Weekly Health Care Policy Update – December 20, 2021

December 27, 2021

Note: This will be SPG’s last weekly update for 2021, although we will continue to distribute notable information that arises to clients individually. As always, please feel free to contact us at any time to discuss any policy issues on your mind. We’d also appreciate any feedback on how we can make our updates more useful. Happy Holidays!

In this update:

  • Covid-19 Updates
    • Summary of the Status of Federal, NYS, and NYC Vaccine Mandates 
      • CMS Vaccination Mandate for Health Care Workers
      • OSHA Vaccination or Testing Mandate for Large Employers
      • NYS Vaccination Mandate for Health Care Workers
      • NYS Indoor Vaccination or Masking Mandate
      • NYC Vaccination Mandate for Private Sector Employers
    • CDC Recommends Not Getting J&J Covid-19 Vaccine If mRNA Available
    • HRSA Releases $9 Billion in Provider Relief Fund Payments 
  • Legislative
    • Manchin Announces He Will Not Support Current Version of Build Back Better Act
    • Congress Passes Legislation to Raise the Debt Ceiling
  • Regulatory
    • CMS Finalizes Second FY 2022 Hospital Inpatient PPS Rule on GME
    • CMS Releases Next Gen ACO Model Beneficiary and Provider Data
    • CMS Releases 2020 National Health Expenditure Data, Showing 9.7% Increase
    • FDA Removes Restriction on Access to Abortion Pills
    • Treasury Plans to Issue Rule on Family Glitch
    • Senate HELP Committee Holds Confirmation Hearings for FDA Nominee Robert Califf
    • Biden Administration Releases Executive Order on Improving Federal Government Customer Experience
  • Other
    • Wyden Sends Letter to HHS on Part B Premium Increase
    • HHS OIG Releases Report on Medicare Beneficiary Use of Medication for Opioid Use Disorder
    • MedPAC Commissioners Approve Several Recommendations for March Report to Congress
    • MACPAC Holds Monthly Public Meeting
  • Congressional Hearings
  • New York State Updates
    • HERO Act Designation Extended Through January 15, 2022
    • Assemblyman Richard Gottfried Announces Retirement
    • DOH Issues Guidance Documents on Regulatory Changes to PCS and CDPAS
    • DFS Issues Circular Letter on Surprise Billing Process
    • DOH Releases Guidance on Medicaid Coverage of At-Home Covid-19 Tests
    • CMS Approves New York State SPA for Intermediate Care Facility Add-on Payments
    • DOH Issues Notice Regarding Forthcoming Children’s HCBS Rate Enhancements
    • DFS Fines Three Health Plans for Mental Health Parity Violations
    • Governor Hochul Signs Several Health Care-Related Bills

COVID-19 Updates

Summary of the Status of Federal, NYS, and NYC Vaccine Mandates
As of this week, five major Covid-19-related vaccine mandates may apply to entities in New York State: 

  • The federal Centers for Medicare and Medicaid Services (CMS) vaccination mandatewith no testing opt-out, which is a Condition of Participation for health care facilities participating in Medicare and Medicaid;
  • The federal Occupational Health and Safety Administration (OSHA) vaccine-or-testing mandate, which applies to staff at large employers (with over 100 employees);
  • The New York State vaccination mandate with no testing opt-out or religious exemption, which applies to staff at certain types of licensed health care facilities;
  • The New York State masking-or-vaccination mandate, which applies to all indoor public places (with masks required regardless of vaccination status in health care facilities);
  • The New York City vaccination mandate, which will apply to any private sector workers NYC. This is planned to require a first dose by December 27th and full vaccination by January 28, 2022.

Legal challenges to these requirements are ongoing, and many are expected to eventually be resolved by the U.S. Supreme Court. A brief summary of their current status is below.
 
CMS Vaccination Mandate for Health Care Workers
The CMS mandate directs all health care facilities participating in the Medicare or Medicaid to require any staff who might come into contact with patients to be fully vaccinated against Covid-19 (i.e., to have received a one-dose Covid-19 vaccine or two doses of a two-dose vaccine). Religious or medical exemptions may be offered. This originally required a first dose by December 6th and full vaccination by January 4, 2022.
 
On December 15th, a panel of the New Orleans-based Fifth Circuit Court of Appeals partly lifted a nationwide injunction on this mandate that had been put into place by a Louisiana district court on November 30th in response to a lawsuit by 14 states. The Fifth Circuit allowed the injunction to continue only in those 14 states. A separate preliminary injunction on appeal before the St. Louis-based Eighth Circuit applies to 10 additional states. These 24 states’ governments are primarily controlled by Republicans. However, CMS issued a letter earlier in December to State Survey Agency Directors indicating that enforcement of the vaccine requirement will be suspended as long as court-ordered injunctions are in effect (available here). This suspension continues nationally for now. The case is expected to come to the U.S. Supreme Court.
 
OSHA Vaccination or Testing Mandate for Large Employers
The OSHA directs all companies with more than 100 employees to require staff to be vaccinated, with an option for regular testing. Religious or medical exemptions may be offered. Originally, this required a first dose by December 6th and full vaccination by January 4, 2022.
 
