In this update:
- Legislative Updates
- Congress Expected to Pass Temporary Funding through March 1st
- Federal Agencies
- CMS Announces Aligned Medicare-Medicaid Community Behavioral Health Model
- CMS Issues Final Rule on Access to Health Information and Prior Authorizations
- CMS to Hold National Stakeholder Call on January 23rd
- DOJ Issues Proposed Rule on Access to Medical Care for People with Disabilities
- HHS Recommends that Marijuana Should Move to Schedule III
- HHS Launches Medicaid/CHIP Renewals Resource Hub
- ARPA-H Launches Three New Programs on Vision Restoration, Rural Health Care, and Prevention Innovation
- HRSA Announces OTAG Webinar on January 31st
- Other Updates
- MedPAC Holds January Meeting
- Epic Makes Changes to App Market
- New York State Updates
- Governor Hochul Issues 2024 State of the State Address and FY 2024-25 Executive Budget
- CMS Approves NYS 1115 Waiver to Implement SDOH Services and Medicaid Global Budgets
- DOH Proposes Regulations on Behavioral Health Network Adequacy and Access
- DOH Releases Sixth Monthly Edition of the State’s Public Health Emergency Unwind Dashboard
- DOH Releases Draft 1115 Waiver Amendment for Continuous Eligibility for Children; Announces Public Hearings
- CMS Approves New York SPA Expanding CHIP Eligibility
- DFS Issues Proposed Guidance on Use of Consumer Data and Artificial Intelligence Systems
- CMS Approves SPA on Medicaid Reimbursement for Interprofessional Consultations and Store-and-Forward Telehealth
Legislative Update
Congress Expected to Pass Temporary Funding through March 1st
This week, Congressional leaders reached a deal on a short-term continuing resolution (CR) to keep the federal government funded. The CR passed the Senate on Thursday afternoon and is expected to pass the House by Friday evening. The current funding agreement would have expired today (January 19th) for some departments and on February 2nd for most of the government.
Last week, Speaker of the House Mike Johnson (R-LA) and Senate Majority Leader Chuck Schumer (D-NY) announced an agreement on topline spending numbers for the federal government’s Fiscal Year (FY) 2024 funding. Recognizing that Congress will need more time to write and pass appropriations bills, the new CR punts funding deadlines for some portions of the government to March 1st and the remainder to March 8th.
Federal Agencies
CMS Announces Aligned Medicare-Medicaid Community Behavioral Health Model
On January 18th, the Centers for Medicare & Medicaid Services (CMS) announced the launch of the Innovation in Behavioral Health (IBH) Model, a new state-based model to encourage whole-person care in community behavioral health practices across both Medicare and Medicaid. The IBH Model aims to improve outcomes and quality of care for Medicare and Medicaid beneficiaries with moderate to severe mental health conditions and/or substance use disorders (SUD).
IBH model participants will be community-based behavioral health providers, including:
- Medicare-designated Community Mental Health Centers;
- Public or private practices;
- Opioid treatment programs; and
- Safety net providers of outpatient mental health and SUD services.
Participating providers will receive supports and incentives to develop and implement interprofessional care teams. Such teams would focus on addressing all elements of a patient’s care, as well as social supports like housing, food, and transportation. IBH will include:
- Infrastructure payments to support health IT capacity building, electronic health records, and practice transformation;
- Technical assistance; and
- A predictable value-based payment model, including a per-beneficiary per-month (PBPM) supplementary payment from Medicare and other performance-based payments.
CMS will partner with State Medicaid agencies to administer IBH in up to eight states, starting in fall 2024 and lasting for eight years, including a three-year pre-implementation period. CMS plans to release the IBH Notice of Funding Opportunity (NOFO) in spring 2024.
More information is available on the CMS website here.
CMS Issues Final Rule on Access to Health Information and Prior Authorizations
On January 17th, the Centers for Medicare and Medicaid Services (CMS) finalized its Interoperability and Prior Authorization final rule. Impacted payers include:
- Medicare Advantage (MA) organizations;
- State Medicaid and Children’s Health Insurance Program (CHIP) Fee-for-Service (FFS) programs;
- Medicaid managed care plans;
- CHIP managed care entities; and
- and Qualified Health Plans (QHP) on the Healthcare.gov federal exchanges.
