Weekly Health Care Policy Update – February 14, 2022

February 22, 2022

In this update: 

  • Covid-19 Updates
    • Administration Issues Subregulatory Guidance on Covid-19 OTC Test Coverage
    • CRS Publishes FAQs on Provider Relief Fund
    • CMS Publishes Nursing Home Covid-19 Booster Vaccination Data
    • CDC Endorses FDA’s Recommendation on Full Approval for Moderna Vaccine
  • Federal Administration
    • Eric Lander Resigns as Director of OSTP and White House Science Advisor
  • Federal Legislative
    • House Passes Stop-Gap Spending Bill; Congressional Leaders Strike Funding Deal
    • Senators Introduce Legislation to Extend Telehealth Access in Medicare after End Covid-19 PHE
  • Federal Agency
    • CMS Issues Draft 2022 Call Letter for QHP Rating System and Enrollee Survey
    • CMMI Updates FAQs on Expanded HHVBP Model
  • Other
    • MedPAC Supports CMS NCD on Aduhelm; Industry and Advocates Push Back
    • MACPAC Brief and Health Affairs Study Examine Racial Differences in Access to Care
  • Legislative Hearings
  • New York State Updates
    • OMH Extends Commissioner’s Regulatory Waiver
    • Governor Hochul Signs Legislation Establishing the Office of the Advocate for People with Disabilities
  • Funding Opportunities
    • NYC DOHMH Releases RFP for School-Based Health Centers

COVID-19 Updates

Administration Issues Subregulatory Guidance on Covid-19 OTC Test Coverage
On February 4th, the Departments of Health and Human Services (HHS), Labor, and Treasury issued additional guidance, via a set of frequently asked questions (FAQs), regarding ways for health plans or issuers to comply with the requirement that private insurers cover over-the-counter (OTC) Covid-19 tests without cost-sharing.
 
In response to stakeholder questions, the Departments revised previous guidance, issued January 10th, to increase flexibility around plans’ “direct coverage” of such tests, meaning that consumers do not need to seek post-purchase reimbursement. Under the previous guidance, the Departments established a safe harbor under which a plan may arrange for direct coverage through both its pharmacy network and a direct-to-consumer shipping program. In this case, plans may otherwise limit reimbursement for tests from non-preferred pharmacies and other retailers to no less than the actual price or $12 (whichever is lower) without being subject to enforcement action.
 
The new guidance clarifies that: 

  • A plan will qualify for this safe harbor so long as it offers at least one direct-to-consumer shipping mechanism and one in-person mechanism.
  • A plan will still qualify for the safe harbor if it has established such a program but, due to supply shortages, is temporarily unable to provide access to OTC Covid-19 tests via its direct-to-consumer shipping or in-person mechanisms.

Other provisions in the updated guidance include: 

  • Although plans are prohibited from applying prior authorization or other medical management processes to coverage of diagnostic Covid-19 tests, they may continue to take steps to address fraud and abuse. As such, plans and issuers may require tests to be purchased from “established retailers” and disallow reimbursement for tests that are purchased from a private individual or a seller that uses an online auction/resale marketplace.
  • Because OTC tests are now a covered benefit, health reimbursement arrangements (HRAs), flexible spending arrangements (FSAs), and health savings accounts (HSAs) are not permitted to provide reimbursement for the tests.
  • Plans are not required to cover COVID-19 tests using a home-collected sample that is sent to a lab for processing under this requirement, but such tests must be covered if ordered by a provider.

The latest FAQs are available here, while the original January 10th FAQs are available here.
 
CRS Publishes FAQs on Provider Relief Fund
On February 7th, the Congressional Research Service (CRS) published a report collecting FAQs on the Provider Relief Fund (PRF). The report provides an overview of the $178 billion PRF’s structure and status, noting that there remains some uncertainty about the allocation of the funds. In particular, it notes that a total of approximately $23 billion has been reported to be used for vaccine development and acquisition costs or administration of the fund and cannot be allocated to provider payments. It also notes that it could not confirm reports that all PRF funds have been allocated, as some PRF funds have been returned by recipients and some payment amounts have been reconsidered.
 
The CRS report is available here.
 
CMS Publishes Nursing Home Covid-19 Booster Vaccination Data
On February 9th, the Centers for Medicare and Medicaid Services (CMS) posted data on Covid-19 vaccine booster shots administered to nursing home residents and staff on the Medicare.gov Care Compare website. The site will display resident and staff booster rates by facility, with national and state averages for comparison. Current data show the booster shot rate for nursing home residents to be comparable to the national average for individuals over 65, but the staff booster shot rate is below the national average for those over 18. CMS currently requires that nursing homes educate their residents and staff and offer the Covid-19 vaccine (including booster) but does not require booster doses.

