Weekly Health Care Policy Update – February 27, 2023

March 7, 2023

In this update: 

  • Federal Agencies
    • OMB Issues Biden Administration’s Fall 2022 Regulatory Agenda
    • DEA Proposes Rule on Post-PHE Telehealth Prescribing of Controlled Substances
    • CMS Releases Provider-Specific Fact Sheets for the End of the Covid-19 PHE
    • CMMI Publishes Primary Care First Model Evaluation Report
    • CMS Publishes Analysis of SNF Use of 3-Day Waivers in ACOs
    • HHS OCR Issues Report on HIPAA Compliance and Breaches
    • CMS Requests Comment on QRS/QHP Enrollee Survey Changes
  • New York State Updates
    • Governor Hochul Extends Statewide Disaster Emergency Due to Health Care Staffing Shortages
    • DOH Hosts 2023-24 Executive Budget Briefing
    • DOH Announces Expiration of Certain Health Home Covid-19 Flexibilities on April 1st 
    • DOH Rescinds Covid-19 Limitations on Non-Essential Elective Procedures 
    • DFS Announces Request for Public Comment on Audits of Pharmacies by PBMs
    • DOH Announces Details on Transition of Medicaid NEMT Benefit Management
    • DOH Proposes Medicaid Coverage of Gambling Disorder Treatment and Rate Increase for OASAS Residential Services
  • Funding Opportunities
    • HRSA Opens Applications for 2023 Advanced Nursing Education Workforce Program
    • DOH Announces First Cycle of New Nurses Across New York Loan Repayment Program

Federal Agencies

OMB Issues Biden Administration’s Fall 2022 Regulatory Agenda
On February 22nd, the Office of Management and Budget (OMB) published the Biden Administration’s Fall 2022 Unified Agenda for regulation. Published twice each year, the agenda describes regulatory actions currently under development in the Administration, with an estimated timeline for release. It is organized by department. The Department of Health and Human Services (HHS), in its statement of priorities, highlighted the following goals: 

  • Expanding access to health care by streamlining enrollment processes and expanding the availability of behavioral health through telehealth;
  • Advancing equity in health and social outcomes, including through rules prohibiting discrimination;
  • Enhancing public health preparedness; and
  • Supporting the wellbeing of families and communities through improving community-based services for older people and youth.

The statement specifically highlights the following: 

  • HHS plans to finalize its “Streamlining Eligibility and Enrollment” proposed rule from August 2022, which would make changes to Medicaid and Children’s Health Insurance Program (CHIP) rules and processes to expand eligibility and reduce the burden of renewals. The rule was briefly summarized in SPG’s September 6, 2022 update here, and a fact sheet is here.
  • HHS plans to issue a new rule to establish cultural competency and person-centered care requirements for all Medicare and Medicaid-participating providers.
  • HHS plans to issue a new rule on requirements for certain plans to avoid provider discrimination.
  • HHS and other departments will issue a new rule clarifying and expanding the implementation of mental health parity requirements.
  • HHS plans to finalize its rule establishing civil monetary penalties (CMPs) for organizations engaging in prohibited information blocking practices, as well as a complementary rule to establish further disincentives for providers who engage in information blocking.
  • HHS will propose rules to improve electronic exchange of health data for Medicare Advantage (MA), Medicaid, CHIP, and Exchange plans.
  • HHS plans to propose rules that would institute minimum staffing standards in nursing homes.

The full Fall 2022 regulatory agenda is available here. Information on individual rules can be viewed on OMB’s site here.
 
DEA Proposes Rule on Post-PHE Telehealth Prescribing of Controlled Substances
On February 24th, the Drug Enforcement Agency (DEA) proposed a rule that would establish a pathway for the prescribing of controlled substances to patients through telehealth without an in-person evaluation. Such prescriptions are typically forbidden under the Ryan Haight Act. Under the new proposed rule, the following exceptions will now apply: 

  • 30-day telemedicine prescription: Prescribers may issue prescriptions through telemedicine without an in-person examination for non-narcotic drugs falling under Schedules III through V, based on their review of the last year of a patient’s prescriptions in their state’s prescription drug monitoring program (PDMP). Such prescriptions would be limited to a total of a 30-day supply, after which in-person examination is required.
  • Qualified telemedicine referral: Upon referral from another practitioner who has conducted an in-person examination, prescribers may issue prescriptions through telemedicine for Schedule II through V drugs, including narcotics, without conducting their own in-person examination. They must also review the last year of patient data in the PDMP.