These payers will now be required to maintain application programming interfaces (APIs) to further facilitate the sharing of health care data. Through these changes, CMS hopes to also streamline the prior authorization program, though none of the changes included apply to prior authorization decisions for drugs. This final rule also includes a new measure for the Merit-based Incentive Payment System (MIPS) on electronic prior authorizations.
The final rule includes the following regulatory changes:
- Patient Access API: Impacted payers must implement an HL7 FHIR Patient Access API with information about prior authorizations by 2027.
- Provider Access API: Impacted payers must create a Provider Access API to share patient data with in-network providers, including individual claims and encounter data. Additionally, these payers must maintain an attrition process for patients and providers with whom a relationship exists. Patients must be able to opt out of having their data available to providers. This API must be implemented by 2027.
- Payer-to-Payer API: Impacted payers must also create a Payer-to-Payer API to make the same tranches of data from the Provider Access API available to other payers in the event that a patient changes payers. There will be a patient opt-in process, and this API must be implemented by 2027.
- Prior Authorization API: Impacted payers must create a Prior Authorization API that includes a list of covered items and services, provides resources on prior authorization approval, and includes support resources for a prior authorization request and response. These APIs must have some capabilities for payers to communicate when and under what circumstances it approves or denies a prior authorization request.
- Other Prior Authorization Processes: Under this rule, most impacted payers must send prior authorization decisions for standard requests within seven calendar days and urgent requests within 72 hours. Impacted payers must also provide specific reasoning for denying a prior authorization request and will be required to publicly report certain annual metrics.
The announcement is available here.
CMS to Hold National Stakeholder Call on January 23rd
On January 23rd, CMS will hold a National Stakeholder Call with Administrator Chiquita Brooks-LaSure and her leadership team. The intent of this call is to highlight key achievements from 2023 and CMS Strategic Plan objectives for 2024. Stakeholders are encouraged to join to learn more about opportunities to engage with CMS in 2024.
Registration is available here.
DOJ Issues Proposed Rule on Access to Medical Care for People with Disabilities
On January 9th, the Department of Justice (DOJ) issued a proposed rule to increase access to medical diagnostic equipment (MDE), such as examination tables, X-ray machines, scales, and dental chairs, for people with disabilities. Without access to MDE, people with disabilities can face major complications, such as inaccurate anesthetic doses. Specifically, the proposed rule includes Americans with Disabilities Act-compliant technical standards for public health care facilities that use MDE. The Department is currently soliciting comments.
The announcement is available here.
HHS Recommends that Marijuana Should Move to Schedule III
On January 12th, the Department of Health and Human Services (HHS) released documents supporting its recommendation that marijuana be moved from Schedule I to Schedule III due to demonstrated medical benefits. As a Schedule I substance under the Controlled Substances Act, the federal government considers marijuana to have high abuse potential and to lack accepted medical uses or demonstrated benefits. Following direction from President Biden in 2022, HHS has been reviewing the available research on marijuana to re-examine its classification.
In this review, the Food and Drug Administration (FDA) reviewed marijuana as a possible therapy for anorexia, anxiety, epilepsy, inflammatory bowel disease, nausea and vomiting, pain, and post-traumatic stress disorder. Given its jurisdiction, the Drug Enforcement Administration (DEA) will ultimately determine marijuana’s classification. This decision is expected in the coming months.
The clinical review by the FDA is available here.
HHS Launches Medicaid/CHIP Renewals Resource Hub
On January 11th, HHS launched a new online hub to collect resources related to the renewal process for Medicaid and Children’s Health Insurance Program (CHIP) coverage. The hub is part of HHS’s ongoing effort to assist Medicaid-eligible people to maintain their enrollment during the unwinding of the continuous coverage provision from the Covid-19 public health emergency. It contains resources for community partners of all types to help individuals with renewing their coverage, including communications toolkits and outreach materials for specific populations. It also has resources on how to connect individuals who are no longer eligible for Medicaid with potential insurance options on Affordable Care Act (ACA) Marketplaces.
The hub is available here.
ARPA-H Launches Three New Programs on Vision Restoration, Rural Health Care, and Prevention Innovation
On January 11th, the Advanced Research Projects Agency for Health (ARPA-H) announced the Transplantation of Human Eye Allografts (THEA) program. This program aims to transplant whole human eyes to the visually impaired and blind, with hopes of fully restoring vision. Utilizing whole eye donations, this program will use microsurgical techniques and nerve regeneration to prevent or reverse degenerative or sudden blindness. Soon, THEA will request proposals for funding through an Innovative Solutions Opening.
