Weekly Health Care Policy Update – March 25, 2022

April 1, 2022

In this update: 

  • Covid-19 Updates
    • HRSA Distributes $413 Million in Provider Relief Funds, Stops Accepting Uninsured Claims
    • Reporting Period for July-December 2020 PRF Payments Ends March 31st
    • Becerra: HHS Unlikely to Provide More than 60 Days’ Notice for the End of the Covid-19 PHE
    • FDA to Hold Advisory Committee Meeting on Covid-19 Boosters
    • Moderna to Request Vaccine EUA for Children Aged 6 Months to 11 Years
    • OSHA to Hold Public Hearing on Covid-19 Prevention Rule
    • New York State HERO ACT Designation for Covid-19 Ends
  • Congressional Updates
    • Schumer Announces Plan to Vote on Insulin Legislation
  • Federal Agencies
    • HHS Releases ACA Data to Mark 12th Anniversary of its Passage
    • CMS Releases Reporting Tools for Medicaid, CHIP Redeterminations
    • HRSA Issues Notice on Hospital Reinstatement into 340B Drug Program
    • CMS Resumes Plan to Increase Nursing Home Quality Measure Rating Thresholds in April
    • Rules Being Reviewed by OMB
  • Legislative Hearings
  • New York State Updates
    • CMS Approves Five-Year Extension of New York’s 1115 Waiver Authority
    • DOH Publishes Proposed Updates to Telehealth Regulations
    • OASAS Issues Proposed Rule Adding New Designations/Endorsements for Addiction Services Providers
    • DOH Proposes to Amend PACE Capitation Payments, Maintains Current Contingent Reserve Requirements
    • Governor Hochul Signs Health Care Legislation
  • Funding Opportunities
    • SAMHSA Announces Three Grants Totaling $44 Million for Behavioral Health Services for HIV/AIDS Populations
    • OMH to Host Webinar on Benefits & Work Incentives Navigators Grant Program

COVID-19 Updates

HRSA Distributes $413 Million in Provider Relief Funds, Stops Accepting Uninsured Claims
On March 22nd, the Health Resources and Services Administration (HRSA) announced the distribution of an additional $413 million to about 3,600 providers through Phase 4 of the General Distribution of the Provider Relief Fund (PRF). This distribution targets smaller providers, including bonuses to those treating Medicare, Medicaid, and Children’s Health Insurance Program (CHIP) enrollees. HRSA has now processed 89% of all Phase 4 applications and distributed $12 billion of the $17 billion available. PRF payments received in the first half of 2022 can be used through June 20, 2023.
 
The HRSA press release, including links to state-by-state breakdowns of Phase 4 and American Rescue Plan rural payments, as well as a public dataset on all individual providers who have agreed to the terms and conditions of Phase 4 payments, can be found here.
 
The PRF also funds the cost of Covid-19 testing, treatment, and vaccination for uninsured individuals. However, as of March 23rd, HRSA is no longer accepting new claims from providers for Covid-19-related testing and treatment, due to insufficient funds. It will stop also accepting new claims for vaccine-related services after April 5th. Claims submitted by the deadline will be reimbursed “subject to the availability of funds.”
 
HRSA has released an FAQ document on the submission deadline for such claims, which is available here.
 
Reporting Period for July-December 2020 PRF Payments Ends March 31st
On March 31st, the second reporting period for the PRF Reporting Portal will close. Providers who received one or more PRF payments exceeding $10,000 in aggregate during the second “Payment Received Period,” which extends from July 1, 2020 to December 31, 2020, must report on their use of funds by this deadline or be potentially subject to enforcement actions.
 
The Reporting Portal is available here.
 