For patients who began receiving such prescriptions during the Covid-19 PHE, DEA is proposing an additional 180-day waiver period for continuity of care. If the PHE expires on May 11th as scheduled, prescribers could continue telemedicine prescription for existing patients through November 7th.
 
This rule does not apply to buprenorphine and other Schedule III through V drugs for maintenance or withdrawal management of opioid use disorder, for which DEA published a separate proposed rule. This rule would allow prescribers to use telemedicine, including audio-only methods, to prescribe buprenorphine, with similar conditions as the “30-day telemedicine prescription” route above, namely: 

  • The prescriber must review the patient’s PDMP data for the last year; and
  • The supply must be limited to a total of 30 days until an in-person examination is conducted.

The rules do not discuss the planned creation of a “Special Registration for Telemedicine,” required under the SUPPORT Act of 2018, which would expand the ability of prescribers to receive a special registration that would allow them to prescribe controlled substances without an in-person examination.
 
The telemedicine rule is available here and the buprenorphine rule is available here. Comments will be accepted for 30 days after its official publication in the Federal Register, which is scheduled for March 1st.
 
CMS Releases Provider-Specific Fact Sheets for the End of the Covid-19 PHE
On February 23rd, the Centers for Medicare and Medicaid Services (CMS) released an update about how the Medicare, Medicaid, CHIP, and Marketplace programs will be affected at the conclusion of the Covid-19 public health emergency (PHE) on May 11th.
 
The update includes provider-specific fact sheets for: 

  • Physicians and other clinicians;
  • Hospitals and critical access hospitals (CAHs);
  • Teaching hospitals, teaching physicians and medical residents;
  • Long-term care facilities;
  • Home health agencies;
  • Hospice;
  • Inpatient Rehabilitation Facilities (IRFs);
  • Long-term care hospitals and extended neoplasticism disease care hospitals;
  • Rural health clinical and federally qualified health centers;
  • Laboratories;
  • Medicare Shared Savings Program (MSSP) participants;
  • Durable Medical Equipment;
  • MA and Part D Plans;
  • Ambulances;
  • End Stage Renal Disease facilities;
  • Participants in the Medicare Diabetes Prevention Program; and
  • Intermediate Care Facilities.

All fact sheets are available here.
 
CMMI Publishes Primary Care First Model Evaluation Report
On February 24th, the Center for Medicare and Medicaid Innovation (CMMI) published its First Evaluation Report for the Primary Care First (PCF) model. The goal of the PCF is to improve quality, improve patient experience, and reduce expenditures through better access to advanced primary care services. The model emphasizes five functions: access and continuity, care management, comprehensiveness and coordination, patient and caregiver engagement, and planned care and population health. Participants coordinate with CMS and 13 public and private payers to receive enhanced and alternate payments, data feedback, and learning to support transformation. Participants take upside and downside financial risk for the most common services for their attributed population.
 
CMS launched PCF in 2021 across 846 practices, serving over 500,000 mostly White and affluent populations. Most practices (760) were in the lowest risk group, treating patients with lower acuity. Only 13 payers participated, and only 5 of these payers offered an alternative to fee-for-service payments, falling short of CMS’s goal. Overall, PCF payments averaged about 20% higher than participating practices would have received under the Medicare physician fee schedule. Care delivery changes were largely enhancements of existing activities.
 
The full report is available here.
 
CMS Publishes Analysis of SNF Use of 3-Day Waivers in ACOs
On February 17th, CMS published a new analysis describing trends in use and outcomes associated with waiving the three-day (two-night) stay requirement at an acute care hospital before discharge to a skilled nursing facility (SNF). In traditional Medicare, beneficiaries must have a medically necessary inpatient hospital stay of at least three consecutive days for the program to pay for SNF services. CMS has waived these requirements for certain Accountable Care Organizations (ACOs). The waiver allows these ACOs to admit patients to certain SNFs directly from the community or after shorter hospital stays.
 
