Weekly Health Care Policy Update – November 5, 2021

In this update: 

• Covid-19 Updates
  • CMS Issues Covid-19 Health Care Staff Vaccination Interim Final Rule
  • Department of Labor Issues Emergency Temporary Standard for COVID-19 Vaccination
  • FDA and CDC Approve Vaccines for Kids Ages 5-11
• Legislative
  • Build Back Better Negotiations Continue; Updated Bill Text Released
• Regulatory
  • CMS Finalizes CY 2022 ESRD PPS Final Rule
  • CMS Finalizes CY 2022 Hospital OPPS and ASC Rule
  • CMS Finalizes CY 2022 Home Health PPS Rule
  • CMS Finalizes Omnibus Rule on CY 2022 Medicare Physician Fee Schedule, Quality Payment Program, and Medicare Diabetes Prevention Program
  • CMS Issues Interim Final Rule on CY 2022 Opioid Treatment Programs
  • HHS Releases Report on Health Insurance Coverage During Covid-19
  • HHS Announces $256 Million for Title X Family Planning Services
• Other
  • MACPAC Holds Second Meeting of 2021-2022 Cycle
  • AmeriCorps Seniors Issues ARP Funding Opportunity for Vaccination and Other Covid-19 Recovery Efforts
  • New Data Show Suicides Declined in 2020
• Congressional Hearings
• New York State Updates
  • Governor Hochul Announces New Administration Nominations and Appointments
  • Governor Hochul Signs Legislation to Establish the Substance Use Disorder Education and Recovery Fund
  • Federal Appeals Court Upholds New York State Vaccine Mandate for Health Care Workers
  • DOH Updates Covid-19 Vaccine Administration Guidance to Include Booster Doses and Vaccines for Children Ages 5-11
  • DOH Announces Implementation Dates of PCS/CDPAS Regulatory Changes
  • HERO Act Designation Extended Through December 15^th
  • OMH Releases Guidance and Attestation Form for Workforce Investments
  • OMH Releases Supplemental Disaster Emergency Billing and Documentation Guidance
  • Updated SPG Regulatory Waiver Tracker

COVID-19 Updates

CMS Issues Covid-19 Health Care Staff Vaccination Interim Final Rule
On November 2^nd, the Centers for Medicare and Medicaid Services (CMS) issued an emergency regulation requiring all health care facilities that participate in the Medicare and Medicaid programs and are regulated under CMS health and safety regulations to ensure that staff become fully vaccinated against Covid-19. This includes staff at all of the following provider types: 

• Ambulatory Surgery Centers
• Community Mental Health Centers
• Comprehensive Outpatient Rehabilitation Facilities
• Critical Access Hospitals
• End-Stage Renal Disease Facilities
• Home Health Agencies
• Home Infusion Therapy Suppliers
• Hospices
• Hospitals
• Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICF/IIDs)
• Clinics
• Rehabilitation Agencies
• Public Health Agencies as providers of Outpatient Physical Therapy and Speech-Language Pathology Services
• Psychiatric Residential Treatment Facilities (PRTFs)
• Programs for All-Inclusive Care for the Elderly (PACE) Organizations
• Rural Health Clinics/Federally Qualified Health Centers
• Long Term Care facilities

It does not, however, include physician offices, assisted living facilities, group homes, Medicaid home and community-based services (HCBS) providers, and others who are not regulated as certified facilities.
 
Regulated providers must establish a policy ensuring that, by December 5^th, all eligible staff have received a single-dose Covid-19 vaccine or the first dose of a two-dose Covid-19 vaccine prior to providing any care, treatment, or other services. Furthermore, all eligible staff must have completed a vaccination series (i.e., received a single-dose vaccine or both doses of a two-dose vaccine) by January 4, 2022. Staff who have received vaccines listed by the World Health Organization for emergency use, or as part of a clinical trial, are also considered to have completed the vaccination series, in keeping with CDC guidelines.
 
The vaccination requirement applies to staff regardless of clinical responsibility or patient contact, including facility employees, licensed practitioners, students, trainees, volunteers, as well as individuals who provide care, treatment, or other services for the facility and/or its patients under contract or other arrangements. However, individuals who provide services 100% remotely and who do not have any direct contact with patients and other staff (e.g., fully remote telehealth or payroll services) are not subject to the vaccination requirements.
 
The regulation provides for employers to offer exemptions or accommodations based on recognized medical conditions or religious beliefs, observances, or practices. This provision preempts any local exemptions that are broader (but not those that are stricter). Facilities must have a process for implementing additional precautions for staff who remain unvaccinated, whether due to an exemption or because they have not yet finished the 14-day period after completing a vaccine series. Such a process must “minimize the risk of transmission of COVID-19 to at-risk individuals.”
 
