Weekly Health Care Policy Update – January 9, 2023

January 16, 2023

In this update: 

  • Federal Agencies
    • CMS Issues Guidance on PHE Unwinding
    • CMS Releases Guidance on Addressing Health-Related Social Needs in Medicaid
    • CMS Issues Guidance on Interprofessional Consultation in Medicaid and CHIP
    • CMMI Publishes VBID Phase II Evaluation
    • OMB Issues Biden Administration’s Fall 2022 Unified Regulatory Agenda
    • FTC Proposes Rule to Ban Non-Compete Clauses
    • FDA, DOJ Revise Rules on Abortion Medication
    • SAMHSA Releases 2021 National Survey on Drug Use and Health Results
  • Other Updates
    • Nursing Home Groups Oppose OSHA Covid-19 Rule
  • New York State Updates
    • DOH Adopts Regulations Implementing Enhanced Adult PDN Reimbursement
    • DOH to Hold Next Webinar on Pharmacy Benefit Transition on January 17th
  • Funding Opportunities
    • NYC DOHMH Releases Concept Paper on Family Acceptance of LGBTQ+ Youth Initiative Program
    • HPD Releases Concept Paper for Citywide Partners in Preservation Program
    • DOH Releases RFA for Personal Responsibility Education Program (PREP)

Federal Agencies

CMS Issues Guidance on PHE Unwinding
On January 5th, the Centers for Medicare and Medicaid Services (CMS) issued an Informational Bulletin entitled “Key Dates Related to the Medicaid Continuous Enrollment Condition Provisions in the Consolidated Appropriations Act, 2023 (CAA),” offering additional guidance on eligibility redeterminations in anticipation of unwinding the Medicaid continuous enrollment policy which was implemented due to the Covid-19 public health emergency (PHE). The CAA decoupled the requirement for this condition from the end of PHE, and state requirements to continue coverage will now end on March 31st.
 
The Bulletin clarifies that states may begin their unwinding process in February, March, or April, as would have been planned under previous guidance had the PHE ended in March 2023. States may initiate eligibility renewals as soon as February 1st, must initiate renewals by March 31, 2024, and must complete all renewals by May 31, 2024. States are still required to submit plans to CMS detailing their unwinding schedule to ensure minimization of beneficiary burden and promotion of continuous coverage by February 15th, or February 1st if they plan to initiate disenrollments on that date. States will also need to submit baseline data on enrollment by the 8th of the month in which they initiate disenrollments. The CAA also established new reporting requirements for states, including monthly reporting on disenrollments once they begin.
 
CMS remains committed to releasing further guidance, offering technical assistance directly to states, and meeting with all state Medicaid directors throughout the unwinding process.
 
The Informational Bulletin is available here.
 
CMS Releases Guidance on Addressing Health-Related Social Needs in Medicaid
On January 4th, CMS released a letter to State Medicaid Directors entitled “Additional Guidance on Use of In Lieu of Services and Settings in Medicaid Managed Care,” containing new guidance to help states address health-related social needs (HRSN) for Medicaid managed care beneficiaries. The guidance discusses the use of In Lieu of Services and Settings (ILOS) in Medicaid managed care to help states offer alternative benefits to address unmet health-related social needs, including housing and food instability.  ILOSs are substitutes for services or settings covered under a state’s Medicaid State Plan, which are offered on a voluntary basis to enrollees. The authority for ILOSs was originally codified in the 2016 Medicaid and CHIP managed care final rule. ILOSs may be approved in the context of any Medicaid managed care plan authority, including an 1115 waiver, such as in the recent California CalAIM proposal, or a 1915(c) waiver.
 
The guidance notes that ILOSs can be used by states and managed care plans as replacements not only for immediate services, but also as longer-term services that are expected to “reduce or obviate” the future need to use State Plan-covered services. The goal of using ILOSs in this way is to offset potential future acute or institutional care, and to improve quality, health outcomes, and enrollee experience. As such, CMS established a set of six principles to guide the use of ILOSs: 

  • ILOSs must advance the objectives of the Medicaid program;
  • ILOSs must be cost-effective;
  • ILOSs must be medically appropriate;
  • ILOSs must preserve enrollee rights and protections;
  • ILOSs must be subject to appropriate monitoring and oversight; and
  • ILOSs must be subject to retrospective evaluation where available.

In the guidance, CMS establishes tiers of review for ILOSs based on the percentage of total capitation that would be attributable to all ILOSs (other than those related to short-term stays in an Institute for Mental Disease, which CMS considers to be separate), out of all costs for the relevant Medicaid managed care program. Specifically, if this ILOS Cost Percentage is less than 1.5 percent, CMS will require a lower level of documentation and oversight. In general, CMS will not approve ILOSs that would result in an ILOS Cost Percentage above 5 percent.
 
