Weekly Health Care Policy Update – March 4, 2022

In this update: 

• Federal Administration
  • President Biden Lists Health Priorities in State of the Union
  • White House Submits Request for Supplemental Covid-19 Funding
• Federal Agencies
  • CMMI Announces Plans to Advance Health Equity
  • CMMI Issues RFA for Second Kidney Care Choices Cohort
  • CMS Releases 2023 RFA for the Part D Senior Savings Model for Insulin
  • Administration Issues Guidance Withdrawing IDR Process for Surprise Bills
  • CMS Posts 2020 QPP Data and Reopens MIPS Extreme and Uncontrollable Circumstances Application for PY 2021
  • CMS Issues Solicitation for New MEDCAC Members
  • ONC Publishes Data on Information Blocking Complaints
• Other
  • National Academies Report Recommends Changes to Organ Transplant System
• Legislative Hearings
• New York State Updates
  • NYS Senate Confirms Kerri Neifeld as OPWDD Commissioner
  • DOH Releases Dual Eligible Integrated Care Roadmap for Public Comment
  • OMH and OASAS Announce Implementation of CORE Service Array
  • OMH and OASAS Release Guidance on Enhanced HCBS Funding for Adult BH HCBS and CORE Services
  • NYS DFS Issues Updated Guidance to Insurers on Covid-19 Testing Coverage
  • CMS Approves New York State 1115 Waiver Interim Evaluation Reports
  • Governor Hochul Signs Package of Health Care Legislation
• Funding Opportunities
  • SAMHSA Releases Notice of Funding Opportunity for Minority AIDS Initiative

Federal Administration

President Biden Lists Health Priorities in State of the Union
On March 1^st, President Biden delivered his first State of the Union address, which mentioned several key health policy priorities. Some elements are familiar from the planned Build Back Better legislation, such as a permanent extension of the American Rescue Plan Act’s (ARP) enhanced premium tax credits for Affordable Care Act (ACA) plans, and capping patient out-of-pocket costs for insulin at $35 per month under all coverage, including private plans.
 
The President also called for the enactment of two new major initiatives, one around mental health and one for nursing home quality and safety. The mental health strategy includes proposals such as: 

• Increasing behavioral health provider capacity with: 
  • A proposed $700 million investment in training, scholarship, and loan forgiveness programs;
  • New pilot programs to train community health workers and other paraprofessionals;
  • A universal certificate program for peer specialists;
  • An expansion of and permanent authorization for the Certified Community Behavioral Health Clinic (CCBHC) program;
  • An expansion of funding for 988 crisis lines; and
  • An investment of $5 million into research for promising new treatment models.
• Expanding mental health parity by: 
  • Issuing new regulations and enhancing enforcement of current ones;
  • Tightening network adequacy standards for behavioral health professionals; and
  • Requiring insurers to cover three behavioral health visits per year without cost sharing.
• Working with Congress on legislation to ensure coverage of virtual behavioral health services across health plans and to support telemedicine across state lines.
• Making it easier for school-based mental health professionals to seek Medicaid reimbursement.
• Testing payment models to support behavioral health integration into whole-person care.

The nursing home safety and quality strategy includes proposals such as: 

• Establishing minimum nursing home staffing requirements.
• Exploring ways to phase out rooms with three or more residents and to promote single-occupancy rooms.
• Making changes to the Skilled Nursing Facility Value-Based Purchasing (SNF VBP) Program to include payments based on staffing adequacy and retention.
• Enhancing oversight of nursing homes, including a proposal to provide $500 million to the Centers for Medicare and Medicaid Services (CMS) to support health and safety inspections, and expanding financial penalties to focus on per-day fines.
• Increasing accountability for chain owners of substandard facilities, including a new database to track and identify owners and operators across states to highlight previous problems, and increased transparency of facility ownership and finances.
• Implementing programs to enhance the nursing home workforce, including: 
  • Improving the affordability of nurse aide training through outreach and notification efforts;
  • Conducting a national nursing career pathways campaign; and
  • Supporting state efforts to tie Medicaid payments to clinical staff wages and benefits, including additional pay for experience and specialization.

More information on the nursing home provisions can be found here. More information on the mental health provisions can be found here.
 