The vaccination data can be found below the Star Ratings on the Care Compare website.
 
CDC Endorses FDA’s Recommendation on Full Approval for Moderna Vaccine
On February 4th, Centers for Disease Control and Prevention (CDC) Director Dr. Rochelle Walensky endorsed the recommendation of the CDC Advisory Committee on Immunization Practices (ACIP) for the use of Moderna’s Covid-19 vaccine, Spikevax, in adults 18 and older. The recommendation follows the Food and Drug Administration’s (FDA) decision to grant full authorization earlier in the week.

Administration Update

Eric Lander Resigns as Director of OSTP and White House Science Advisor
On February 7th, Dr. Eric Lander, the Director of the Office of Science and Technology Policy (OSTP) and Science Advisor to President Biden, resigned from his post after an internal White House investigation showed “credible evidence of disrespectful interactions with staff,” including “demeaning or abrasive” behavior. In total, 14 of 140 staff at the OSTP shared descriptions of a “toxic work environment.” Lander was the first White House Science Advisor to be included in a Cabinet. The White House had initially stated that Lander would remain in place while corrective actions were taken. Lander’s resignation will be effective February 18th.

Federal Legislative Update

House Passes Stop-Gap Spending Bill; Congressional Leaders Strike Funding Deal
On February 9th, the U.S. House of Representatives passed a short-term appropriations bill to keep the government funded through March 11th. The Senate is expected to take up the Continuing Resolution (CR) this week.
 
Also on February 9th, House and Senate Appropriations Committee leaders Senator Patrick Leahy (D-VT) and Representative Rosa DeLauro (D-CT) announced that they had reached an agreement on a framework for a broader, bipartisan bill that would raise both military and non-defense spending. The omnibus, 12-bill spending bundle could be enacted in the next few weeks and would fund the government for the rest of the fiscal year. Details on the contents of the framework were not released, but several controversial issues could be addressed, such as the future of the Direct Contracting program and further health care provider relief in the form of a delay to Medicare sequestration.
 
Bill text of the continuing resolution can be found here, and a summary can be found here.
 
Senators Introduce Legislation to Extend Telehealth Access in Medicare after End Covid-19 PHE
On February 7th, Senators Catherine Cortez Masto (D-NV) and Todd Young (R-IN) introduced the Telehealth Extension and Evaluation Act. This bipartisan legislation would provide a two-year extension of coverage of telehealth services under Medicare after the end of the Covid-19 public health emergency (PHE), while requiring HHS to study the impact of such flexibilities.
 
Like other similar bills introduced in recent months, the bill’s prospects are uncertain, but the issue remains prominent due to the possibility that the Covid-19 PHE will expire shortly, limiting Medicare telehealth access. The Biden Administration has said that it will provide at least 60 days’ notice before the expiration of the PHE, but has also indicated that it may not be extended significantly beyond the current expiration date of April 16th. A temporary Medicare telehealth extension could also potentially be dealt with in the omnibus spending legislation discussed above.
 
A press release on the Telehealth Extension and Evaluation Act can be found here.

Federal Agency Updates

CMS Issues Draft 2022 Call Letter for QHP Rating System and Enrollee Survey
On February 8th, CMS released the draft 2022 Call Letter for the Quality Rating System (QRS) and Qualified Health Plan (QHP) Enrollee Experience Survey. All issuers of QHPs on an Exchange are required to submit QRS data, which provides relative quality and price information on such plans to help consumers in the individual and small group markets. Notable provisions of the draft Call Letter include:

