Weekly Health Care Policy Update – July 30, 2021

August 6, 2021

In this update: 

  • Administration
    • Biden Administration Announces Updates on COVID-19 Response 
      • Biden Establishes Vaccination Requirements and Incentives
      • FDA Extends J&J Vaccine Shelf Life
      • CDC Updates Masking Guidance
      • CDC Updates Testing Guidance
      • Administration Releases Guidance on Long COVID as a Disability
      • VA Establishes Vaccination Mandate
  • Legislative
    • Congress Moves Forward on Bipartisan Infrastructure Deal
  • Regulatory
    • CMS Finalizes Four Payment Rules for FY 2022
    • CMS Says Part D Premiums Will Increase by 5% in 2022
    • Office of Minority Health Issues NOFO Regarding Policies Contributing to Health Disparities
  • Other
    • U.S. News Releases 2021-2022 Best Hospitals Ranking
    • Major Health Care Organizations Call for Mandatory Vaccination
    • Pfizer/BioNTech Release Six-Month Vaccine Data
    • Pfizer and Moderna Expand COVID-19 Vaccine Study Size for Ages 5 to 11
    • Lawsuit Accuses HHS of GME Underpayments
  • Congressional Hearings
  • New York State
    • DOH Rescinds COVID-19 Community Based Long-Term Services and Supports Guidance
    • OMH Releases Young Adult ACT Team RFP
    • NYS Submits Interim Independent Evaluation for the Children’s Design 1115 Waiver

Administration Updates

Biden Administration Announces Updates on COVID-19 Response
This week, the Biden Administration announced new updates on the COVID-19 response: 

  • Biden Establishes Vaccination Requirements and Incentives: On July 29th, President Biden announced that all civilian federal employees must attest to being fully vaccinated against COVID-19 or adhere to restrictions, including weekly or twice-weekly testing, masking, and limits on travel. Following the announcement, the Pentagon announced that the vaccine requirement would also apply to all active-duty military. The President also announced a program, funded through the American Rescue Plan (ARP), to reimburse the cost of paid leave to small- and medium-sized businesses that offer it to employees to help a family member be vaccinated.
  • FDA Extends J&J Vaccine Shelf Life: On July 28th, the Food and Drug Administration (FDA) extended the authorized shelf-life for Johnson & Johnson’s COVID-19 vaccine to 6 months at 2-8 degrees Celsius. The vaccine was previously approved to be stored for up to 4.5 months.
  • CDC Updates Masking Guidance: On July 27th, the Centers for Disease Control and Prevention (CDC) updated its masking guidance in response to the rise of the Delta variant, recommending that vaccinated Americans resume indoor mask wearing in areas of the country that have recorded more than 50 new infections per 100,000 residents over the previous week, or where the test positively rate is above 8%. In New York, this currently includes New York City, Nassau, Suffolk, and Orange Counties. The CDC also recommended universal indoor masking in schools this fall.
  • CDC Updates Testing Guidance: On July 27th, the CDC also revised testing guidance, recommending that fully-vaccinated individuals who are exposed to someone with a confirmed case of COVID-19 after three to five days, even if they are not experiencing symptoms. The CDC recommends that such individuals wear masks indoors while awaiting test results, but do not need to quarantine unless the test is positive.
  • Administration Releases Guidance on Long COVID as a Disability: On July 26th, on the 31st anniversary of the Americans with Disabilities Act (ADA), President Biden announced that Americans with “long COVID” (who have new or ongoing symptoms four or more weeks after first being infected with the virus that causes COVID-19) will be eligible for disability protections under the ADA, if the disease substantially limits one or more major life activities. These include accommodations and services in the workplace, in school, and in the health care system. The Departments of Health and Human Services (HHS) and Justice issued accompanying joint guidance on long COVID as a disability.
  • VA Establishes Vaccination Mandate: On July 26th, the Department of Veterans Affairs announced that it would require 115,000 frontline health care workers to receive the COVID-19 vaccine within the next eight weeks. It is the first federal agency to mandate inoculation. The mandate applies to doctors, dentists, registered nurses, physician assistants, and some specialists. Penalties for non-compliance could include termination.

Congressional Update

Congress Moves Forward on Bipartisan Infrastructure Deal
On July 28th, the Senate voted 67-32 to move forward on a bipartisan infrastructure deal, with 17 Republicans joining all 50 Democrats to support a $1 trillion package with $550 billion in new spending for infrastructure like roads, bridges, water, and public transit. The bill includes no major health care funding and is expected to extend the Medicare sequester by one year (through FY 2031), which would generate roughly $8.7 billion in savings, and delay the Trump-era Part D Medicare drug rebate rule for three years, which would create a budgetary savings of $49 billion.
 
Additionally, the bill will repurpose $200 billion in other unused virus relief funds, such as supplemental unemployment assistance rejected by states. However, it is not expected to cut funds from the Provider Relief Fund (PRF) as had been rumored. In fact, also on July 28th, Senators Michael Bennet (D-CO) and Kevin Cramer (R-ND) introduced legislation to give providers additional time to spend PRF funds, until the end of the year or the end of the COVID-19 public health emergency (PHE), whichever is later.
 