White House Submits Request for Supplemental Covid-19 Funding
On March 2^nd, the Office of Management and Budget (OMB) wrote a letter to Speaker Nancy Pelosi outlining a request for supplemental funding for Covid-19 response activities in federal fiscal year (FY) 2022, which runs through September 30^th. Previous reports had indicated that the Department of Health and Human Services (HHS)  would request about $30 billion, but the final letter request is lower, at $18.25 billion. The proposal includes: 

• $12.2 billion to fund additional Covid-19 medical countermeasures, including vaccines and antivirals.
• $2 billion for HHS’s efforts to provide no-cost community Covid-19 testing and for other testing supplies.
• $1.5 billion for research and development of new vaccines to prepare for future variants.
• $1.5 billion for continued reimbursement for Covid-19 treatment and testing for the uninsured, which is currently funded through the Provider Relief Fund (PRF). Currently available funds from the PRF are projected to be exhausted in late April or early May.
• $1.05 billion for the Centers for Disease Control and Prevention (CDC) for surveillance and global vaccination.

The request does not include additional funding for another General Distribution of the PRF or other provider relief. The full request may be found here.

Regulatory Updates

CMMI Announces Plans to Advance Health Equity
On March 3rd, CMS Innovation Center (CMMI) Chief Medical Officer Dora Hughes published an article in Health Affairs discussing further details of CMMI’s focus on advancing health equity. This was one of five strategic objectives included in CMMI’s “2030 vision” strategy refresh document released in October 2021. The article describes four key ways in which CMMI plans to achieve this objective: 

1. Model Design and Development: In new models and in modifications to existing ones, CMMI will implement design features (such as quality metrics, enhanced benefits, and payment incentives) specifically targeted to address inequities.
2. Safety Net Provider Participation: CMMI will engage with care providers in underserved communities, such as Federally Qualified Health Centers (FQHCs), CCBHCs, and Rural Health Clinics (RHCs). It will consider providing incentives to such providers for participation (such as prospective payment, benchmark modifications, and enhanced risk adjustment).
3. Equity Data: CMMI will seek to use existing equity data sources (including proxies for social risk, like dual eligibility, and widely-used indices, such as the Area Deprivation Index) to monitor model performance. In the longer term, it will require model participants to seek to collect self-reported demographic and social-needs data from beneficiaries.
4. Monitoring and Evaluation: CMMI will seek to systematically determine whether models improve health care quality for all beneficiaries. Evaluation contracts will include explicit requirements for equity assessments.

The article highlights the new ACO REACH Model, which redesigned the Direct Contracting model, as an operational example of this strategy. ACO REACH includes five provisions to advance health equity: 

• Scoring applications based on an applicant’s experience caring for underserved populations;
• Requiring applicants to submit health equity plans;
• Incentivizing participants to collect demographic data;
• Offering a benchmark adjustment to participants serving a disproportionate number of underserved beneficiaries; and
• Including an option for a new nurse practitioner (NP) benefit enhancement intended to expand access to care in areas with workforce shortages.

The Health Affairs article is available here.
 
CMMI Issues RFA for Second Kidney Care Choices Cohort
On February 28^th, CMMI published a Request for Applications (RFA) for the second cohort of the Kidney Care Choices (KCC) Model. The KCC model brings dialysis facilities, nephrologists, and other health care providers together into End Stage Renal Disease (ESRD)-focused accountable care organizations to manage care for beneficiaries with ESRD. The Model adds financial incentives for providers to manage the care of Medicare beneficiaries with chronic kidney diseases stages 4 and 5, and ESRD, to delay the onset of dialysis and to encourage kidney transplantation.
 
After this cohort, the Innovation Center does not plan to conduct any further solicitations for the KCC Model. Applications are due March 25^th, and accepted organizations will begin operating on January 1, 2023. Application instructions can be found here.
 
The CMS PDSS Team will host a webinar on March 9^th at 3pm to provide an overview of the Model and the application process. Registration is available here.
 
CMS Releases 2023 RFA for the Part D Senior Savings Model for Insulin
On February 28^th, CMS released an RFA for Part D plan sponsors who are interested in participating in the Part D Senior Savings (PDSS) Model in calendar year (CY) 2023. The PDSS model is designed to “provide Medicare beneficiaries with new choices of Part D plans that offer insulin at an affordable and predictable price.” The PDSS offers an alternative version of the Medicare Coverage Gap Discount Program that will allow a plan to offer a Part D supplemental benefit to reduce cost sharing after the provision of manufacturer discount payments. This means that the supplemental benefit will not reduce the amount of discount paid by the manufacturer.
 
