Weekly Health Care Policy Update – February 14, 2023

In this update:

• Administration Updates
  • Biden Delivers State of the Union Address
• Federal Agencies
  • HHS Renews PHE to End May 11^th and CMS Issues Transition Roadmap; AHA Requests Continuation of Certain Policies
  • CMS Proposes 2024 Medicare Advantage and Part D Advance Notice
  • CMS Announces New Strategy for Aligning Quality Measures
  • CMS Releases Initial Guidance on Medicare Drug Inflation Rebate Program
  • HHS Approves California Waiver to Support Justice-Involved People
  • Administration Issues Proposed Rule on Contraception Coverage
  • CDC Adds Covid-19 Vaccinations to Immunization Schedule
  • CMS to Hold Webinars on Data Science and Addressing Inequities in Health Care
  • AHRQ to Hold Webinar on the Use of Digital Health Technologies for Underserved Populations
• Other Updates
  • Texas Judge Tosses Part of Surprise Billing Rule; TMA Files Additional Case
  • FTC Issues First Health Breach Notification Enforcement Action Against GoodRx
• New York State Updates
  • DOH Requests Public Comment on Draft Waiver to Expand the Essential Plan
  • NYS Emergency Mask Mandate in Health Care Settings Will Expire February 12^th
  • DOH Issues Special Medicaid Update on the Medicaid Pharmacy Carve-Out
  • DOH and OMH Formalize Guidance on Prescribing Controlled Substances During and After the PHE
  • OASAS Issues Guidance on the Elimination of the DEA X-Waiver for the Prescription of Buprenorphine
  • DOH Posts Executive Budget Scorecard
  • OMH Extends Commissioner’s Covid-19 Regulatory Waiver
  • NYSOFA Adopts Final Rule Allowing Flexibility for EISEP Assessment Requirements
  • OASAS Announces Availability of Overdose Reversal Medication and Fentanyl Test Strips for Service Providers
  • CMS Approves New York SPA Streamlining the Medicaid FFS Utilization Threshold Program
  • CMS Approves New York SPA Revising Methodology for Distributing Clinic Safety Net Payments
• Funding Opportunities
  • OASAS Announces RFA for Development of Comprehensive Integrated Outpatient Treatment Programs
  • SAMHSA Releases NOFO for Assertive Community Treatment Services
  • OPWDD Announces RFP for the Promotion of Developmental Disability Services

Administration Update

Biden Delivers State of the Union Address
On February 7^th, President Biden delivered his second State of the Union address. In the address, Biden called on Congress to extend the $35 per month out-of-pocket cost cap for Medicare patients established in the Inflation Reduction Act (IRA) to all patients enrolled in private insurance, and to make permanent the enhanced Affordable Care Act (ACA) subsidies originally passed in the American Rescue Plan Act and extended through 2025 in the IRA.
 
Biden also outlined new proposals on several health care issues with the potential for bipartisan action, following up on the “Unity Agenda” he proposed in his first State of the Union last year. The White House also released a fact sheet describing progress on the Unity Agenda and more details on these new proposals, which are: 

• Improving cancer care, including through investments in research and more access to patient navigation services.
• Supporting veterans, including by expanding access to peer mental health supports in Veterans Affairs medical centers.
• Supporting mental health, including: 
  • Directing the Departments of Health and Human Services (HHS) and Education to issue guidance and regulations on school-based mental health “making it easier for them to provide health care to students and more easily bill Medicaid funding”;
  • Proposing new and expanded rules to promote mental health parity;
  • Expanding access to telehealth, such as through HHS “tripling resources dedicated to supporting interstate licensure reciprocity”; and
  • Launching a new campaign to promote mental health and resiliency resources for the health care workforce.
• Combating the opioid epidemic, including forthcoming guidance from the Centers for Medicare and Medicaid Services (CMS) “allowing states to use Medicaid funds to provide health care services—including treatment for people with substance use disorder—to individuals in [state and local jails and prisons] prior to their release.”

A fact sheet on this agenda is available here. The transcript of the State of the Union address is available here.

Federal Agencies

HHS Renews PHE to End May 11^thand CMS Issues Transition Roadmap; AHA Requests Continuation of Certain Policies
On February 9^th, the Department of Health and Human Services (HHS) announced the renewal of the Covid-19 public health emergency (PHE) effective February 11^th. This renewal is expected to be the final one and will result in the PHE ending on May 11^th, as the White House has previously briefed. The PHE has been in place since January 27, 2020.
 
