Weekly Health Care Policy Update – February 4, 2022

February 11, 2022

In this update: 

  • Covid-19 Updates
    • Pfizer Requests EUA for Vaccine for Children Under 5
    • Novavax Requests EUA for Covid-19 Vaccine for Adults
    • FDA Provides Full Authorization to Moderna Covid-19 Vaccine
    • CMS to Cover OTC Covid-19 Tests for Medicare Beneficiaries
  • Regulatory
    • CMS Proposes 2023 Medicare Advantage and Part D Advance Notice
    • HHS Releases Semiannual Regulatory Agenda
  • Other
    • Federal Appeals Court Grants Right to Appeal Gap in Nursing Home Coverage
    • HHS Releases Data on Telehealth Usage and Disparities
    • Yale Study Finds Readmission Rates Not Fully Explained by Socioeconomic Factors
    • Health Care Entities Paid 90% of All False Claims Act Settlements in FY 2021
    • President Biden Relaunches Cancer “Moonshot”
  • Legislative Hearings
  • New York State Updates
    • DOH and DFS Issue Letter to CMS Urging Commercial Insurance Coverage for Covid-19 Vaccine Counseling Visits for Children
    • DFS Extends Suspension of Certain Utilization Review Requirements
    • Governor Hochul Extends Disaster Emergency Due to Healthcare Staffing Shortages
    • DOH Updates Covid-19 Vaccine Mandate FAQ with Booster Requirements
    • CMS Approves Updates to CDPAP Fiscal Intermediary Reimbursement Methodology
  • Funding Opportunities
    • HRSA Offers $19 Million for Community-Based Primary Care Residency Programs
    • SAMHSA Issues Grant for Residential SUD Treatment for Pregnant and Postpartum Women
    • NYC Releases Concept Paper for Culturally Competent SUD Services in Asian Communities
    • DOH Releases SOI for the Infertility Reimbursement Program

COVID-19 Updates

Pfizer Requests EUA for Vaccine for Children Under 5
On February 1st, Pfizer and BioNTech requested an Emergency Use Authorization (EUA) for its Covid-19 vaccine in children under age 5. In an unusual move, the Food and Drug Administration (FDA) asked the companies to apply earlier than they had planned for approval of a two-dose series while the companies await data on protection supplied by a third dose. The companies tested a dosage that is one-tenth the amount of the adult vaccine and one-third the amount authorized for children ages 5-12. The two-dose series appears to provide protection in babies, but is less effective for children ages 2-4. FDA’s panel of external advisors will meet in mid-February to review the data and determine whether to grant authorization, after which the Centers for Disease Control and Prevention’s (CDC) immunization advisory committee will meet to determine whether to recommend the shots for this age group.
 
Novavax Requests EUA for Covid-19 Vaccine for Adults
On January 31st, Novavax requested an EUA for its protein-based Covid-19 vaccine for use in adults. Already available in more than 170 other countries, the Novavax vaccine uses an older technology, synthesized proteins, which has not been linked to myocarditis, unlike the vaccines that use mRNA-technology. The FDA’s advisory panel will meet to determine whether to grant EUA, followed by the CDC immunization advisory committee’s potential recommendation. In 2020, the U.S. agreed to purchase 110 million doses of the Novavax vaccine, but production and other delays impeded the vaccine maker’s progress. 
 
FDA Provides Full Authorization to Moderna Covid-19 Vaccine
On January 31st, the FDA fully approved Moderna’s Covid-19 vaccine, Spikevax. The vaccine has been deployed under an EUA but is now fully approved for adults aged 18 and older. It is the first product Moderna has ever brought to full licensure in the U.S.
 
More information on Spikevax is available from the FDA here.
 
CMS to Cover OTC Covid-19 Tests for Medicare Beneficiaries
On February 3rd, the Centers for Medicare & Medicaid Services (CMS) announced that it is launching an initiative to provide Medicare beneficiaries and Medicare Advantage enrollees with eight over-the-counter Covid-19 tests per month without cost sharing. Medicare will pay the supplying entities directly. Tests will be available through participating pharmacies and other entities beginning in early spring 2022, although CMS did not specify an exact date. CMS notes that this is the first time an over-the-counter test has been made available to Medicare beneficiaries without cost sharing, and “a number of issues” had made identifying a pathway to coverage difficult.
 