Participating Part D sponsors will offer enhanced alternative Prescription Drug Plans (PDPs) or Medicare Advantage Prescription Drug plans (MA-PDs) that cover a broad set of plan-formulary insulins that may have cost-sharing of no more than $35 each in the deductible, initial coverage, and coverage gap phases. The model does not change cost-sharing in the catastrophic phase of coverage. CMS estimates that beneficiaries who take insulin and enroll in a plan participating in the Model will save an average of $446 in annual out-of-pocket costs.
 
The following pharmaceutical manufacturers are participating in the Model for CY23: 

• Eli Lilly
• MannKind
• Mylan
• Novo Nordisk
• Sanofi-Aventis

Applications are due April 8^th. The application is in two parts, an online form (available here) and an Excel template which must be submitted by email (available here). More information on the program is available here.
 
Administration Issues Guidance Withdrawing IDR Process for Surprise Bills
On February 28^th, the Departments of HHS, Labor, and the Treasury issued a memorandum to offer guidance after a federal district court judge struck down the guidelines for the independent dispute resolution (IDR) process established as part of the No Surprises Act’s prohibition on surprise billing.
 
The guidance emphasizes that all other consumer protections in the No Surprises Act remain in place, and states that the Departments are still considering next steps in response to the ruling. While this could potentially include an appeal, the guidance states that the Departments intend to withdraw the IDR rules and revise them, which indicates that an appeal is unlikely. After revision, the Departments will repost the guidance, provide training for disputing parties, and reopen the IDR process for submissions.
 
The memorandum is available here.
 
CMS Posts 2020 QPP Data and Reopens MIPS Extreme and Uncontrollable Circumstances Application for PY 2021
On March 1^st, CMS announced it has reopened the Merit-based Incentive Payment System (MIPS) Extreme and Uncontrollable Circumstances (EUC) application to provide relief to clinicians responding to the Covid-19 public health emergency (PHE). CMS has applied an automatic EUC to all individual MIPS-eligible clinicians for the 2021 performance year. However, groups, virtual groups, and Alternative Payment Model (APM) entities must submit an application that cites Covid-19 as the triggering event by March 31^st.
 
A link to the application portal is available here. CMS also provides a guide to the EUC application, here, and a fact sheet on changes to the Quality Payment Program (QPP) made due to Covid-19, here.
 
In addition, on March 3^rd, CMS added 2020 Quality Payment Program (QPP) performance information to the Doctors and Clinicians section of the Medicare Care Compare website and in the Provider Data Catalog. Details on the 2020 QPP performance data is available here.
 
CMS Issues Solicitation for New MEDCAC Members
On March 2^nd, CMS issued a solicitation for new members of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC). MEDCAC provides independent guidance and expert advice to CMS on specific clinical topics, relating to the benefits, harms, and appropriateness of medical items and services covered by Medicare or that may be eligible for coverage under Medicare. MEDCAC includes up to 100 experts in a variety of areas, but CMS selects no more than 15 members with specific relevant knowledge to serve on the panel for each MEDCAC meeting.
 
More information on MEDCAC is available here. Nominations must be received by March 28^th via email to MEDCACnomination@cms.hhs.gov. Additional information on the application requirements can be found in the Federal Register publication here.
 
ONC Publishes Data on Information Blocking Complaints
On February 28^th, the Office of the National Coordinator (ONC) at HHS released data showing it has received 274 complaints of potential information blocking since April 2021, when ONC’s rule prohibiting such practices went into effect. The rule, part of the implementation of the 21^st Century Cures Act, requires providers, health information exchanges, and developers of certified health IT to share data with patients and with third-party entities, with patient authorization, upon request, and outlines limited circumstances in which a provider may decline to fulfill such requests.
 
More than three-quarters of the complaints accused health care providers of violating the rules, followed by health IT developers. Patients and their representatives were the most common authors of submitted complaints, followed by health care providers. Once submitted to ONC, information blocking complaints are passed to the HHS Office of the Inspector General (OIG) for potential investigation. Currently, there are no financial penalties for blocking health data, but OIG is expected to issue a final rule that will implement civil monetary penalties this month.
 
More information on the submissions received is available here.

Other Updates

National Academies Report Recommends Changes to Organ Transplant System
On February 25^th, the National Academies of Sciences, Engineering, and Medicine released a report characterizing the U.S. organ transplant system as “demonstrably inequitable.” The report says that the current system results in “significant nonuse of donated organs” and demonstrates unexplained variation in performance across systems. The study was sponsored by the National Institutes of Health. More than 110,000 patients are on the national transplant waitlist, with 17 individuals dying each day waiting for a transplant.
 