The full State Medicaid Director letter is available here.
 
CMS Issues Guidance on Interprofessional Consultation in Medicaid and CHIP
On January 5th, CMS issued guidance allowing state Medicaid and Children’s Health Insurance Program (CHIP) programs to pay specialists directly when a beneficiary’s primary health care provider asks for advice, even when the patient is not present. These interprofessional consultations will allow individuals with complex health needs to receive expert insights more quickly, without the delay of waiting for an in-person visit or administrative paperwork. Such consultations are particularly important in areas with provider shortages, like child and adolescent behavioral health.
 
The policy eliminates the need for coordinating payment via separate agreements with the treating practitioner, offering flexibility for payment methods that reimburse consulting practitioners directly. This aligns Medicaid and CHIP with standards of practice across health care, including Medicare, which initiated a similar policy in 2019.
 
The letter to State Medicaid Directors is available here.
 
CMMI Publishes VBID Phase II Evaluation
On December 30th, the Center for Medicare and Medicaid Innovation (CMMI) published evaluation reports for several CMMI programs, including Phase II of the Medicare Advantage Value-Based Insurance Design (VBID) Model. The evaluation report covers the first two years of Phase II’s implementation, 2020 and 2021. Overall, the VBID Model Aims to increase the use of high-value services for Medicare Advantage members with specific chronic illnesses. Phase I allowed Medicare Advantage plans to tailor benefit designs for beneficiaries with specific chronic conditions to offer reduced cost sharing for such high-value services and providers, additional supplemental benefits, or incentives to use care management or disease management. Phase II expanded the model to all states and territories and all categories of Special Needs Plans (SNPs), and allowed plans to offer benefits beyond traditional VBID including Benefit Design Innovations (BDIs) and a Hospice component.
 
The evaluation notes that BDI implementation was associated with a “marginally significant” increase in enrollment, declines in per-member per-month MA prescription drug bids, and increases in premiums and projected costs of mandatory supplemental benefits. The cost of supplemental benefits was the most substantial increase (23%) followed by the increase in average monthly premiums (8%). These elements did not change significantly with Hospice component implementation in 2021.
 
The full Phase II VBID evaluation is available here.
 
OMB Issues Biden Administration’s Fall 2022 Unified Regulatory Agenda
On January 4th, the Office of Management and Budget (OMB) published the Fall 2022 Unified Regulatory Agenda. This document is generally released in the spring and fall each year. Though it has no force of law, it indicates the Biden Administration’s regulatory agenda and a rough timeline for planned new regulations to be released. This fall’s Agenda indicates that the Administration has plans to address the following areas of health care policy: 

  • Health information technology (HIT), including a focus on: 
    • Interoperability, including the Interoperability and Prior Authorization proposed rule released in December 2022 and a new rule establishing expanded uses of application programming interfaces (APIs);
    • Information blocking, including the final rule establishing civil monetary penalties for violators); and
    • New standards for HIT, including updates to the voluntary HIT Certification Program and finalizing modifications to the HIPAA Privacy Rule related to care coordination exceptions;
  • Minimum staffing requirements for skilled nursing facilities;
  • The 340B Drug Program (in response to the American Hospital Association v. Becerracase, which overturned the Trump Administration’s attempt to reduce reimbursements);
  • Medicare and Medicaid disproportionate share hospital (DSH) payments;
  • Medicare Part B rates; and
  • New rules related to Medicaid managed care, including “access to care requirements, states’ use of In Lieu of Services or Settings (ILOS), state directed payments, quality rating systems, and other policy and reporting changes.”

The full Fall 2022 Unified Regulatory Agenda is available here.
 
FTC Proposes Rule to Ban Non-Compete Clauses
On January 5th, the Federal Trade Commission (FTC) proposed a new rule to ban employers from imposing non-compete provisions on their workers. In its rule, the FTC argues that non-compete provisions constitute an unfair method of competition and therefore violate Section 5 of the Federal Trade Commission Act. The FTC argues that non-compete provisions harm competition by blocking workers from pursuing better opportunities, preventing employers from hiring the best available talent, and hindering innovation.
 
Specifically, the rule would make it illegal to: 

  • Enter into or attempt to enter into a noncompete with a worker;
  • Maintain a noncompete with a worker; or
  • Represent to a worker, under certain circumstances, that the worker is subject to a non-compete.

The rule would apply to independent contractors and anyone who works for an employer, whether paid or unpaid. It would also require employers to rescind existing non-compete provisions and to inform workers that such provisions are no longer valid. The rule would not however, apply to other parts of employment contracts, like non-disclosure agreements. The FTC estimates that the rule would increase wages by nearly $300 billion per year and expand career opportunities for approximately 30 million Americans.
 