Becerra: HHS Unlikely to Provide More than 60 Days’ Notice for the End of the Covid-19 PHE
During a press conference on March 18th, HHS Secretary Xavier Becerra said that HHS will likely be unable to provide much more than 60 days’ notice before the end of the federal Covid-19 Public Health Emergency (PHE) declaration. Several stakeholders, including states, providers, and payer groups, have asked for additional time (such as 120 days’ notice) to prepare for unwinding various requirements and flexibilities tied to the PHE. Currently, the PHE expires April 16th, but it is expected to be renewed for at least another 90 days. Becerra indicated that the process for reviewing the need for the PHE begins immediately after each extension, making the provision of more than 60 days’ notice challenging.
 
FDA to Hold Advisory Committee Meeting on Covid-19 Boosters
On March 21st, the Food and Drug Administration (FDA) announced that it would convene a virtual meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on April 6th to discuss considerations for future Covid-19 vaccine booster doses, such as: 

  • Conditions to update the composition of COVID-19 vaccines to address specific variants; and
  • Timing and populations for Covid-19 vaccine booster doses in the coming months. 

Members of VRBPAC will be joined by staff representatives from the Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH). The meeting will not include a vote.
 
A livestream of the meeting will be available here.
 
Moderna to Request Vaccine EUA for Children Aged 6 Months to 11 Years
On March 23rd, Moderna announced that it will request an emergency use authorization (EUA) from the FDA for its Covid-19 vaccine for children aged six months to 11 years. The request consists of two separate applications—one for children aged 6 months to under 6 years, and another for children aged 6 to 11 years. Both age groups received half the adult dose. Currently, Moderna’s vaccine is only authorized for use in adults. The FDA has not yet indicated when it will meet to consider Moderna’s authorization requests.
 
OSHA to Hold Public Hearing on Covid-19 Prevention Rule
On April 27th, the Occupational Safety and Health Administration (OSHA) announced that it will hold an informal virtual public hearing on the Emergency Temporary Standard (ETS) it published in June 2021 entitled “Occupational Exposure to COVID-19.”
 
OSHA is reopening the ETS’s comment period for another 30 days to support the development of a modified final standard. The original ETS prescribed a programmatic approach to Covid-19 prevention in health care settings, which some stakeholders viewed as “overly prescriptive.” Some provisions also no longer match updated CDC guidance. OSHA now seeks public comment on the following topics and questions: 

  • Alignment with CDC recommendations for health care infection control practices;
  • Additional flexibility for employers;
  • Removal of scope exemptions (ambulatory care, home health care, etc.);
  • Tailoring controls to address interactions with people with suspected or confirmed Covid-19;
  • Vaccination status, including booster doses, employer support of employee vaccination, and requirements for vaccinated workers;
  • Limited coverage of construction activities in health care settings;
  • Recordkeeping and reporting (including a new cap for Covid-19 log retention period);
  • Triggering requirements based on the level of community transmission; and
  • How to apply the standard if SARS-CoV-2 evolves into a new strain.

Comments may be submitted through the Federal e-Rulemaking Portal here (Docket Number OSHA-2020-0004). Those interested in appearing at the hearing should submit a Notice of Intention to Appear by April 6th here. More information is available on the OSHA website here.
 
New York State HERO ACT Designation for Covid-19 Ends
On March 17th, the designation of Covid-19 as an airborne infectious disease that presents a serious risk of harm to the public health under the New York State HERO Act ended. As a result, private sector employers are no longer required to implement workforce safety plans that were mandated under the Act in response to the Covid-19 pandemic.
 
The DOH press release is available here. Questions may be submitted to airborne.infectious.diseases@labor.ny.gov.

Congressional Updates

Schumer Announces Plan to Vote on Insulin Legislation
On March 22nd, Senate Majority Leader Chuck Schumer announced that he plans to hold a vote in late April on legislation to address the cost of insulin. The legislation is currently under negotiation, based on two bills: legislation that would create an out-of-pocket cap of $35 per month for insulin, championed by Senator Raphael Warnock (D-GA), and a bipartisan plan currently under negotiation by Senators Jeanne Shaheen (D-NH) and Susan Collins (R-ME), which would encourage manufacturers to set prices at roughly their 2006 levels by preventing insurers and pharmacy benefit managers (PBMs) from receiving rebates for insulin provided by such manufacturers and preventing them from applying a deductible to such products.
 