The report includes a list of recommendations for HHS to enact, some of which include: 

• Requiring hospitals with transplant centers to better manage surgical scheduling, to make it easier for organ transplant centers to agree to organ offers;
• Sending organs at risk of nonuse to transplant centers with a demonstrated history of accepting and using medically-complex organs;
• Requiring all of the nation’s 57 organ procurement organizations (OPOs) to create, establish, and mandate a donor care unit; and
• Creating a publicly-available dashboard of standardized performance measures to identify variations in practices and performance among donor hospitals, OPOs, and transplant centers.

The press release, including a link to the report, can be found here.

Legislative Updates

No major health care-related hearings are scheduled next week.

New York State Updates

NYS Senate Confirms Kerri Neifeld as OPWDD Commissioner
On March 2^nd, the New York State Senate confirmed Kerri Neifeld as Commissioner of the New York State Office for People with Developmental Disabilities (OPWDD). Neifeld previously served as Assistant Secretary for Human Services & Mental Hygiene and as Assistant Deputy Commissioner at the New York State Office of Temporary and Disability Assistance (OTDA).
 
DOH Releases Dual Eligible Integrated Care Roadmap for Public Comment
On March 3^rd, the New York State Department of Health (DOH) released a draft of the New York State Dual Eligible Integrated Care Roadmap for public comment. The Roadmap outlines the State’s priority to promote integrated care for beneficiaries who are dually eligible for Medicare and Medicaid and describes the coordinated initiatives for improving integrated care options statewide.
 
The Roadmap is available here. Comments may be submitted to dualintegration@health.ny.gov with the subject line “Duals Integration Comments” through March 25^th.
 
OMH and OASAS Announce Implementation of CORE Service Array
On March 2^nd, the New York State Office of Mental Health (OMH) and Office of Addiction Services and Supports (OASAS) issued notices in the State Register (available here) announcing the implementation of the new Community Oriented Recovery and Empowerment (CORE) service array.
 
Effective February 1^st, providers currently designated to provide one or more of the Behavioral Health Home and Community Based Services (BH HCBS) transitioning to CORE will be automatically provisionally designated to provide those services until July 31^st, after which such providers who meet the requirements for designation will be fully designated. Providers who are currently licensed, certified, or funded by OMH or OASAS may apply for a designation to provide CORE services. OMH intends to accept such applications through an online portal.
 
Questions may be submitted through April 15^th to legal@oasas.ny.gov.
 
OMH and OASAS Release Guidance on Enhanced HCBS Funding for Adult BH HCBS and CORE Services
On February 18^th, OMH and OASAS released guidance (available here) on eligible activities for supplemental funding that will support the expansion and implementation of Adult BH HCBS and CORE services. This supplemental funding is available through the time-limited enhancement of the Federal Medical Assistance Percentage (FMAP) authorized under Section 9817 of the ARP. Providers will receive funding through service rate increases that will be effective retroactive to October 1, 2021 and through March 31, 2023 (18-month funding period).
 
Designated providers may choose to use funding to support one or more of the following initiatives: 

• Increasing program capacity by recruiting, hiring, and training qualified staff and/or purchasing program materials;
• Investing in devices/hardware and software, including Electronic Health Record (EHR) and telehealth platform licensing fees/technical assistance;
• Creating marketing materials and implementing community education efforts to develop an effective referral network; and
• Making one-time or initial investments in transportation and community connections.

Given the time-limited nature of the enhanced rates, providers are strongly encouraged not to use funding for ongoing salary or fringe benefit increases that cannot be supported beyond the funding period. Providers must complete an attestation form (available here) by March 31, 2022 in order to receive funds. Provider attestations may be submitted to OMH.Workforce@omh.ny.gov.
 
NYS DFS Issues Updated Guidance to Insurers on Covid-19 Testing Coverage
On February 25^th, the New York State Department of Financial Services (DFS) issued guidance (available here) reminding regulated insurance plans of their obligations to cover Covid-19 testing under New York State and federal law. Insurance plans must cover laboratory tests and visits (including via telehealth) to diagnose Covid-19 without cost-sharing, prior authorization, or other medical management.
 
For over-the-counter Covid-19 tests, insurance plans may limit reimbursement in accordance with federal guidance (available here), including limiting reimbursement to no less than eight tests per calendar month. Coverage of testing for public health surveillance or employment purposes is permitted but not required. Insurance plans may impose cost-sharing for any follow-up care or treatment for Covid-19, including an inpatient hospital admission, as otherwise permitted by law and in accordance with the applicable policy or contract.
 
This guidance repeals and replaces previous guidance issued by DFS in May 2020 (available here). Questions may be submitted to health@dfs.nys.gov.
 