A press release is available here and an FAQ document is available here.

Regulatory Updates

CMS Proposes 2023 Medicare Advantage and Part D Advance Notice
On February 2nd, CMS released the proposed calendar year (CY) 2023 Advance Notice for Medicare Advantage (MA) plans, which updates the MA and Part D capitation rates and payment policies. Major factors include an effective growth rate of 4.75% and a risk score trend of 3.5% on average. Overall, CMS estimates that the policies proposed in the Advance Notice will increase MA plan revenue by nearly 8% relative to CY 2022, which was significantly higher than generally expected. Notably, CMS continued to apply the minimum coding pattern adjustment required by law of 5.9%.
 
The Notice’s policy proposals included: 

  • A proposal to implement a revised risk adjustment model to be used for enrollees in end stage renal disease (ESRD) status. The revised model is calibrated using more recent encounter data records and incorporates recent updates made to the CMS-Hierarchical Condition Category (CMS-HCC) model with regard to clinical updates and revised segmentation.
  • A proposal to calculate the normalization factor trend using fee-for-service (FFS) risk score data from 2016-2020, rather than the most recent data available, due to concerns that the Covid-19 pandemic caused a changing use of services in 2020 and resulted in an anomalous 2021 risk score.
  • A proposal to update the prescription drug HCC (RxHCC) risk adjustment model to use ICD-10-CM diagnosis codes, rather than ICD-9-CM codes, and update the data (2018 diagnoses to predict 2019 costs).

CMS also solicited comment on several topics, including: 

  • Whether enhancements to the risk adjustment model, such as by incorporating additional factors, can be made to address the impacts of social determinants on beneficiary health status.
  • Potential new measurement concepts and methodological changes to the Part C and Part D Star Ratings, including: 
    • Reporting stratified Star Ratings by social risk factors to help plans identify opportunities for improvement;
    • Developing a Health Equity index to summarize measure-level performance by social risk factors into a single score;
    • Developing a measure to assess whether plans are screening enrollees for health-related social needs;
    • How MA plans are using value-based models with providers to improve quality, and how such efforts might be used in the development of a future Star Ratings measure.

Comments on the proposed policies are due by March 4th. The final 2023 Rate Announcement will be published no later than April 4th.
 
The Advance Notice is available here. A fact sheet is available here, and a press release is available here.
 
HHS Releases Semiannual Regulatory Agenda
On January 28th, the Department of Health and Human Services released its semiannual regulatory agenda, outlining regulatory priorities for the near future. The agenda includes references to future proposed and final rules related to the Covid-19 pandemic, access to affordable health care, and health disparities and equity, among other topics. Notably, a proposed rule regarding the 340B program’s Administrative Dispute Resolution process, which was included in the Office of Management and Budget’s Fall 2021 Unified Regulatory Agenda, was absent from the HHS agenda.
 
The HHS regulatory agenda is available here; the OMB Fall 2021 Unified Agenda is available here.

Other Updates

Federal Appeals Court Grants Right to Appeal Gap in Nursing Home Coverage
On January 25th, a three-judge federal appeals court panel in Connecticut gave Medicare patients the right to appeal for nursing home coverage if they were admitted to a hospital as an inpatient, but were later switched to observation care. Medicare beneficiaries are currently ineligible for nursing home care without a three-day inpatient stay, meaning the “observation” designation left beneficiaries paying for nursing home care out-of-pocket. Beneficiaries in this situation also had no path to appeal to Medicare for coverage as inpatients. The appeals court panel agreed that “plaintiffs have not been afforded the process required by the Constitution” when patients are switched from inpatient to observation care, and given no opportunity for recourse through the Medicare program. Certain beneficiaries now have the right to appeal for coverage as a hospital inpatient, including those who:

  • Have been hospitalized since January 1, 2009; and
  • Were an original Medicare beneficiary during the hospitalization; and
  • Were admitted as an inpatient but were then changed to observation status; and
  • Received a notice from the hospital or Medicare indicating receipt of hospital observation services not covered by Medicare Part A; and
  • Have Medicare Part A only OR have both Parts A and B, and have been hospitalized for at least three consecutive days but for fewer than three days as an inpatient, and were or still could be admitted to a skilled nursing facility within 30 days of discharge.