Vaccine requirements will apply to approximately 76,000 providers and cover over 17 million health care workers. Non-compliant facilities may be subject to civil money penalties, denial of payment for new admissions, or termination of their Medicare and Medicaid provider agreement. Though this Interim Final Rule with comment (IFC) is an emergency regulation, meaning the requirements go into effect immediately, stakeholders will still have 60 days to submit formal comment. The comment period will officially close on January 4, 2022. At that point, CMS will consider and respond to comments as part of potential future rulemaking.
 
The IFC can be found here. CMS held a National Stakeholder Call on November 5^th to discuss the rule. The slides are available here and a recording is available here. An FAQ can be found here.
 
Department of Labor Issues Emergency Temporary Standard for COVID-19 Vaccination
On November 4^th, the Department of Labor, through the Occupational Safety and Health Administration (OSHA), issued an emergency temporary standard (ETS) requiring covered employers to either implement and enforce a mandatory COVID-19 vaccination policy or adopt a policy requiring employees to choose between vaccination or undergoing regular testing and wearing a face covering at work. The ETS applies to employers with 100 or more workers and requires employers to provide paid time off for workers to get vaccinated and to recover from any side effects. Employers have until January 4, 2022, to comply with the ETS.
 
Providers who are subject to the CMS IFC described above should look to those requirements first. However, in rare situations, the OSHA standards may apply in such facilities to any staff who are not subject to requirements under the CMS IFC.
 
The interim final rule establishing the ETS is available here, a press release is available here, and FAQs are available here.
 
FDA and CDC Approve Vaccines for Kids Ages 5-11
On October 29^th, the Food and Drug Administration (FDA) authorized the emergency use of the Pfizer/BioNTech Covid-19 vaccine for children ages 5 through 11. The authorization followed the recommendation of the FDA’s independent advisory committee, which voted unanimously in favor of making the vaccine available to children in this age group earlier in the week.
 
Following this, on November 2^nd, the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices met to consider further clinical recommendations for the Pfizer/BioNTech vaccine in the younger age group, and unanimously endorsed its use as well. Later that evening, CDC Director Dr. Rochelle Wallensky accepted ACIP’s recommendation, giving final clearance for shots to begin in the pediatric population.
 
Coverage for Covid-19 vaccines is available without cost-sharing for all beneficiaries in the Medicare, Medicaid, and Children’s Health Insurance programs, as well as in the commercial market.

Legislative Update

Build Back Better Negotiations Continue; Updated Bill Text Released
Democrats continued to negotiate elements of the Build Back Better reconciliation bill this week. On November 3^rd, the House Rules Committee voted to approve updated legislative language, which includes additional provisions that were omitted from previous versions of the bill. However, the bill’s progress in the House stalled out on Friday afternoon as several House members said they would not support it without an official cost analysis by the Congressional Budget Office (CBO), which House Majority Leader Steny Hoyer said would not be released on Friday, and which could be weeks away.
 
The revised bill includes a new prescription drug negotiation provision that permits the government to negotiate the cost of 10 drugs covered by Medicare Parts B or D beginning in 2025, increasing to 20 drugs by 2028. The policy is limited to drugs that are beyond their initial exclusivity period (and thus have been on the market 9 or 12 years), and there is a carve-out for small biotech companies. In addition, beginning in July 2023, price increases by pharmaceutical manufacturers would be limited to the 2021 inflation rate, or manufacturers will be required to pay a rebate. Finally, the agreement would create an out-of-pocket cap on drug spending of $2,000 for seniors.
 
If and when it passes the House, the bill will be subject to further consideration in the Senate. Currently, most other health care provisions are expected to remain similar to the versions outlined in SPG’s last weekly update. An updated fact sheet released by committees in the House of Representatives is available here. The updated text of the House bill is available here (redline here), with an updated section-by-section summary here.

Regulatory Updates

CMS Finalizes CY 2022 ESRD PPS Final Rule
On October 29^th, CMS published the End Stage Renal Disease (ESRD) Prospective Payment System (PPS) final rule. Under the ESRD PPS for Calendar Year (CY) 2022, Medicare will pay a base rate of $257.90, an increase of about 2.5 percent. CMS estimates this will result in total payments of $8.8 billion to approximately 7,700 ESRD facilities for furnishing renal dialysis services. Hospital-based ESRD facilities can expect an increase in total payments of 3.3 percent,
and freestanding facilities can expect an increase in total payments of 2.5 percent. CMS is also updating the Acute Kidney Injury (AKI) dialysis payment rate for CY 2022 to $257.90. Other policy changes are detailed below: 

