Weekly Health Care Policy Update – December 12, 2022

December 19, 2022

In this update: 

  • Legislative Update
    • Congress Continues Slow Progress on Spending Bill
    • Senate Finance Committee Releases Final Draft Behavioral Health Legislation on Parity
    • House Lawmakers Express Concern on No Surprises Act Implementation
    • Bipartisan Group of Senators Seeks Input on Dual Eligibles
  • Administration Updates
    • Administration Launches New Opioid Surveillance Tracker, Announces One-Year Progress on Overdose Prevention Strategy
  • Federal Agencies
    • CMS Replaces Proposed Rule on New Prior Authorization Requirements for Payers
    • HHS Proposes to Revise SUD Privacy Rules
    • CMS Delays Enforcement of Good Faith Estimates in No Surprises Act
    • HHS Publishes Proposed Revisions to 340B Program Resolution Process
    • FDA Grants EUA for Pfizer, Moderna Bivalent Boosters for Children Down to Six Months Old
    • CMS Releases GPDC Quality and Payment Results for 2021
    • HHS Promotes Benefits of “Community Care Hubs” to Address SDH
  • Other Updates
    • AHRQ Releases Health System Carbon Emission Reduction Guidelines
    • AMA/Manatt Release Study on Optimizing Digital Healthcare
    • Coalition for Health Artificial Intelligence (CHAI) Publishes Blueprint
    • Health Affairs Publishes Study Showing Misallocation of DSH Payments
    • Study Correlates Mental Health Provider Shortages with Increased Youth Suicides
  • New York State Updates
    • NYS Health Commissioner Dr. Mary Bassett to Resign
    • SED Adopts Final Regulations for Mental Health Practitioner Diagnostic Privileges
    • NYS HCBS Final Rule Statewide Transition Plan Open for Public Comment
    • DOH Adopts Regulations Addressing Nursing Home Expenditures and Staffing
    • OPWDD Issues Proposed Amendment to Person-Centered Behavioral Intervention Services
    • CMS Approves New York SPA Maintaining the Quality Incentive Program for Nursing Homes
    • Governor Hochul Signs Package of Health Care-Related Bills
  • Funding Opportunities
    • OMH Releases SOI for Evidence-Based Practice Opportunities
    • OPWDD Releases RFP for Career-Specific Vocational Training Services
    • OPWDD Announces Public Comment Period for New Housing Subsidy Funding Opportunity
    • OMH Releases RFP for Coordination of Statewide Suicide Prevention Activities
    • OASAS Releases RFP for 2022 NYS Partnership for Success
    • DHS Releases Open-Ended RFP for the Development and Operation of Safe Havens

Legislative Updates

Congress Continues Slow Progress on Spending Bill
Facing a December 16th deadline, Congressional leaders have been meeting with the White House since late November for negotiations to keep the government funded. Reports indicate that all four Congressional leaders are committed in principle to passing an omnibus funding bill, rather than settling for another continuing resolution (CR) that extends government funding at current levels. However, Democrats have recently warned that a full-year CR is a possibility if agreement cannot be reached.
 
An omnibus funding bill would likely allow more substantive policy provisions to be included. Notable items under discussion include a scheduled end to the Medicaid continuous coverage requirement and a bill requiring dialysis coverage by group health plans in response to the June Supreme Court decision on that topic.
 
As of today (December 12th), Senate Appropriations Committee Chair Patrick Leahy (D-VT) stated that they would delay plans to introduce party-line omnibus legislation, in a sign that negotiations on an omnibus are producing some progress. Given the imminent deadline, a short-term CR is likely to be needed regardless.
 
Senate Finance Committee Releases Final Draft Behavioral Health Legislation on Parity
The Senate Finance Committee continues bipartisan work on a package of mental health legislation. On December 1st, the Committee released a discussion draft of legislation regarding mental health parity. The Committee has previously released four discussion drafts on potential legislation, including: 

  • A draft on telehealth in May (available here);
  • A draft on youth mental health in June (available here);
  • A draft on the mental health workforce in September (covered in SPG’s September 26th update here); and
  • A draft on physical and mental health integration November (available here).

The parity bill is the fifth part of the Committee’s mental health package. Policies that are under discussion include: 

  • Strengthening requirements for plans in Medicare and Medicaid to maintain accurate provider directories;
  • Directing the Department of Health and Human Services (HHS) to provide new guidance on the availability of partial hospitalization services to people with substance use disorder;
  • Directing the Government Accountability Office (GAO) to study differences in medical and behavioral payment rates in Medicaid; and
  • Directing GAO to study differences in utilization management and cost-sharing in medical and behavioral health services in Medicare Advantage.

More information on this draft is available at the Senate Finance Committee website here.
 
House Lawmakers Express Concern on No Surprises Act Implementation
Last month, House Ways and Means Committee Chair Richard Neal (D-MA) and Ranking Member Kevin Brady (R-TX) sent a letter to HHS, the Department of Labor, and the Treasury, expressing “serious concerns” with implementation of the No Surprises Act. The Departments rescinded their original final rule in response to a federal court’s decision and released a new one in August 2022. However, the letter claims that the revised rule continues to violate the intention of the law because the Departments are still prioritizing the qualifying payment amount (QPA) as the main factor in the independent dispute resolution (IDR) process.
 