Also on February 9^th, CMS published a fact sheet laying out a “Transition Roadmap” for policy changes that will result as the end of the PHE. Notably, the guidance notes that the following policies will not immediately change: 

• Vaccinations and Products: Medicare, Medicaid, and most regulated private insurers will still be required to cover Covid-19 vaccinations. Existing Emergency Use Authorizations (EUAs) issued by the Food and Drug Administration (FDA) for Covid-19 products will remain in effect.
• Medicare and Medicaid Coverage of Testing: Medicare Part B will continue to cover tests without cost-sharing, as will Medicaid programs through September 30, 2024.
• Telehealth: Most current Medicare telehealth flexibilities will remain in place through December 2024. State Medicaid programs have discretion over telehealth coverage and their permanent policies will not be affected by the end of the PHE.

Notable policies that will be changing include:

• Telehealth Prescription of Controlled Substances: Under the PHE, the Drug Enforcement Administration (DEA) and HHS are allowing DEA-registered practitioners to prescribe controlled substances to patients without an in-person interaction. Although this policy will end with the PHE, CMS states that “there will be rulemaking that will propose to extend these flexibilities” and that DEA “will provide additional guidance to providers soon.” In the interim, New York has issued guidance indicating that providers will need to be in compliance with pre-emergency requirements after the PHE (see below under New York State Updates).
• Blanket Waivers and Disaster Waivers: In general, blanket waivers issued by CMS will expire with the PHE. Medicaid waivers issued under 1915(c) Appendix K, Medicaid Disaster Relief State Plan Amendments, and other authorities will also expire with the PHE or shortly thereafter, as well as Section 1135 waivers. CMS is expected to continue updating provider-specific documents (available here) outlining which flexibilities will expire.
• HIPAA Enforcement Discretion: Guidance relaxing enforcement of data privacy and security under the Health Insurance Portability and Affordability Act (HIPAA) will expire with the PHE.
• Private Coverage of Testing: The requirement for private insurance companies to cover tests without cost sharing, both for OTC and laboratory tests, will end.
• Hospital Reporting: Hospital data reporting will continue as required by the CMS conditions of participation through April 30, 2024, but reporting may be reduced from the current daily reporting to a lesser frequency.

The PHE announcement is available here. The Transition Roadmap fact sheet is available here.
 
On February 7^th, the American Hospital Association (AHA) wrote a letter to HHS requesting that it undertake administrative actions to continue some of the PHE-era policies, including permanently extending telehealth policies, eliminating HHS-level scope of practice limitations for nurse practitioners, and continuing enhanced reimbursement for hospitals for Covid-19 patients.
 
AHA’s letter is available here.
 
CMS Proposes 2024 Medicare Advantage and Part D Advance Notice
On February 1^st, CMS released the Calendar Year (CY) 2024 Advance Notice of Methodological Changes for Medicare Advantage (MA) Capitation Rates and Part C and Part D Payment Policies (the Advance Notice). The Advance Notice proposes an effective growth rate of 2.09% for MA plans and a risk score trend of 3.30% on average. Overall, CMS estimates that the policies proposed in the Advance Notice will increase MA plan revenue by 1.03% relative to CY 2023, although MA plan advocates argue that after the risk score trend increase, this will result in an effective negative rate impact of -2.27%. Notably, CMS proposes to continue to apply the statutory minimum coding pattern adjustment of 5.90%, which is the same as the adjustment applied in CY 2023.
 
Policies proposed in the Advance Notice include: 

• A technical correction to the per capita cost calculations related to indirect and direct medical education costs associated with service furnished to MA enrollees, resulting in a one-time adjustment to the growth rates;
• A revised Part C risk adjustment model, including technical updates such as restricted condition categories using ICD-10 (rather than ICD-9) and updated underlying fee-for-services data years (2018 diagnoses and 2019 expenditures, rather than 2014 and 2015, respectively). Additional revisions to the model are designed to reduce its sensitivity to coding variation.
• Implementation of changes to the standard Part D drug benefit (part of the Inflation Reduction Act) that will take effect in CY 2024, including: 
  • Eliminating cost-sharing for beneficiaries in the catastrophic phase of coverage;
  • Expanding the full low-income subsidy (LIS) who earn up to 150% of the Federal Poverty Level (FPL), rather than up to 135% of FPL;
  • Implementation of new rules for insulin cost-sharing, including a $35/month cap during the initial coverage phase and coverage gap phase;
  • Implementation of the prohibition on applying the deductible to or charging cost-sharing for certain adult vaccines;
  • Capping the growth in the Base Beneficiary Premium at 6%.