More information on the rule is available here.
 
FDA, DOJ Revise Rules on Abortion Medication
On January 3rd, the Food and Drug Administration (FDA) and the Department of Justice (DOJ) took separate actions related to access to abortion medication. The FDA revised rules surrounding the use of mifepristone to allow chain and independent pharmacies to stock and dispense the drug to individuals with a prescription. Previously, the drug, which is used with misoprostol to terminate a pregnancy within the first 10 weeks, could only be received directly from a prescriber or via mail, when prescribed via telemedicine, depending on state law. Pharmacies in more than a dozen states with near-total bans on abortion will be prohibited from participating, while pharmacies in states without bans will need to be certified to participate.
 
More information on the change is available here under “The January 2023 REMS Modification.”
 
Also on January 3rd, DOJ issued a legal opinion clearing the U.S. Postal Service (USPS) to deliver abortion drugs to states that have strict limits on terminating pregnancy. One week after the Supreme Court overturned Roe v. Wade in June 2022, the USPS requested legal guidance on use of the mail to send abortion drugs to individuals in states that ban abortions. The memo states that “the U.S. code does not prohibit the mailing of certain drugs that can be used to perform abortions where the sender lacks the intent that the recipient of the drugs will use them unlawfully,” and that “the mere mailing of such drugs to a particular jurisdiction is an insufficient basis for concluding that the sender intends them to be used unlawfully.”
 
The legal opinion can be found here.
 
SAMHSA Releases 2021 National Survey on Drug Use and Health Results
On January 4th, the Substance Abuse and Mental Health Services Administration (SAMHSA) released the results of its annual National Survey on Drug Use and Health (NSDUH). The Survey details how Americans report their experiences with mental health conditions, substance use, and treatment, and includes estimates by race, ethnicity, and age group. Given that the survey presents data from 2021, SAMHSA encourages results not to be compared with previous years because of methodological changes to data collection required by the pandemic. Highlights of the report include:
 
Drug Use and Substance Use Disorder

  • Among people aged 12 or older, 61.2 million people (21.9 percent of the population) used illicit drugs in the past year. The most commonly used illicit drug was marijuana, which 52.5 million people used. 9.2 million people 12 and older misused opioids in the past year.
  • 46.3 million people aged 12 or older (16.5 percent of the population) met the applicable DSM-5 criteria for having a substance use disorder in the past year: 
    • 29.5 million people were classified as having an alcohol use disorder.
    • 24 million people were classified as having a drug use disorder.
  • The percentage of people who were classified as having a past year substance use disorder was highest among young adults aged 18 to 25.
  • In 2021, 94% of people aged 12 or older with a substance use disorder did not receive any treatment. Nearly all people with a substance use disorder who did not get treatment at a specialty facility did not think they needed treatment.

Major Depressive Episodes (MDE) Among Adolescents

  • In 2021, 1 in 5 adolescents had a major depressive episode in the past year. Of these, nearly 75 percent had symptoms consistent with severe impairment.
  • The prevalence of past year MDE among Black and Asian adolescents was lower compared to adolescents from most other racial/ethnic groups.
  • More than half of youth with an MDE did not receive treatment in the past year.

Mental Illness among Adults

  • Nearly 1 in 4 adults 18 and older, and 1 in 3 among adults aged 18 to 25, had a mental illness in the past year.
  • Adults with serious mental illness had higher rates of treatment compared to those with any mental illness. However, despite having the highest rate of serious mental illness, people aged 18 to 25 had the lowest rate of treatment in comparison to adults in other age groups.
  • White and Multiracial adults were more likely to receive mental health services in the past year than Black, Hispanic or Latino, or Asian adults.

Serious Thoughts of Suicide, Suicide Plans, and Suicide Attempts

  • 12.3 million adults aged 18 or older had serious thoughts of suicide in the past year. 3.5 million made suicide plans, and 1.7 million attempted suicide.
  • Hispanic or Latino adults were more likely than White or Asian adults to have attempted suicide in the past year, and Black adults were more likely than Asian adults to have attempted suicide in the past year.

Recovery

  • 72.2 percent of adults who ever had a substance use problem considered themselves to be recovering or in recovery.
  • 66.5 percent of adults who ever had a mental health issue considered themselves to be recovering or in recovery.

The full data set is available here.

Other Updates

Nursing Home Groups Oppose OSHA Covid-19 Rule
On January 4th, the American Healthcare Association and the National Center for Assisted Living sent a letter to the Occupational Safety and Health Administration (OSHA) expressing their opposition to OSHA’s pending Final Healthcare Standard on Covid-19. The organizations note that many of the standards proposed in the rule already exist, and that further changes will only serve to “exacerbate the morass of federal and state regulatory confusion currently faced by our members.” The letter also notes that many provisions have already negatively affected quality of life and working conditions, such as social distancing, source control masks, and lack of visitation. The organizations also note that any new standards will have a burdensome financial impact on a field already facing historic workforce challenges. Instead, the letter encourages a focus on vaccines, treatment, and testing.
 