The lawmakers note that Congress “intentionally required arbiters to equally consider a series of factors for their decision-making process” and not to “give preference or outsized weight to any one factor.” Under the final rule, IDR entities are directed to consider whether any additional information submitted is “already accounted for in the QPA,” and not to consider it if so. The letter says that this new “double counting” test in the final rule continues to prioritize the QPA and has no basis in the statute, requiring providers to disprove double-counting before considering factors such as patient acuity or service complexity.
 
Separately, the letter also expresses concerns about the slow implementation of the Advanced Explanation of Benefits (AEOB) provision. The No Surprises Act required rulemaking to implement the AEOB by plan years starting on or after January 1, 2022. However, to date, the Departments have only issued a Request for Information related to the AEOB.
 
Since the letter’s date, HHS has further extended compliance deadlines for good faith estimates (GFEs), another part of the Act (described below). The lawmakers’ letter is available here.
 
Bipartisan Group of Senators Seeks Input on Dual Eligibles
On November 23rd, a bipartisan group of Senate Finance Committee members published a letter requesting feedback from health care stakeholders on potential legislation to improve coverage, cost containment, and care for individuals dually eligible for Medicare and Medicaid.
 
The letter’s authors, who include Senators Tom Carper (D-DE), Bill Cassidy (R-LA), John Cornyn (R-TX), Bob Menendez (D-NJ), Tim Scott (R-SC), and Mark Warner (D-VA), acknowledge the diversity and complexity of the care needs of the nation’s 12.2 million dual eligibles and notes the disproportionate share of spending that these patients represent in both the Medicare and Medicaid programs. In 2019, combined Medicare and Medicaid spending for this population hit $440.2 billion, with $164.3 billion coming through state Medicaid programs.
 
The Senators express a set of core principles for reforming care for dual eligibles: 

  • Reforms must consider that “dual eligibles” make up a heterogeneous population with very diverse needs, particularly for those duals with the highest care costs.
  • States have “varying levels of technical expertise and administrative capacity,” so solutions must be flexible enough to account for this variance as well as variance in each states’ dual eligible population.
  • New solutions should realign current financial incentives to achieve the best outcomes for patients, not the most revenue for the health system.

The letter invites public comment and data from patients, providers, payors and other stakeholders on a series of highly specific, in-depth questions. These include:
 
Integrated Care

  • Definitions of “integrated care,” “care coordination,” and “aligned enrollment” with respect to duals;
  • Policy recommendations to improve coordination and integration of Medicare and Medicaid programs;
  • Examples of successful integrated care models;
  • Whether respondents would recommend building on current systems serving duals involving multiple responsibility (such as aligned plans) or creating a new, unified system with a single primary payer for each beneficiary, and if so, how such a unified system should be designed;
  • Ensuring minimal disruption with any system changes; and
  • Suggestions to reduce patient migration from one plan to another.

Dual Subpopulations and Subgroups

  • How to define appropriate subgroups of duals and how to target interventions to address these subgroups;
  • Coverage strategies for partial-benefit duals versus full-benefit duals;
  • Data on subgroups of duals who experience particular inefficiencies in or poor outcomes from care;
  • How geographic differences affect the dually eligible population, including differences between urban and rural care; and
  • Potential approaches towards the specific populations of duals who: 
    • Become dual eligible by spending down assets on medical care, and specifically, whether Medicare Advantage supplemental benefits can help prevent this; or
    • Are Medicaid beneficiaries at risk of developing end-stage renal disease (ESRD), and specifically, care models that may delay the onset of ESRD and therefore their dual eligibility.

Feedback is requested to dualeligibles@cassidy.senate.gov by January 13, 2023. The full text of the letter is available here.

Administrative Update

Administration Launches New Opioid Surveillance Tracker, Announces One-Year Progress on Overdose Prevention Strategy
On December 8th, the Biden Administration unveiled the Non-Fatal Opioid Overdose Surveillance Tracker, a dashboard to provide first responders, clinicians, and policymakers with real-time data on overdose rates, drug supply, and the efficacy of local emergency response. The tracker will use existing reports submitted by emergency response teams to the National Highway Traffic and Safety Administration, to provide data on a roughly two-week lag. This represents a significant improvement over the current lag of about six months. The tracker will focus on four key metrics: 

  • The non-fatal opioid overdose rate;
  • The average number of times first responders administer naloxone to each patient;
  • EMS response time; and
  • The percentage of overdose victims not transported to a medical facility for additional care.

The tracker will, however, be limited to overdoses involving a 911 call and will only consider opioid-related cases (leaving out cases involving methamphetamine, for example). The Non-Fatal Opioid Overdose Surveillance Tracker is available here.

Additionally, on December 2nd, HHS released a fact sheet outlining progress on the one-year anniversary of the release of its Overdose Prevention Strategy. The fact sheet highlights accomplishments in the areas of prevention, harm reduction, treatment, and recovery across the Administration. Notable accomplishments include Medicare’s new coverage of chronic pain management, a variety of awarded grants, studies and reports, guidance expanding the availability of naloxone, and the launch of the Office of Recovery in the Substance Abuse and Mental Health Services Administration (SAMHSA).