CMS also solicits comments on several topics, including: 

• Potential new measurement concepts and methodological changes to the Part C and Part D Star Ratings, including adult immunization status and screening for depression and follow-up plan. If included, these measures would become part of CMS’s “Universal Foundation” of standard measures to measure quality across programs (see below).
• A measure in development to complement the Social Need Screening and Intervention (SNS-E) measure to assess enrollee health-related social needs, specifically housing instability, food insecurity, and transportation availability.

CMS will accept comments on the Advance Notice through March 3^rd and will publish the final Rate Announcement by April 3^rd.
 
The Advance Notice is available here. A fact sheet is available here, and a press release is available here.
 
CMS Announces New Strategy for Aligning Quality Measures
On February 8^th, CMS leadership published an article entitled “Aligning Quality Measures Across CMS—The Universal Foundation” in the New England Journal of Medicine. The document lays out CMS’s planned approach to focus on “creating more parsimonious sets of measures.”
 
In the article, CMS acknowledges that the proliferation of quality measures has “caused confusion, increased reporting burden, and misalignment of approaches to common clinical scenarios.” It proposes a building-block approach to CMS quality rating and value-based care programs, with a “Universal Foundation” of quality measures that apply to as many programs as possible. CMS views the Universal Foundation as a building block to which programs will add additional aligned or program-specific measures. As a start, each program is considering which measures included in the Universal Foundation are not currently in their programs and the steps to add them over time if appropriate.
 
The change is intended to focus providers’ attention on measures that are meaningful, reduce provider burden, advance equity, aid the transition from manual reporting of quality measures, and permit comparisons among various quality and value-based care programs. Thus far, the Universal Foundation includes preliminary measures for adult and pediatric components across domains like wellness and prevention, chronic conditions, and behavioral health.
 
CMS will continue development of its quality measure strategy via listening sessions, requests for information, and proposed rulemaking. The full NEJM article is available here.
 
CMS Releases Initial Guidance on Medicare Drug Inflation Rebate Program
On February 9^th, CMS released initial guidance for the Medicare Prescription Drug Inflation Rebate Program. The program (part of the IRA) will require drug companies to pay rebates to Medicare when their drug prices increase faster than inflation for certain drugs. This program is supplemental to but distinct from the Medicare Drug Price Negotiation Program (the latest guidance on which was summarized in SPG’s January 17^th update here).
 
CMS notes that the first periods for which manufacturers may be subject to rebate requirements have already begun, as follows: 

• October 1, 2022: Start of the first 12-month period for which rebates would be required for certain Part D drugs.
• January 1, 2023: Start of the first quarterly period for which rebates would be required for certain Part B drugs.
• April 1, 2023: Medicare will decrease the required coinsurance for certain Part B drugs with higher-than-inflation price increases to 20% of the inflation-adjusted payment amount.
• September 30, 2025: CMS is required to have sent the first invoices to drug companies for Part B rebates.
• December 31, 2025: CMS is required to have sent the first invoices to drug companies for Part D rebates.

CMS expects to issue revised guidance on the program in the fourth quarter of 2023. It is seeking public comment on the following topics: 

• How to determine the number of drug units for rebatable drugs on prescription claims, including how to remove non-rebatable 340B units and how to include Part B drugs furnished to Medicare Advantage members;
• How rebates should be allocated when there are multiple manufacturers;
• Scenarios under which CMS should reduce the required rebate amounts, such as shortages severe supply chain disruptions;
• The process to impose civil monetary penalties on manufacturers of Part D rebatable drugs that fail to pay rebates; and
• Assuring accuracy of the rebate payments.

The Part B guidance is available here and the Part D guidance is available here. Comments should be sent to IRARebateandNegotiation@cms.hhs.gov with the subject line “Medicare Part D Inflation Rebate Comments,” and will be accepted through March 11^th. A fact sheet on the guidance is available here.

