Weekly Health Care Policy Update – April 24, 2023

In this update: 

• Administration Updates
  • Biden to Nominate Dr. Monica Bertagnolli as NIH Director
• Federal Agencies
  • HHS Finalizes 2024 Notice of Benefit and Payment Parameters for Marketplace Plans
  • CMS Announces New Medicaid Reentry Section 1115 Demonstration Opportunity
  • HHS Offers Resources to Address Cyberattacks
  • FDA Authorizes Additional Bivalent Covid-19 Vaccine Doses for Older or Immunocompromised Individuals
  • CMS to Hold Office Hours on Ending the Covid-19 PHE on April 25^th
  • CMMI to Hold BPCI Advanced Model Application Webinar on April 27^th
  • HHS Releases Hospice and Home Health Ownership Information
  • FDA Authorizes Additional Bivalent Covid-19 Vaccine Doses for Older or Immunocompromised Individuals
  • HHS to Amend PREP Act to Extend Certain PHE Protections
  • White House to Launch Project Next Gen, Successor to Operation Warp Speed
• Other Updates
  • MedPAC Holds April Public Meeting
  • MACPAC Holds April Public Meeting
• New York State Updates
  • NYS Budget Deadline Extended to April 28^th
  • Governor Hochul Extends Statewide Disaster Emergency Due to Health Care Staffing Shortages
  • NYS DOH Proposes to Reduce FFS Medicaid Utilization Review Requirements
  • NY State of Health Releases 2023 Health Insurance Report
  • DOH Issues Proposed Rule on the Investigation of Communicable Diseases
  • DOH Issues Public Notice for the Renewal of the Nursing Home Transition and Diversion (NHTD) 1915(c) Waiver Program
• Funding Opportunities
  • DOH Issues SOI for Nutrition Education and Obesity Prevention Grant Program

Administration Updates

Biden to Nominate Dr. Monica Bertagnolli as NIH Director
On April 19^th, the New York Timesreported that President Biden plans to nominate Dr. Monica Bertagnolli as the next Director of the National Institutes of Health (NIH). Dr. Bertagnolli currently serves as the head of the National Cancer Institute (NCI)—the first woman to serve in this role—and was previously the Richard E. Wilson Professor of Surgery in surgical oncology at Harvard Medical School, a surgeon at Brigham and Women’s Hospital, and a member of the Gastrointestinal Cancer Treatment and Sarcoma Centers at Dana-Farber Cancer Institute.
 
The NIH has not had a permanent director since December 2021 when Dr. Francis Collins stepped down from the role. Dr. Lawrence Tabak has been serving as acting director since that time. If officially nominated, Dr. Bertagnolli will require confirmation by the Senate.

Federal Agencies

HHS Finalizes 2024 Notice of Benefit and Payment Parameters for Marketplace Plans
On April 17^th, the Department of Health and Human Services (HHS) finalized its calendar year 2024 Notice of Benefit and Payment Parameters (NBPP). While the NBPP primarily focuses on the Federally Facilitated Exchanges (FFE) and State-Based Exchanges using the Federal Platform (SBE-FP), some provisions do affect issuers of Qualified Health Plans (QHPs) on fully State-Based Exchanges (SBEs), such as the New York State of Health. Provisions affecting SBEs include: 