The full letter is available here.

New York State Updates

DOH Adopts Regulations Implementing Enhanced Adult PDN Reimbursement
On January 4th, the New York State (NYS) Department of Health (DOH) adopted regulations that increase Private Duty Nursing (PDN) fee-for-service reimbursement for services provided to medically fragile adults. The enhanced rate was implemented by the NYS 2022-23 Enacted Budget and is effective April 1, 2022. The increase will eliminate the disparity between pediatric and adult PDN reimbursement. 
 
The final rule is available in the State Register here.
 
DOH to Hold Next Webinar on Pharmacy Benefit Transition on January 17th
On January 17th from 1pm to 2pm, DOH will hold the next in its series of webinars on the Pharmacy Benefit Transition. In accordance with the NYS 2020-2021 Enacted Budget, as amended, DOH plans to carve out Medicaid pharmacy benefits into fee-for-service on April 1st. Previously, the transition was delayed by two years by legislation.
 
Registration for the webinar is available here. Questions may be submitted in advance by January 13th here, with the password “rxtransition2023.”

Funding Opportunities

NYC DOHMH Releases Concept Paper on Family Acceptance of LGBTQ+ Youth Initiative Program
On January 5th, the New York City (NYC) Department of Health and Mental Hygiene (DOHMH) released a Concept Paper outlining a forthcoming funding opportunity for the Family Acceptance of LGBTQ+ Youth Initiative Program. This program is designed to promote family and community acceptance of LGBTQ+ youth ages 12-21 years. Through this opportunity, DOHMH plans to award $1.5 million in total funding to one organization during the two-year program period.
 
Eligible applicants are not-for-profit 501(c)(3) organizations that operate a brick-and-mortar site in NYC and that have at least two years of experiencing delivering relevant services (e.g., workshops, support groups). Organizations must be able to articulate the needs of LGBTQ+ youth and craft thoughtful and intentional services, programming, and other opportunities to encourage parents, caregivers, family members, and communities to accept and support their LGBTQ+ youth.
 
The Concept Paper is available here. Comments are due on February 21st and may be submitted via the Public Health Solutions Procurement Portal here. DOHMH anticipates releasing the RFP in February/March, with a projected contract start state of July 1st.
 
HPD Releases Concept Paper for Citywide Partners in Preservation Program
On December 29th, the New York City Department of Housing Preservation and Development (HPD) released a Concept Paper outlining a forthcoming Request for Proposals (RFP) for contractors to provide support to rent-stabilized tenants facing harassment and displacement citywide. Program services will include, but not be limited to: 

  • Canvassing and outreach;
  • Tenant organizing;
  • Leadership training;
  • Know your rights workshops;
  • 1-on-1 tenant counseling;
  • Referrals to legal services; and
  • Other activities to address tenant harassment and untenable living conditions in rent-regulated buildings.

Through this RFP, HPD intends to award five annual contracts to implement a citywide expansion of the Partners in Preservation pilot program, with one award allocated per borough. The payment structure of contracts will be budget-based. Contracts are expected to begin in fall/winter 2023.
 
The Concept Paper is available here. Comments may be submitted to PIP@hpd.nyc.govwith the subject line “Citywide Partners in Preservation Program Concept Paper” through February 13th. There will be a pre-response conference on January 25th at 2pm, which may be accessed here.
 
DOH Releases RFA for Personal Responsibility Education Program (PREP)
On January 5th, DOH released a Request for Applications (RFA) for the provision of the Personal Responsibility Education Program (PREP) initiative throughout NYS. The PREP initiative implements evidence-based practices to educate adolescents on both abstinence and contraception with the goal of preventing pregnancy and sexually transmitted infections.
 
Through this opportunity, DOH will award up to $2.1 million annually during the five-year program period. Applicants that propose to provide services in the downstate region may apply for annual funding up to $350,000. Applicants that propose to provide services in the upstate region may apply for annual funding up to $250,000. Applicants may only submit one application per region. If proposing services in both the downstate and upstate regions, a separate application for each is required.
 
Eligible applicants are youth-serving not-for-profit organizations, including Article 28 health care providers, community-based health and human service providers, and local health and human services providers. If not licensed under Article 28 of the NYS Public Health Law, applicants must include a letter from one or more organizations licensed under Article 28 stating their intent to collaborate with the PREP applicant organization to accept referrals and provide a full range of medical family planning services.
 
The RFA is available here. Applications are due on February 23rd. Questions may be submitted to preprfa@health.ny.gov through January 25th.