  • Covid-19 Adjustments: The Letter proposes to continue temporary Covid-19-related adjustments for QRS scoring methodology for the 2022 ratings year (i.e., for data collected and enrollee surveys fielded in 2022). This rule, first included in the Final 2021 Call letter, ensures that both overall global ratings and the three summary indicator categories continue to mirror the historic distribution based on the 2017-2019 average, and that plans’ Star Ratings, both overall and by summary indicator, may decrease by no more than one star.
  • Measure Refinements: The Letter proposes refinements to some measures in the QRS measure set, beginning with the 2023 ratings year. Proposals include: 
    • Adding the Kidney Health Evaluation for Patients with Diabetes measure;
    • Refining the Colorectal Cancer Screening measure to reflect updated guidelines from the U.S. Preventive Services Task Force; and
    • Temporarily removing the Initiation and Engagement of Alcohol and Other Drug Abuse or Dependence Treatment measure from 2023 scoring.
  • New Data Collection and Reporting Methods: Beginning with the 2023 ratings year, CMS proposes to incorporate optional Electronic Clinical Data System reporting and to require reporting stratified race and ethnicity data for five measures.
  • Revisions to the QRS Rating Methodology: Beginning with the 2023 ratings year, CMS will move towards a static cut point approach, using threshold values of 60, 70, 80, and 90 to define Star Rating categories. This would allow all plans to receive high ratings, if merited, rather than the current clustering approach, which requires all five Star Rating levels to be populated.  
  • Potential Future QRS and QHP Enrollee Survey Refinements: CMS seeks comment on other potential modifications to the QRS and QHP Enrollee Survey for the 2024 ratings year and beyond. Topics under consideration include: 
    • Modifying and removing questions from the enrollee survey, including to better address health equity; and
    • Refinements to QRS scoring methodology.

The draft Call Letter may be found here. Comments on the draft are due March 9th. The Final Call Letter will be released in May, with Technical Guidance available in the fall.
 
CMMI Updates FAQs on Expanded HHVBP Model
On February 10th, the Center for Medicare and Medicaid Innovation (CMMI) published updated FAQs on the expanded Home Health Value-Based Purchasing (HHVBP) model. HHVBP is one of four CMMI models that has been evaluated to meet the statutory requirements on reducing costs and improving quality that are required to expand the model nationally. CMS finalized a rule establishing the expanded HHVBP model on November 2, 2021.
 
The model will be mandatory for all Medicare-certified home health agencies, also known as Certified Home Health Agencies (CHHAs). The expanded model started January 1, 2022, although 2022 is a “pre-implementation year” and performance will not be evaluated until 2023. The 2023 performance year will determine payment adjustments in the first payment year, which will be 2025. Adjustments may be up to 5% of a CHHA’s Medicare fee-for-service payments in either direction, based on their performance on quality measures relative to peers.
 
The FAQs are available here.

Other Updates

MedPAC Supports CMS NCD on Aduhelm; Industry and Advocates Push Back
On February 10th, the Medicare Payment Advisory Commission (MedPAC) published a comment submitted to CMS on its National Coverage Determination (NCD) for Aduhelm, the controversial drug that was the first Alzheimer’s disease treatment to be approved by the FDA in decades. CMS’s NCD applies a “coverage with evidence development” (CED) standard, meaning that Medicare will only cover Aduhelm in the context of an approved clinical trial.
 
Although MedPAC does not normally comment on NCDs, it noted that the Aduhelm NCD is particularly significant due to fiscal implications and the invocation of a CED standard. MedPAC supports the use of a CED paradigm in this case and encourages CMS to expand its use for other “items and services of potentially low value.” MedPAC also supports the establishment of a precedent that CMS will not use FDA approval as “sole proxy for Medicare coverage.”
 
Republican lawmakers, patient groups, and industry organizations have pushed back against the NCD, arguing that it represents a precedent that FDA approval will be insufficient for access: 

  • On February 8th, a group of 78 House Republicans wrote to HHS to request further justification of the NCD.
  • On February 9th, a coalition of more than 50 patient advocacy groups wrote to HHS stating that the approach “disregards the primary of the FDA’s jurisdiction.”
  • On February 10th, the Biotechnology Innovation Organization (BIO) wrote to HHS arguing that the NCD is a “de factodisapproval” that would “send a strong signal […] that FDA scientific determinations are now subject to CMS second-guessing.”

CMS will issue a final NCD by April 11th. The MedPAC comment is available here.
 
MACPAC Brief and Health Affairs Study Examine Racial Differences in Access to Care
Last week saw two notable publications on racial and ethnic disparities is access to health care. On February 7th, Health Affairspublished a study that found significant racial and ethnic disparities existed in the reported care experiences of enrollees in Medicaid managed care plans. Overall, the study found that “minority enrollees reported significantly worse care experiences,” and that “[d]isparities were largely attributable to worse experiences by race or ethnicity within the same plan.”
 
The study used data from 2014 through 2018 on the patient experiences of 242,274 non-elderly Medicaid managed care enrollees in 37 states. It found that enrollees who were Black, Hispanic/Latino, or Asian American and Pacific Islanders all reported significantly worse care experiences compared to White enrollees on four experience-of-care measures: ease of access to needed care, ease of access to a checkup or routine care, ease of access to a specialist, and whether enrollees had a personal doctor. For all measures except “ease of access to needed care,” the disparities were greater within plans than between them. The authors note that this was consistent with disparities in perceived quality of care in a national survey of low-income Medicare- and commercially-insured individuals.
 