The HHS fact sheet on the Overdose Prevention Strategy is available here.

Federal Agencies

CMS Replaces Proposed Rule on New Prior Authorization Requirements for Payers
On December 6th, CMS proposed a rule that would create new requirements for managed care plans to facilitate interoperability and provide more information on prior authorizations. In order to promote multi-payer alignment, the rule would apply to Medicare Advantage (MA) organizations, state Medicaid and Children’s Health Insurance Program (CHIP) agencies, Medicaid managed care plans, CHIP managed care entities, and Qualified Health Plan (QHP) issuers on the Federally-facilitated Exchanges (FFEs). The rule withdraws and replaces the December 2020 “CMS Interoperability and Prior Authorization” proposed rule.
 
The proposed rule includes five key provisions, for each of which compliance would begin January 1, 2026: 

  • Expansion of Patient Access API: Existing regulations already require payers to provide patients with access to their data through a standard Health Level 7 (HL7) Fast Healthcare Interoperability Resources (FHIR) Application Programming Interface (API), the Patient Access API. The proposed rule would require payers to also make information about prior authorization decisions available through the Patient Access API.
  • Provider Access API: Payers must build and maintain a Provider Access API to share patient data with in-network providers with whom the patient has a treatment relationship. Available data would include patient claims and encounter data, data elements included in the United States Core Data Set for Interoperability (USCDI) version 1, and prior authorization requests and decisions. Payers would also need to provide a mechanism for patients to opt out of making their data available to providers through this API.
  • Payer-to-Payer Data Exchange: Payers would be required to exchange patient data, as defined above, when a patient changes health plans, with the patient’s permission (opt-in requirement). If an enrollee has concurrent coverage with two or more payers, all impacted payers must make the enrollee’s data available to each other at least quarterly.
  • Prior Authorization Requirements, Documentation, and Decision (PARDD) API: Payers would be required to build and maintain a new PARDD API to automate the process for providers to determine whether a prior authorization is required, identify prior authorization information and documentation requirements, facilitate the exchange of prior authorization requests and decisions from their electronic health records (EHRs) or practice management system, provide a specific reason for denial of a prior authorization request, send decisions within 72 hours, and publicly report certain prior authorization metrics. This would not change the current HIPAA adopted standard for prior authorization transactions.
  • New Merit-Based Incentive Payment System (MIPS) Measure for Prior Authorizations: CMS will create a new electronic prior authorization measure under the Promoting Interoperability performance category of MIPS and under the Medicare Promoting Interoperability Program. Eligible clinicians and hospitals would be required to report the number of prior authorizations requested electronically through a PARDD API.

The rule withdraws the December 2020 rule’s proposal to require the use of certain Implementation Guides to implement APIs, although the guides are still “strongly recommended”. The rule also includes several Requests for Information (RFIs) related to: 

  • Accelerating the adoption of standards related to social risk factor data;
  • Electronic exchange of behavioral health information;
  • Improving the electronic exchange of information in Medicare fee-for-service;
  • Advancing the Trusted Exchange Framework and Common Agreement; and
  • Advancing interoperability and improving prior authorization processes for maternal health.

The full text of the rule is available here. The rule is open for comment through March 13, 2023. A fact sheet is available here.
 
HHS Proposes to Revise SUD Privacy Rules
On November 28th, HHS issued a proposed rule to modify federal privacy requirements related to substance use disorder (SUD). The rule is intended to align SUD-specific regulations under 42 CFR Part 2 (“Part 2”) with the standard protections for all patients available under the Health Insurance Portability and Accountability Act (HIPAA). Part 2 currently imposes different, more stringent requirements for certain SUD treatment records, including the requirement for written consent before each disclosure. This has created barriers to information sharing by patients and among health care providers as well as duplicative obligations and compliance challenges for regulated entities. Congress, in the CARES Act in 2020, required that HHS implement changes to better align the two requirements.

Proposed changes include: 

  • Allowing the use and disclosure of Part 2 records based on a single patient consent, given once, for all future uses and disclosures;
  • Allowing the redisclosure of Part 2 records in manners permitted by the HIPAA Privacy Rule (with certain exceptions, in particular for proceedings against the patient);
  • New patient rights under Part 2 to obtain an accounting of disclosures and to request restrictions on certain disclosures, matching those available under the HIPAA Privacy Rule;
  • Expanded prohibitions on the use and disclosure of Part 2 records in civil, criminal, administrative, and legislative proceedings;
  • New HHS enforcement authority, including the imposition of civil monetary penalties for violations of Part 2;
  • Updated breach notification requirements to HHS and affected patients; and
  • Updated requirements for the HIPAA-required Notice of Privacy Practices that practices must provide to patients in order to address rights related to Part 2.

The proposed rule will remain open for comment through January 31, 2023. The proposed rule is available here. The press release is available here. A fact sheet issued by HHS is available here.
 
CMS Delays Enforcement of Good Faith Estimates in No Surprises Act
On December 2nd, the Centers for Medicare and Medicaid Services (CMS) issued a Frequently Asked Questions (FAQ) document announcing that it will delay the enforcement of requirements for providers to provide good faith estimates (GFEs), as provided in the No Surprises Act.
 