Overall, the analysis found that waiver stays led to shorter SNF lengths of stay and higher rates of discharge-to-home, as well as lower or similar rates of adverse outcomes relative to non-waiver stays. Direct waiver admissions were most common, particularly for beneficiaries who needed rehabilitation following an injury but not hospitalization. However, very few SNF stays were SNF waiver stays.
 
The full report is available here.
 
HHS OCR Issues Report on HIPAA Compliance and Breaches
On February 17th, the HHS Office of Civil Rights (OCR) delivered two reports to Congress, entitled “HIPAA Privacy, Security, and Breach Notification Rule Compliance” and “Breaches of Unsecured Protected Health Information,” which cover compliance with and breaches of patient privacy and security rules in the Health Insurance Portability and Accountability Act (HIPAA) that occurred in the year 2021. The reports are intended to: 

  • Benefit regulated entities to assist in their HIPAA compliance efforts;
  • Share steps taken by OCR to investigate complaints, breach reports, and compliance reviews regarding potential violations of the HIPAA rules; and
  • Include important information on the numbers of HIPAA cases investigated, areas of noncompliance, and insights into trends such as cybersecurity readiness.

The first report specifically identifies the number of complaints received, the method by which those complaints were resolved, the number of compliance reviews initiated by OCR, and the outcomes of each review. The second report specifically identifies the number and nature of breaches of unsecured protected health information (PHI) that were reported to the Secretary of HHS during calendar year 2021 and the actions taken in response to those breaches.
 
Both reports are available here.
 
CMS Requests Comment on QRS/QHP Enrollee Survey Changes
On February 21st, CMS requested comment on the Draft 2023 Call Letter for the Quality Rating System (QRS) and the Qualified Health Plan (QHP) Enrollee Experience Survey. The Call Letter proposes changes to the QRS and QHP Enrollee survey in four key areas: 

  • Refinements to measures in the QRS measures set;
  • Expansion of additional data collection and reporting methods;
  • Revisions to the QRS scoring methodology; and
  • QRS and QHP Enrollee survey refinements.

The Call Letter specifically notes CMS’ interest in feedback around its new “Universal Foundation” for quality measures. The Universal Foundation includes a core set of measures aligned across quality rating and value-based care programs. CMS intends it to serve as a building block upon which programs would add additional aligned or program-specific measures, in an effort to focus providers and payer attention, reduce burden, allow for consistent stratification of measure to identify disparities in care, accelerate the transition to interoperable, digital quality measures, and allow for cross-comparisons across quality and value-based care programs to better understand what drives quality and equity improvement.
 
The Call Letter is available here. Comments may be submitted to Marketplace_Quality@cms.hhs.gov with “Marketplace Quality Initiatives (MQI)-Draft 2023 QRS and QHP Enrollee Survey Call Letter” in the subject line, by March 22nd. The final Call Letter will be published in late spring 2023.

New York State Updates

Governor Hochul Extends Statewide Disaster Emergency Due to Health Care Staffing Shortages
On February 21st, Governor Hochul issued Executive Order 4.18, which extends through March 23rd the provisions in Executive Order 4 and its successors that reinstated many workforce and scope of practice flexibilities that applied during the original New York State Covid-19 public health emergency. Certain provisions of the Order have previously expired, including those related to prior authorization and nursing home staffing and revenue requirements.
 
Executive Order 4.18 also ends the following flexibilities: 

  • Allowing recent graduates of certain health care programs to practice in NYS under supervision; and  
  • Allowing hospitals to use qualified volunteers or personnel affiliated with different hospitals.  

The Executive Order is available here. SPG has updated its Regulatory Waiver Tracker, which is available here.
 
