In this update:
- Federal Agencies
- CMS Proposes New Nursing Home Transparency Rule
- FDA Advisory Committees Recommend Making Naloxone Available OTC
- CBO Issues Report on the Debt Ceiling
- CMS Proposes NCD for Power Seat Elevation Equipment on Wheelchairs as DME
- MEDCAC Makes Recommendations for Revising CMS Rules on Coverage with Evidence Development
- CMMI Announces Three New Models on Prescription Drugs
- CMMI Extends BPCI Advanced Model through 2025 with New Application Period
- HHS Selects First Six QHINs to Participate in TECFA
- CMS Measures Under Consideration Entry/Review Information Tool Now Open
- Other Updates
- CDC Releases Data on Recent Changes in Suicide Rates
- CDC Releases Data from the Youth Risk Behavior Survey
- American College of Healthcare Executives Releases Annual Survey
- Updated SPG Regulatory Waiver Tracker Available
- New York State Updates
- Governor Hochul Announces Statewide Health Care Facility Transformation Program Round 3 and 4 Awardees
- DOH Delays Medicaid Managed Care Carve-In for School-Based Mental Health Centers to April 1, 2024
- DOH Issues PHE Unwind Clarification for Health Homes and Children’s Waiver Services
- DFS Issues Reminder that Plans Must Accept Psychiatrist E/M Codes Based on Current CPT Rules
- DFS Issues Proposed New and Amended Regulations on Pharmacy Benefit Managers
- DOH Updates Applied Behavior Analysis Provider Manual
- OPWDD Adopts Regulations to Limit the Number of Individuals in Family Care Homes
- DOH to Host Webinar Reviewing Medicaid Proposals Included in 2023-24 Executive Budget
- Funding Opportunities
- OMH Releases RFP To Build and Operate 48-Bed Community Residence-Single Room Occupancy Program
- DOH Releases RFP for Web Based Training for Early Intervention Program Providers
- HRSA Offers $30 Million for FQHCs to Increase Access to Early Childhood Services
Federal Agencies
CMS Proposes New Nursing Home Transparency Rule
On February 13th, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule to require nursing homes to disclose additional ownership and management information to both CMS and states. The rule implements portions of section 6101 of the Affordable Care Act, and requires nursing homes enrolled in Medicare or Medicaid to disclose information regarding owners, operators, management, and entities that lease or sublease property to nursing homes. Information would be collected upon initial enrollment, revalidation, changes in ownership, or, for Medicaid nursing facilities, as prescribed by a state.
Given CMS’s increased concerns about the quality of care and operations of nursing facilities owned by private equity companies and other types of investment firms, the rule also provides definitions of “private equity company” and “real estate investment trust” to encourage disclosure of whether direct and indirect nursing home owners are private equity companies or real estate investment trusts. This additional data provided by nursing homes will be publicly reported and available, to allow consumers to make more informed choices and to allow CMS to investigate any correlation between care outcomes and care environments.
A fact sheet is available here. The proposed rule may be found in the Federal Register here. The rule will remain open for comment until April 14th.
FDA Advisory Committees Recommend Making Naloxone Available OTC
On February 15th, members of two Food and Drug Administration (FDA) advisory committees voted 19-0 to recommend making naloxone nasal spray available over the counter (OTC). Members agreed that the evidence of the benefits of naloxone, a medication first approved in 1971 and used to reverse opioid overdoses, far outweighs the risk of granting the drug OTC status. Committee members agreed that the drug fits the parameters of nonprescription products: safe, has low misuse and abuse potential, does not require a health care practitioner for safe and appropriate use, the condition to be treated is self-diagnosable, and has adequate labeling so consumers can self-diagnose, self-select, self-administer, and know when to stop use.
Two manufacturers, Emergent Biosolutions and Harm Reduction Therapeutics, are both applying for nonprescription status, and the FDA has granted both companies a priority review. Approval of such nonprescription use could mean that the drug would be available not only at pharmacies, but at vending machines, convenience stores, supermarkets, and big box stores.
More information is available here.
CBO Issues Report on the Debt Ceiling
On February 15th, the Congressional Budget Office (CBO) issued a report on the federal debt and the statutory limit. In the report, the CBO projects that “if the debt limit is not raised or suspended, the government’s ability to issue additional debt – other than to replace maturing securities – will be exhausted between July and September 2023.”