HHS Releases Data on Telehealth Usage and Disparities
On February 1st, the HHS Office of Health Policy released an issue brief on national trends in telehealth usage in 2021. Using data from the Census’s Household Pulse Survey from April to October of 2021, the brief found that about 23% of respondents had used telehealth services on average in a four-week period. Among subgroups, the highest rates of telehealth usage were among people with Medicaid (29.3%) and Medicare (27.4%), Black individuals (26.8%), and people earning less than $25,000 (26.7%).
 
The report also noted significant disparities in the usage of audio-only telehealth, which were used more frequently by Black, Latino, and Asian individuals, as well as individuals without a high school diploma.
 
The full issue brief is available here.
 
Yale Study Finds Readmission Rates Not Fully Explained by Socioeconomic Factors
On January 28th, Yale University researchers published an article in JAMA entitled “Factors Associated with Disparities in Hospital Readmission Rates Among US Adults Dually Eligible for Medicare and Medicaid.” The study revealed that hospital disparities in 30-day readmission rates in a cohort of 2.5 million Medicare beneficiaries were not fully explained by causes that “stem from patient- and community-level factors seemingly beyond hospital’s immediate control.” In other words, disparities in readmission rates could not be fully explained solely because a hospital serves patients from more socioeconomically disadvantaged communities.
 
The analysis compared readmission rates between dually-eligible and non-dual beneficiaries within the same hospital, using Medicare data from 2014 through 2017 to examine Medicare patients hospitalized for acute myocardial infarction, heart failure, or pneumonia. It found that risk-adjusted readmissions were higher for dually-eligible patients, compared to non-duals, for most hospitals, and that the disparities persisted even after accounting for state Medicaid eligibility policies, primary care availability, and social factors. Researchers suggest that the findings show that “hospitals may have a distinct role in advancing equity for socioeconomically disadvantaged patients.”
 
The study can be found here.
 
Health Care Entities Paid 90% of All False Claims Act Settlements in FY 2021
On February 1st, the Department of Justice (DOJ) reported that it secured more than $5 billion in settlements and judgments involving fraud and false claims by the health care industry, including drug and medical device manufacturers, managed care providers, hospitals, pharmacies, hospice organizations, laboratories and physicians. Health care claims were once again the largest source of False Claims Act settlements and judgments, comprising more than 90% of total federal funds obtained by the DOJ, the second largest annual total. The largest settlements involved prescription opioid manufacturers, though substantial settlements were made involving providers and managed care organizations participating in Medicare Advantage. Settlements involving unlawful kickbacks were made with a mail-order diabetic testing supply company, and electronic health records vendor, as well as psychiatric hospitals, home health agencies, hospitals, and others.
 
A press release is available here and an overview of fraud-related statistics is available here.
 
President Biden Relaunches Cancer “Moonshot”
On February 2nd, President Biden announced a new goal for his cancer “moonshot,” an initiative he first launched as Vice President in 2016. The moonshot’s new goal is to reduce cancer deaths by 50% over the next 25 years, part of a larger effort to “end cancer as we know it.” The relaunch includes the formation of a “cancer cabinet” from across the federal government, urging Americans to resume cancer screenings, after many were missed due to the pandemic, and improving cancer detection and treatment. No new funding for the initiative was announced.
 
A fact sheet is available here.

