Weekly Health Care Policy Update – October 15, 2021

In this update: 

• COVID-19 Response
  • FDA Panel Meets to Consider Moderna and J&J Booster Doses
  • Merck and Ridgeback Biotherapeutics Apply for EUA for Covid-19 Oral Antiviral
• Administration
  • Melanie Anne Egorin Sworn in as Assistant Secretary for Legislation
• Legislative
  • Democratic Ways and Means Staff Release Report on Race in Clinical Decision Support Tools
• Regulatory
  • Colorado to Cover Gender-Affirming Services as Essential Health Benefit
  • HRSA Announces $100 Million for State Loan Repayment Program
  • CMS Continues Issuing Warnings to Hospitals on Price Transparency Compliance
  • ONC Launches New Effort to Support Data Standardization
• Other
  • MedPAC Discusses Hospital Wage Index, APMs, at Monthly Meeting
  • AHRQ Solicits Input on Telehealth Effects on Women and During Covid-19
  • USPSTF Changes Aspirin Guidance in Draft Recommendation
• Congressional Hearings
• New York State
  • Federal Judge Issues Preliminary Injunction on Religious Exemptions for Covid-19 Health Care Worker Vaccine Mandate
  • OPWDD Commissioner Ted Kastner Leaves Office
  • DOH Officially Repeals “Soft Cap” Prohibition on Executive Compensation
  • DOH Proposes to Increase Rates for PROS Services

COVID-19 Response

FDA Panel Meets to Consider Moderna and J&J Booster Doses
On October 14^th, the Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee met to consider whether to recommend FDA authorization of booster doses for the Moderna and J&J Covid-19 vaccines. The panel unanimously supported authorizing Moderna booster doses for individuals over 65, those 18 to 64 at risk of severe illness from Covid-19, or those whose professions put them at high risk of infection, at least six months after a second dose. These are the same groups the Committee recommended for the Pfizer vaccine booster. However, the Moderna booster will contain half the dose (50 micrograms) of the original vaccine.
 
Today, October 15^th, the Committee is meeting to consider whether to recommend a booster dose for individuals who received the one-dose J&J Covid-19 vaccine. The panel is also discussing results from a National Institutes of Health trial investigating outcomes for individuals who received booster doses from a different manufacturer than their original vaccine.
 
Merck and Ridgeback Biotherapeutics Apply for EUA for Covid-19 Oral Antiviral
On October 11^th, Merck and Ridgeback Biotherapeutics announced they had submitted a request to the Food and Drug Administration (FDA) for an Emergency Use Authorization (EUA) for their investigational oral Covid-19 antiviral, molnupiravir. The companies stated that in a clinical trial on non-hospitalized adult patients with mild to moderate Covid-19 who were at risk for progressing to severe Covid-19 and/or hospitalization, the drug reduced the risk of hospitalization or death by approximately 50%, and no deaths were reported in patients who received the drug (compared to 8 deaths in patients who received placebo). Adverse events were similar between the treatment and placebo groups. Merck expects to produce 10 million courses of treatment by the end of 2021 with more produced in 2022. The FDA has scheduled a meeting for November 30^th to consider the application, indicating that it will likely not issue a decision until December.
 
The Merck press release is available here.

Administration Updates

Melanie Anne Egorin Sworn in as Assistant Secretary for Legislation
On October 7^th, Melanie Anne Egorin was sworn in as Assistant Secretary for Legislation at the U.S. Department of Health and Human Services (HHS). Egorin most recently served as the Deputy Staff Director for the Health Subcommittee and professional tax staff for the Committee on Ways and Means in the U.S. House of Representatives. Egorin has also worked at the Government Accountability Office (GAO). The Office of the Assistant Secretary for Legislation serves as the primary link between HHS and Congress.

Legislative Updates

Democratic Ways and Means Staff Release Report on Race in Clinical Decision Support Tools
On October 14^th, the House Ways and Means Committee released a Majority Staff Report entitled “Fact Versus Fiction: Clinical Decision Support Tools and the (Mis)Use of Race.” The report discusses examples of how racial correction in clinical algorithms can be harmful, highlighting a study published in the New England Journal of Medicine “in which researchers found that while CDSTs can be helpful […] they can also incorporate racial biases that have detrimental effects on patients of color.” As an example, they cite algorithms that make racial corrections to estimates of kidney function resulting in higher reported functional levels for anyone identified as black, and therefore, lower prioritization for kidney transplants. The report does not include specific new recommendations for legislative proposals.

The report is available here.