Schumer is expected to bring the eventual proposal to the floor as soon as possible after the Easter recess. Afterwards, Congress is expected to return to attempts to consider a wider reconciliation package that would include other health care components from the Build Back Better proposal.

Federal Agencies

HHS Releases ACA Data to Mark 12thAnniversary of its Passage
On March 23rd, the 12th anniversary of the signing of the Affordable Care Act (ACA), HHS released the 2022 Open Enrollment Report for ACA Marketplaces. More than 14.5 million individuals obtained coverage through an ACA Marketplace in 2022, an increase of 2.5 million over 2021. The HHS Assistant Secretary for Planning and Evaluation (ASPE) additionally released a briefing book summarizing key findings from two dozen reports on the ACA’s impact released in the past year. The report includes topics such as enrollment estimates and state trends, deductibles among HealthCare.gov enrollees, and access to preventive services without cost sharing.
 
Of note, ASPE estimates New York’s uninsured rate dropped from 10.7% in 2013 to 5.2% in 2019. New York had total coverage gains of roughly 1.5 million individuals during this period, including more than 395,000 newly eligible Medicaid enrollees as of December 2020, more than 197,000 enrollees in Marketplace coverage had effectuated their enrollment as of February 2021, and more than 898,000 enrollees in its Basic Health Program (BHP) as of April 2021.
 
The briefing book is available here.
 
CMS Releases Reporting Tools for Medicaid, CHIP Redeterminations
On March 22nd, CMS held an All-State Medicaid and CHIP call in which they discussed the “unwinding” timeline for the resumption of Medicaid redeterminations and disenrollments after the end of the Covid-19 PHE. Alongside this call, CMS released new reporting tools that states will be required to submit as part of CMS’s monitoring efforts. These include Data Reporting Templates and a State Renewals Distribution Report.
 
Upon receiving notice of the date of the end of the PHE, states may choose to begin their 12-month unwinding process up to two months prior to that date, and must begin it by the month after the end of the PHE. For example, if the PHE ends on July 16th, a state’s unwinding period could begin at the start of June, July, or August. States must initiate all renewals and redeterminations for all Medicaid and CHIP enrollees by the last month of their unwinding period, and complete them by the end of the 14th month.
 
The new tools include a one-time State Renewals Report, which states must submit by the 45th day before the end of the month in which the PHE ends. This report will include the number of Medicaid and CHIP renewals the state intends to initiate each month and its plan to prioritize and distribute work during the unwinding period. It must also include the State’s strategies to ensure eligible individuals remain enrolled or are transferred to the appropriate program. States will also be required to submit monthly reports describing the number of pending applications received and the number of renewals initiated, among other data elements.
 
Slides from the All-State Medicaid and CHIP call are available here. Other information, including copies of the reporting tools, are available here.
 
HRSA Issues Notice on Hospital Reinstatement into 340B Drug Program
On March 18th, HRSA sent a notice to providers to implement provisions recently passed in the federal fiscal year (FFY) 2022 spending omnibus that would allow certain providers to be reinstated into the 340B Drug Pricing Program. Section 121 of the Consolidated Appropriations Act of 2022 allows eligible facilities’ 340B status to be reinstated if they were terminated due to failure to meet the required disproportionate share hospital (DSH) adjustment from October 1, 2019 to December 31, 2022.
 
Eligible hospital types include: 

  • Disproportionate Share Hospitals,
  • Sole Community Hospitals,
  • Rural Referral Centers,
  • Children’s hospitals; and
  • Freestanding cancer hospitals.

In general, 340B hospitals must have a DSH percentage of at least 11.75% to remain in the 340B program. To qualify for reinstatement, hospitals must have been terminated due to failing to meet this standard because of actions or impacts related to the Covid-19 PHE. Eligible hospitals may contact the 340B Prime Vendor, with requests being evaluated on a case-by-case basis.
 