• ESRD Treatment Choices (ETC) Model: The ETC model is a mandatory payment model focused on encouraging greater use of home dialysis and kidney transplants. The final rule includes two new provisions that are one of the CMS Innovation Center’s (CMMI) first moves to directly address health equity: 
  • The improvement scoring methodology for the home dialysis and transplant rates will have a Health Equity Incentive, which will provide additional points to participants who demonstrate an improvement of at least 2.5 percent (down from 5 percent in the proposed rule) in either of these measures among enrollees who are dually eligible for Medicare and Medicaid or Low Income Subsidy (LIS) recipients.
  • CMS will stratify achievement benchmarks by the proportion of beneficiaries who are dually eligible or LIS recipients. Benchmarks will be set separately for participants for whom more than 50 percent of beneficiary years represent this population.
• ESRD Quality Incentive Program (QIP): The ESRD QIP bases a portion of payment on a provider’s performance on quality measures. In the rule, CMS finalized policies to ensure that facilities are not penalized under the ESRD QIP for circumstances caused by the pandemic. CMS will therefore suppress four QIP quality measures and adopt special scoring and payment policies for Payment Year 2022 that ensure that no facility receives a payment reduction.

The fact sheet is available here and the full rule is available here.
 
CMS Finalizes CY 2022 Hospital OPPS and ASC Rule
On November 2^nd, CMS finalized the CY 2022 Medicare Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) payment system final rule. Overall, CMS is updating the CY 2022 OPPS payment rates for hospitals by 2.0 percent, which includes a projected hospital market basket increase of 2.7 percent reduced by the productivity adjustment of 0.7 percent. CMS is also updating the ASC payment rates for CY 2022 by 2.0 percent. Due to the pandemic, CMS is generally using CY 2019 claims data to set CY 2022 OPPS and ASC rates. Other major provisions include the following:

• Price Transparency of Hospital Standard Charges: As proposed, CMS is increasing the civil monetary penalties for hospitals who fail to comply with price transparency regulations. CMS will assess a minimum civil monetary penalty of $300/day for hospitals with 30 or fewer beds, and $10 per bed per day for hospitals with more than 30 beds, not to exceed a maximum daily amount of $5,500. As such, hospitals will be subject to a maximum total penalty of $2,007,500 per calendar year. CMS is also requiring that machine-readable files be accessible to automated searches and direct downloads.
• Inpatient Only List: CMS finalized its proposal to halt the elimination of the inpatient only (IPO) list and add back the services removed in 2021, with the exception of lumbar spine fusion, shoulder joint reconstruction, ankle joint reconstruction, and their corresponding anesthesia codes. Given this, CMS also finalized the proposal to revise the two-midnight exemption for services removed from the IPO list on or after January 1, 2021.
• ASC Covered Procedures List: After changing its long-standing criteria for adding covered surgical procedures to the ASC Covered Procedures List (CPL) in the CY 2021 rule, CMS is now reinstating the criteria for adding procedures to the ASC CPL that were in place in CY 2020. CMS is also finalizing a new process to allow external parties to nominate surgical procedures to be added to the ASC CPL.
• OPPS Payment for 340B Drugs: CMS will continue the Trump-era policy of paying average sales price (ASP) minus 22.5% for certain separately payable drugs or biologics acquired through the 340B program.
• Partial Hospitalization: CMS finalized a proposal to maintain the existing unified rate structure, with a single Partial Hospitalization Program Ambulatory Payment Classification for each provider type for days with three or more services per day.
• Radiation Oncology Model: CMS made changes to the Radiation Oncology Model to account for its implementation delay until January 1, 2022. These changes include a modified performance period, baseline period, discount percentages, addition of an extreme and uncontrollable circumstances policy, adjustments for beneficiaries who switch between traditional Medicare and Medicare Advantage, and some modification to the Three Track system. More details on the model can be found here.
• Hospital Outpatient/ASC Quality Reporting Programs: Within the Hospital Outpatient Quality Reporting (OQR) Program, CMS adopted three new measures including Covid-19 Vaccination of Health Care Personnel, made reporting of two voluntary or suspended measures mandatory, removed two measures, and updated the validation policies of the Hospital OQR Program. Within the Ambulatory Surgical Center Quality Reporting Program, CMS also adopted the Covid-19 Vaccination of Health Care Personnel measure, and made reporting of six voluntary or suspended measures mandatory.

The final rule can be found here, and the fact sheet can be found here.
 