Regulatory Updates

Colorado to Cover Gender-Affirming Services as Essential Health Benefit
On October 12^th, the Centers for Medicare and Medicaid Services (CMS) announced that it would approve Colorado’s request to require Marketplace health plans to cover a wide range of gender-affirming services for transgender individuals, beginning January 1, 2023. Colorado is the first state to receive the federal government’s approval to make such services an essential health benefit. Specifically, Colorado will require all plans in the individual and small group health insurance markets to cover, if deemed medically necessary, services such as: 

• Eye and lid modifications;
• Face tightening;
• Facial bone remodeling for facial feminization;
• Breast and chest construction and reductions; and
• Laser hair removal.

Prior to this change, marketplace plans in Colorado were required only to cover hormone therapy and some surgeries for treatment of gender dysphoria.
 
The CMS press release is available here.
 
HRSA Announces $100 Million for State Loan Repayment Program
On October 14^th, the Health Resources and Services Administration (HRSA) issued a Notice of Funding Opportunity (NOFO) for $100 million for the State Loan Repayment Program (SLRP). Under this program, HRSA will make up to 50 awards of up to $1 million per year over four years to State governments. Awarded States will design programs to repay educational loans for primary care providers working in Health Professional Shortage Areas in their geographies. Unlike other HRSA loan repayment programs, the SLRP allows states to choose service disciplines and locations to prioritize. These funds do not come with a cost-sharing requirement and allow States to use up to 10 percent of the award for administrative costs.
 
More information is available here.
 
CMS Continues Issuing Warnings to Hospitals on Price Transparency Compliance
CMS has begun to issue corrective action plans to hospitals that have received a first warning regarding their lack of compliance with price transparency regulations. The regulations, which went into effect January 1^st, require hospitals to disclose prices, including payer-negotiated prices, for at least 300 “shoppable services” in a consumer-friendly format. As of the end of September, CMS had sent warning letters to 256 hospitals that were not in compliance with price transparency regulations, and corrective action plans to 32 hospitals, of which six have made adjustments. Hospitals have 45 days to respond and 90 days to address the deficiencies before CMS imposes financial penalties of $10 per bed per day (with a minimum of $300 per day and a maximum of $5,500 per day), so CMS would not be likely to impose its first fine before late November.
 
ONC Launches New Effort to Support Data Standardization
On October 8^th, the Office of the National Coordinator for Health Information Technology (ONC) announced a new initiative to support data standardization across federal government agencies. The effort, called the United States Core Data for Interoperability Plus (USCDI+), builds on the core set of data elements developed by ONC to establish standards for federal agencies that have domain- or program-specific needs but that do not need to be included in the USCDI standards set. Standards established as part of USCDI+ will not be mandatory for certified EHRs and interoperability transactions, unlike the core USCDI standards.
 
A blog post announcing the initiative is available here, and a home page for the initiative is available here.

Other Updates

MedPAC Discusses Hospital Wage Index, APMs, at Monthly Meeting
On October 7^th and 8^th, the Medicare Payment Advisory Commission (MedPAC) held its monthly meeting to discuss prescription drug prices, access to care, Medicare alternative payment models (APMs), Medicare Advantage risk adjustment, and the hospital wage index. With regard to APMs, Commissioners focused on advanced APMs and continued a conversation stemming from a recommendation the Commission made in its June 2021 report that CMS implement a smaller number of APMs that are designed to work together. This recommendation was made in response to concerns that providers and beneficiaries are participating in/aligned to multiple models and that this overlap makes model evaluation difficult.

With regard to the hospital wage index, MedPAC staff presented an overview of the current wage index calculation, which it called “byzantine,” and noted that 67% of IPPS hospitals received at least one special adjustment to its wage index in 2022. Staff also reviewed a 2007 recommendation MedPAC made to replace the wage index with an adjustment based on wage data from all employers and sensical geographic boundaries (like counties), that smoothes differences across areas, and phases in any major payment changes that result. Next spring, Commissioners will discuss these principles and any modifications that may be warranted.

The meeting agenda, briefs, and staff presentations are available here.

AHRQ Solicits Input on Telehealth Effects on Women and During Covid-19
This week, the Agency for Healthcare Research and Quality (AHRQ) published two notices in the Federal Register requesting submissions of data and evidence for their forthcoming reports on telehealth. On October 12^th, AHRQ posted a solicitation for studies and clinical trials relating to the effectiveness of telehealth for women to inform their forthcoming review through the Evidence-based Practice Centers (EPC) program entitled “Telehealth for Women.” On October 13^th, AHRQ published a similar solicitation for studies for their EPC report entitled “Telehealth During Covid-19,” including studies on adverse effects.

The Telehealth for Women solicitation is available here. The Telehealth During Covid-19 solicitation is available here.