The notice can be found here.
 
CMS Resumes Plan to Increase Nursing Home Quality Measure Rating Thresholds in April
On March 21st, CMS announced that it plans to resume the implementation of a plan to update the Quality Measure (QM) rating thresholds for nursing homes starting in April 2022. CMS’s plan, which was originally published in a March 2019 memorandum, is to increase QM thresholds by 50% of the average rate of improvement in facilities’ QM rating scores every six months. CMS’s goal is to create incentives for continuous quality improvement and reduce the need for larger adjustments to thresholds in the future. These changes were put on hold during the Covid-19 PHE, but will be implemented beginning in the April 2022 refresh of Nursing Home Compare.
 
The March 2019 memorandum can be found here.
 
Rules Being Reviewed by OMB
Currently, the following health care-related rules are under review at the Office of Management and Budget (OMB) before publication in the Federal Register:
 
Prospective Payment Systems (PPSs)

  • Proposed rule on the Hospital Inpatient PPS and Long-Term Care Hospital PPS for FY 2023
  • Proposed rule on the Inpatient Psychiatric Facilities PPS for FY 2023
  • Proposed rule on Inpatient Rehabilitation Facility PPS Rates for FY 2023
  • Proposed rule on Skilled Nursing Facility PPS Rates for FY 2023
  • Proposed rule on the FY 2023 Hospice Wage Index

Medicare Advantage

  • The Notice of CY 2023 Medicare Advantage (MA) Capitation Rates and MA and Part D Payment Policies
  • Final rule on policy and technical changes to MA and the Medicare Prescription Drug Benefit Program

QHPs and Basic Health Program

  • The 2023 Notice of Benefit and Payment Parameters (NBPP) for Qualified Health Plans (QHPs)
  • Proposed rule on the ACA “family glitch”
  • Proposed rule on the Program Year 2023 Basic Health Program (BHP) Federal Funding Methodology and Changes to the BHP Regulations

Other

  • Proposed rule on the Radiation Oncology model
  • Proposed rule on the 340B Drug Pricing Program and administrative dispute resolution
  • Proposed rule on nondiscrimination in health programs and activities from the Office of Civil Rights.

Legislative Hearings

Tuesday, March 29th:

  • At 9am, the House Oversight and Reform Committee will hold a hearing to examine pathways to universal health coverage, including the Medicare for All Act. More information is available here.
  • At 10am, the House Budget Committee will hold a hearing to examine the President’s Fiscal Year (FY) 2023 Budget Proposal. More information is available here.
  • At 10am, the Senate Banking, Housing, and Urban Affairs Committee will hold a hearing entitled “Economic Impact of the Growing Burden of Medical Debt.” More information is available here.

Wednesday, March 30th:

  • At 10am, the House Select Subcommittee on the Coronavirus Crisis will hold a hearing entitled “Moving Beyond the Coronavirus Crisis: The Biden Administration’s Progress in Combating the Pandemic and Plan for the Next Phase.” More information is available here.
  • At 10am, the House Energy and Commerce Subcommittee on Health will hold a hearing entitled “FDA User Fee Reauthorization: Ensuring Safe and Effective Medical Devices.” More information is available here.
  • At 10am, the House Natural Resources Subcommittee on Oversight and Investigations will hold a hearing entitled “Preventing Pandemics through U.S. Wildlife-borne Disease Surveillance.” More information is available here.
  • At 10am, the Senate Finance Committee will hold a hearing entitled “Behavioral Health Care When Americans Need It: Ensuring Parity and Care Integration.” More information is available here. 
  • At 11am, the Senate Budget Committee will hold a hearing to examine the President’s FY 2023 Budget Proposal. More information is available here.