CMS Finalizes CY 2022 Home Health PPS Rule
On November 2^nd, CMS finalized the CY 2022 Home Health Prospective Payment System Rule. Overall, CMS estimates that Medicare payments to Home Health Agencies (HHAs) in CY 2022 will increase by $570 million (or 3.2 percent). This increase reflects a 2.6 percent payment update, a 0.7 percent increase for effects of the updated fixed-dollar loss ratio, and a 0.1 percent decrease due to changes in the rural add- on percentages for CY 2022. CMS is updating the payment rates for home infusion therapy services by 5.1 percent. Other policy changes include: 

• Home Health Value-Based Purchasing Model Expansion: CMS is expanding the Home Health Value-Based Purchasing (HHVBP) model nationwide, as proposed. However, the expansion has been delayed by one year from the proposed rule. Under the final rule, the first performance year of the expanded model will be CY 2023, with quality performance data from that year used to calculate payment adjustments for CY 2025.
• Home Health Quality Reporting Program: CMS is removing an OASIS-based measure that is no longer demonstrating meaningful differences in performance, replacing two claim-based measures to address concerns about attribution. It also finalized its proposal on two new measures and six categories of standardized patient assessment data elements that HHAs will be required to collect data on starting in January 2023. The rule also finalizes mandatory Covid-19 reporting requirements for Long Term Care facilities.
• Home Health Conditions of Participation: CMS is making permanent a policy to allow home health aide supervision and use of telecommunications in conducting assessment visits. This had previously been permissible under a Covid-19 Public Health Emergency waiver.
• Survey and Enforcement Requirements for Hospice Programs: CMS finalized several changes to the hospice program survey process that are intended to expand oversight requirements and establish new enforcement remedies.

The final rule can be found here. The fact sheet can be found here.

CMS Finalizes Omnibus Rule on CY 2022 Medicare Physician Fee Schedule, Quality Payment Program, and Medicare Diabetes Prevention Program
On November 2^nd, CMS released an omnibus final rule to update the CY 2022 Physician Fee Schedule (PFS), the CY 2022 Quality Payment Program (QPP), and policies for the Medicare Diabetes Prevention Program Expanded Model (MDPP). 
 
PFS Provisions

• Rate Setting and Conversion Factor: CMS finalized the CY 2022 PFS conversion factor at $33.59, representing a decrease of $1.30 from the CY 2021 PFS conversion factor of $34.89. The conversion factor includes the budget neutrality adjustment to account for changes in RVUs (required by law), expiration of the 3.75 percent payment increase provided by the Consolidated Appropriations Act, reflects the statutory update of zero percent, and adjusts for changes in RVUs and expenditures that will result from finalized policies.
   
• Evaluation and Management (E/M) Visits: CMS finalized several updates to coding and payment for E/M visits, including for a visit that is split or shared by both a physician and a non-physician nurse practitioner (NPP). CMS defines a split/shared visit to include only E/M visits in institutional settings for which “incident to” payment is unavailable. The physician or practitioner who provides the substantive portion of the visit will bill for the visit. CMS also finalized changes to its existing policy to allow for split/shared visits for both new and established patients and for critical care and certain skilled nursing facility/nursing facility visits. In addition, CMS finalized changes to E/M visit billing by certain teaching hospital primary care centers, clarifying that when time is used to determine the office/outpatient E/M visit level, only time spent by the teaching physician in qualifying activities can be included for visit level selection purposes.
   
• Telehealth Extensions: CMS finalized its proposal to maintain much of the Medicare telehealth expansion that occurred during the COVID-19 public health emergency for two years, through December 31, 2023. This includes allowing all services defined by CPT code that have been temporarily added to the Medicare telehealth list (on a “Category 3” basis) to continue through that date, allowing CMS to gather more information to consider adding them permanently. A complete list of allowable telehealth services is available here.
   
• Telehealth Expansion for Mental Health: CMS finalized implementation of provisions in the 2020 Consolidated Appropriations Act (CAA) to permanently expand telehealth, with restrictions, for certain mental health services. CMS finalized removal of Medicare geographic restrictions on telehealth for mental health providers who have an existing and ongoing in-person relationship with a patient. This requires an in-person, non-telehealth service to be conducted by the provider within six months prior to the initial telehealth service, and every 12 months thereafter, with exceptions allowed for certain beneficiary circumstances. CMS clarified that mental health services include services for treatment of substance use disorders (SUD). Additionally, CMS finalized a revised definition of “interactive telecommunications system” to include audio-only communication technology when used for the diagnosis, evaluation, or treatment of mental health disorders furnished to established patients in their homes. However, the use of audio-only is limited to providers who have the ability to provide two-way audio and video communications but use audio-only communications due to beneficiary choice.
   
• Remote Therapeutic Monitoring: CMS finalized the five proposed Remote Therapeutic Monitoring codes as proposed, and clarified that, as general medicine codes, physicians and other qualified health care professionals may bill them, including physical therapists. They will be classified as “sometimes therapy” codes, so that they may be billed outside a therapy plan of care by a physician and certain non-physician practitioners (NPPs), but only when appropriate. However, for practitioners whose Medicare benefits do not include “incident to” services (e.g., physical therapists, clinical social workers, certified registered nurse anesthetists, etc.), the services must be furnished directly by the billing practitioner. For physical and occupational therapy, they may also be billed by a therapy assistant under the therapist’s supervision (at 85 percent of the otherwise applicable amount, per below). CMS did not choose to establish a generic device code or other new G codes.
   