The Treasury already reached the current debt limit of $31.4 trillion last month and has therefore begun using extraordinary measures to allow it to continue to borrow additional amounts for a limited time. Congressional negotiations to raise the debt limit have yet to produce meaningful legislation, with Republicans insisting that spending cuts be part of any debt limit legislation, and President Biden insisting that the issues are disconnected.
The CBO report is available here.
CMS Proposes NCD for Power Seat Elevation Equipment on Wheelchairs as DME
On February 15th, CMS issued a proposed National Coverage Determination (NCD) to expand coverage for power seat elevation equipment on certain power wheelchairs to Medicare beneficiaries. If finalized, the NCD would allow coverage of power seat elevation equipment for beneficiaries with a Group 3 power wheelchair, including it as durable medical equipment (DME). Such wheelchairs are designed to meet the needs of people with severe disabilities and improve beneficiary health as they transfer from the wheelchair to other services. The NCD proposes that coverage is reasonable and necessary for individuals using power wheelchairs when the following conditions are met:
- The individual performs weight bearing transfers to/from the power wheelchair while in the home, using either their upper extremities during a non-level (uneven) sitting transfer and/or their lower extremities during a sit to stand transfer. Transfers may be accomplished with or without caregiver assistance and/or the use of assistive equipment (e.g. sliding board, cane, crutch, walker); and
- The individual has undergone a specialty evaluation by a practitioner who has specific training and experience in rehabilitation wheelchair evaluations, such as a physical therapist (PT) or occupational therapist (OT), that assesses the individual’s ability to safely use the seat elevation equipment in the home.
Their proposed NCD will be open for public comment for 30 days, until March 17th. More information is available here.
MEDCAC Makes Recommendations for Revising CMS Rules on Coverage with Evidence Development
On February 14th, the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) recommended that the Medicare program make changes to its regulatory option to authorize Medicare coverage with evidence development (CED). Under CED, Medicare may cover items and services only conditionally, when they are furnished in the context of approved clinical studies or with the collection of additional clinical data. CED was most recently applied to the class of Alzheimer’s drugs that target amyloid plaques in the brain, which includes Aduhelm and Leqembi. Prior to MEDCAC’s most recent meeting, the CED process had not been evaluated in eight years.
MEDCAC advisors intend to ensure that “CED studies are evaluated with consistent, feasible, transparent, and methodologically rigorous criteria” and that the criteria are “appropriate to ensure that CED-approved studies will produce reliable evidence that CMS can rely on to help determine whether a particular item or service is reasonable and necessary.” To that end, MEDCAC made several recommendations:
- A new requirement for a written plan for completing a study, including a timeline for research completion;
- A new requirement that the research generate data showing evidence of net benefit, with clarity as to who will benefit;
- A new requirement that study participants reflect the diversity of all Medicare beneficiaries in terms of race and ethnicity, gender, and socioeconomic status; and
- A new requirement that data generated be shared with Medicare or a third party.
More information about MEDCAC’s meeting is available here.
CMMI Announces Three New Models on Prescription Drugs
On February 14th, the CMS Innovation Center (CMMI) released a report that announces that it will test three new models, in response to the President’s Executive Order 14087 on “Lowering Prescription Drug Costs for Americans.” This Order directed CMMI to consider testing new models to “lower drug costs and promote access to innovative drug therapies for beneficiaries enrolled in the Medicare and Medicaid programs, including models that may lead to lower cost-sharing for commonly used drugs and support value-based payment that promotes high-quality care.” The three selected models are:
- The Medicare $2 Drug List: Under this model (the Medicare High-Value Drug List Model), Part D plans would be encouraged to offer a low, fixed copayment across all cost-sharing phases of the Part D drug benefit for a standardized Medicare list of generic drugs that treat chronic conditions. Patients picking plans that participate in the model will have more certainty that their out-of-pocket costs for these generic drugs will be capped at a maximum of $2 per month per drug.