DOH Hosts 2023-24 Executive Budget Briefing
On February 23rd, the New York State (NYS) Department of Health (DOH) hosted a webinar that reviewed the Medicaid and other health care provisions included in the Governor’s proposed 2023-24 Executive Budget. The webinar provided an overview of Medicaid spending under the proposed budget and outlined the impact of the Medicaid redetermination process, during which enrollment in Medicaid is project to decline to 6.9 million individuals in 2024. The webinar also reviewed various budget proposals, including but not limited to: 

  • Discontinuation of quality incentive pools;
  • Increases to the Medical Loss Ratio (MLR) for managed care plans;
  • Reforms to managed long term care (MLTC), including a proposal to competitively procure MLTC plans;
  • The Essential Plan expansion waiver;
  • The NYRx pharmacy transition and associated reinvestments;
  • “Graduation” of low- and medium-acuity Health Home members by limiting the use of rate codes 1873 and 1874 to 9 months;
  • Expansion of existing licensure thresholds to 30% for clinics to increase access to integrated physical and behavioral health services;
  • Expanding Medicaid reimbursement for services provided by mental health professionals in Article 28 settings;
  • Benchmarking Medicaid fee-for-service reimbursement rates to 80% of current Medicare reimbursement rates;
  • Expanding access to dental services for children and individuals with intellectual/developmental disabilities; and
  • Statewide Medicaid coverage and higher reimbursement for doulas.

The presentation is available here and a recording of the webinar will be available here.
 
DOH Announces Expiration of Certain Health Home Covid-19 Flexibilities on April 1st 
On February 21st, DOH issued guidance on the expiration of Covid-19-related flexibilities for Health Homes. Effective April 1st, these flexibilities will end or be modified as follows: 

  • Plans of Care must be signed by the member/parent/guardian/legally authorized representative, and verbal consent is no longer permitted (signatures may be collected on paper forms or electronically).
  • Plans of Care and Comprehensive Assessments must be completed within 60 calendar days of Health Home enrollment.
  • Multidisciplinary/care team meetings are no longer waived and must be conducted upon request of the member/family, or as determined by the care manager (may be conducted in-person or virtually as determined by the member/parent/guardian/legally authorized representative).
  • Consent to share information must be provided in writing, either collected on paper forms or electronically, and verbal consent in lieu of a signature is no longer permitted.

Guidance regarding the delivery of Health Home care management services in-person or via telehealth is under development and will be issued separately.
 
The guidance is available here. Questions may be submitted to healthhomes@health.ny.gov.
 
DOH Rescinds Covid-19 Limitations on Non-Essential Elective Procedures 
On February 17th, DOH rescinded guidance (available here) that limited non-essential elective procedures for in-hospitals or systems with limited capacity due to the ongoing Covid-19 pandemic. The decision to rescind the guidance was based on a decrease in new Covid-19 admissions and daily hospitalizations statewide. DOH will continue to monitor hospital bed capacity, new Covid-19 cases, and hospital admissions to ensure that community access to appropriate emergency and inpatient care is maintained.
 
The announcement is available here. Questions may be submitted to hospinfo@health.ny.gov.
 
DFS Announces Request for Public Comment on Audits of Pharmacies by PBMs
On February 23rd, the NYS Department of Financial Services (DFS) announced a request for public engagement to support the development of regulatory standards for Pharmacy Benefit Managers (PBMs). The request for public comment specifically seeks information on whether and how DFS should regulate audits of pharmacies conducted by PBMs. The request includes specific questions targeted at both pharmacies and PBMs regarding the current PBM audit process, including the scope and duration of the audits, communication by PBMs to pharmacies during the audit, documentation requirements, and the impact of audits on pharmacy staffing and network participation, among others.
 
The DFS press release is available here. The request for public comments is available here. Responses should be emailed to PBM@dfs.ny.gov through March 24th with “PBM2022-07” in the subject line.
 
DOH Announces Details on Transition of Medicaid NEMT Benefit Management
On February 22nd, DOH issued a public notice notifying stakeholders that effective on or after May 1st, based on a competitive procurement, non-emergency medical transportation (NEMT) will be transitioned from the current Medicaid Transportation Managers to one or more Medicaid Transportation Broker(s). The Medicaid Transportation Broker(s) will contract directly with transportation providers to develop an adequate network, ensure compliance with transportation network driver and vehicle requirements, and negotiate fee-for-service transportation provider reimbursement.
 