• Therapy Services: CMS finalized implementation of Bipartisan Budget Act of 2018 requirements to use new modifiers to identify and make payment at 85 percent of the otherwise applicable Part B payment amount for physical and occupational therapy (PT and OT) services provided in whole or in part by PT or OT assistants (PTAs or OTAs). CMS finalized revisions to its proposed policy regarding the de minimis threshold for PTA and OTA time.
   
• COVID-19 Vaccine Administration Services and Monoclonal Antibody Products: CMS will maintain the payment rate of $40 per dose for administration of the COVID-19 vaccine through the end of the calendar year in which the current PHE ends. At that point, the payment rate will be set to align with payment for other Part B preventive vaccines ($30 for CY 2022). CMS will continue the $35.50 add-on payment for COVID-19 vaccine administration in the home, also through the end of the calendar year in which the PHE ends. Similarly, CMS will continue to pay $450 for COVID-19 monoclonal antibody administration in a health care setting, and $750 for administration in the home, through the end of the calendar year in which the PHE ends.

• Opioid Use Disorders: CMS finalized its proposal to include adjustments for take-home supplies of opioid antagonist medications in which non-drug components would be geographically adjusted using the Global Assessment of Functioning (GAF) Scale. The agency also codified its proposal to adjust regulations for take-home supplies of opioid antagonist medications to be annually adjusted based on the Medicare Economic Index (MEI). The final rule provides that OTPs are able to continue furnishing therapy using audio-only communication after the COVID-19 PHE in cases where audio/ video is not available for the beneficiary.
   
• FQHCs and Rural Health Clinics (RHCs): CMS finalized three significant changes for FQHCs and RHCs, that would: 
  • Allow RHCs and FQHCs to furnish mental health visits through telehealth, including audio-only interactions in cases where beneficiaries are not capable of, or do not consent to, the use of two-way audiovisual technology; and
  • Implement statutory changes for independent RHCs and provider-based RHCs in a hospital with 50 or more beds to receive a per visit payment limit increase over an eight-year period, with a prescribed amount for each year from 2021 through 2028, followed by updates that reflect increases in the Medicare Economic Index (MEI); and
  • Make FQHCs and RHCs eligible to receive payment, starting January 1, 2022, for hospice attending physician services when provided by an FQHC/RHC physician, nurse practitioner, or physician assistant who is employed by an FQHC or RHC but is not employed by a hospice program.
     
• Electronic Prescribing of Controlled Substances (EPCS): CMS finalized its proposed exceptions to EPCS requirements under the SUPPORT Act, which mandates that Schedule II through V drugs covered through Medicare Part D must be prescribed electronically. CMS will delay the EPCS compliance date from January 1, 2022 to January 1, 2023. Similarly, CMS will delay the compliance deadline for Part D controlled substance prescriptions written for beneficiaries in long-term care (LTC) facilities, excluding beneficiaries who are residents of nursing facilities and whose care is provided under Part A of the benefit, from January 1, 2022 to January 1, 2025.
   
• Average Sales Price (ASP) Reporting: Beginning January 1, 2022, manufacturers will be required to report ASP for drugs and biologicals payable under Medicare Part B. CMS proposes to amend the definition of “drug” to include an item, service, supply or product that is payable under Medicare Part B as a drug or biological.

Quality Payment Program Provisions
CMS finalized several changes to the Quality Payment Program, including: 

• Setting the performance threshold at either the mean or median of the final scores for all Merit-based Incentive Payment System (MIPS) eligible clinicians for a prior period.
• Beginning to transition to the MIPS Value Pathways (MVPs) with the 2023 Merit-Based Incentive Payment System (MIPS) performance year (2025 payment year), with a sunset of traditional MIPS beginning with the 2028 performance year (2030 payment year). CMS finalized the following seven MVPs for the 2023 performance year:

1. Advancing Rheumatology Patient Care
2. Coordinating Stroke Care to Promote Prevention and Cultivate Positive Outcomes
3. Advancing Care for Heart Disease
4. Optimizing Chronic Disease Management
5. Adopting Best Practices and Promoting Patient Safety within Emergency Medicine (finalized with modification)
6. Improving Care for Lower Extremity Joint Repair (finalized with modification)
7. Support of Positive Experience with Anesthesia (finalized with modification)