• Network adequacy and essential community provider (ECP) regulations: HHS finalized a requirement that all QHPs, including stand-alone dental plans (SADPs), and all Small Business Health Options Program (SHOP) plans, across all Exchange types must comply with network adequacy and ECP standards, eliminating an exception for plans that do not use a provider network. In addition, HHS finalized a limited exception to this requirement for certain SADPs operating in areas where it is prohibitively difficult to establish a network of providers. Finally, HHS established two additional major ECP categories for 2024 and beyond: Mental Health Facilities and Substance Use Disorder Treatment Centers.
• Stand-alone dental plans: HHS finalized a requirement that issuers of SADPs on all Exchanges use an enrollee’s age at the time of policy issuance or renewal as the sole method to calculate an enrollee’s age for rating and eligibility purposes. HHS will apply this requirement to products sold both on- and off-Exchange. Further, HHS finalized a requirement that issuers of SADPs on all Exchanges submit guaranteed rates beginning with plan year (PY) 2024.
• Re-enrollment hierarchy to promote use of CSRs: Beginning in PY 2024, HHS will allow Exchanges to direct re-enrollment for members eligible for cost-sharing reductions (CSRs) from a bronze QHP to a silver QHP with a lower or equivalent post-APTC premium within the same product and QHP issuer, regardless of whether their current plan is available or not. In addition, HHS will require all Exchanges to ensure enrollees whose QHPs are no longer available and who would be re-enrolled into a silver-level QHP to receive income-based CSRs are re-enrolled into plans with the most similar network to their previous plan.
• Special Enrollment Periods: SBEs will have the option to provide consumers losing Medicaid or CHIP coverage with the greater of 90 days after their loss of Medicaid/CHIP coverage or the number of days provided for during the applicable Medicaid or CHIP reconsideration period, as determined by the State Medicaid Agency. In addition, SBEs are allowed to implement this provision as soon as the final rule takes effect (60 days after publication), rather than waiting until January 1, 2024.
• Risk adjustment: HHS finalized its proposal to determine the 2024 benefit year risk adjustment model using 2018, 2019, and 2020 External Data Gathering Environment (EDGE) data. HHS did not finalize a proposal to recalibrate adult age and sex data using only 2018 and 2019 data and will instead use 2018, 2019, and 2020 data for this purpose as well.  HHS finalized proposals to repeal states’ flexibility to request reductions of risk adjustment State transfers calculated by HHS, to extract a new data element from issuers’ EDGE Server Enrollment Submission files (the Qualified Small Employer Health Reimbursement Arrangement indicator), and to amend the materiality threshold below which certain issuers are exempt from the risk adjustment data validation program.

Finally, though not applicable to SBEs, HHS finalized a proposal on standardized plan options but eliminated the standardized plan option for the non-expanded bronze metal level. In addition, HHS increased the limit of non-standardized plan options an issuer may offer from two to four per product network type and metal level.
 
The provisions of this final rule are effective June 18^th. The text of the rule is available here, a fact sheet is available here, and a press release is available here.
 
CMS Announces New Medicaid Reentry Section 1115 Demonstration Opportunity
On April 17^th, the Centers for Medicare and Medicaid Services (CMS) issued a State Medicaid Director (SMD) letter on the Medicaid Reentry Section 1115 Demonstration Opportunity. This letter provides guidance to states on parameters that CMS would expect to be able to approve for Section 1115 Medicaid waiver proposals that would provide new Medicaid services to individuals who are incarcerated, immediately prior to their release. This option is similar to a proposal that was included in New York’s recently-submitted waiver proposal, New York Health Equity Reform (NYHER), and could be used to replace that component.
 
The guidance outlines various “best and promising practices” for offering a package of pre-release community re-entry services, up to 90 days prior to a Medicaid-eligible individual’s expected release date from incarceration. CMS expects minimum services should include: 

• Case management to assess and address physical and behavioral health needs and health-related social needs (HRSNs);
• Medication-assisted treatment (MAT) services for all types of substance use disorder (SUD) and accompanying counseling;
• A 30-day supply of all prescription medications that have been prescribed for the beneficiary at the time of release.

States may also request to provide other services, such as: 

• Family planning services and supplies;
• Behavioral health or preventive services, including those provided by peer supporters or community health workers (CHWs) with lived experience;
• Treatment for Hepatitis C; and
• Medical supplies, equipment, and applies prior to formal release.

States are encouraged to leverage other initiatives to address SUD and other chronic health conditions and to help individuals to create health care connections in the community as they transition out of the justice system. The demonstration also aims to improve coordination and communication between correctional systems, Medicaid systems, managed care plans, and community-based providers.
 
The SMD letter is available here.
 
HHS Offers Resources to Address Cyberattacks
On April 17^th, HHS announced the availability of new resources to help address cybersecurity concerns in the health care and public health sectors. These tools include: 

• Knowledge on Demand: an online educational platform that offers free cybersecurity trainings for health and public health organizations to improve cybersecurity awareness;
• Health Industry Cybersecurity Practices (HICP) 2023 Edition: a publication that aims to raise awareness of cybersecurity risks, provide best practices, and help set standards to mitigate cybersecurity threats; and
• Hospital Cyber Resiliency Initiative Landscape Analysis: a report on domestic hospitals’ current state of cybersecurity preparedness, including a review of participating hospitals benchmarked against standard cybersecurity guidelines.