HHS Approves California Waiver to Support Justice-Involved People
On January 26^th, HHS approved California’s Medicaid and Children’s Health Insurance Plan (CHIP) demonstration authority to support care for justice-involved people. The 1115 demonstration amendment is the first waiver that allows Medicaid reimbursement for pre-release health care services in correctional facilities. Specifically, California will be able to offer people who are scheduled to be released from jails and prisons within 90 days services that include: 

• Substance-use treatment before a Medicaid beneficiary is released from jail, prison, or a youth correctional facility; and
• Connection to community-based Medicaid providers 90 days before release to create continuity of care once an individual is released.

The waiver approval will also increase and sustain provider payment rates, and Medicaid managed care payment rates, in obstetrics, primary care, and behavioral health.
 
More information is available here.
 
Administration Issues Proposed Rule on Contraception Coverage
On January 30^th, HHS, the Department of Labor, and the  Department of the Treasury issued a proposed rule regarding required coverage of contraceptive items and services under the ACA. The rule focuses on existing exemptions from the requirement to cover certain contraceptive services without cost-sharing for group health plans, student health insurance coverage, health insurance issuers, and individuals with religious or moral objections to providing (or purchasing/enrolling in) coverage of contraceptive services. In general, the proposed rule would: 

• Leave in place the religious exemption.
• Rescind the moral exemption. The Departments note there is no legal requirement to treat non-religious moral objectors in the same manner as religious objectors and that the Religious Freedom Restoration Act does not require any exemption for non-religious moral objections that do not result in a substantial burden on the exercise of religion. The Departments also note the “strong public interest in assuring contraceptive coverage to women enrolled in group health plans, or group or individual (including student) health insurance coverage.”
• Establish a new pathway (“an individual contraceptive arrangement”) for individuals enrolled in plans or coverage sponsored/provided by an objecting entity (assuming the objecting entity has not opted for the existing accommodation). An individual contraceptive arrangement requires no involvement from the objecting entity. Under the arrangement, a provider or facility that furnishes contraceptive services would be able to be reimbursed for its costs by entering into an arrangement with an insurer on the Federally-facilitated Exchange (FFE), or State-based Exchange on the Federal platform (SBE-FP) which would in turn seek an Exchange user fee adjustment. This is the same user fee adjustment mechanism in place now for third party administrators in connection with the optional accommodation for self-insured group health plans.

The proposed rule is available here. A Fact Sheet is available here. Comments are due April 3^rd.
 
CDC Adds Covid-19 Vaccinations to Immunization Schedule
On February 9^th, the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) recommended the addition of Covid-19 vaccinations for children, adolescents, and adults to its immunization schedule. This move formalizes guidance that was previously the agency’s recommendation. The schedule specifically advises that: 

• Healthy children 6 months to 4 years old should receive a primary series of two doses of the Moderna or Pfizer-BioNTech monovalent vaccines, followed by a third dose of a bivalent booster.
• Children aged 5 to 12 should receive two doses of the Moderna or Pfizer-BioNTech Covid-19 vaccine, followed by a bivalent booster.
• Healthy adults and adolescents 12 and up should receive two doses of the Moderna, Pfizer, or Novavax vaccines, followed by a bivalent booster. Adults may choose to receive a Novavax booster instead if they prefer or if other boosters are not available.
• Immunocompromised children should receive three doses of the Moderna or Pfizer-BioNTech vaccine as a primary series instead of two, and should also receive a bivalent booster.
• Immunocompromised adults should receive either two doses of the Novavax vaccine, or three doses of the Pfizer-BioNTech or Moderna vaccine and a bivalent booster.

More information is available here.
 
CMS to Hold Webinars on Data Science and Addressing Inequities in Health Care
On January 31^st, CMS announced that it will hold two webinars titled “From Data to Action: How CMS and Its Stakeholders Are Addressing Inequities in Healthcare.” The webinars will focus on “the CMS Health Equity Framework and how key stakeholders are leveraging changes in data science and quality measurement to drive progress toward more equitable care for all.” The webinar times are as follows: 

• Tuesday, February 28^th, 3:00-4:00pm ET
• Wednesday, March 8^th, 12:00-1:00pm ET

Registration for the February webinar is available here. Registration for the March webinar is available here.
 
AHRQ to Hold Webinar on the Use of Digital Health Technologies for Underserved Populations
On February 28^th at 2:30pm, the Agency for Healthcare Research and Quality (AHRQ) will host a webinar entitled “Leveraging Digital Health Technologies to Address the Needs of Underserved Populations.” The webinar will include several presentations on approaches providers have taken to employ technology to improve services for vulnerable populations, including: 

• Telepsychiatry consultations with automated interpretation to provide mental health services for patients with limited English proficiency;
• An artificial intelligence communication system used to identify and mitigate health risks for young African American women prior to pregnancy; and
• Usage of an electronic social needs screening tool in the emergency department to improve referrals for patients.