• Changing traditional MIPS policies to: 
  • Include clinical social workers and certified nurse midwives as MIPS eligible clinicians;
  • Set the performance threshold at 75 points for the 2022 performance year/2024 payment year;
  • Set the additional performance threshold at 89 points; and
  • Weight the performance categories as follows: 30% for quality performance, 30% for cost performance, 15% for improvement activities performance, and 25% for promoting interoperability performance.
• Finalizing several changes to the Medicare Shared Savings Program (MSSP), including: 
  • A longer transition for Accountable Care Organizations (ACOs) to prepare for reporting electronic clinical quality measures/MIPS clinical quality measures under the Alternative Payment Model (APM) Performance Pathway. CMS will extend the availability of the CMS Web Interface collection type for three years, through performance year (PY) 2024; and
  • A delay in the increase in the quality performance standard ACOs must meet to be eligible to share in savings until PY 2024.

Medicare Diabetes Prevention Program
CMS finalized several changes to the Medicare Diabetes Prevention Program (MDPP) expanded model which aim to increase supplier enrollment to improve beneficiary access to and participation in services that prevent the onset of type 2 diabetes. These include: 

• Waiving the provider enrollment Medicare application fee for all organizations that apply on or after January 1, 2022;
• Shortening the MDPP services period to one year (from two years) to align with the CDC National DPP;
• Redistributing payments that would have been made in year two of MDPP services to certain Core and Core Maintenance Session performance payments.

The final rule is available here. A fact sheet on the Physician Fee Schedule is available here;  fact sheet on the Quality Payment Program is available here; and a fact sheet on the Medicare Diabetes Prevention Program is available here.
 
CMS Issues Interim Final Rule on CY 2022 Opioid Treatment Programs
On November 2^nd, CMS released an Interim Final rule with comment period regarding payments to opioid treatment programs (OTPs) in CY 2022. In order to avoid a significant decrease in the payment amount for methadone that could negatively affect access to methadone for beneficiaries receiving services at OTPs, CMS will maintain the payment amount for methadone at the CY 2021 rate for the duration of CY 2022. Payment for methadone is based on manufacturer-reported average sales price (ASP) data, and newly reported data for methadone tablets caused a 50% drop in ASP compared to last year’s rate, which reflected sales of only methadone oral concentrate.
 
In order to understand how OTPs utilize different methadone formulations, CMS is also seeking comment on OTP utilization patterns for methadone, particularly, the frequency with which methadone oral concentrate is used compared to methadone tablets in the OTP setting, including any applicable data on this topic.
 
The interim final rule is available here.
 
HHS Releases Report on Health Insurance Coverage During Covid-19
On October 29^th, the Department of Health and Human Services (HHS) released a report, conducted by researchers in the Office of the Assistant Secretary for Planning and Evaluation (ASPE), detailing how public insurance programs prevented major coverage losses since the beginning of the pandemic. The report analyzed how the nation’s uninsured rate remained the same during the pandemic, despite significant decreases in employer-sponsored coverage due to the pandemic-related economic downturn. The report attributes the stability of coverage numbers to gains in the Medicaid program, which has enrolled roughly 10 million individuals during the pandemic, and to the 2021 Special Enrollment Period, which allowed another 2.8 million Americans to gain coverage through federal Marketplaces. This year’s Open Enrollment for Healthcare.gov begins this week, running from November 1, 2021 through January 15, 2022.
 
The full report can be found here.
 
HHS Announces $256 Million for Title X Family Planning Services
On October 27^th, HHS announced the availability of $256 million in grant funding to support access to family planning services through the Title X program. This is the first funding announcement since issuance of a final rule earlier in October which revoked several requirements included in a 2019 rule on counseling and referral for abortion services and financial separate of abortion-related services and Title X activities by grantees. HHS expects to award approximately 90 grants with this round of funding and will focus on efforts to achieve health equity by expanding access to affordable, client-centered, quality family planning services with a priority on grants that focus on low-income clients.
 
A press release is available here and the grant opportunity is available here.

Other Updates

MACPAC Holds Second Meeting of 2021-2022 Cycle
On October 28^th and 29^th, the Medicaid and CHIP Payment and Access Commission (MACPAC) met for its monthly public meeting. Key discussions included:

• Supporting state efforts to integrate care for dually-eligible beneficiaries, during which Commissioners considered six policy options, which they will vote on in April 2022: 
  • Making additional federal financing available to states that want to advance integrated care;
  • Requiring that every state develop a strategy to integrate care;
  • Requiring that states establish an ombudsman for integrated care projects;
  • Requiring that states contracting with D-SNPs select at least one Medicare Improvements for Patients and Providers contracting strategy and include it at the next contract renewal;
  • Requiring that states only contract with D-SNPs designated as highly integrated dual eligible or fully integrated dual eligible SNPs; and
  • Requiring that every state fully integrate care for full-benefit daully eligible beneficiaries.
• Workforce for home- and community-based services, during which commissioners discussed the acute workforce shortages of direct care workers, and the problems of low wages, demanding conditions, limited opportunities for advancement, and how these challenges may be exacerbated when American Rescue Plan funding dries up. The purpose of the panel was to contribute towards a MACPAC issue brief on the home- and community-based workforce, to be published this winter.