More information is available here.
 
CMS to Hold Office Hours on Ending the Covid-19 PHE on April 25^th
On April 25^th, from 3:30pm to 4:30pm ET, CMS will hold an informational session to help Medicare providers, facilities, and beneficiaries prepare for the end of the Covid-19 Public Health Emergency (PHE) on May 11^th. The webinar will focus the effects of the PHE’s end on current waivers and flexibilities.
 
Questions may be submitted in advance through the registration form. Registration is available here.
 
CMMI to Hold BPCI Advanced Model Application Webinar on April 27^th
On April 27^th, from 2pm to 3pm ET, the CMS Innovation Center (CMMI) will host a webinar detailing key elements of the Bundled Payments for Care Improvement (BPCI) Advanced Model and the application process for the program.
 
CMS announced in February that the BPCI Advanced program would reopen for a new application period, which is open through May 31^st. Under this new application period, Medicare-enrolled providers, suppliers, and Medicare Accountable Care Organizations (ACOs) to begin participation in BPCI Advanced on January 1, 2024 (for Model Year 7). Active Model Participants in 2023 do not need to apply, and instead may simply sign an amended participation agreement.
 
Registration for the webinar is available here.
 
HHS Releases Hospice and Home Health Ownership Information
On April 20^th, HHS announced the release of ownership data for all Medicare-certified hospice and home health agencies. The information on more than 6,000 hospices and 11,000 home health agencies includes: 

• Enrollment information, such as organization name, type, practice location addresses, National Provider Identifier (NPI), and CMS Certification Number (CCN);
• Information about each owner such as whether it is an organization or an individual and whether it is a direct owner or indirect owner; and
• Information about mergers, acquisitions, consolidations, and changes of ownership since 2016.

All data will be available on the CMS website, and will be updated quarterly. CMS intends for the release of this data to enable identification of common owners that have had histories of poor performance, analysis of how market consolidation impacts consumers, evaluation of relationships between ownership and changes in health care costs and outcomes, and informed decision-making about care.
 
All CMS datasets are available here.

FDA Authorizes Additional Bivalent Covid-19 Vaccine Doses for Older or Immunocompromised Individuals
On April 18^th, the Food and Drug Administration (FDA) amended the emergency use authorizations (EUAs) of the Moderna and Pfizer-BioNTech Covid-19 bivalent mRNA vaccines. The amendment allows individuals 65 years of age and older who have received a single dose of the bivalent vaccine to receive one additional dose at least four months following their initial bivalent dose. The amendment also allows most immunocompromised individuals who have received a bivalent vaccine to receive a single additional dose at least two months following a dose of a bivalent vaccine, and additional doses administered at the discretion of their health care provider. Most unvaccinated individuals may also now receive a single dose of a bivalent vaccine, rather than multiple doses of the original monovalent vaccine.
 
More information is available here.
 
HHS to Amend PREP Act to Extend Certain PHE Protections
On April 14^th, HHS Secretary Xavier Becerra sent a letter to state governors providing clarity on the future of coverage of Covid-19 countermeasures under the Public Readiness and Emergency Preparedness (PREP) Act. The PREP Act declaration has enabled broad access to Covid-19 vaccines, tests, and treatments by providing immunity from liability for qualified health care providers who offer such services, thereby preempting other federal or state requirements that would prevent their provision. Under the declaration, providers are immune from liability for any claims of loss relating to the use of these treatments, unless they have engaged in willful misconduct.
 
HHS intends to amend the PREP Act declaration to extend certain protections that were available during the Covid-19 PHE through December 2024, while ending others. Under the amended declaration, HHS will: 

• Extend immunity coverage to pharmacists, pharmacy interns, and pharmacy technicians to provide Covid-19 vaccines, seasonal influenza vaccines, and Covid-19 tests;
• Extend immunity coverage for federal agreements, including all activities related to the provision of Covid-19 countermeasures such as vaccines and treatments purchased and provided by the US government;
• End immunity coverage for Covid-19 vaccination by non-traditional providers and vaccinations across state lines by licensed providers or pharmacists; and
• End immunity coverage for routine childhood vaccinations.