- The Cell and Gene Therapy Access Model: Under this model, state Medicaid agencies would assign CMS to coordinate and administer multi-state, outcomes-based agreements with manufacturers for certain cell and gene therapies. As new therapies come to market, this will help Medicaid beneficiaries gain access to life-changing, high-cost specialty drugs for illnesses like sickle cell disease and cancer.
- The Accelerating Clinical Evidence Model: CMS would develop payment methods for drugs approved under accelerated approval, in consultation with the Food and Drug Administration, to encourage timely confirmatory trial completion and improve access to post market safety and efficacy data. This would reduce Medicare spending on drugs that have no confirmed clinical benefit.
In addition, CMS identified three areas in which CMMI will evaluate potential future models:
- Accelerating biosimilar adoption;
- Data access changes to support price transparency; and
- Cell and gene therapy access in Medicare fee-for-service.
The full report is available here.
CMMI Extends BPCI Advanced Model through 2025 with New Application Period
On February 21st, CMMI announced that it would extend the Bundled Payments for Care Improvement (BPCI) Advanced model by two years, through 2025. New applicants may apply to participate in a third cohort that will begin in 2024, while existing participants may continue to participate without the need for a new application.
Under BPCI Advanced, participants receive a single retrospective bundled payment for all services rendered to a patient during a clinical episode. Episodes start when a patient begins a qualifying inpatient stay or has a qualifying outpatient procedure, identified retrospectively based on claims coding. An episode lasts for 90 days after the end of the originating inpatient stay or outpatient procedure.
Applicants may either convene a group of downstream providers (Convener Applicants) or participate solely on their own behalf (Non-Convener Applicants). Eligible Convener Applicants must be Medicare-enrolled providers, suppliers, or Accountable Care Organizations (ACOs). Non-Convener Applicants must be acute care hospitals or physician group practices.
More information on the BPCI Advanced model is available on CMMI’s website here. CMMI has posted the Request for Applications here. Applications will be accepted through May 31st.
HHS Selects First Six QHINs to Participate in TECFA
On February 13th, the Department of Health and Human Services (HHS) announced that it had approved six organizations as Qualified Health Information Networks (QHINs) under the Trusted Exchange Framework and Common Agreement (TEFCA) to facilitate patient health care data sharing. The organizations include Epic, CommonWell Health Alliance, Health Gorilla, Kn02, eHealth Exchange, and KONZA. The selection of these six organizations was approved by the Sequoia Project, the Recognized Coordinating Entity (RCE).
The QHINs are intended to serve as “networks of networks” that will allow for the sharing of secure basic clinical information with one another. The QHINs have entered a legal contract called the Common Agreement which lays out common policies and practices to allow for expanded connectivity among the networks. HHS has the option to choose additional entities to become QHINs in the future. The six chosen entities must now go through pre-production testing and project planning. Although they have 12 months to be onboarded, all organizations have committed to begin exchanging data by the end of 2023.
CMS Measures Under Consideration Entry/Review Information Tool Now Open
On February 13th, CMS opened its Measures Under Consideration (MUC) Entry/Review Information Tool (CMS MERIT) for 2023 quality and efficiency measure submissions. The tool allows measure developers to submit their clinical quality measures for consideration by CMS. The process was established under Section 3014 of the Affordable Care Act, creating a pre-rulemaking process for the selection of quality and efficiency measures.
The MERIT tool can be found here. The measure submission period will close in May, and the MUC list will be published no later than December 1st, with final recommendations published February 1, 2024.
Other Updates
CDC Releases Data on Recent Changes in Suicide Rates
On February 10th, the Centers for Disease Control and Prevention (CDC) released data on recent changes in suicide rates. Following two years of declines in suicides from 2019 to 2020, overall suicides increased to 48,183 in 2021, nearly reaching the 2018 peak of 48,344. Some notable findings included:
- Age-adjusted suicide rates in 2021 were highest among non-Hispanic American Indian or American Native persons (28.1 per 100,000), followed by non-Hispanic White persons (17.4 per 100,000). In the former case, this represented a 26% increase since 2018, compared to a 4% decrease in the latter cohort.
- Suicide rates also increased significantly among Black persons aged 10-24 years (36.6%) from 2018 to 2021.
- Suicide rates in the 25 to 44 age group were also 5% higher overall, while rates among persons aged 45 to 64 decreased 12.4%.