Additional topics of discussion at the meeting included: 

• Data issues in monitoring access to care for Medicaid beneficiaries; and
• A mandated study on Money Follows the Person qualified residence criteria;
• Vaccines for adults enrolled in Medicaid;
• MACPAC’s annual analysis of disproportionate share hospital allotments to states; and
• A response to Senate Finance Committee request for information on behavioral health priorities.

Slide presentations from the meeting are available here.
 
AmeriCorps Seniors Issues ARP Funding Opportunity for Vaccination and Other Covid-19 Recovery Efforts
On November 1^st, AmeriCorps Seniors published a notice of funding opportunity (available here) for the AmeriCorps Seniors ARP Demonstration Program. This opportunity will provide $10 million in total funding available from the American Rescue Plan (ARP) to support national service projects to be carried out with the help of AmeriCorps Seniors volunteers that relate to Covid-19 recovery.
 
Eligible applicants, which include not-for-profit organizations, are required to address one or more of the following focus areas: 

• Disaster Services
• Economic Opportunity
• Education
• Environmental Stewardship
• Healthy Futures/Access to Care
• Veteran and Military Families

AmeriCorps is specifically interested in applications that establish or support education, vaccination, and vaccination education efforts, particularly in hard-to-reach communities. Award amounts are expected to be in the range of $100,000 to $500,000, but will vary based on the scope of the project. The project period will last for two years starting on July 1, 2022. Applications are due on February 3, 2022.
 
New Data Show Suicides Declined in 2020
On November 3^rd, the National Center for Health Statistics (NCHS) shared provisional data showing that suicides declined by 3% in 2020. This followed a 2% decline in 2019. However, suicide rates did not decline for all populations. In particular, suicide rates for females across all racial and ethnic groups declined, but rates of suicide among non-Hispanic black, non-Hispanic American Indian or Alaska Native, and Hispanic males increased.
 
A Vital Statistic Rapid Release report on the new data is available here and a blog from the NCHS is available here.

Congressional Hearings

No Major health care-related hearings are scheduled to be held next week.

New York State Updates

Governor Hochul Announces New Administration Nominations and Appointments
On November 1^st, Governor Hochul announced the following nominations and appointments to her administration: 

• Kerri Neifeld has been nominated as Commissioner of the Office for People with Developmental Disabilities (OPWDD). Neifeld previously served as Assistant Secretary for Human Services & Mental Hygiene and as Assistant Deputy Commissioner at the New York State Office of Temporary and Disability Assistance (OTDA). Neifeld will require confirmation from the New York State Senate and will serve as Acting Commissioner in the interim.
• Jihoon Kim has been appointed Deputy Secretary for Human Services and Mental Hygiene. Kim most recently served as Special Assistant to the Executive Deputy Commissioner at the Office of Mental Health (OMH).
• Trisha Schell-Guy has been appointed Director of Program Development and Management at the Office of Health Insurance Programs (OHIP). Schell-Guy most recently served as General Counsel for the Office of Addiction Services and Supports (OASAS).
• Nivardo Lopez has been appointed Deputy Secretary for Transportation. Lopez most recently served as Bronx Borough Commissioner for the New York City Department of Transportation.
• Kate C. Harris has been appointed Deputy Secretary for Financial Services and Technology. Harris previously served as Director of the Reimagine New York Commission, which was focused on the state’s recovery from the pandemic, and was the minority counsel for the U.S. Senate Select Committee on Intelligence.

The Governor’s press release is available here.
 
Governor Hochul Signs Legislation to Establish the Substance Use Disorder Education and Recovery Fund
On November 3^rd, Governor Hochul signed legislation (S4086/A6553) amending the tax law to: 

• Authorize gifts on personal income tax returns for substance use disorder education and recovery;
• Establish the substance use disorder education and recovery fund for the receipt and expenditure of monies from such gifts; and
• Direct OASAS to provide grants to organizations engaged in activities dedicated to providing education, prevention, treatment, or recovery to those suffering from substance use disorders.

Federal Appeals Court Upholds New York State Vaccine Mandate for Health Care Workers
On October 29^th, the U.S. Court of Appeals for the Second Circuit ruled that New York State’s Covid-19 vaccine mandate for health care workers may proceed without a religious exemption. The Court upheld a ruling by the U.S. District Court for the Eastern District denying a preliminary injunction sought by plaintiffs and vacated a preliminary injunction granted by the U.S. District Court for the Northern District granted in a similar case.
 