A fact sheet on the bipartisan deal is available here. The bill text is expected to be released shortly.

Regulatory Updates

CMS Finalizes Four Payment Rules for FY 2022
On July 29th, the Centers for Medicare & Medicaid Services (CMS) published four rules finalizing the federal fiscal year (FY) 2022 Medicare payment parameters for skilled nursing facilities (SNFs) and other specialty provider types. The four rules are: 

More details will be included in SPG’s update next week.
 
CMS Says Part D Premiums Will Increase by 5% in 2022
On July 29th, CMS announced that the average Medicare Part D premium is projected to increase by about 5%, from $31.47 to $33, in 2022, according to a report in Fierce Healthcare. Part D premiums had previously decreased from $34.70 in 2017 to a low of $30 in 2020, a drop of about 12%, but have recently begun to rise again. Final information on 2022 Part D premiums and cost-sharing is expected to be released in the fall.
 
Office of Minority Health Issues NOFO Regarding Policies Contributing to Health Disparities
On July 16th, the HHS Office of Minority Health released a Notice of Funding Opportunity (NOFO) seeking applicants to implement demonstration projects as part of the “Framework to Address Health Disparities through Collaborative Policy Efforts” initiative. Under this initiative, applicant sites will help develop a “methodological framework, structured process, and tool” that they will use to support: 

  • The assessment and identification of policies that may create or perpetuate health disparities by contributing to structural racism;
  • The modification, development, and implementation of policies to improve health outcomes; and
  • Evaluation of these activities.

The Office of Minority Health will provide up to $375,000 per year over three years to each of four awardees, for a total funding of $4.5 million. Eligible applicants may be public or private not-for-profit entities. Awarded entities will work in collaboration with the separately-awarded Coordinating Center to develop the framework and tool within six months, and then use the tool to conduct a review and analysis of existing policies related to health, housing, education, and other areas. Policies reviewed may be implemented at state, county, or local levels.

Applications are due on August 23rd. The NOFO is available here.

Other Updates

U.S. News Releases 2021-2022 Best Hospitals Ranking
On July 27th, U.S. News & World Report released its 2021-2022 Best Hospitals rankings and ratings. U.S. News ranks hospitals for excellent care for the most complex cases in 15 adult specialties. Three New York hospitals made the 2021-22 Best Hospitals Honor Roll: New York-Presbyterian (7), NYU Langone (8), and Mount Sinai (17). Five New York hospitals also ranked among the top 10 in certain specialty areas: 

  • Hospital for Special Surgery 
    • Orthopedics (1), Rheumatology (4)
  • Mount Sinai 
    • Cardiology and Heart Surgery (6), Diabetes and Endocrinology (10), Geriatrics (1), Neurology and Neurosurgery (10)
  • Memorial Sloan Kettering 
    • Cancer (2), Ear, Nose & Throat (1), Gynecology (2), Urology (3)
  • New York-Presbyterian: 
    • Cardiology and Heart Surgery (4), Diabetes and Endocrinology (5), Gastroenterology and GI Surgery (8), Geriatrics (7), Neurology and Neurosurgery (2), Orthopedics (9), Psychiatry (4), Pulmonology and Lung Surgery (10), Rheumatology (4), Urology (6) 
  • NYU Langone 
    • Cardiology and Heart Surgery (5), Diabetes and Endocrinology (4), Gastroenterology and GI Surgery (5), Geriatrics (5), Neurology and Neurosurgery (5), Orthopedics (4), Psychiatry (10), Pulmonology and Lung Surgery (6), Rehabilitation (8), Rheumatology (8), Urology (9) 

For the first time, U.S. News also measured hospitals on health equity. Hospitals were rated on how well the surrounding community was represented in the population treated by the hospital. At four out of five hospitals, U.S. News found that minority residents “were underrepresented among patients receiving services such as joint replacement, cancer surgery and common heart procedures.” Of Honor Roll hospitals in New York, only Mount Sinai received the highest scores for serving non-white, Black, Asian American/Pacific Islander, and Hispanic patients at a rate comparable to or higher than its community. 
 
Major Health Care Organizations Call for Mandatory Vaccination
On July 26th, nearly 60 major health care organizations released a joint letter calling on all health care and long-term care employers to require their employees to be vaccinated against COVID-19. Pointing to the recent surge in COVID-19 infections and the widespread availability of safe and effective vaccines, the letter says health care workers should get vaccinated to help protect the vulnerable who cannot be vaccinated and to help avoid the resumption of stringent public health measures. Signatories of the letter include the American Academy of Family Physicians, American Medical Association, American Nurses Association, American Osteopathic Association, and many more specialty and state societies.
 
The letter is available here.
 
Pfizer/BioNTech Release Six-Month Vaccine Data
On July 28th, Pfizer/BioNTech issued a press release on six-month follow-up results on the safety and efficacy of their COVID-19 vaccine. Pfizer/BioNTech’s preprint data shows that the vaccine’s efficacy remains highly effective, although effectiveness dropped from 96% to 84% after six months. Over the full six-month period, this represents a 91% overall efficacy rate for preventing even minor symptoms of COVID-19, falling an average of 6% every two months, with a peak of 96% efficacy within two months of vaccination. Protection against severe disease remained at an overall rate of 97% over six months. It is unclear whether efficacy is waning due to time or the emergence of variants against which the vaccine is less effective, though Pfizer/BioNTech lab studies suggest that their vaccine should be able to neutralize the Delta variant.
 