The full dataset is available here.
CDC Releases Data from the Youth Risk Behavior Survey
On February 13th, CDC released data from the Youth Risk Behavior Survey (YRBS) collected in the fall of 2021. The YRBS is the largest public health surveillance system in the U.S. and has monitored multiple health-related behaviors among high school students since 1991. The latest batch of data is the first to have been released since the start of the Covid-19 pandemic. Key findings from this YRBS include:
Teenage Girls
- Almost 1 in 5 teen girls experienced sexual violence in the past year—a 20% increase since 2017.
- More than 1 in 10 teen girls reported they had ever been forced to have sex—up 27% since 2019 and the first increase since CDC began monitoring this measure.
- 3 in 5 girls felt persistently sad and hopeless, a marker for depressive symptoms, in 2021, up nearly 60% from 2011.
- More than 1 in 4 girls reported they seriously considered attempting suicide in 2021, up nearly 60% from 2011.
- More than 1 in 10 girls reported they attempted suicide in 2021, up 30% from a decade ago.
- Alcohol use is also higher among girls than boys.
LGBQ+ Teens
- In 2021, more than 1 in 10 LGBQ+ students did not go to school because of safety concerns. Nearly 1 in 4 reported experiencing sexual violence, and nearly 1 in 4 were bullied at school.
- In 2021, almost half of LGBQ+ students seriously considered attempting suicide, nearly 1 in 4 attempted suicide, and nearly 3 in 4 reported persistent feelings of sadness or hopelessness.
- In 2021, 1 in 5 LGBQ+ students reported having ever used illicit drugs.
The full report is available here.
American College of Healthcare Executives Releases Annual Survey
On February 13th, the American College of Healthcare Executives (ACHE) released its 2022 survey of hospital CEOs. The ACHE asked executives to rank 11 issues affecting their hospitals in order of concern. Workforce challenges topped the list followed by financial challenges, behavioral health issues, patient safety and quality, and government mandates. Issues of least concern included technology, population health management, and mergers, acquisitions, and partnerships. Within workforce challenges, CEOs expressed greatest concern about the shortage of registered nurses and technicians, followed by burnout among non-physician staff. Within financial challenges, CEOs expressed greatest concern about the increasing cost of labor and supplies. This is the second year in a row that workforce or personnel challenges topped the list.
The full survey can be found here.
Updated SPG Regulatory Waiver Tracker Available
As of February 14th, SPG has updated its Regulatory Waiver Tracker document to reflect the end of the New York State mask mandate and the planned end of the Covid-19 public health emergency on May 11th. This resource also includes a summary of New York State and federal policy, including extensions and proposed permanent amendments to telehealth regulations.
Our updated resource is available here.
New York State Updates
Governor Hochul Announces Statewide Health Care Facility Transformation Program Round 3 and 4 Awardees
On February 15th, Governor Hochul announced the award of $658 million to 127 projects through the Statewide Health Care Facility Transformation Program (SHCFTP). This program supports capital projects, debt retirement, working capital, and certain non-capital projects directly related to a capital project with the goal of facilitating health care transformation activities. This funding was awarded to applications submitted under the SHCFTP Round 3 RFA, which was initially released in September 2021 with applications due in February 2022. The awarded funds included the $208 million remaining from the SHCFTP Round 3 as well as $450 million in last year’s Budget for SHCFTP Round 4 which was dedicated to supplementing Round 3 funding. Awards ranged from $65,000 to almost $39 million, with $263 million awarded in New York City, $84 million in the Mid-Hudson region, $40 million in Long Island, and the remaining $271 million in the rest of the state.
SHCFTP Round 4 still has an additional $1.15 billion appropriated among four pools:
- $750 million is available for projects that “build innovative, patient-centered models of care”;
- $150 million is available for “technological and telehealth transformation projects”;
- $200 million is available for renovation of “emergency departments of regional significance,” which must be a Level 1 Trauma Center and meet other criteria (the RFA for this pool has been released); and
- $50 million is available for projects establishing nursing home alternatives.
Governor Hochul’s proposed Executive Budget also includes $1 billion in additional funding to support SHCFTP Round 5, which would dedicate an additional $500 million to each of the first two pools mentioned above.