The Court’s Order is available here.
 
DOH Updates Covid-19 Vaccine Administration Guidance to Include Booster Doses and Vaccines for Children Ages 5-11
On November 3^rd, the New York State Department of Health (DOH) updated its coverage policy and billing guidance for the administration of Covid-19 vaccines (available here). The updated guidance includes CPT codes and fees for the Moderna and Janssen Covid-19 booster doses and for the first and second doses of the Pfizer-BioNTech Covid-19 vaccine for children ages 5-11.
 
DOH Announces Implementation Dates of PCS/CDPAS Regulatory Changes
On November 1^st, DOH announced the implementation timeline for changes to the regulations for Personal Care Services (PCS) and Consumer Directed Personal Assistance services (CDPAS). These revised regulations (available here) are in line with the reforms to PCS and the CDPAS program approved by the second Medicaid Redesign Team (MRT II), including a revised assessment process (including parts that may now be conducted through telehealth) and narrower eligibility criteria.
 
DOH published a letter (available here) that outlines which regulatory provisions will take place on November 8^th and which regulatory provisions will be effective at a later date. For the provisions taking place at a later date, DOH will provide notice at least 60 days prior to the effective date, which is not expected to be before January 1, 2022.
 
Questions may be sent to independent.assessor@health.ny.gov.
 
HERO Act Designation Extended Through December 15^th
On October 31^st, DOH extended its designation of Covid-19 as an airborne infectious disease that presents serious risk of harm to the public health in New York State. This designation, initially implemented on September 6^th, triggers the HERO Act that requires all employers to implement workforce safety plans to protect employees against exposure and disease. The designation will now run through December 15^th.
 
The Commissioner’s designation is available here and additional details on the HERO Act are available here.
 
OMH Releases Guidance and Attestation Form for Workforce Investments
On October 29^th, OMH released the guidance documents that outline eligible workforce funding activities for eligible licensed, regulated, and designated providers. Eligible activities for workforce development initiatives include, but are not limited to: 

• Recruitment and retention incentives, such as hiring bonuses and longevity pay;
• Education expenses, such as tuition and loan forgiveness; and
• Career development and support, such as the creation or enhancement of internship/fellowship programs.

The first guidance document (here) outlines workforce funding available through the Community Mental Health Services (CMHS) Block Grant under the Coronavirus Response and Relief Supplemental Appropriations Act (CRRSAA). Eligible providers, which include licensed outpatient treatment programs and non-residential community support programs, have been notified directly by OMH of their workforce investment awards. Providers must accept or reject funds by December 31^st per instructions in the award notification and must complete the attestation form (here) by March 31, 2022.
 
The second guidance document (here) outlines funding available through the enhanced Federal Medical Assistance Percentage (FMAP) for Home and Community Based Services (HCBS) under the ARPA. Eligible entities include all Medicaid HCBS providers who will receive funding through service rate increases and grant-based awards. Rate increases will be effective as of October 2021. Providers must complete the attestation form (here) by March 31, 2022.
 
OMH Releases Supplemental Disaster Emergency Billing and Documentation Guidance
On October 31^st, OMH released supplemental disaster emergency billing and documentation guidance (available here) for the following programs: 

• Assertive Community Treatment (ACT)
• Personalized Recovery Oriented Services (PROS)
• Continuing Day Treatment (CDT)
• Children’s Day Treatment
• Partial Hospitalization Programs
• Adult Behavioral Health HCBS
• Adult and Children’s Residential Programs
• Clinics

OMH will continue to allow flexibilities for billing and documentation as outlined in OMH-issued Covid-19 guidance (available here) for the duration of the federal Public Health Emergency (PHE) for these programs. When the federal PHE expires (currently scheduled for January 16, 2022), providers will be immediately required to resume appropriate billing and documentation activities pursuant to pre-pandemic guidance and regulations. OMH encourages providers to being resuming and completing outstanding documentation activities, such as treatment or service planning and utilization review, over the next few months.
 
Updated SPG Regulatory Waiver Tracker
Governor Hochul’s Executive Order 4, issued on September 27^th to address the health care workforce shortage and modified and extended on October 27^th, has reinstated a number of the emergency provisions that had originally expired with the end of New York’s original Covid-19 public health emergency that expired on June 24^th.  Various state agencies have issued waivers and guidance clarifying the status of emergency Covid-19 policies.

As a result, SPG has updated our Regulatory Waiver Tracker document to show which flexibilities are in effect and which have expired. This document also includes a summary of NYS agency policy and relevant federal guidance, starting on page 14.