be enforced. The lawmakers express concerns about reports of recent denials of coverage and extensive medical management requirements “in contravention of the requirements under the law that ensure individuals can obtain coverage without cost-sharing for the full range of FDA-approved contraceptives.” They ask the secretaries of Health and Human Services, Labor, and the Treasury to evaluate whether additional enforcement actions or the issuance of additional guidance is necessary.

NIH Director Collins to Retire

National Institutes of Health (NIH) Director Francis Collins has announced plans to resign after a nearly three-decade career at the agency. Collins, a physician-geneticist, was nominated to lead the NIH by President Obama in 2009 and was confirmed unanimously by the Senate. He is the longest-serving NIH director and the first presidentially appointed NIH director to serve in more than one administration. Collins previously directed the National Human Genome Research Institute and led the Human Genome Project. He plans to retire by the end of the year, and the President is expected to nominate a replacement before Collins leaves the agency.

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