Thursday, March 31st:

  • At 10am, the House Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies will hold a hearing to examine the FY 2023 Budget Request for the Department of Health and Human Services (HHS). More information is available here.
  • At 10am, the House Science, Space, and Technology Subcommittee on Investigations and Oversight will hold a hearing entitled “The New Normal: Preparing for and Adapting to the Next Phase of COVID-19.” More information is available here.

New York State Updates

CMS Approves Five-Year Extension of New York’s 1115 Waiver Authority
On March 23rd, CMS approved New York’s request to extend its 1115 Medicaid Redesign Team (MRT) waiver demonstration through March 31, 2027. This extension does not contain new programmatic elements, but rather lays the groundwork for a major new 1115 waiver amendment submission that New York is expected to submit shortly. Last year, CMS approved a temporary one-year extension of the MRT waiver, which would have otherwise expired March 31st. This five-year extension allows New York’s current Medicaid managed care system to continue operating and creates a new window for a budget neutrality calculation.
 
In this approval letter, CMS also formally approved New York’s proposal to retain “well duals” in Medicaid managed care on a voluntary basis. Specifically, dually eligible members who do not need Community-Based Long Term Care Services (CBLTCS) may choose to enroll in a Medicare Advantage (MA) organization’s Dual Eligible Special Needs Plan (D-SNP). Under the approval, such individuals may now remain in or voluntarily enroll in a Medicaid managed care (MMC) plan offered by that MA organization.
 
The State had also requested changes enacted under the second Medicaid Redesign Team (MRT II), which would increase the requirements for individuals to be eligible for Managed Long Term Care (MLTC) plans to include the need for assistance with more than two activities of daily living (ADL), or more than one ADL for beneficiaries with dementia or Alzheimer’s disease. CMS is not expected to review this proposal until April 2024, when maintenance of effort requirements associated with the enhanced Home and Community Based Services (HCBS) funding under the American Rescue Plan (ARP) will expire.
 
The State had also submitted a waiver amendment request to carve out non-emergency medical transportation (NEMT) and pharmacy benefits from managed care contracts. CMS indicated that it does not believe that 1115 approval is required for these proposals, which should instead be enacted through changes to New York’s managed care model contracts.
 
The CMS approval letter is available here.
 
DOH Publishes Proposed Updates to Telehealth Regulations
On March 23rd, the New York State Department of Health (DOH) posted a proposed rule in the State Register (available here) that would add a new Part 538 to Title 18 of the New York Codes, Rules, and Regulations (NYCRR), outlining state reimbursement for telehealth services. The proposed regulation: 

  • Expands the types of providers who can deliver care via telehealth, as long as such telehealth services are appropriate to meet a patient’s needs and are within a provider’s scope of practice; and
  • Adds audio-only, eConsult, virtual check-in, and virtual patient education as telehealth modalities, as well as parameters for appropriately using these modalities and standards for reimbursement.

The proposed rule also revises radiology regulations to allow for the provision of teleradiology. The proposed regulations provide: 

  • Definitions for interventional and diagnostic radiology, which may be conducted without a physical encounter; and
  • Reimbursement guidelines for physicians and hospitals billing for professional, technical, and administrative components of a radiology service. References to an outdated fee schedule have been removed.

The proposed regulations are available here. Public comment may be submitted to regsqna@health.ny.gov through May 22nd.
 
OASAS Issues Proposed Rule Adding New Designations/Endorsements for Addiction Services Providers
On March 23rd, the New York State Office of Addiction Services and Supports (OASAS) issued a proposed rule in the State Register (available here) that would add the following new optional components to Part 830 of Title 14 NYCRR: 

  • Adolescent Program Endorsement;
  • Ancillary Withdrawal Designation; and
  • Open Access Services Designation.

OASAS proposes to add these optional designations and endorsement to make it easier for individuals seeking OASAS services to identify programs providing specific services.

Public comment may be submitted to Kelly.grace@oasas.ny.gov through May 22nd.
 