CMS Approves New York State 1115 Waiver Interim Evaluation Reports
On February 22^nd,CMS approved New York State’s Medicaid Redesign Team (MRT) Interim Evaluation Report and the Children’s Design Interim Evaluation Report. CMS determined that the reports are in alignment with the approved Evaluation Design and the requirements set forth in the Special Terms and Conditions (STCs) of New York’s Section 1115 MRT waiver demonstration.
 
Both reports were independently conducted by the RAND Corporation. The Children’s Design report identified the facilitators of, and barriers to, the implementation of the Children’s waiver demonstration and provided baseline metrics for children in Medicaid fee-for-service, managed care, and Health Homes. The MRT report assessed the success of the Managed Long Term Care (MLTC) program and the MLTC 12-month continuous eligibility policy.
 
The CMS approval letter is available here and the Interim Evaluations are available here.
 
Governor Hochul Signs Package of Health Care Legislation
Over the past week, Governor Hochul signed the following health care-related bills into law:

• Hospitals 
  • S7885/A8834 clarifies requirements for health equity impact assessments for hospital Certificate of Need (CON) projects.
  • S7884/A8751 clarifies that a legal guardian of an individual with a disability, in addition to the individual, may designate a single primary essential support person (limited to such individual’s spouse, parent, or caretaker) to assist with communicating medical needs and managing everyday needs during hospitalization.
  • S7717/A8787 requires every general hospital to comply with and meet all applicable requirements of the federal Medicare and Medicaid conditions of participation for antimicrobial stewardship programs in health care facilities, including training requirements.
• Long-Term Care 
  • S7776/A8798 amends provisions of the “reimagining long-term care task force” legislation related to membership, reporting requirements, and effective date.
  • S7777/A8592 amends regulations related to the establishment of policies and procedures for staff and volunteers of the long-term care ombudsman program.
  • S7886/A8839 requires nursing homes and residential health care facilities to provide certain contact information related to the long-term care ombudsman program at or prior to a patient’s admission and twice per year.
  • S7888/A8826 makes the contact details of approved education or training programs that offer competency exams to home health aides available on the DOH website.
  • S7717/A8787 requires every nursing home to comply with and meet all applicable requirements of the federal Medicare and Medicaid conditions of participation for antimicrobial stewardship programs in health care facilities, including training requirements.
• Behavioral Health 
  • S7850/A8711 directs the Commissioner of OMH, in consultation with the Commissioner of OASAS, to submit a report that details the resources necessary to make the National Suicide Prevention Lifeline (9-8-8) available, operational, and effective statewide.
  • S7761/A8702 amends legislation that enables licensed mental health practitioners to bill Medicaid directly for their services, defining such practitioners as mental health counselors and marriage and family therapists and specifically removing creative arts therapists and psychoanalysts.
  • S7798/A8776 amends legislation requiring reporting of alcohol overdose data in addition to existing overdose reporting requirements to keep opioid reporting practices status quo and instead creating a distinct reporting requirement on excessive alcohol consumption and alcohol poisoning.
• Covid-19 
  • S7817/A8774 changes the reporting deadline from one to two years for the Commissioner of Health study on the delivery of ambulatory care and other medical care in response to the Covid-19 pandemic.
• Pharmacy 
  • S7837/A8838 amends the public health, insurance, and state finance laws in relation to registration and licensing of pharmacy benefit managers and the establishment of the pharmacy benefit manager regulatory fund.
  • S7767/A8697 makes technical changes to legislation prohibiting health care plans from removing a prescription drug from a formulary or adding new or additional formulary restrictions during an enrollment year.
• I/DD 
  • S7794/A8841 clarifies legislation regarding orders of support for adults with developmental disabilities.

Funding Opportunities

SAMHSA Releases Notice of Funding Opportunity for Minority AIDS Initiative
On February 25^th, the Substance Abuse and Mental Health Services Administration (SAMHSA) released a Notice of Funding Opportunity (NOFO) for the fiscal year 2022 Minority AIDS Initiative. This program provides resources to help reduce the co-occurring epidemics of HIV, Hepatitis, and mental health disorders through accessible, evidence-based, culturally appropriate mental and co-occurring disorder treatment that is integrated with HIV primary care and prevention services.
 
SAMHSA will award $8.73 million in total funding across 18 awards over the four-year program period. Eligible applicants are domestic public and private not-for-profit organizations, including community- and faith-based organizations.
 
The NOFO is available here. Applications are due on April 25^th.