The Act requires that GFEs for uninsured (self-pay) individuals include cost estimates from co-providers and co-facilities as of January 1, 2023. However, CMS notes that feedback has indicated that compliance is not possible by the start of 2023. Stakeholders have requested a delay of enforcement of this provision until HHS has established a standard technology to automate comprehensive GFEs and until providers have had time to implement these standards. The FAQ notes that HHS believes the universal adoption of an application programming interface (API) is necessary to facilitate the sharing of cost data among providers, which will allow the production of GFEs for co-providers and co-facilities. HHS is therefore extending enforcement discretion pending future rulemaking.
 
The CMS FAQ is available here.
 
CMS Issues RFI on Essential Health Benefits
On December 2nd, CMS released an RFI seeking comment on issues related to essential health benefits (EHBs), which under the Affordable Care Act must be covered by all qualified health plans. CMS is seeking to better understand: 

  • Definitions of EHBs and how EHB benchmark plans differ from state to state;
  • Whether the scope of benefits of a “typical employer plan,” to which EHBs are compared, has changed since the original definition in 2014;
  • Potential updates to EHBs to address any significant barriers consumers experience accessing needed benefits, or to address changes in the evidence base since 2014;
  • Whether CMS should change the prescription drug standard for EHBs; and
  • Whether CMS should modify policies regarding substitution of an actuarially equivalent benefit for an EHB within the same category. CMS has offered this flexibility since 2014 but has no information that any plan has taken up the option.

The RFI is available in the Federal Register here. Responses should be submitted by January 31, 2023.
 
HHS Publishes Proposed Revisions to 340B Program Resolution Process
On December 2nd, the Health Resources and Services Administration (HRSA) published a notice of proposed rulemaking (NPRM) to revise the 340B administrative dispute resolution (ADR) process. Overall, the NPRM proposes a “more accessible” ADR process that is more like an “administrative process rather than a trial-like proceeding.” The NPRM would restructure the 340B ADR Panel’s composition, require both parties to a dispute to undertake good faith efforts to resolve disputes, and create an appeal and/or reconsideration process available to either party in a 340B Panel decision.
 
Specific provisions of the NPRM on which HHS seeks stakeholder feedback, include: 

  • Revisions to the ADR Process: 
    • How to allow stakeholders to utilize the ADR process without the need for significant resources or legal expertise;
    • Whether to keep the existing minimum threshold for damages ($25,000), eliminate it entirely, or establish a new minimum threshold;
    • How to reduce the burden on covered entities and manufacturers in resolving overcharging, duplicate discounts and diversions; and
    • How to refine the HHS internal administrative processes.
  • Modifications to the ADR Panel: 
    • How to revise the composition of the Panel to include subject matter experts from HRSA’s Office of Pharmacy Affairs (OPA) and house the Panel within the OPA.
  • Alignment with 340B Statue: 
    • Whether alternate limitations would better contain ADR claims within 340B statutory areas;
  • Appeal and/or Reconsideration process:
    • Whether, as proposed, to allow either party to take up an appeal or reconsideration process of the 340B ADR Panel decision.

If the NPRM is finalized, any submitted claims not yet completed would be transferred automatically to the new process. The NPRM will remain open for comment for 60 days. The full text of the NPRM is available here.
 
FDA Grants EUA for Pfizer, Moderna Bivalent Boosters for Children Down to Six Months Old
On December 8th, the Food and Drug Administration (FDA) amended Emergency Use Authorizations (EUAs) for the Moderna and Pfizer-BioNTech bivalent Covid-19 vaccines to include the youngest groups of children. Both vaccines are now approved for all children six months of age and older. Those children six months to five years of age who received the original monovalent Moderna vaccine may receive a single booster of the updated, bivalent Moderna vaccine two months after completing the primary Moderna series. For children six months to four years of age who have not begun their three-dose primary series of Pfizer-BioNTech vaccines or have not received the third of their primary series will now receive the updated, bivalent Pfizer-BioNTech vaccine following two doses of the original Pfizer-BioNTech vaccine. Those children aged six months to four years who have completed their three-dose primary series are not eligible for a booster dose at this time, but they are expected to have protection against the current omicron variant. Further data to support giving this last group of children updated boosters are expected in January.
 
The FDA EUA amendment is available here.
 
CMS Releases GPDC Quality and Payment Results for 2021
On November 23rd, the CMS Innovation Center (CMMI) released Performance Year (PY) 2021 results from the Global and Professional Direct (GPDC) Model. In PY 2021, about 350,000 Medicare beneficiaries were attributed to one of the 53 Direct Contracting Entities (DCEs). Overall, CMMI found that “moderate but meaningful shared savings” were demonstrated. Notable results overall included: 

  • DCEs in 2021 generated approximately $119 million in gross savings, or approximately a 3.3 percent gross savings rate.
  • Net savings generated for Medicare based on the financial benchmark totaled approximately $70 million in 2021.
  • Net payments to DCEs for Shared Savings/Losses totaled approximately $47 million, which represents an approximate average net savings of 1.3 percent.
  • Of the 53 DCEs in PY 2021, 38 DCEs (72%) earned shared savings, whereas 15 DCEs (38%) incurred losses.
  • Standard, New Entrant, and High Needs Population DCEs achieved aggregated averages of 2.6 percent, 5.6 percent, and 11.6 percent gross savings rates on average, respectively. Their net savings rates were 0.7 percent, 3.4 percent, and 6.9 percent, respectively, on average.
  • All 53 DCEs in PY 2021 achieved quality scores of 100%. Of the DCE quality score, 80% was assessed on a pay-for-reporting basis on claims-based measures, and all participants received the full 80 percent. The remaining 20 percent of a DCE’s quality score derived from a pay-for-performance basis, where points were awarded if the DCE performed above the 30th percentile nationally on at least one quality measure, which all did.