More information, including a registration link, is available here.

Other Updates

Texas Judge Tosses Part of Surprise Billing Rule; TMA Files Additional Case
On January 30^th, the Texas Medical Association (TMA) filed its fourth lawsuit against HHS and other federal agencies challenging their implementation of the No Surprises Act. This latest challenge alleges that the bill favors insurers due to high administrative fees required to initiate an independent arbitration process to solve billing disputes. The fee increased from $50 to $350 at the beginning of this year, which the TMA argues will make the process cost prohibitive for many providers to access, particularly for providers like radiologists who bill low-value claims. The lawsuit also disputes the law’s prohibition on batching claims, which requires providers to go through a separate payment dispute process for each claim related to an individual’s care episode.
 
On February 6^th, Judge Jeremy Kernodle of the U.S. District Court for the Eastern District of Texas ruled in favor of one of the TMA’s earlier challenges to the rule. In this case, the TMA argued that the final rule placed too much emphasis on the insurer’s median in-network rate, referred to as the Qualifying Payment Amount (QPA), unfairly weighting the process in favor of insurers. HHS had argued that the final rule directs arbiters to use the offer that best represents the value of the disputed item or service, regardless of which amount is closer to the QPA. However, Kernodle ruled that the final rule requires arbiters to begin with the QPA and then imposes restrictions, which do not appear in statute, on other factors arbiters might consider. The ruling directs HHS to revise its final rule surrounding the dispute resolution process. HHS indicated it is reviewing the ruling. 
 
FTC Issues First Health Breach Notification Enforcement Action Against GoodRx
On January 31^st, the Department of Justice, on behalf of the Federal Trade Commission (FTC), filed a complaint and proposed order for permanent injunction against GoodRx, a telemedicine platform that tracks prescription drug prices and provides free drug coupons for discounts on medications. The order, which requires approval by the U.S. District Court for the Northern District of California, would fine the company $1.5 million and prohibit GoodRx from sharing health information with third parties.
 
The FTC claims that GoodRx uploaded protected information about its users to Facebook and then used that personal information to target users with advertisements on various social media platforms, giving Facebook access to the information. The FTC also claims the company misrepresented its HIPAA compliance to consumers. The order requires any third-party companies who received GoodRx shared data to delete it. The complaint is the first enforcement action by the FTC under the 2009 Health Breach Notification Rule. GoodRx has agreed to settle the case but disagrees with the allegations and admits no wrongdoing.

New York State Updates

DOH Requests Public Comment on Draft Waiver to Expand the Essential Plan
On February 10^th, the New York State (NYS) Department of Health (DOH) released a draft Section 1332 State Innovation Waiver which seeks CMS approval to use existing federal funding to expand eligibility for New York’s Essential Plan. The Essential Plan is a health insurance option authorized through Section 1331 of the ACA for adults aged 19 to 64 with incomes too high for Medicaid (between 138% of FPL and 200% of FPL) or with lower incomes but who are ineligible for Medicaid. The Essential Plan is offered through New York’s health exchange, New York State of Health (NYSOH), and has no monthly premium, no deductible, and minimal cost-sharing for current enrollees.
 
DOH specifically proposes to suspend New York’s existing Section 1331 plan and enact a new but identical Section 1332 insurance option. However, eligibility for the new option would be expanded to include adults with incomes of up to 250% of FPL. People with incomes between 200% of FPL and 250% of FPL would have a $15 per month premium, with no deductible and an out-of-pocket maximum of $2,000. They would become ineligible for tax credits to purchase qualified health plans (QHPs) in the individual market (unless due to changes in income). Like the current Essential Plan, the new option would not include children under 19 or seniors 65 and older.
 
This request is pursuant to language passed in New York’s Fiscal Year (FY) 2023 Enacted Budget and elaborated upon in Governor Hochul’s proposed FY 2024 Executive Budget. DOH estimates that this expansion would increase Essential Plan enrollment by about 10%, or up to 100,000 enrollees, while reducing enrollment in New York’s individual market for qualified health plans (QHPs) by almost 25%, or up to 70,000 enrollees in 2024.
 