Legislative Hearings

Tuesday, February 8th:

  • At 9:30am, the New York State Assembly and Senate will hold a joint legislative hearing on the Fiscal Year (FY) 2022-23 Executive Budget, focusing on provisions related to health and Medicaid. More information is available here. 
  • At 10am, the U.S. Senate Health, Education, Labor, and Pensions (HELP) Committee will hold a hearing entitled “Lessons Learned from COVID-19: Highlighting Innovations, Maximizing Inclusive Practices and Overcoming Barriers to Employment for People with Disabilities.” More information is available here. 
  • At 10am, the U.S. Senate Finance Committee will hold a hearing entitled “Protecting Youth Mental Health: Part I – An Advisory and Call to Action.” More information is available here. 
  • At 10:30am, the U.S. House Energy and Commerce Subcommittee on Health will hold a hearing on the proposed Advanced Research Projects Agency for Health (ARPA-H) entitled “ARPA-H: The Next Frontier of Biomedical Research.” More information is available here. 

Thursday, February 10th:

  • At 9:30am, the U.S. Senate Committee on Aging will hold a hearing entitled “Improving Care Experiences for People with both Medicare and Medicaid.” More information is available here. 
  • At 10am, the U.S. Senate HELP Subcommittee on Employment and Workplace Safety will hold a hearing entitled “Recruiting, Revitalizing & Diversifying: Examining the Health Care Workforce Shortage.” More information is available here.

New York State Updates

DOH and DFS Issue Letter to CMS Urging Commercial Insurance Coverage for Covid-19 Vaccine Counseling Visits for Children
On February 1st, the New York State Department of Health (DOH) and Department of Financial Services (DFS) published a letter (available here) they wrote to CMS asking to issue guidance establishing that Covid-19 vaccination consultations for children/youth and their families are preventive services required to be covered by all insurers under the Affordable Care Act (ACA). CMS has already established such coverage as a requirement under the Medicaid program. The State also proposed that vaccination consultations should be reimbursed irrespective of vaccine administration, and with no cost-sharing for families.
 
In addition, DFS has issued guidance (available here) to regulated insurance plans encouraging the development of new incentives and rewards for New Yorkers who get vaccinated or boosted. DFS indicated it will fast-track any approvals needed to add these programs to insurance policies.
 
The Governor’s press release is available here. The DFS press release is available here.
 
DFS Extends Suspension of Certain Utilization Review Requirements
On February 3rd, DFS issued a supplement to Circular Letter No. 1 (available here) directing DFS-regulated insurance plans to continue the suspension of certain utilization review requirements. These requirements were originally suspended in the January 6thletter to assist hospitals with staffing shortages and resource issues during the current Covid-19 surge.
 
The supplement directs hospitals to continue to suspend through February 28th the following: 

  • Preauthorization requirements for transfers between in-network hospitals; and
  • Preauthorization requirements for in-network inpatient rehabilitation services following an inpatient hospital stay.

DFS also continues to encourage Medicare Advantage plans and third-party administrators of self-funded plans to adhere to the circular letter’s provisions to alleviate statewide hospital capacity issues.
 
The supplemental letter is available here. Questions may be submitted to health@dfs.ny.gov.
 
Governor Hochul Extends Disaster Emergency Due to Healthcare Staffing Shortages
On January 30th, Governor Hochul issued Executive Order 4.5 (available here), which extends through March 1st the provisions in Executive Order 4 and its successors that reinstate many workforce and scope of practice flexibilities that applied during the original New York State Covid-19 public health emergency. The Orders also delay the requirements, enacted in the last year’s budget, that would impose penalties on nursing homes that fail to meet daily staffing requirements or to spend the required minimum proportion of revenue on direct resident care and resident-facing staff.
 
DOH Updates Covid-19 Vaccine Mandate FAQ with Booster Requirements
On January 25th, DOH updated its Frequently Asked Questions (FAQ) document (available here) on the Covid-19 vaccination requirements for covered health care entities to include details on the recently implemented booster vaccine requirement. Covered entities must document compliance with the emergency regulation regarding booster vaccinations by February 21st. The FAQ also includes information regarding the timeframe for personnel to receive their booster and outlining instances in which personnel would not be eligible for a booster or supplemental dose.
 
CMS Approves Updates to CDPAP Fiscal Intermediary Reimbursement Methodology
On January 25th, CMS approved New York State’s State Plan Amendment (SPA) to update the Fiscal Intermediary reimbursement methodology for the Consumer Directed Personal Assistance Program (CDPAP). Effective April 1, 2021, reimbursement will be based on a tiered per member per month approach.
 