Because of the public health emergency, the first year of the GDPC was delayed until April 2021, resulting in only nine months of program activity by the 53 DCEs being reflected in these results. Beginning in January 2023, the ACO Realizing Equity, Access, and Community Health (REACH) Model will replace the GPDC Model, and DCEs will be replaced by REACH Accountable Care Organizations (ACOs).
  
The full data set is available here.
 
HHS Promotes Benefits of “Community Care Hubs” to Address SDH
On November 29th, HHS published a blog in Health Affairs outlining their strategic approach to addressing social determinants of health (SDH). HHS envisions aligned health and social care systems and identifies factors critical to achieving this vision.
 
The blog identifies multistakeholder collaborations as key in addressing SDH and in establishing the infrastructure necessary to link the health care system with CBOs. Increasingly, community care hubs support networks of CBOs, offering them centralized governance and planning. HHS states that such hubs can: 

  • Help identify sources of funding;
  • Centralize administrative functions;
  • Provide a single point of contracting for providers and payers;
  • Receive reimbursement for health-related social needs;
  • Incorporate input from community leaders;
  • Reflect the demographics and lived experience of those served;
  • Provide community members with social and medical needs screening;
  • Connect community members with appropriate providers;
  • Coordinate referral feedback with providers; and
  • Track outcomes.

Hubs may include governmental as well as non-governmental organizations and can collaborate with local public health departments to help integrate SDH into population health strategies.
 
The blog highlights several examples of highly successful hubs across the country and notes that core competencies and standards for hubs are currently in development. Through the Administration for Community Living (ACL), HHS has funded 12 hubs and plans to fund up to 20 more in 2023.
 
The blog post is available here.

Other Updates

AHRQ Releases Health System Carbon Emission Reduction Guidelines
On November 22nd, the Agency for Healthcare Research and Quality (AHRQ) published a primer in the Journal of the American Medical Association to help health care organizations cut their carbon footprints. The primer aligns with the federal goals of decreasing greenhouse gas emissions by at least 50% of 2005 levels by 2030 and moving to operations with net-zero carbon dioxide emissions by 2050.  The AHRQ primer specifically covers anesthetic gas, energy use, food procurement, transportation, medical devices and supplies, and pharmaceuticals and chemicals as contributors to emissions. It also offers prioritized measures to monitor progress and guide strategic management and suggests examples of interventions that health care organizations may use toward their decarbonization goals.
 
Key strategies for reducing waste include: 

  • Conserving and optimizing energy efficiency;
  • Centralizing oversight to actively reduce transportation usage;
  • Minimizing fresh gas flow rates;
  • Decommissioning or avoiding construction of central nitrous oxide piping;
  • Preventing disease exacerbation;
  • Launching appropriate use campaigns for pharmaceuticals and chemicals;
  • Ensuring resource stewardship over medical devices and supplies; and
  • Adopting food waste prevention and diversion programs.

The full JAMA article is available here. The AHRQ primer is available here.
 
AMA/Manatt Release Study on Optimizing Digital Healthcare
Last month, the American Medical Association (AMA) and Manatt Health jointly released “The Future of Health,” a report which discusses the so-called “digital health disconnect” between the potential benefit and the actual impact of digital health approaches, to date. The report claims that to date, digital health tools have done little to address the health system’s struggles with access, quality, outcomes, affordability, and equity, and presents a vision for how digitally-enabled care can be “optimized” to realize its potential.
 
The report presents a blueprint with six “foundational pillars” to optimize digital care: 

  • Build for patients, physicians and clinicians, placing patient and providers needs before regulatory and billing requirements;
  • Design with an equity lens, including principles for equitable health innovation;
  • Recenter care around the patient-physician relationship to ensure care is optimally managed and coordinated;
  • Improve and adopt payment models that incentivize high-value care by extending payment methods for telehealth care beyond the public health emergency;
  • Create technologies and policies that reduce fragmentation, allowing interoperability, coordination, and information sharing across digital and in-person sites of care; and
  • Scale evidence-based models quickly through increasing communication around and accelerating adoption of evidence-based models and practices, allowing organizations to learn from each other, and to work on collaborative care model development. 

The full report is available here.
 
Coalition for Health Artificial Intelligence (CHAI) Publishes Blueprint
On December 7th, the Coalition for Health Artificial Intelligence (CHAI) published a blueprint calling for independent testing bodies and a national registry of clinical algorithms to allow physicians and patients to assess the suitability and performance of artificial intelligence (AI). The coalition’s blueprint is intended to initiate a conversation about how to govern the use of AI in medicine. Experts contributing to the blueprint represent Microsoft, Google, MITRE Corp, Stanford, Duke, Johns Hopkins, the Office of the National Coordinator for Health Information Technology, the Food and Drug Administration, National Institutes of Health, and the Centers for Medicare and Medicaid Services. The Coalition intends to “harmonize standards and reporting for health AI,” “educate end-users on how to evaluate these technologies to drive their adoption,” and “ensure high quality care, increase credibility among users, and meet health care needs.”
 
