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July 26, 2021
2021-1420

This Week in Health Policy for July 26

This Week (July 26 - 30)

The Senate Health, Education, Labor and Pensions Committee holds a hearing on "The Path Forward: Building on Lessons Learned from the COVID-19 Pandemic."

  • Details: 10:00 AM EDT on 07/27/2021
  • Witnesses: Anita Cicero, Deputy Director of the Johns Hopkins Bloomberg School of Public Health's Center for Health Security; Phyllis Arthur, Vice President for infectious diseases and diagnostics policy at the Biotechnology Innovation Organization; Les Becker, Deputy Secretary of Innovation in the Washington State Department of Health; David Janz, Director of medical critical care services at the University Medical Center New Orleans.
  • More information available here.

The House Veterans' Affairs Health Subcommittee holds a hearing on "Aging in Place: Examining Veterans' Access to Home and Community Based Services."

  • Details: 10:00 AM EDT on 07/27/2021
  • More information available here.

The Senate Judiciary Committee holds a markup of S. 1425 (117), the "Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics (STALLING) Act"; S. 1428 (117), the "Preserve Access to Affordable Generics and Biosimilars Act"; S. 1388 (117), the "Prescription Pricing for the People Act of 2021"; and S. 1435 (117), the "Affordable Prescriptions for Patients Act of 2021."

  • Details: 9:00 AM EDT on 07/29/2021
  • More information available here.

The House Energy and Commerce Health Subcommittee holds a hearing on "The Path Forward: Advancing Treatments and Cures for Neurodegenerative Diseases."

  • Details: 11:00 AM EDT on 07/29/2021
  • More information available here.

Last Week (July 19 - 23)

Health Care Highlights

CMS issues proposed Medicare Hospital OPPS/ASC rule. On Monday (July 20), the Centers for Medicare & Medicaid Services (CMS) issued their Calendar Year (CY) 2022 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System Proposed Rule. Among the proposals is a provision to increase the fines waged against hospitals that fail to comply with the Trump-era Hospital Price Transparency rule, which requires hospitals to post a comprehensive, machine-readable file of all items and services, along with standard and payer-negotiated prices. In an effort to reduce high rates of noncompliance, CMS proposes to set a minimum fine of $300 a day for hospitals with 30 or fewer beds and $10 per bed per day for larger hospitals, with a cap at $5,500 per day. Previously, the penalty was capped at $300 a day across all hospitals. Biden’s CMS also retained Trump-era cuts to reimbursement for 340B drugs and is moving forward with their Radiation Oncology (RO) model, with various refinements, beginning January 1, 2022. Other Trump-era proposals, however, were walked back in the rule, including reversal of the  phase out of the inpatient-only procedures list, as well as the move to allow ASCs to perform more procedures. (Press Release; Fact Sheet; Proposed Rule)

Delay of Trump-era rebate rule poised for infrastructure offset. It seems increasingly likely that senators will delay a Trump-era Medicare drug rebate rule to help pay for the proposed bipartisan infrastructure legislation, and there’s a chance Democrats could use a full repeal of the rule as an offset in their separate, $3.5 trillion budget reconciliation bill later this year. Sen. Joe Manchin (D-WV), one of the 22 senators negotiating the infrastructure bill, said on Thursday (July 22) that the rebate rule measure will be included in the infrastructure bill, and Senate Finance Chair Ron Wyden (D-OR) said the rebate measure will be included in one of the three bills moving at the same time: infrastructure, reconciliation and transportation. The rule would have effectively eliminated rebates in Part D, disallowing them unless they’re passed through directly to the point of sale. The Congressional Budget Office (CBO) estimated that repealing the rule would cut federal Medicare spending by around $177 billion over a decade. Senators could release details on the bipartisan effort as soon as Monday (July 26), however the deal could still face resistance  in both chambers, making the prospects uncertain.