Under the State’s proposal, funding for the 1332 waiver would consider the savings to the federal government due to the suspension of the Section 1331 Essential Plan (between $9-11 billion per year over the next five years). It remains an open question whether the ACA’s statutory language would permit this interpretation.
 
The full public notice is available here. The draft of the waiver application and actuarial analysis is available here. Written comments may be submitted through March 11^th here. Verbal comments may be submitted during the two virtual public hearings scheduled for later this month, details for which are available here.
 
NYS Emergency Mask Mandate in Health Care Settings Will Expire February 12^th
On February 9^th, DOH Acting Commissioner Dr. James McDonald announced that the emergency regulation on masking in health care settings will expire on February 12^th. DOH is directing hospitals and other health care facilities to follow CDC guidance (available here) and to “come up with their own plan for when masking may be required for their staff based on community cases.”
 
The current regulations are available here.
 
DOH Issues Special Medicaid Update on the Medicaid Pharmacy Carve-Out
On February 9^th, DOH issued a special edition of its Medicaid Update that covers various aspects of the carveout of the Medicaid pharmacy benefit ino fee-for-service that is set to take effect on April 1^st. Once effective, Medicaid members in mainstream plans, Health and Recovery Plans (HARPs), and HIV Special Needs Plans (SNPs) will receive their pharmacy benefits through the NYS Medicaid Pharmacy Program (NYRx) instead of through their managed care plan.
 
The update contains various information for pharmacies and providers, including an overview of NYRx billing procedures, provider enrollment requirements, resources, and a member fact sheet. It emphasizes that DOH is currently planning for the carve-out to take effect April 1^st. As of that date, if the carve-out proceeds, pharmacies would need to directly bill Medicaid FFS for pharmacy claims and plans would be required to implement point-of-service denials.
 
The update is available here.
 
DOH and OMH Formalize Guidance on Prescribing Controlled Substances During and After the PHE
On February 2^nd, the NYS Office of Mental Health (OMH) issued guidance on the prescription of controlled substances after the federal Covid-19 PHE ends. The guidance indicates that, without further federal action, at the conclusion of the PHE on May 11^th, programs must return to compliance with the pre-emergency requirements of the Ryan Haight Act. This means that: 

• Patients who have been seen in-person prior to or during the PHE by the practitioner prescribing the controlled medication may continue to be prescribed such medications using telehealth.
• Patients who have never been seen in-person must be seen in-person by the prescribing practitioner at least once prior to the renewal or new prescription for a controlled substance after the PHE ends. The guidance strongly encourages programs to begin scheduling in-person appointments before the end of the PHE to manage practitioner workload and mitigate risk to patients.
• Patients who were seen in-person prior to or during the PHE, but have their medications prescribed by another practitioner (the covering practitioner), must be seen in-person by the prescribing practitioner within two years of the last in-person visit.

As discussed above, the Biden Administration has indicated that it will pursue rulemaking to allow for continued prescriptions without gaps in care. On January 31^st, DOH Acting Commissioner Dr. James McDonald issued a commissioner’s determination to formalize and clarify existing policy that, for the duration of the PHE, New York State’s policy on controlled substances is identical with the current federal DEA policy. This includes audio-only prescribing of buprenorphine for the treatment of opioid use disorder (OUD) without a requirement for an in-person visit. No other controlled substances are subject to this temporary exemption.
 
The OMH guidance is available here. The DOH press release is available here and the commissioner’s determination is available here. Questions may be submitted to narcotic@health.ny.gov.
 
OASAS Issues Guidance on the Elimination of the DEA X-Waiver for the Prescription of Buprenorphine
On January 19^th, the Office of Addiction Services and Supports (OASAS) issued guidance on the elimination of the Drug Enforcement Agency (DEA) “X-waiver” to prescribe buprenorphine. The Consolidated Appropriations Act (CAA) of 2023, signed by President Biden on December 29, 2022, removes the remaining limitations on buprenorphine prescribing and allows all health care providers, as permissible under state law, to prescribe buprenorphine for the treatment of OUD by: 

• Eliminating the requirement that practitioners apply for an X-waiver through the DEA; and
• Eliminating the limit on the number of patients that practitioners can treat with buprenorphine at a given time.

The law now requires all health care providers, with a few exceptions, who prescribe any controlled substances to complete a required training in the identification and treatment of substance use disorders when applying for a DEA registration or at the time of their next DEA registration renewal. This requirement will become effective in June 2023.  
 
The guidance is available here.
 