The Governor’s press release is available here and a list of awardees is available here.
DOH Delays Medicaid Managed Care Carve-In for School-Based Mental Health Centers to April 1, 2024
On February 14th, the New York State (NYS) Department of Health (DOH) announced that the carve-in date for school-based health center (SBHC) services into the Medicaid managed care benefit package has been changed to “no sooner than April 1, 2024.” The Fiscal Year 2022 Enacted NYS Budget previously continued the carve-out of SBHC services “until at least April 1, 2023.”
Additional details are available here.
DOH Issues PHE Unwind Clarification for Health Homes and Children’s Waiver Services
On February 16th, DOH issued a notice to Health Homes and Children’s Waiver service providers announcing that it intends to issue guidance in the coming weeks regarding the impact of the end of the federal Public Health Emergency (PHE), which is set to expire on May 11th. The guidance will include:
- What services will be required to be delivered in-person and what may be delivered via telehealth for Health Home care management and Children’s Home and Community Based Services (HCBS);
- Minimum monthly service requirements to maintain enrollment in the Children’s Waiver;
- Obtaining member signatures for consents, Health Home Plans of Care; and HCBS service plans;
- Timelines for completion of the Health Home Plan of Care and Comprehensive Assessment;
- Requirements related to HCBS Level of Care eligibility determination and supporting documentation;
- Requirements related to multidisciplinary team/care team meetings;
- Utilization management by Medicaid Managed Care plans; and
- Guidance related to providing respite in-person.
DOH previously issued guidance (available here) indicating that children’s respite services flexibility expired on January 1, 2023, including the ability to bill for respite services delivered via telehealth.
The notice is available here. Questions may be submitted to BH.Transition@health.ny.govor healthhomes@health.ny.gov.
DFS Issues Reminder that Plans Must Accept Psychiatrist E/M Codes Based on Current CPT Rules
On February 10th, the NYS Department of Financial Services (DFS) issued a circular letter to regulated insurance plans reminding plans that they must accept and initiate processing of all health care claims submitted by psychiatrists pursuant to, and consistent with, the current version of the American Medical Association (AMA) current procedural terminology (CPT) codes, reporting guidelines, and conventions.
DFS was notified that some plans may be reviewing office and other outpatient E/M codes submitted by psychiatrists in a manner that is inconsistent with updates to the AMA CPT codes made in January 2021. These updates permit psychiatrists to base their choice of evaluation and management (E/M) code on either:
- The level of the medical decision-making as defined for each service provided; or
- The total time for the E/M service performed on the date of the encounter.
However, if psychotherapy is reported as an add-on code when a patient receives an E/M service and a psychotherapy service on the same day from the same psychiatrist, the E/M code is determined solely by the level of medical decision-making. Previously, E/M codes were generally based on history of present illness, physical examination, and medical decision-making. While documentation should include a medically appropriate history and physical or mental examination, the extent of these elements is not a factor in the selection of the level of office or other outpatient E/M codes.
The circular letter is available here. Questions may be submitted to health@dfs.ny.gov.
DFS Issues Proposed New and Amended Regulations on Pharmacy Benefit Managers
On February 15th, DFS issued proposed regulations to add a new Part 452 to Title 11 of the New York Codes, Rules, and Regulations (NYCRR) that outlines the general duties, accountability, and transparency provisions for pharmacy benefit managers (PBMs). The new Part 452:
- Clarifies, defines, and limits the duties, obligations, requirements, and other provisions related to PBMs under Public Health Law Section 280-a(2) and provides a safe harbor provision for compliance with the regulations;
- Defines, limits, and clarifies the requirements for PBMs to provide an accounting to health plans;
- Sets forth the terms and conditions of contract relating to PBM services provided to health plans by PBMs, including provisions related to an appeal to the bureau for a determination on disclosure; and
- Defines what activities, policies, practices, contracts, or arrangements shall be considered conflicts of interest for purposes of Public Health Law Section 280-a(2).
The proposed regulations also amend Part 6 of Title 11 NYCRR to require electronic filing of certain PBM documents.
The proposed regulations are available here. Comments may be submitted to Kristina.Magne@dfs.ny.gov through April 16th.