The State will reimburse the Medicaid Transportation Broker(s): 

  • Monthly through an administrative fee on a per-member per-month basis for each Medicaid-eligible individual whose transportation is being managed by the broker; and
  • Annually through a risk-sharing arrangement pursuant to a gain-sharing agreement in which the broker will share with the State net income gains over specified limits (the State will not share in net losses).

Additional details are available in the State Register here. Comments may be submitted to spa_inquiries@health.ny.gov.
 
DOH Proposes Medicaid Coverage of Gambling Disorder Treatment and Rate Increase for OASAS Residential Services
On February 22nd, DOH issued a public notice announcing its intent to authorize Medicaid reimbursement for standalone problem gambling disorder treatment. Currently, problem gambling is authorized when it is a secondary treatment for substance use disorder. DOH proposes that, effective on or after March 1st, the NYS Medicaid benefit will include coverage and reimbursement for problem gambling treatment provided to individuals receiving Office of Addiction Services and Supports (OASAS) certified services. Providers of such services must have the OASAS gambling designation.
 
DOH also announced that, effective on or after March 1st, the State will adjust rates for OASAS Part 820 Residential Services. The stabilization element of the service in the downstate region will receive a parity adjustment with respect to the upstate region, and will also receive a 15 percent rate increase. The rehabilitation element will receive a 4.5 percent rate increase.
 
Additional details are available in the State Register here. Comments may be submitted to spa_inquiries@health.ny.gov.

Funding Opportunities

HRSA Opens Applications for 2023 Advanced Nursing Education Workforce Program
On February 14th, the Health Resources and Services Administration (HRSA) issued a Notice of Funding Opportunity (NOFO) for the 2023 cycle of the Advanced Nursing Education Workforce (ANEW) program. This year, the ANEW program will offer $34.8 million to up to 53 awardees operating programs that sponsor tuition and other eligible supports for the training and graduation of advanced practice registered nurses (APRNs) specializing in primary care, mental health and substance use disorder care, and/or maternal health care.
 
Eligible applicants may include nursing schools, nursing centers, academic health centers, and other public or private not-for-profit entities deemed appropriate by HRSA. Each awardee would be eligible for up to $650,000 per year for four years. Awardees must provide at least 70% of the funds through traineeship awards of up to $25,000 per year per full-time student or $15,000 per year per part-time student.
 
More information is available here. The NOFO is available here. Applications are due April 7th.
 
DOH Announces First Cycle of New Nurses Across New York Loan Repayment Program
On February 23rd, DOH issued a Solicitation of interest (SOI) for the first cycle of the new Nurses Across New York Loan Repayment Program. This program, established by the 2022-23 Enacted NYS Budget, makes funds available to help recruit registered professional nurses (RNs) and licensed practical nurses (LPNs) and encourage them to remain in medically underserved areas of the state. Up to $2.5 million in total funding is available through this SOI.
 
Awards will provide up to $25,000 for an RN or $10,000 for an LPN who agrees to practice in an underserved area for a three-year service obligation period. It is expected that 80 percent of funding will be awarded to RNs and 20 percent will be awarded to LPNs. Funding may be awarded directly to the RN or LPN, or to a health care facility to recruit or retain a nurse by providing the nurse funds to repay qualifying outstanding debt. Eligible health care facilities include: 

  • Article 28 general hospitals, diagnostic and treatment centers (D&TCs), or nursing homes;
  • Article 31 Office of Mental Health (OMH) facilities;
  • Article 32 OASAS facilities;
  • Certified Home Health Agencies (CHHAs) or Licensed Home Care Services Agencies (LHCSAs); and
  • Medical practices registered as a Professional Corporation (PC) or Professional Limited Liability Corporation (PLLC).

The health care facility must be located in an underserved area, as defined in Attachment 6 of the SOI.
 
The SOI is available here. Applications are due on April 12th. Questions may be submitted to NANY@health.ny.gov through March 9th.