Certain key features of the PREP Act will not change under the amended declaration. The Act will continue to offer liability immunity for pharmacists, pharmacy technicians, and pharmacy interns dispensing Covid-19 treatments, as well as prescribing tests in the “Test to Treat” program.
 
More information is available here.
 
White House to Launch Project Next Gen, Successor to Operation Warp Speed
On April 17^th, White House Covid-19 Response Coordinator Ashish Jha announced that the Biden Administration will launch Project Next Gen, a $5 billion effort to accelerate and improve future Covid-19 vaccines. The program, a successor to Operation Warp Speed, will also partner with private-sector companies, and will have three goals: creating long-lasting monoclonal antibodies, accelerating development of vaccines that produce mucosal immunity, and accelerating the development of pan-coronavirus vaccines that protect against new SARS-CoV-2 variants and other coronaviruses. Given Republican opposition to additional appropriations for Covid-19 programs, Project Next Gen will be funded with dollars originally intended for testing and other priorities. The Administration has yet to announce Project Next Gen leadership.

Other Updates

MedPAC Holds April Public Meeting
On April 13^th and 14^th, the Medicare Payment Advisory Commission (MedPAC) met for its April public meeting. Highlights of the session include: 

• Drug Prices under Medicare Part B: Commissioners voted in favor of three draft recommendations, to: 
  • Cap the Medicare payment rate for Part B drugs and biologics approved under the accelerated approval program under certain circumstances;
  • Create a single average sales price-based payment rate for Part B drugs and biologics with similar health effects; and
  • Reduce add-on payments for high-price Part B drugs and biologics paid based on average sales price.
• Medicare Safety Net Payments for Skilled Nursing Facilities and Home Health Agencies: Commissioners were supportive of targeted payments to skilled nursing facilities and home health agencies through a quality incentive program or amending the case-mix adjustments, while indicating they were unlikely to recommend safety net add-on payments at this time.
• Telehealth in Medicare: Commissioners discussed a report that offered inconclusive findings as to whether telehealth improved quality or lowered costs of care. Some Commissioners suggested not making recommendations to Congress on permanently expanding telehealth flexibilities until a later date.
• Reforming the Wage Index: Commissioners voted in favor of an alternative wage index that would: 
  • Use all-employer, occupation-level wage data with different occupation weights for the wage index of each type of provider;
  • Rflect local area differences in wage between and within metropolitan statistical areas and statewide rural areas; and
  • Smooth wage index differences across adjacent local areas.

MedPAC also held sessions on post-sale rebates for prescription drugs in Medicare Part D, behavioral health services, aligning fee-for-service payment rates across ambulatory settings, and a mandated report on a prototype design for a post-acute care prospective payment system.  The next MedPAC meeting will take place on September 7-8, 2023.
 
More information on the meeting is available here.
 
MACPAC Holds April Public Meeting
On April 13^th and 14^th, the Medicaid Access and Payment Advisory Commission (MACPAC) convened for its monthly public meeting. Highlights from the meetings sessions include: 

• Automatic Adjustments to Disproportionate Share Hospital (DSH) Payments: Commissioners unanimously approved four policy recommendations that would automatically adjust Medicaid DSH payments, which will be included in the Commission’s June Report to the Congress. These include: 
  • Improving the relationship between total DSH funding and measures of need for DSH payments should allotment reductions go into effect;
  • Changing the basis of DSH allotments from federal funding to total funding;
  • Including DSH allotments in a countercyclical financing mechanism for Medicaid to preserve DSH funding when there is an economic recession; and
  • Removing the requirement for CMS to compare DSH allotments to Medicaid spending so that allotments can be finalized in a timelier manner.
• Integrating Care for Dually Eligible Beneficiaries: Commissioners reviewed a draft chapter for the June 2023 report to Congress on this topic and discussed next steps in their efforts to improve care integration for this population. 
• Medicaid Services for Adults Leaving Incarceration: Commissioners reviewed a draft chapter for the June 2023 report to Congress on this topic, which includes recommendations for guidance and other action CMS and other federal agencies can take to support states in implementing pre-release Medicaid services.
• Dental Benefits for Adult Medicaid Beneficiaries: The Commissioners heard a panel discussion on this topic and discussed approaches to providing dental services for certain high-need populations.
• Unwinding Continuous Coverage Requirements: MACPAC Staff provided an update on beneficiary communication efforts and stakeholder coordination as states resume eligibility redeterminations. 
• Medicaid DSH Third-Party Payer Policy: Commissioners reviewed the February 2023 proposed rule and considered potential policy areas on which they might comment.
• Access to Medicaid Home- and Community-Based Services (HCBS): Commissioners reviewed a draft chapter for the June 2023 report to Congress on this topic and discussed ongoing work to identify policies that streamline HCBS delivery systems to increase beneficiary access and reduce administrative burden on states.
• Managed Care Denials and Appeals: MACPAC staff presented findings from the Commission’s ongoing examination of denials and appeals in Medicaid managed care, focusing on interview findings related to whether denial and appeal processes ensure beneficiary access to covered and medically necessary care and how state and federal officials monitor these processes.