DOH Posts Executive Budget Scorecard
On February 1^st, Governor Kathy Hochul submitted her second Executive Budget to the Legislature, covering New York State Fiscal Year (FY) 2024. The Budget includes major health proposals outlined in the Governor’s State of the State, including a $1 billion investment in increased inpatient and outpatient behavioral health care capacity, a new round of capital funding for health care transformation (totaling $1 billion), and a new process for DOH to conduct oversight of “material transactions” involving less-regulated health care providers and affiliates such as management services organizations (MSOs).
 
DOH has released the Executive Budget Scorecard, which includes a projection of the effects of budget initiatives, including administrative actions, on the Medicaid Global Cap. DOH projects a base Global Cap deficit of $756 million in FY 2024, which will be addressed by various Budget actions, including: 

• Redirection of the $93.5 million Nursing Home Staffing Pool established in the FY 2022 Budget to help distressed nursing homes comply with staffing requirements;
• The increase of Medicaid managed care plan minimum medical loss ratios (MLRs) to 89%, which would save $55 million from managed long-term care (MLTC) plans and $12 million from mainstream plans;
• The discontinuation of managed care quality pools, saving $51.8 million on MLTC plans and $60 million from mainstream plans;
• The discontinuation of the MLTC distressed plan pool, saving $15 million; and
• The carve-out of the Medicaid pharmacy benefit into fee-for-service, projected to reduce costs by $410 million in FY 2024 and $548 million in FY 2025.

These savings would be reinvested into various other budget initiatives, including the 5% increases in reimbursement for hospitals, nursing homes, and assisted living programs as well as $125 million in supplemental payments to compensate federally qualified health centers (FQHCs) for lost 340B revenue from the pharmacy carve-out. The Scorecard also projects the effects of planned administrative actions to invest in the health system, including: 

• Increasing primary care reimbursement under fee-for-service to 80% of Medicare ($17.7 million in FY 2024 and $35.3 million in FY 2025);
• Increasing dental reimbursement rates, including for dentists serving the intellectually and/or developmentally disabled populations (I/DD);
• Establishing reimbursement for screening for adverse childhood experiences (ACE);
• Increasing reimbursement for school-based health centers ($1.4 million per year); and
• The release of integrated licensure standards.

The scorecard is available here. SPG’s detailed summary of the full Budget is available here, and other 2024 budget materials are available on the Division of the Budget’s website here.
 
OMH Extends Commissioner’s Covid-19 Regulatory Waiver
On February 1^st, the OMH Commissioner extended the previously issued Commissioner’s Waiver for an additional 120 days through June 1^st. OMH adopted new Part 596 telehealth regulations in September 2022 that codify many of the telehealth flexibilities put in place under the Commissioner’s Waiver. However, the Waiver continues other flexibilities, including: 

• Requirements continuing the reduction of minimum service durations and allowing rounding up of service times; and
• Requirements to waive timeframes around treatment planning reviews and to waive initial in-person assessments.

The waiver is available here.
 
NYSOFA Adopts Final Rule Allowing Flexibility for EISEP Assessment Requirements
On February 8^th, the New York State Office for the Aging (NYSOFA) adopted regulations to provide flexibility for service provision under the Expanded In-Home Services for the Elderly Program (EISEP) and Home-Delivered Meals. The final rule does not eliminate any current EISEP program requirements, but allows for the extension of the timelines related to required client assessments (generally needed within 10 days of initiating services) if strict compliance is impracticable.
 
The notice of adoption is available here.
 
OASAS Announces Availability of Overdose Reversal Medication and Fentanyl Test Strips for Service Providers
On February 3^rd, OASAS announced a new mechanism for all OASAS and OMH service providers to order overdose reversal medication and fentanyl test strips. OASAS will provide Narcan Nasal Spray (naloxone) and the fentanyl test strips to all OASAS and OMH providers through a new direct ordering system on the OASAS website.
 
The OASAS press release is available here. Information on how to order the supplies is available here.
 
CMS Approves New York SPA Streamlining the Medicaid FFS Utilization Threshold Program
On January 26^th, CMS approved New York’s request for a State Plan Amendment (SPA) to streamline requirements in the Medicaid fee-for-service Utilization Threshold (UT) program by eliminating the requirement for provider-submitted benefit increase requests for certain services. The SPA also moves the monitoring of service utilization from a prospective to retrospective review process. The changes are effective October 1, 2022.
 
The SPA is available here. The CMS approval letter is available here.
 