On February 9th, the Medicaid and CHIP Payment and Access Commission (MACPAC) published an issue brief on “Experiences in Accessing Medical Care by Race and Ethnicity.” The brief, which examines data from the 2015-2018 National Health Interview Survey, “found disparities in many key measures of access.” For example, Black and Hispanic adults were less likely than white, non-Hispanic adult Medicaid beneficiaries to have received primary care visits and mental health care in the past 12 months. Similarly, white, non-Hispanic children were more likely to self-report having very good or excellent health.
 
The Health Affairs article can be found here. The MACPAC brief is available here.

Legislative Hearings

Monday, February 14th: 

  • Starting at 9:30am, the New York State Assembly and Senate has been holding a joint legislative hearing on the Fiscal Year (FY) 2023 Executive Budget, focusing on provisions related to mental hygiene. The webcast is available here. 

Tuesday, February 15th: 

  • At 10am, the U.S. Senate Finance Committee will hold a hearing entitled “Protecting Youth Mental Health: Part II – Identifying and Addressing Barriers to Care.” More information is available here. 
  • At 10am, the U.S. Senate Health, Education, Labor, and Pensions (HELP) Committee will hold a hearing entitled “Supporting Quality Workforce Development Opportunities and Innovation to Address Barriers to Employment.” More information is available here.
  • At 2pm, the U.S. House Judiciary Subcommittee on Immigration and Citizenship will hold a hearing entitled “Is There a Doctor in the House? The Role of Immigrant Physicians in the U.S. Healthcare System.” More information is available here. 

Wednesday, February 16th:

  • At 12:15pm, the U.S. House Education and Labor Subcommittee on Early Childhood, Elementary, and Secondary Education will hold a hearing entitled “Serving All Students: Promoting a Healthier, More Supportive School Environment.” More information is available here. 

Thursday, February 17th:

  • At 11:30am, the U.S. House Energy and Commerce Subcommittee on Oversight and Investigations will hold a hearing entitled “Americans in Need: Responding to the National Mental Health Crisis.” More information is available here. 
  • At 12pm, the U.S. House Education and Labor Subcommittee on Health, Employment, Labor, and Pensions will hold a hearing entitled “Exploring Pathways to Affordable, Universal Health Coverage.” More information is available here.

New York State Updates

OMH Extends Commissioner’s Regulatory Waiver
On February 4th, the Commissioner of the New York State Office of Mental Health (OMH) extended the telehealth regulatory waiver (available here) through June 5th. The waiver, which was last updated on December 7, 2021, indicates that the emergency/proposed rule updating the Part 596 telehealth regulations posted in the State Register (here) remains fully effective (with the exception of Part 596.5(a)-(e), which outlines approval requirements). OMH is in the process of receiving and reviewing final comments on the proposed changes to Part 596, with final regulations and associated guidance documents forthcoming.
 
The emergency/proposed regulations are available here. SPG’s summary of the regulations is available here.
 
Governor Hochul Signs Legislation Establishing the Office of the Advocate for People with Disabilities
On February 4th, Governor Hochul signed legislation (A3130/S1836) establishing the Office of the Advocate for People with Disabilities. This office will advocate for individuals with disabilities and will advise and assist state agencies in developing policies designed to meet the needs of individuals with disabilities.

Funding Opportunities

NYC DOHMH Releases RFP for School-Based Health Centers
On January 31st, the New York City (NYC) Department of Health and Mental Hygiene (DOHMH) released a Request for Proposals (RFP) for the provision of health care services to students through School-Based Health Centers (SBHCs) in select NYC public schools. Awardees will provide comprehensive primary preventive care (including age-appropriate reproductive health care services) and mental health services. Mental health services must be provided on-site and must include mental health assessments, crisis intervention, counseling, and referrals to a treatment continuum of supportive services including emergency psychiatric care, community-based support programs, and inpatient care.
 
DOHMH will provide a total of $48 million across all contracts, with $6 million as the maximum reimbursable amount of each contract. Contracts will last for up to nine years. Services must be provided through the applicant’s Article 28 institution or freestanding Article 28 Diagnostic and Treatment Center. If the applicant is a Federally Qualified Health Center (FQHC), services must be provided through another licensed Article 28 provider via a written agreement. 
 
The RFP is available in the PASSPort system here. SPG’s summary of the opportunity is available here. Applications will be accepted on an ongoing basis.