On January 16th, ARPA-H launched another new program, the Platform Accelerating Rural Access to Distributed & InteGrated Medical care program (PARADIGM). PARADIGM will seek to address ongoing provider shortages by enhancing early detection and chronic disease management in rural communities. Specifically, the program will create a new care delivery platform, similar to a mobile clinic, to increase the reach of diagnostic and essential medical services. PARADIGM hopes to create an electric vehicle platform retrofit with medical devices and software to mimic hospital-level care. Soon, PARADIGM will use a Program Solicitation to initiate awards in a handful of technical domains.
Finally, on January 9th, ARPA-H launched the Health care Rewards to Achieve Improved Outcomes (HEROES) program. The HEROES program is intended to encourage investment in innovative new community-level prevention activities. Under HEROES, ARPA-H will solicit applications from “Health Accelerators,” consortiums of community health providers and organizations, to undertake efforts to address preventable negative health outcomes, such as alcohol-related harm and cardiovascular disease. Health Accelerators will be eligible for outcome-based payments from ARPA-H based on their performance. They will engage with investors and other organizations, who may be eligible to share in outcome payments, to help support and fund the intervention.
The press release for THEA is available here; the press release for PARADIGM is available here; and the press release for HEROES is available here.
HRSA Announces OTAG Webinar on January 31st
On January 31st, the Health Resources and Services Administration (HRSA) will host a webinar for the Organ Transplantation Affinity Group (OTAG). Clinicians and other donation and transplantation professionals, along with donors and recipients are encouraged to attend. The intent of the webinar is to solicit feedback on CMS and HRSA goals for addressing donation and transplantation infrastructure and system challenges, particularly from a diverse set of perspectives.
Registration is available here.
Other Updates
MedPAC Holds January Meeting
On January 11th and 12th, the Medicare Payment Advisory Commission (MedPAC) held its January public meeting. Commissioners voted unanimously to update the physician fee schedule rates and enact a previous recommendation of add-on payments for safety-net providers furnishing services to low-income beneficiaries. The commissioners also made recommendations to update payments for end stage renal disease (ESRD), hospice base payment rates, and home health agencies.
Aside from these recommendations, the Commissioners also:
- Convened a session to provide a status report on ambulatory surgical centers (ASCs). The session discussed ASC supply, volume of services provided to beneficiaries, and Medicare spending, and reiterated MedPAC’s past recommendation to require ASCs to submit cost data.
- Held discussions on the Medicare Advantage (MA) program. The Commissioners expressed ongoing concern about the level of spending and difficulty discerning quality in the MA program.
- Discussed the annual status report on Part D plans, including the need for additional clarifications regarding Medicare’s increased overall subsidy rate due to the annual premium growth cap; the importance of an accurate and easy-to-navigate plan finder; the impact of the Part D redesign on patients and plans; and the results from the Enhanced Medication Therapy Management (MTM) model.
The slide presentations are available here.
Epic Makes Changes to App Market
On January 17th, Epic unveiled Showroom, a new website to support users its electronic health records software, which includes a revamped version of its previous App Orchard for third-party vendors offering solutions that interact with Epic. The Showroom’s “Products” section now categorizes third-party vendors that integrate with Epic into three sections:
- Connection Hub, which is an online directory that lists products and vendors that operate on at least one health system’s HER;
- Toolbox, which highlights a subset of software categories from the Connection Hub that includes apps that follow Epic-recommended software integration practices; and
- Workshop, which contains vendors who are co-developing technology with Epic directly. Workshop is considered the most exclusive category and involves the highest level of integration.
The Showroom website’s Products section is here.