The meeting’s transcript and presentations are available here. MACPAC’s next meeting will take place virtually on September 21^st and 22^nd.

New York State Updates

NYS Budget Deadline Extended to April 28^th
Today (April 24^th), Governor Hochul signed a bill (S.6480) to further extend emergency appropriations for the State government through April 28^th, pending the enactment of a full budget. While the Governor and the Legislature are still negotiating policy provisions in the Budget, reports indicate that significant progress has been made and legislative language is expected to be released in the coming week. This would indicate that a full agreement on the budget could be reached by the end of April or start of May.
 
Governor Hochul Extends Statewide Disaster Emergency Due to Health Care Staffing Shortages
On April 22^nd, Governor Hochul issued Executive Order 4.20, which extends through May 22^nd (past the end date of the federal Covid-19 PHE) the provisions in Executive Order 4 and its successors that reinstated many workforce and scope of practice flexibilities that applied during the original NYS Covid-19 public health emergency. Certain provisions of the Order have previously expired, including those related to prior authorization, nursing home staffing, revenue requirements, and scope of practice for health care program graduates and volunteers or personnel affiliated with different hospitals.
 
The Executive Order is available here.
 
NYS DOH Proposes to Reduce FFS Medicaid Utilization Review Requirements
On April 19^th, pursuant to legislation passed in the NYS FY 2023 budget, the NYS Department of Health (DOH) released proposed regulations to reduce the administrative burden on enrolled fee-for-service (FFS) Medicaid members and their providers by eliminating utilization thresholds as service limits.
 
These regulations would move monitoring of Medicaid FFS service utilization from a prospective to a retrospective basis and remove the requirement for providers to request increases for a member’s benefit limits upon the member reaching utilization thresholds. Utilization monitoring would continue during a post-payment process to correct misutilization practices and for referrals to be made to the Office of the Medicaid Inspector General (OMIG) in cases of suspected fraud, waste, or abuse. The regulations outline the provider type services that have volume limits within a benefit year for Medicaid FFS members along with services excluded from the regulations.
 
The proposed regulation is available in the State Register here. Comments may be submitted to regsqna@health.ny.gov through June 18^th.
 
NY State of Health Releases 2023 Health Insurance Report
On April 20^th, NY State of Health (NYSOH), the state’s official health plan Marketplace, released the 2023 Health Insurance Coverage Update report. The report provides a detailed summary of Marketplace enrollment, including data on demographics, quality measures, and cost savings.
 
Since March 2020, NYSOH has extended coverage without requiring annual renewal for individuals enrolled in Medicaid, Child Health Plus, and the Essential Plan, in alignment with federal continuous coverage requirements during the Covid-19 Public Health Emergency (PHE). This has contributed to the growth in NYSOH enrollment from 4.9 million enrollees (including QHP enrollees) in March 2020 to more than 6.9 million enrollees in January 2023. As continuous coverage provisions expire in spring 2023, NYSOH will begin sending renewal notices to enrollees depending on their enrollment end date.
 
The report is available here. The press release is available here.
 