The press release is available here.
 
Pfizer and Moderna Expand COVID-19 Vaccine Study Size for Ages 5 to 11
On July 26th, both Pfizer-BioNTech and Moderna announced that they will expand the size of their COVID-19 vaccine trials in children ages 5 to 11. This expansion was encouraged by the FDA, with the intention to improve detection of rare side effects like myocarditis and pericarditis. The current cohort sizes will be doubled to 3,000 children per company in the 5 to 11 age group. As a result, Moderna will now seek emergency authorization for this age group in “winter 2021/early 2022,” while Pfizer said it may still be able to do so by the end of September, even with the bigger trial. 
 
Lawsuit Accuses HHS of GME Underpayments
On July 26th, a group of 14 teaching hospitals filed a lawsuit alleging that the Medicare program has been underpaying teaching hospitals for the cost of graduate medical education (GME) to train resident physicians. The group includes the Hospital for Special Surgery, Bridgeport Hospital, St. Joseph’s Regional Medical Center, and Yale New Haven Hospital. The suit, filed in the U.S. District Court for the District of Columbia, argues that the formula HHS has been using for years is flawed. The complaint centers on payments for physicians whose residencies or fellowships extend beyond five years. For these longer residencies and fellowships, Medicare GME payments are cut in half, but the plaintiffs argue that HHS has modified reimbursements so that academic medical centers do not receive even the reduced amount.
 
This lawsuit follows the D.C. Court’s decision in June in Hershey Medical Center v. Becerra, which overturned a different GME reimbursement regulation, relating to situations where hospitals exceeded their resident cap, which dated back to 1997.
 
More information on the lawsuit is available here.

Congressional Hearings

The House is in recess through August 30th. The Senate has not announced major health-related hearings next week.

New York State Updates

DOH Rescinds COVID-19 Community Based Long-Term Services and Supports Guidance
On July 26th, the New York State Department of Health (DOH) rescinded COVID-19 guidance for Community Based Long Term Services and Supports (CBLTSS) covered by Medicaid. The now-rescinded guidance (available here) was initially issued on March 18, 2020 in response to the COVID-19 outbreak, offering flexibilities and waivers of requirements, particularly related to in-person assessments. These flexibilities applied to CBLTSS delivered through Licensed Home Health Care Services Agencies (LHCSAs) or the Consumer Directed Personal Assistance Program (CDPAP).
 
DOH has issued transitional guidance for relevant stakeholders to support the return to pre-emergency protocols in the following areas: 

  • Requirements for physician orders;
  • Community health assessments;
  • Reassessments and home visits;
  • Personal assistant annual assessments; and
  • Facility-based assessments.

Effective immediately, all community health assessments, periodic reassessments, six-month care management home visits, and facility-based assessments must be completed in-person. Additionally, CDPAP Personal Assistants must obtain an annual health assessment, if due, no later than September 30, 2021.
 
The DOH rescission notice and transition guidance is available here. Questions may be sent to MLTCinfo@health.ny.gov.
 
OMH Releases Young Adult ACT Team RFP
On July 29th, the New York State Office of Mental Health (OMH) released a Request for Proposals (RFP) for the development of a Young Adult Assertive Community Treatment (ACT) team in Brooklyn or the Bronx. The Young Adult ACT team will serve 48 individuals, ages 18-25, who: 

  • Have serious mental illness (SMI);
  • Have not been successfully engaged by the traditional mental health treatment and rehabilitation system; and
  • Can benefit from the specialty ACT team’s goals, including helping young adults become independent.

The Young Adult ACT team will be funded through Medicaid and net deficit funding, in addition to $425,000 in start-up and transition/ramp-up funding. Contracts will last for five years.
 
The full RFP is available here. Required Letters of Intent are due on September 16th and applications are due on September 29th. SPG will shortly distribute a full summary of the RFP. 
 
NYS Submits Interim Independent Evaluation for the Children’s Design 1115 Waiver
On July 27th, the State submitted an independent evaluation of the Children’s Design 1115 Waiver Amendment to the Centers for Medicare and Medicaid Services (CMS). Conducted by the RAND Corporation, the interim evaluation identified the facilitators of, and barriers to, the implementation of the Children’s Design. The report provides baseline metrics for children in Medicaid fee-for-service (FFS), managed care, and enrolled in Health Homes. It also examines stakeholder perspectives on the early implementation of the demonstration and presents suggestions for the summative evaluation to follow.
 
The report found that families, providers, advocates, and managed care plans considered the transition from the pre-demonstration system to be challenging and shared concerns over care access and care coordination. RAND stated that it was unable to fully assess the impact of the Children’s Design on quality of care and outcomes because of the recency of implementation and the impact of the COVID-19 pandemic.

The research report is available here.