More information on CHAI is available here.
 
Health Affairs Publishes Study Showing Misallocation of DSH Payments
On December 5th, Health Affairs published the results of a study conducted by researchers at the University of Pennsylvania School of Medicine on Medicaid disproportionate share hospital (DSH) payments. About 57.2 percent of acute care hospitals received Medicaid DSH payments totaling over $14.5 billion in 2015. The researchers found that, although the majority of payments went to hospitals determined to be “disproportionate share” through some methodology, up to 31.6 percent of all DSH payments went to hospitals that do not meet their state’s median threshold for uncompensated care. The report states that many of these recipients are academic medical centers, functioning at margins which could qualify them for alternate funding sources. The study also found that of the $14.5 billion in 2015 payments, 3.2 percent went to hospitals which meet none of the DSH requirements.
 
The Health Affairs article is available here.
 
Study Correlates Mental Health Provider Shortages with Increased Youth Suicides
On November 21st, a study appeared in the Journal of the American Medical Association (JAMA) which found a correlation between HRSA-designated mental health professional shortages at the county level with rates of youth suicides. HRSA designates shortage areas based on mental health professionals relative to the population, the level of need for mental health services, and the availability of services in contiguous areas. Scores run on a scale from 0 to 25, with higher scores indicating greater levels of shortage. Using the Centers for Disease Control and Prevention’s (CDC) Compressed Mortality File representing all U.S. counties, the study considered 5,034 suicides of youths ages five to 19 from December 2015 through January 2016. During this period, 67.6% of U.S. counties qualified as mental health provider shortage areas. After adjusting for county characteristics, the study found that suicide rates for youths aged 5 to 19 showed a correlation to county mental health provider shortages, with a suicide rate that was higher by 4% for every point increase in the county’s HRSA shortage score.
 
The full report is available here.

New York State Updates

NYS Health Commissioner Dr. Mary Bassett to Resign
On December 2nd, New York State Department of Health (DOH) Commissioner Dr. Mary T. Bassett announced that she had submitted her resignation, effective January 1, 2023. Following her resignation, Dr. Bassett plans to return to the Harvard Chan School of Public Health. Dr. Bassett was appointed Commissioner by Governor Hochul in September 2021, and has served as Commissioner since December 2021.
 
Dr. Bassett’s statement is available here.
 
SED Adopts Final Regulations for Mental Health Practitioner Diagnostic Privileges
On November 30th, the New York State Education Department (SED) finalized regulations allowing licensed mental health counselors (LMHCs), licensed marriage and family therapists (LMFTs), and licensed psychoanalysts (LPs) to earn a “diagnostic privilege” by meeting specified requirements. These professions did not previously have the authority diagnosis but were permitted to do so since 2002 under the “Social Worker Exemption” that expired on June 24, 2022. New York passed legislation to address the expiration of the exemption, allowing such professionals to continue to diagnose and develop treatment plans without additional requirements through June 24, 2025. During this period, they must apply to receive limited permits and gain experience for the diagnostic privilege.
 
The regulations include the following provisions, among others:  

  • To receive the diagnostic privilege, applicants must submit the application/application fee and meet all education requirements;
  • Applicants must be under appropriate supervision while they gain the required experience for the diagnostic privilege and be practicing in authorized settings;
  • Supervisors may not supervise more than five limited permit holders of any type at one time; and
  • The limited diagnostic permit is valid for up to 24 months and may be extended for up to two additional 12-month periods.

The final regulations are available in the State Register here.
 
NYS HCBS Final Rule Statewide Transition Plan Open for Public Comment
On December 7th, the NYS Department of Health (DOH) announced that it is seeking public comment on its Home and Community-Based Services (HCBS) Final Rule Statewide Transition Plan (STP), prior to submitting the plan to CMS. The STP describes the State’s assessment and remediation of its HCBS regulations, policies, and procedures that are completed or in the process of being completed to achieve compliance with the federal HCBS Final Rule. Issued by CMS in 2014, the Final Rule: 

  • Requires all HCBS settings to meet criteria for community integration, individual choice, privacy, and other consumer protections;
  • Updates requirements for compliance assessments; and
  • Identifies certain settings as presumptively not qualified for Medicaid HCBS.

New York now has four 1915(c) waivers to which the HCBS Final Rule applies: 

  • Nursing Home Transition and Diversion Waiver;
  • Traumatic Brain Injury Waiver;
  • Children’s Waiver; and
  • Office for People with Developmental Disabilities (OPWDD) HCBS Waiver.

The Final Rule also applies to HCBS provided under the Medicaid Redesign Team 1115 demonstration waiver. CMS requires HCBS systems to be fully compliant with the Final Rule by March 17, 2023.
 
The STP is available here. Comments may be submitted to hcbsrule@health.ny.govthrough January 6, 2023.
 