The SPA and CMS approval letter are available here.

Funding Opportunities

HRSA Offers $19 Million for Community-Based Primary Care Residency Programs
On February 3rd, the Health Resources and Services Administration (HRSA) announced the availability of $19.2 million to support and expand community-based primary care residency programs. The funding, provided through the American Rescue Plan, will be made available through the Teaching Health Center Graduate Medical Education (GME) program. Awardees will provide training to residents to provide quality care to diverse populations, particularly in underserved and rural communities. The funding will be distributed to up to 30 awardees and should support the equivalent of approximately 120 full-time resident positions.
Eligible applicants include: 

  • Native American tribal governments;
  • Public and State controlled institutions of higher education;
  • Native American tribal organizations (other than Federally recognized tribal governments);
  • Private institutions of higher education; and
  • Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education.

All applicants that meet eligibility criteria may apply through this announcement. This includes any applicants who previously applied through the FY 2022 THCGME NOFO (HRSA-22-105), as the baseline requirements (Academic Year 2018-2019) have changed and applicants may be eligible for additional resident FTEs.
 
The press release is available here.
 
SAMHSA Issues Grant for Residential SUD Treatment for Pregnant and Postpartum Women
On February 3rd, the Substance Abuse and Mental Health Services Administration (SAMHSA) published a Notice of Funding Opportunity (NOFO) that will award a total of $10 million for providers to offer specialty residential and outpatient substance use disorder (SUD) treatment to pregnant and postpartum women. Up to $525,000 per year would be awarded to each of 19 applicants for up to five years. Eligible entities must be not-for-profit entities. A cost match will be required of 10% ($1 for every $9) in years 1 and 2, and 25% ($1 for every $3) in years 3 through 5.
 
HHS highlighted the release of this NOFO alongside a set of new reports that identify strategies for evidence-based prevention and treatment of substance-exposed pregnancies, related to Fetal Alcohol Spectrum Disorder (here) and integrating SUD and pregnancy care (here). The full NOFO can be found here.
 
NYC Releases Concept Paper for Culturally Competent SUD Services in Asian Communities
On February 2nd, the New York City Department of Health and Mental Hygiene (DOHMH) released a Concept Paper outlining a forthcoming Request for Proposals (RFP) that will seek one organization to provide culturally and linguistically competent, evidence-based, outpatient substance use disorder (SUD) treatment services in the Lower East Side/Chinatown area of Manhattan. Funding allocated through this RFP should be used to support the operational costs of SUD treatment services to Asian New Yorkers struggling with and impacted by substance use, including individuals, families, and their loved ones.
 
Eligibility for the RFP is limited to: 

  • Existing Office of Addiction Services and Supports (OASAS)-licensed Part 822 Medically Supervised Outpatient providers with an active operating certificate, with preference for providers who are also Office of Mental Health (OMH)-licensed; or
  • Organizations that are currently registered as Opioid Overdose Prevention Programs (OOPPs) or will become OOPPs.

DOHMH anticipates providing over $4.5 million in total funding over the nine-year project period to the awarded applicant. Contracts are expected to begin on January 1, 2023.
 
The Concept Paper is available here. Comments may be submitted to RFP@health.nyc.govwith “SUD Services Concept Paper” in the subject line through March 28th.
 
DOH Releases SOI for the Infertility Reimbursement Program
On January 19th, DOH released a Solicitation of Interest (SOI) for the Infertility Reimbursement Program. Through this SOI, DOH seeks eligible high-volume providers of infertility services in New York State who will be offered grant assistance to provide such services to insured patients who meet eligibility criteria but whose insurance does not cover (or only partially covers) these costs. DOH will provide over $3.82 million in total funding ($1.9 million annually) to eligible providers during the two-year program period.
 
The SOI is available here. Applications are due on March 7th and will be reviewed in the order in which they are received. Questions may be submitted to bwh@health.ny.gov with the subject line “Infertility Reimbursement Program” through February 21st.