DOH Issues Proposed Rule on the Investigation of Communicable Diseases
On April 19^th, DOH released proposed regulations that update DOH’s and local health departments’ authority to take specific actions to monitor the spread of disease, including actions related to investigation and response to a disease outbreak. Specifically, these regulations propose to: 

• Make explicit DOH’s authority to lead disease investigation activities, in collaboration with impacted local health departments, under certain circumstances where there is the potential for multiple jurisdictions or for other states to be impacted. In all other cases, local health departments retain the primary authority and responsibility to control communicable disease within their respective jurisdictions;
• Clarify specific actions that local health departments must take to investigate a case, outbreak, or unusual disease;
• Require individuals and entities subject to a public health investigation to cooperate with DOH and local health departments;
• Authorize the Commissioner of Health to direct hospitals to take patients during an outbreak of a highly contagious communicable disease;
• Codify existing requirements around mandatory reporting, including: 
  • Hospitals must report syndromic surveillance data during an outbreak of a highly contagious communicable disease.
  • Clinical laboratories must immediately report positive test results for diseases that are designated as requiring “prompt attention” in a manner and format designated by DOH.
  • Clinical laboratories must report all results (including negative and indeterminate) for such diseases via the Electronic Clinical Laboratory Reporting System.
• Require DOH to designate communicable diseases that require prompt action;
• Change the name of “monkeypox” to “MPox” to reduce stigma and misinformation.

The proposed regulations are available in the State Register here. Comments may be submitted to regsqna@health.ny.gov through June 18^th.
 
DOH Issues Public Notice for the Renewal of the Nursing Home Transition and Diversion (NHTD) 1915(c) Waiver Program
On April 19^th, DOH issued a public notice for the proposed five-year renewal of the Nursing Home Transition and Diversion (NHTD) 1915(c) Waiver Program, which is set to expire on June 30^th. The renewal application seeks to make the following modifications:  

• Allows modality flexibilities for meetings between providers and participants, including telephonic and virtual methods;
• Updates requirements for Service Coordination visits and flexibilities related to Level of Care assessments;
• Updates state minimum wage language and cost reporting languages;
• Adds language to provide consistency between Licensed Home Care Services Agency (LHCSA) regulations and waiver service definitions; and
• Clarifies the state’s timeline for federally mandated 372 reporting.

The notice is available in the State Register here. A draft of the proposed waiver amendment is available here. Comments may be submitted to waivertransition@health.ny.gov by May 19^th.

Funding Opportunities

DOH Issues SOI for Nutrition Education and Obesity Prevention Grant Program
On April 19^th, DOH issued a Solicitation of Interest (SOI) seeking an organization to implement the Just Say Yes to Fruits and Vegetables Stellar Farmers’ Markets Program (JSY SFM), an evidence-based obesity prevention intervention that focuses on improving the nutrition and physical activity behaviors of low-income and food-insecure families residing in New York City (NYC) neighborhoods. DOH anticipates that up to $487,535 of Federal Supplemental Nutrition Assistance Program Education (SNAP-Ed) funding will be available annually to implement the JSY SFM for a five-year contract period, beginning on October 1^st.

The awarded organization will be expected to implement the following activities: 

• Staff an educational team comprised of a nutritionist, culinary educator, and bilingual educator to conduct seasonal nutritional education workshops and cooking demonstrations at up to 15 farmers’ markets throughout the five boroughs of NYC from July to November;
• Collaborate with partner community organization(s) to implement at least one policy, systems, and environmental strategy (PSE) in 2 neighborhoods to address goals such as increasing the consumption of fruits and vegetables;
• Evaluate the effectiveness of implemented PSEs; and
• Implement activities designed to sustain PSEs.

Eligible applicants are public or private not-for-profit 501(c)(3) organizations with at least one year of experience within the last three years providing nutrition education to low-income populations at farmers’ markets in NYC. Applicants must have an office location within the five boroughs of NYC. At the time an award is made, the organization must not already have SNAP-Ed grant funding for similar programs.

The SOI is available here. Interested organizations should submit a statement of interest, maximum of two pages, describing their eligibility, location, and experience that demonstrates their capacity to administer the SFM initiative to jsy@health.ny.gov no later than May 17^th with the subject line “JSY SFM SOI”. Questions may be directed to Clare DiSanto at Clare.DiSanto@health.ny.gov.