Hospital groups speak out about other infrastructure “pay fors.” Hospital groups raised concern with Capitol Hill this week over the possibility that the bipartisan infrastructure package will be paid for in part by an extension of automatic Medicare cuts (known as sequestration) and/or clawing back COVID-19 provider relief funds (PRF), of which around $24 billion remains. Early frameworks for the infrastructure deal listed an extension of sequestration and collecting unspent pandemic aid. While its looking increasingly likely that the Trump-era rebate rule will be used as a key offset for the bipartisan package, the other “pay fors” could still be on the table for the bipartisan deal or the future $3.5 trillion “human infrastructure” package Democrats hope to pass later this year via budget reconciliation.

Pfizer vaccine poised for full approval. National Institutes of Health (NIH) Director Francis Collins said this week that full approval of Pfizer’s COVID-19 vaccine could happen as early as the end of the summer, months ahead of the January 2022 target date. His remarks follows a Pfizer announcement last week that it’s received priority review and that the FDA would decide if it will approve Pfizer’s vaccine for people 16 and older by early next year. President Joe Biden said in a CNN town hall this week that he thinks children under the age of 12 will be allowed to get vaccinated on an emergency basis "soon." During the event, Biden fielded questions about the delta variant and low vaccination rates in parts of the country, urging more Americans to get vaccinated.

Missouri Supreme Court rules in favor of Medicaid expansion. The Missouri Supreme Court this week ruled in favor of Medicaid expansion advocates, reversing a lower-court ruling from last month that held the voter-passed Medicaid expansion ballot measure, approved in August 2020, was unconstitutional because it appropriated money without identifying a source of funding. The ruling means expansion can go forward, which would make an estimated 275,000 Missourians newly eligible for coverage.

Hearings and Mark-ups

House Energy and Commerce Markup: On Wednesday (July 21), the House Energy and Commerce Committee advanced 16 health care bills to the full house, aimed at addressing the ongoing opioid and substance use disorder epidemic; improving our nation’s public health systems; increasing vaccine access; extending Medicaid funding for Puerto Rico and other U.S. territories. Among those advanced include:

  • H.R. 2379, to reauthorize and expand a grant program for state response to the opioid use disorders crisis;
  • H.R. 2364, to provide for a public education campaign to raise public awareness of synthetic opioids;
  • H.R. 2355, to facilitate responsible, informed dispensing of controlled substances and other prescribed medications;
  • H.R. 951, to carry out a national campaign to increase awareness of the importance of maternal vaccinations for the health of pregnant and postpartum individuals and their children;
  • H.R. 3742, to issue revised regulations to require the dissemination of information on Advisory Committee on Immunization Practices recommended immunizations to staff of nursing facilities;
  • H.R. 2347, to ensure adequate access to vaccines under the Medicaid program and the Vaccines for Children program;
  • H.R. 4406, to extend Medicaid funding for five years for Puerto Rico and eight years for American Samoa, Guam, the Northern Mariana Islands, and the U.S. Virgin Islands.

Reports, Studies, and Journals

Centers for Disease Control and Prevention: Changes in Influenza and Other Respiratory Viral Activity During the COVID-19 Pandemic - United States, 2020-2021. Influenza viruses and human metapneumovirus circulated at historic lows through May 2021.

Kaiser Family Foundation: Tracking Global COVID-19 Vaccine Equity. As of July 7, 2021, of the estimated 3.3 billion COVID-19 vaccine doses administered globally, most had been provided in a small number of countries only. For much of the world, particularly for those living in low- and middle-income countries, COVID-19 vaccines remain out of reach.

JAMA: Medical Debt in the US, 2009-2020. This study provides an estimate of the amount of medical debt in collections in the US based on consumer credit reports from January 2009 to June 2020, reflecting care delivered prior to the COVID-19 pandemic, and suggests that the amount of medical debt was highest among individuals living in the South and in lower-income communities, although further study is needed regarding debt related to COVID-19.

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Contact Information
For additional information concerning this Alert, please contact:
 
Washington Council Ernst & Young
   •  Laura Dillon (laura.dillon@ey.com)