DOH Adopts Regulations Addressing Nursing Home Expenditures and Staffing
On December 7th, DOH adopted the following two rules in the State Register, which implement legislation passed in the New York State 2021-22 Enacted Budget:  

  • Implementing standard minimum nursing home staffing levels; and
  • Requiring every Residential Health Care Facility (RHCF) to spend a minimum of 70 percent revenue on direct resident care and 40 percent of revenue of resident-facing staffing.

The Notices of Adoption are available in the State Register here.
 
OPWDD Issues Proposed Amendment to Person-Centered Behavioral Intervention Services
On December 7th, the NYS Office for People with Developmental Disabilities (OPWDD) issued a proposed amendment to section 633.16 of Title 14 of the New York Codes, Rules, and Regulations (NYCRR) that regulates Person-Centered Behavioral Intervention services. The proposed regulations would: 

  • Update diagnostic terminology to match changes in diagnoses reflected in current manuals and classification systems;
  • Make minor changes to the qualifications required to be a behavior intervention specialist, including clarifying the pathway to achieving a higher-level clinical status and reducing the time requirement to attain that higher level status;
  • Change the section regulating the use of restrictive/intrusive interventions to define, describe, and separate the use of blocking pads when used in response to challenging behavior;
  • Amend what licensed clinicians can supervise behavior intervention specialists and what procedures may be consented to by an informed consent committee (ICC) in the event that a person with disability is unable to provide their own consent and has no other guardian, family member, or other authorized entity who can provide consent on their behalf; and
  • Clarify the procedures for implementation and due process rights related to any clinically needed limitation on specified rights articulated in regulation.

The changes to the behavior intervention specialist qualifications have been made to ensure that no current behavior intervention specialist will be negatively affected by the change.
 
The proposed regulations are available in the State Register here. Comments may be submitted through February 5, 2023.
 
CMS Approves New York SPA Maintaining the Quality Incentive Program for Nursing Homes
On November 18th, CMS approved New York’s State Plan Amendment (SPA) maintaining the quality incentive for nursing homes into the 2022 rate year and clarifying the reporting requirements related to 2022 quality adjustments. To offset the impact of Covid-19, some of the quality and the efficiency measures were removed from the 2021 Nursing Home Quality Incentive (NHQI), with the intent of bringing back the measures for future editions of the NHQI. The SPA is retroactively effective to January 1, 2022.
 
The SPA is available here. The CMS approval letter is available here.
 
Governor Hochul Signs Package of Health Care-Related Bills
Governor Hochul has recently signed into law the following health care-related legislation: 

  • S6522A/A7363 protects patients from liens against their primary residence and wage garnishment due to medical debt owed to hospitals or health care providers.
  • S3932/A2211 specifies procedures for the closure and/or decertification of assisted living residences.
  • S8677/A9664 expands the definition of provider or provider agency to include private, nonprofit incorporated agencies that meet the State Office of Children and Family Services (OCFS) program standards for child advocacy centers.
  • S5663A/A3202 allows patients up to ten visits with an occupational therapist without a referral from a physician or nurse practitioner.
  • S8157/A8604 prevents limited coverage and access to non-invasive prenatal testing under Medicaid based on the age of the pregnant patient.
  • S7501/A7408 requires health care providers to accept payments by the county health authority for human post-exposure treatment for rabies at a rate set by the Commissioner of Health, which will be no less than the Medicaid rate.
  • S4253/A6506 codifies OMH’s current practice of providing a report to the State Legislature on the status of the State’s inpatient mental health beds, and also requires the monthly reports to be posted publicly on the OMH website.
  • S1785A/A6052 requires residential health care facilities to update residents, authorized family members, and guardians of residents within 12 hours of the detection of an infection, and to have a plan or procedure designating a separate cohort area during the infection outbreak.

Funding Opportunities

OMH Releases SOI for Evidence-Based Practice Opportunities
On December 5th, the NYS Office of Mental Health (OMH) announced that it is seeking Letters of Interest for the following two opportunities: 

  • Pilot projects on evidence-based practice (EBP) diagnostic and case conceptualization; and 
  • A needs assessment of EBPs in children’s mental health in NYS.

These opportunities will support the State’s efforts to create a Center of Excellence (COE) to disseminate best practices and support the implementation of EBPs. 
 
The first Solicitation of Interest (SOI) seeks organizations interested in implementing pilot projects related to diagnostic screening, assessment, and/or case conceptualization of mental health problem areas for children and youth. Applicants will be responsible for planning, implementing training and technical assistance, developing evaluation plans, and preparing a summary report. Multiple organizations will be selected for these pilot projects. 
 
The second SOI seeks organizations interested in conducting a needs assessment of EBPs in children’s mental health during a nine-month period. One organization or agency will be selected to conduct this needs assessment. Applicants must have expertise in statewide needs assessment and in implementation of EBPs for children and families.
 
Links to each opportunity are available here. SPG’s summary of the opportunities is available here. Letters of Interest must be submitted by December 27th.
 
OPWDD Releases RFP for Career-Specific Vocational Training Services
On December 2nd, OPWDD released a Request for Proposals (RFP) for the provision of career-specific vocational training programs for individuals with intellectual/developmental disabilities (I/DD). OPWDD will award contracts for one type of career-specific vocational training per region (OPWDD regional map available here); however, each region may provide more than one type of training. OPWDD will award over $13.6 million in total funding during the four-year program period, starting on March 17, 2023.
 