USPSTF Changes Aspirin Guidance in Draft Recommendation
On October 12^th, the U.S. Preventive Services Task Force (USPSTF) issued a draft recommendation statement revising its guidance on the use of aspirin to prevent cardiovascular disease. In the proposal, the USPSTF recommended that older adults without heart disease should not take daily low-dose aspirin to prevent a first heart attack or stroke. The USPSTF now believes that the potential bleeding risks for adults in their 60s and older who have not had a heart attack or stroke outweigh any potential benefits from aspirin. There may, however, be a small benefit for adults in their 40s who have no bleeding risk, while the evidence is less clear for those in their 50s. The recommendation is intended to apply to individuals with high blood pressure, high cholesterol, obesity, or other conditions that increase a person’s chances for a heart attack or stroke.

The recommendation will be open for comment here through November 8, 2021.

Congressional Hearings

Wednesday, October 20^th: 

• At 10am, the House Judiciary Subcommittee on the Constitution, Civil Rights, and Civil Liberties will hold a hearing entitled “Oversight of the Americans with Disabilities Act of 1990: The Current State of Integration of People with Disabilities.” More information is available here. 
• At 10am, the Senate Finance Committee will hold a hearing entitled “Health Insurance Coverage in America: Current and Future Role of Federal Programs.” More information is available here. 
• At 10:30am, the House Energy and Commerce Subcommittee on Health will hold a hearing entitled “Enhancing Public Health: Legislation to Protect Children and Families” that will examine 12 bills, including the Protecting Access to Lifesaving Screenings (PALS) Act of 2021 (H.R.4612), the Improving the Health of Children Act (H.R.5551), and the Oral Health Literacy and Awareness Act of 2021 (H.R.4555).  More information is available here.

New York State Updates

Federal Judge Issues Preliminary Injunction on Religious Exemptions for Covid-19 Health Care Worker Vaccine Mandate
On October 12^th, Judge David N. Hurd of the U.S. Northern District granted a preliminary injunction against New York State’s Covid-19 vaccine mandate for health care workers. The preliminary injunction prevents the State from enforcing any requirement that employers deny religious exemptions from Covid-19 vaccinations, interfering in any way with the granting of religious exemptions, or taking any disciplinary or other actions against the plaintiffs for obtaining a religious exemption.
 
The preliminary injunction, which may now be appealed to a higher court, is available here. Governor Hochul’s statement in response to the preliminary injunction is available here.
 
OPWDD Commissioner Ted Kastner Leaves Office
On October 12^th, the Office for People with Developmental Disabilities (OPWDD) announced that Dr. Ted Kastner had ended his service as Commissioner of OPWDD as of October 8^th. Dr. Kastner had held the position since June 2019. Executive Deputy Commissioner Roger Bearden will lead the agency until a replacement is announced.
 
DOH Officially Repeals “Soft Cap” Prohibition on Executive Compensation
On October 13^th, the New York State Department of Health (DOH) published a Notice of Adoption in the State Register (available here) of an amendment that officially repeals the “soft cap” prohibition contained in Governor Cuomo’s Executive Order 38 on covered executive salaries. The “soft cap” was overturned by the New York judiciary in a series of court cases starting in 2015, with a final ruling by the New York Court of Appeals in October 2018.
 
As a result, regulations now state that, unless a covered provider has obtained a waiver, the covered provider may not use more than $199,000 annually in State funds or authorized payments for executive compensation. However, executives may receive additional compensation from other sources of income outside of State funds or authorized payments. DOH will review the $199,000 hard cap amount annually to determine whether adjustment is necessary.
 
The full regulations are available here.
 
DOH Proposes to Increase Rates for PROS Services
On October 13^th, DOH posted a notice in the State Register (available here) outlining its intent to increase reimbursement rates for Personalized Recovery Oriented Services (PROS), as follows:  

• Permanently increase rates by 10.3 percent, effective October 14^th.
• Increase rates by an additional 12 percent from October 14^th through March 31, 2022 to support providers with their response to the Covid-19 emergency and to enhance programs through higher staff-to-recipient ratios.
• Increase rates by an additional 13.1 percent from October 14^th through March 31, 2022 to allow providers to increase recruitment and retention of staff, including through loan forgiveness, tuition reimbursement, and signing bonuses.

The proposed rate enhancements are contingent upon CMS approval of the State’s spending plan for the enhanced Federal Medical Assistance Percentage (FMAP) for home and community-based services (HCBS) contained in the American Rescue Plan (ARP). Stakeholders may submit public comments on the proposed training enhancements via email to spa_inquiries@health.ny.gov.