CMS Approves New York SPA Revising Methodology for Distributing Clinic Safety Net Payments
On February 1^st, CMS approved New York’s SPA to revise the method of distributing the Clinic Safety Net (CSN) payments for eligible diagnostic and treatment centers (D&TCs), not including FQHCs. Effective April 1, 2022, all non-FQHC D&TCs licensed under Article 28 or Article 31 will be eligible for the CSN payment if they provide at least 3% of their annual visits to uninsured individuals (previously 5%). Eligible D&TCs will receive a uniform add-on payment rather than a payment based on the current tiered system, which will be calculated by dividing the total D&TC safety net payment available by the sum of the total number of uninsured visits and Medicaid fee-for-service visits for all eligible D&TCs. Each D&TC’s safety net payment will be calculated by multiplying the uniform rate add-on by the sum of each D&TC’s uninsured visits and Medicaid fee-for-service visits.
 
The SPA is available here. The CMS approval letter is available here.

Funding Opportunities

OASAS Announces RFA for Development of Comprehensive Integrated Outpatient Treatment Programs
On February 7^th, OASAS released a Request for Applications (RFA) for the development of Comprehensive Integrated Outpatient Treatment Programs statewide. These programs have co-located OASAS Part 822 outpatient services and OASAS Part 822 Opioid Treatment Program (OTP) services that are merged under one operating certificate. While services are physically merged, billing and reporting for OTP and outpatient services will continue to be submitted through separate Program Reporting Units (PRUs).
 
Through this opportunity, OASAS will award over $8.6 million in total funding across 18 organizations. Funding will be allocated as follows: 

• Six one-time awards of up to $374,000 for existing co-located outpatient and OTP programs to assist with integration;
• Six one-time awards of up to $660,000 for existing outpatient programs that intend to apply to add OTP services; and
• Six one-time awards of up to $402,000 for existing OTPs that intend to apply to add outpatient program services.

Certified Behavioral Health Clinics (CCBHCs) that are funded by NYS, outpatient rehabilitations, proprietary entities, and applicants that have Part 822 outpatient and/or OTP certificates/applications that are integrated or hosted by OMH or DOH (but not OASAS) are not eligible to apply.
 
The RFA is available here. Applications are due on March 15^th. Questions may be submitted to OASAS.sm.Grants@oasas.ny.gov with the subject line “RFA SETT – 23004” through February 22^nd.
 
SAMHSA Releases NOFO for Assertive Community Treatment Services
On February 8^th, the Substance Abuse and Mental Health Services Administration (SAMHSA) released a Notice of Funding Opportunity (NOFO) for the establishment, expansion, and maintenance of Assertive Community Treatment (ACT) programs for transition-aged youth and adults with a Serious Mental Illness (SMI) or Serious Emotional Disturbance (SED). The ACT team model is composed of 10-12 multidisciplinary behavioral health care staff who work together to deliver a mix of individualized, recovery-oriented services to individuals living with SMI/SED to help them be successfully integrated into the community. Core services, which include assessment, substance use disorder treatment, and therapy, among others, are expected to be provided 24 hours per day, 7 day per week.
 
Through this opportunity, SAMSHA will award over $5 million in total funding to seven applicants during the five-year program period (up to $678,000 per year per award). Eligible applicants are community-based behavioral health non-profit organizations, mental health systems, and health care facilities.
 
The full RFP is available here. Applications are due on April 10^th. Questions may be submitted to Dawnielle Tillman at ACTMonitoringTeam@samhsa.hhs.gov.
 
OPWDD Announces RFP for the Promotion of Developmental Disability Services
On February 6^th, the NYS Office for People with Developmental Disabilities (OPWDD) released a Request for Proposals (RFP) seeking a vendor to provide consultant marketing services that promote and elevate the profession of direct support for individuals with intellectual/developmental disabilities. The awardee will create branded marketing/educational materials and a functional website for use by job seekers and service providers with the goal of supporting provider recruitment and retention of Direct Support Professionals (DSPs) and educating the public about career opportunities in the direct services field.
 
Eligible applicants must have a minimum of three years of experience with multimedia marketing campaigns and recruitment strategies and should have experience building a website in Drupal. The contract will last for one year, starting on May 1^st.
 
The full RFP is available here. Applications are due on April 7^th. Awards are expected to be announced on April 26^th. Questions may be submitted to fmapcontracts@opwdd.ny.gov by March 3^rd.