New York State Updates
Governor Hochul Issues 2024 State of the State Address and FY 2024-25 Executive Budget
Last week, Governor Kathy Hochul delivered her State of the State speech outlining her policy agenda for the 2024 Legislative Session. This was followed by the release of the Governor’s proposed Executive Budget for Fiscal Year (FY) 2024-25, which contained further details on these and many other legislative proposals. Some of the most notable health care-related proposals include:
- Certificate of Need (CON) reforms, including increasing the monetary thresholds for higher review tiers;
- Development of a Paramedic Telemedicine Urgent Care program in rural areas;
- Creation of a new, streamlined designation process for Children and Family Treatment and Support Services (CFTSS);
- Creating a total of 200 new or renovated psychiatric inpatient beds;
- Strengthening mental health parity enforcement and fines;
- Promulgating new network adequacy regulations for Medicaid and commercial insurers to set standards for behavioral health access, including limits on appointment wait times;
- Introducing legislation to require commercial plans to reimburse Article 31 and 32 clinics at the Medicaid rate, at minimum;
- Increasing Medicaid reimbursement rates for mental health services at Article 28 clinics and private practices;
- Introducing legislation to eliminate co-pays for insulin for all regulated insurance plans;
- Expanding New York’s Paid Family Leave program to cover 40 hours of additional paid leave for prenatal medical appointments; and
- Creating “Empire AI,” a consortium of research institutions to promote New York’s leadership in the field of AI, which will be funded by $400 million in public and private investments
SPG earlier published full summaries of the State of the State (available here) and the Executive Budget (available here).
CMS Approves NYS 1115 Waiver to Implement SDOH Services and Medicaid Global Budgets
On January 9th, CMS approved a new amendment to New York’s Medicaid Redesign Team (MRT) 1115 Demonstration Waiver. The new amendment will run during the 3.25-year period from January 2024 through March 2027, when New York will need to pursue an extension of the waiver. It includes four initiatives—Health-Related Social Needs (HRSN), the Health Equity Regional Organization (HERO), Medicaid Hospital Global Budgets, and Strengthening the Workforce—offering a total of up to $6.69 billion in federal funding. The State has also committed to providing associated investments of $1.5 billion.
SPG earlier published a full summary of the waiver’s provisions here.
DOH Proposes Regulations on Behavioral Health Network Adequacy and Access
On January 10th, the NYS Department of Health (DOH) issued proposed regulations to establish new network adequacy and access standards for behavioral health services. The FY 2023-24 Enacted Budget required DOH, in consultation with the Department of Financial Services (DFS), Office of Mental Health (OMH) and Office of Addiction Services and Supports (OASAS) to develop regulations by the end of last year on this topic.
The regulations, which would be effective January 1, 2025, would require Managed Care Organizations (MCOs) to ensure that its network has adequate capacity and availability to offer behavioral health services appointments within:
- 10 business days for an initial appointment with an outpatient facility or clinic;
- 10 business days for an initial appointment with a health care professional who is not employed by or contracted with an outpatient facility or clinic; and
- 7 days for an appointment following a discharge from a hospital or an emergency room visit.
The MCO may meet these requirements using telehealth, unless the enrollee specifically requests an in-person visit. If an enrollee is unable to schedule an appointment within these timeframes, the enrollee may submit a complaint to the MCO. The MCO will have three business days from receipt of the complaint to locate a participating provider to treat the enrollee’s behavioral health condition. If the MCO is not able to locate a participating provider within this timeframe, the MCO must allow the enrollee to receive services from an out-of-network provider and may not impose additional cost-sharing.
The regulations also include a particular requirement that an adequate network must include the following sub-acute and crisis services (effective after the State determines that there is a sufficient number of such providers in the State to meet this standard):
- Residential facilities that provide sub-acute care;
- Assertive Community Treatment (ACT) providers;
- Critical Time Intervention (CTI) services providers; and
- Mobile crisis intervention providers.
The proposed regulations also include provider directory requirements, reporting requirements, and additional MCO responsibilities regarding network adequacy and access. Such responsibilities include a requirement for the MCO to have designated staff to help enrollees with finding participating behavioral health providers and a plan for monitoring capacity and access.
The full text of the proposed regulations is available here. Comments may be submitted to regsqna@health.ny.gov through March 11th.
DOH Releases Sixth Monthly Edition of the State’s Public Health Emergency Unwind Dashboard
On January 16th, DOH released the sixth issue of the State’s Public Health Emergency (PHE) Unwind Dashboard, a monthly enrollment report on the renewal process for New York’s Medicaid, Child Health Plus, and Essential Plan populations. All individuals in these programs will need to renew their eligibility through May 31st.