Applicants must be not-for-profit organizations that provide Home and Community-Based Services (HCBS) that support employment through the OPWDD Medicaid Waiver. Applicants may submit more than one proposal; however, a separate application is required for each. Groups of providers may submit a join application that identifies a “Lead Provider” that will receive payment from OPWDD and reimburse member agencies for services. Members of the provider group do not need to be from the same OPWDD region but should be located close enough to the training location to effectively and efficiently send individuals to the program.
 
The RFP is available here. Applications are due on February 2, 2023. Questions may be submitted to OPWDDGrants@opwdd.ny.gov through December 15th.
 
OPWDD Announces Public Comment Period for New Housing Subsidy Funding Opportunity
On November 29th, the New York State Office for People with Developmental Disabilities (OPWDD) announced that the draft of the new Funding Opportunity for Independent Living Letters of Support (FOFILLS) is now available for public comment. The new FOFILLS funding opportunity will be used to request groups of housing subsidies for individuals with intellectual and/or developmental disabilities (I/DD) whose living arrangement would include of four or more individuals. Proposed projects may include the development of an apartment complex, apartment style living, large single-family home, or a group of co-located houses by an OPWDD provider or a family or group of families/people with I/DD that are affiliated with an OPWDD provider.
 
Funding may not be used: 

  • To supplant existing funding for housing units with other rental subsidy funding, such as Empire State Supportive Housing Initiative (ESSHI) units or Housing and Urban Development (HUD) Section 8 funded units.
  • To request housing subsidies for proposed projects that receive any other form of state or federal supportive housing capital subsidy, such as those funded by the New York State Homes and Community Renewal (HCR).

The draft funding opportunity is available here. Public comment may be submitted to housing.initiatives@opwdd.ny.gov through December 29th. It is expected that the final application for this funding will be released in late spring 2023.
 
OMH Releases RFP for Coordination of Statewide Suicide Prevention Activities
On November 22nd, the New York State Office of Mental Health (OMH) released a Request for Proposal (RFP) for eligible organizations that can support the coordination and alignment of OMH-funded suicide prevention program initiatives. The Suicide Prevention Center of New York (SPCNY) implements suicide prevention research and activities through a variety of evidence-based trainings, workshops, online learning modules, and resources to meet the specific needs of clinicians, other health care workers, community members, and school staff. The selected organization will assist in the coordination of initiatives and disbursement of contract funds in the areas of: 

  • Training coordination and management;
  • Public awareness and education; and
  • Suicide prevention implementation support.

Through this RFP, OMH will award over $2.6 million in total funding to one awardee during the five-year program period. Contracts will begin on April 1, 2023. Eligible applicants are not-for-profit agencies with 501(c)(3) incorporation, located and doing business in New York State, that have experience providing mental health services to individuals with serious mental illness.
 
The full RFA is available here. Proposals are due on January 17, 2023. Interested applicants must submit a non-binding Letter of Intent to Amanda.Szczepkowski@omh.ny.gov by January 10, 2023. Questions may be submitted to the email address above through December 13th.
 
OASAS Releases RFP for 2022 NYS Partnership for Success
On November 16th, the New York State Office of Addiction Services and Supports (OASAS) released an RFP to support substance use/misuse prevention-focused coalitions with the development and implementation of environmental change prevention strategies in vulnerable and isolated communities. OASAS will provide $1.05 million in total funding to support six awardees (a maximum of $175,000 per awardee). Priority will be given to coalitions that serve the following communities: 

  • Veterans;
  • Transitional youth (i.e., transitioning out of foster care or juvenile justice system);
  • Immigrants, migrants, refugees;
  • People over the age of 50; and/or
  • People with disabilities.

Eligible applicants are not-for-profit community coalitions or not-for-profit agencies that have experience in coalition building but do not currently have funding for the coalition and its activities. Coalitions must use the Substance Abuse and Mental Health Services Administration (SAMHSA) Strategic Prevention Framework (available here) to develop their plan, and must collaborate with local resources to develop culturally responsive and sustainable environmental prevention strategies targeting vulnerable communities.
 
The RFP is available here. Applications are due on December 30th.
 
DHS Releases Open-Ended RFP for the Development and Operation of Safe Havens
On December 2nd, the New York City Department of Homeless Services (DHS) released an open-ended RFP for the development and operation of new stand-alone “Safe Havens” for street homeless single adults and/or adult couples without minor children. Safe Havens are transitional housing options for unsheltered New Yorkers. Awarded applicants must accept clients 24 hours a day, 7 days a week and must accept all referral deemed appropriate by DHS.
 
Contracts may include both capital and expense funding. The payment structure for contracts will be line-item reimbursement.
 
Applicants must be not-for-profit 501(c)(3) organizations with at least three years of experience working directly with the target population. Greater consideration will be given to providers that can accept clients with pets and that specialize in handling clients with issues around violence. Contracts will last for five years, with an option to renew for four additional years.
 
The RFP is available in the PASSPort system here by searching “Safe Havens.” Applications will be accepted and reviewed on an ongoing basis until the units necessary for the program have been met. Questions may be submitted to Cinnamon Warner at ACCOContractPlanning@dss.nyc.gov.