DOH Proposes to Amend PACE Capitation Payments, Maintains Current Contingent Reserve Requirements
On March 23rd, DOH issued a public notice in the State Register (available here) proposing to amend the capitation payments for services provided by the Program of All-Inclusive Care for the Elderly (PACE) plans. DOH proposes to update the Amount that Would have Otherwise been Paid (AWOP) calculation and rate methodology description contained in the present state plan for PACE plans due to modifications in the premium rate structure effective April 1, 2022. Specifically, beneficiary cost data in managed care will also be used in the development of the AWOP and in the rate methodology, in addition to fee-for-service and other acceptable data sources. Rates will continue to be subject to Upper Payment Limit provisions. Public comment may be submitted to spa_inquiries@health.ny.gov.
 
DOH also published a notice of adoption in the State Register maintaining the contingent reserve requirement applied to MMC, HIV SNP, and Health and Recovery Plan (HARP) programs at 7.25 percent through 2022. DOH received no public comment on the rule.

Governor Hochul Signs Health Care Legislation
Over the past week, Governor Hochul signed the following health care-related legislation: 

  • S7692/A8713 clarifies how health plans can satisfy requirements related to explanations of pharmaceutical benefits, which includes sending members quarterly written summaries or making the information available in the online member portal.
  • S7703/A8843 clarifies that local jails must operate a substance use disorder program and that the program must be approved by the Office of Addiction Services and Supports (OASAS) and updates language to use “incarcerated individual.”
  • S7870/A8757 requires that money expended from the Opioid Settlement Fund is used consistent with the terms of any statewide opioid settlement agreements.
  • S8288/A9277 changes the Office of the Advocate for People with Developmental Disabilities to become the Chief Disability Officer, a part of the Executive Chamber.

Funding Opportunities

SAMHSA Announces Three Grants Totaling $44 Million for Behavioral Health Services for HIV/AIDS Populations
On March 18th, the Substance Abuse and Mental Health Services Administration (SAMHSA) announced three funding opportunities to strengthen mental health and substance use services for individuals at risk for or living with HIV/AIDS. The funding opportunities total $43.7 million and are all part of the HHS’s new Overdose Prevention Strategy. The three grant programs are: 

  • Substance Use Disorder Treatment for Racial Ethic/Minority Populations at High Risk for HIV/AIDS: This program increases care for racial and ethnic minority individuals with co-occurring substance use and mental health challenges who are at risk for or are living with HIV/AIDS and receive HIV primary care and other services. This grant will fund up to $30.5 million over five years for up to 61 grantees.
  • Substance Abuse and HIV Prevention Navigator Program for Racial and Ethnic Minorities: This program provides training and education around the risks of substance use and HIV/AIDS, as well as the integration of a range of services for individuals with HIV/AIDS. The program uses a navigation approach, working through community health workers, neighborhood navigators, and peer support specialists, to expedite services for these populations. This grant will fund up to $4.5 million over five years for up to 18 grantees.
  • Minority AIDS Initiative – Service Integration: This program reduces the co-occurring epidemics of HIV, Hepatitis, and mental health challenges through accessible, evidence-based, culturally appropriate treatment that is integrated with HIV primary care and prevention services. The grant will fund $8.7 million over four years for up to 18 grantees.

The press release, including links to the individual funding opportunities, is available here. Funding will be awarded in the fall.
 
OMH to Host Webinar on Benefits & Work Incentives Navigators Grant Program
On March 28th from 11am to 12pm, the New York State Office of Mental Health (OMH) will host a webinar to explain the application process and answer questions regarding the one-time block grants to train certified and credentialed Benefits & Work Incentives Navigators. Through this investment, OMH will provide a total of $1 million to OMH-licensed, funded, or designated programs who will apply for one-time reimbursement of $5,000 per eligible staff member.
 
Registration for the webinar is available here. Questions may be submitted during the session using the chat function. The opportunity may be accessed here. Applications are due on May 17th.