This sixth issue includes the renewal status, demographics, and program transitions of enrollees who had a November 30, 2023 coverage end date. The report shows that 75 percent of the 624,268 individuals in this cohort have renewed their coverage across the NY State of Health marketplace and Local Departments of Social Services. The report does not include information on former enrollees who found coverage through non-public sources, such as employer-based insurance.
The November cohort marks the mid-way point of the PHE Unwind for NYS, with nearly 3 million renewals having been initiated between June and November 2023. Overall, 81% of renewals are complete, including 77% of adults and 92% of children.
The sixth issue and previous reports may be accessed here. This process will continue each month until each enrollee cohort has had their eligibility redetermined.
DOH Releases Draft 1115 Waiver Amendment for Continuous Eligibility for Children; Announces Public Hearings
On January 16th, DOH released its draft Medicaid Redesign 1115 Waiver amendment request that would authorize continuous enrollment for children up to age six in Medicaid and CHIP, regardless of whether a child’s family income exceeds eligibility limits. The State currently covers children ages zero to one up to 223 percent of the Federal Poverty Level (FPL) and children ages one to six up to 154 percent FPL with Medicaid funds and up to 400 percent FPL with CHP funds. The State will continue to allow disenrollments of children in the following cases:
- If they are no longer NYS residents;
- Upon enrollee request;
- Enrollment in error;
- Non-compliance with eligibility requirements;
- Death; and
- If they are receiving treatment in a setting where Medicaid eligibility is not available, such as an Institute for Mental Disease (IMD).
The State estimates that an average of 66,177 young children will receive continuous enrollment on an annual basis under this proposal. The total estimated state and federal funds to implement the proposal is $44.5 million annually. The State plans to implement continuous eligibility for children by September 1st.
The draft amendment is available here. Public comment may be submitted to 1115waivers@health.ny.gov through February 16th. The State will also host two virtual public hearings in February, details for which are available here.
CMS Approves New York SPA Expanding CHIP Eligibility
On January 11th, CMS approved New York’s request for a State Plan Amendment (SPA) to extend CHIP eligibility for children from-conception-to-end-of-pregnancy (FCEP) with family incomes up to and including 218 percent FPL whose birth parents are not otherwise eligible for Medicaid or CHIP. Coverage for the FCEP population is identical to the benefit package provided to pregnant individuals in Medicaid. The SPA is effective April 1, 2022.
The SPA is available here. The CMS approval letter is available here.
DFS Issues Proposed Guidance on Use of Consumer Data and Artificial Intelligence Systems
On January 17th, the NYS Department of Financial Services (DFS) issued proposed guidance for insurance plans regarding the use of artificial intelligence systems (AIS) and external consumer data and information sources (ECDIS) used for insurance underwriting and pricing. DFS notes that while AIS and ECDIS can simplify and improve the underwriting and pricing process, “the self-learning behavior of AIS may also increase the risks of unfair or unlawful discrimination in violation of the Insurance Law, which may disproportionately impact vulnerable communities or otherwise undermine the New York insurance market.”
Specifically, the guidance outlines DFS’s expectations for developing a governance and risk management framework for the use of ECDIS, artificial intelligence, and other predictive models to mitigate potential harm to consumers and comply with all relevant legal obligations. The guidance expects insurers to:
- Analyze ECDIS and AIS for unfair and unlawful discrimination;
- Demonstrate the actuarial validity of ECDIS and AIS;
- Maintain a corporate governance framework that provides appropriate oversight of the insurer’s use of ECDIS and AIS; and
- Maintain appropriate transparency, risk management, and internal goals.
The proposed guidance is available here. The DFS press release is available here. Comments may be submitted to innovation@dfs.ny.gov with “Proposed Circular Letter on the use of AI and ECDIS in Insurance Underwriting and Pricing” through March 17th.
CMS Approves SPA on Medicaid Reimbursement for Interprofessional Consultations and Store-and-Forward Telehealth
On December 12th, CMS approved New York’s request for a SPA to add interprofessional consultations to the list of services that may be reimbursed by Medicaid under telehealth store-and-forward services. Interprofessional consultations “assist the originating site provider in the management of patients whose medical needs are outside of the originating provider’s expertise and/or scope of practice.” The SPA also ensures that such services are reimbursed at parity with in-person visits by changing the reimbursement for store-and-forward technology from 75% to 100% of the applicable evaluation and management fee. The SPA is effective retroactive to April 1, 2023.
The SPA is available here. The CMS approval letter is available here.