DOH Updates Applied Behavior Analysis Provider Manual
DOH has updated the Medicaid fee-for-service provider manual for licensed behavior analysts and certified behavior analyst assistants providing Applied Behavior Analysis (ABA) services. The updated guidance includes a new section on scope of practice/services that reviews the role of unlicensed individuals (“technicians”) in assisting with the delivery of ABA services under the direction of a licensed behavior analyst.
The updated provider manual is available here. Questions may be submitted to FFSMedicaidPolicy@health.ny.gov.
OPWDD Adopts Regulations to Limit the Number of Individuals in Family Care Homes
On February 15th, the Office for People with Developmental Disabilities (OPWDD) adopted an amendment to Part 687 of Title 14 NYCRR that changes the certified capacity of family care homes for individuals with intellectual and/or developmental disabilities to a maximum of four individuals (previously six). Current family care home providers will have their certified capacity reduced upon the discharge or death of an individual residing in the home until the capacity is reduced to a maximum of four. The amended regulations also define and clarify the roles and responsibilities of the sponsoring agency and substitute providers.
The notice of adoption is available in the State Register here.
DOH to Host Webinar Reviewing Medicaid Proposals Included in 2023-24 Executive Budget
On February 23rd from 9am to 10am, NYS Medicaid Director Amir Bassiri will host an informational webinar outlining the 2023-24 NYS Executive Budget Medicaid proposals. The webinar will include a question-and-answer period open to all interested stakeholders. Questions may be submitted in advance to mrtupdates@health.ny.gov.
Funding Opportunities
OMH Releases RFP To Build and Operate 48-Bed Community Residence-Single Room Occupancy Program
On February 1st, the NYS Office of Mental Health (OMH) released a Request for Proposal (RFP) for the development and operation of a 48-bed Community Residence-Single Room Occupancy (CR-SRO) program on the grounds of the Creedmoor Psychiatric Center campus in Queens. The site is a currently vacant building which requires substantial rehabilitation and has been designed as a 48-bed CR-SRO. There will be one award granted to oversee the development, secure licensure for the program, and operate the CR-SRO.
OMH will provide capital funding necessary for development of the project and Program Development Grant (PDG) funds are also available to assist with development. PDG funding will be based on the most current rate at the time of opening, which is currently $9,048 per bed. OMH will also provide operating reimbursement of $22,958 per bed, which will be available annually to the licensed CR-SRO in addition to consumer fees (currently $7,002 per person). OMH will cover debt service payments on the OMH capital financing needed to complete development. Eligible applicants are not-for-profit 501(c)(3) agencies with experience operating an OMH licensed, congregate mental health housing program and developing housing for persons with serious mental illness. Contracts will last for five years, starting on July 1st.
The RFP is available here. Applications are due on March 21st. Questions may be submitted to Amanda.Szczepkowski@omh.ny.gov by February 21st with the subject line “Operation of a CR-SRO RFP”.
DOH Releases RFP for Web Based Training for Early Intervention Program Providers
On January 30th, DOH released an RFP for qualified vendors to deliver statewide web-based training for Early Intervention Program (EIP) providers and other interested stakeholders. EIP is a statewide program that provides a wide range of therapeutic and supportive services for eligible children and their families. Qualified vendors will develop and deliver web-based training on early intervention topics for EIP stakeholders.
Eligible applicants must have at least two years of experience with learning management systems, developing training courses, and incorporating learning techniques. Contracts will last for five years, starting on July 1st.
The RFP is available here. Applications are due on March 1st.
HRSA Offers $30 Million for FQHCs to Increase Access to Early Childhood Services
On February 17th, the Health Resources and Services Administration (HRSA) issued a Notice of Funding Opportunity (NOFO) for $30 million for federally qualified health centers (FQHCs) to expand early childhood development services. Up to 150 FQHCs will receive $200,000 per year for two years for projects that aim to:
- Increase the number of children ages 0-5 who receive developmental screenings; and
- Increase the number of children and families assisted with follow-up services after a screening identifies an area of concern.
Grants may be used for activities that include workforce recruitment and development, improving the patient/caregiver experience, improving access and affordability, and addressing population health and health-related social needs.
More information, including the NOFO, is available on HRSA’s website here. Applications are due by March 17th.