On December 17th, a panel of the Cincinnati-based Sixth Circuit reinstated the second mandate, issued by the Occupational Safety and Health Administration (OSHA), The Sixth Circuit decision, which consolidated a number of cases around the mandate, overturned a previous ruling by the Fifth Circuit that blocked the rule from going into effect. In response, OSHA posted a notice (available here) stating that to account for uncertainty, it would delay enforcement of the rule until January 10th, and delay the enforcement of the rule’s testing requirement until February 9th. This case is expected to come to the U.S. Supreme Court.
 
New York State Vaccination Mandate for Health Care Workers
The Public Health and Health Planning Council (PHHPC) emergency regulation required all staff at covered health care providers to be vaccinated, with no testing opt-out or religious exemption. The covered provider types include: Article 28 licensed hospitals, nursing homes, and diagnostic and treatment centers (DTCs); Article 36 home health agencies; Article 40 hospices; and adult care facilities. Full vaccination was required by all staff by October 7th at the latest for all provider types.
 
On December 13th, the U.S. Supreme Court refused to block New York’s vaccine requirement for health care workers. The unsigned order included no reasoning, as is typical with rulings on emergency applications, but Justices Gorsuch, Thomas, and Alito dissented, with Justices Gorsuch and Alito citing religious liberty. The Court had previously denied relief to health care workers in Maine who brought a similar challenge and rejected challenges to vaccination requirements in three other cases that did not involve religion. As of December 15th, New York State data indicates that about 37,000 health care workers statewide, or about 4%, have been fired, resigned, or been placed on unpaid leave due to the mandate. 
 
New York State Indoor Masking Mandate
On December 10th, Governor Hochul announced a masking mandate for all indoor public places for individuals over age two, with exceptions allowed for businesses or venues who implement a vaccination requirement. The policy applies to all non-private residences, including office spaces. Health care providers that are already covered by the NYS vaccination mandate (above) must require all individuals on their premises to wear masks regardless of vaccination status.
 
Businesses and venues that implement a proof of vaccination requirement must ensure that anyone 12 years of age or older is fully vaccinated before entering indoors. If the business or venue does not require proof of vaccination as a condition of entry, all individuals (including vaccinated individuals) must wear masks except when eating, drinking, or alone in an enclosed room.
 
The mandate is effective December 13th through January 15, 2022, at which time the State will re-evaluate. The Governor’s press release is available here. Frequently Asked Questions are available here.
 
New York City Vaccination Mandate for Private Sector Employers
On December 13th, New York City Mayor Bill de Blasio issued an Emergency Executive Order (available here) that directs all NYC-based private employers to require workers to be vaccinated. Medical and religious exemptions may be offered, including accommodations to allow unvaccinated employees to submit to regular Covid-19 testing. Employees must receive at least one dose of the Covid-19 vaccine by December 27th and be fully vaccinated by January 28, 2022.
 
The following individuals are exempt from the requirement: 

  • Individuals who work from their own home and whose employment does not involve interacting in-person with other individuals;
  • Individuals entering the covered premise for a quick and limited purpose (i.e., using the bathroom or picking up an order);
  • Artists, athletes, and anyone who accompanies them who are not residents of New York City;
  • Individuals five years of age or older participating in a school or after-school program;
  • Individuals who are voting and those who are accompanying them;
  • Individuals younger than five years of age on December 13th, until 45 days after their fifth birthday; and
  • Individuals who request and are granted reasonable accommodations for medical or religious reasons.

The Order also requires employers to check the proof of vaccination before allowing a worker to enter the workplace and to maintain a record of the verification. Additionally, businesses must post an affirmation of compliance (available here) with the vaccine requirements in a public-facing location by December 27th.
 
Mayor-elect Eric Adams has not yet confirmed whether and how he will proceed with the mandate once he enters office on January 1, 2022, although he has stated that he has heard concerns from businesses about the scope and speed of its implementation. Litigation is also likely to occur.
 
A FAQ document is available here. Guidance on medical and religious accommodations is available here. Guidance for employers on equitable implementation of the Covid-19 vaccine requirements is available here. Guidance for public accommodations on equitable implementation of Covid-19 vaccine requirements is available here.

CDC Recommends Not Getting J&J Covid-19 Vaccine If mRNA Available
On December 16th, the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) recommended that Americans not get the Johnson & Johnson (J&J) Covid-19 vaccine when the mRNA vaccines are available. The panel voted unanimously to declare mRNA vaccines the “clinical preference,” offering greater protection and fewer risks than the J&J vaccine. The J&J vaccine has been linked to thrombosis with thrombocytopenia syndrome (TTS), a blood clotting condition that has affected at least 54 vaccine recipients in the U.S., including nine deaths. ACIP’s meeting follows a Food and Drug Administration (FDA) meeting earlier in the week to add a contraindication to the J&J vaccine, noting that people who had previously developed TTS after one dose should not receive a second dose. CDC endorsed the panel’s recommendation.
 
HRSA Releases $9 Billion in Provider Relief Fund Payments
On December 14th, the Health Resources and Services Administration (HRSA) announced the distribution of nearly $9 billion in Provider Relief Fund (PRF) Phase 4 payments. The payments went out to over 69,000 providers who have experienced revenue losses and expenses related to the Covid-19 pandemic, covering the period from July 1, 2020 to March 31, 2021. Providers are expected to begin receiving these payments as early as this week.
 
Funding will be distributed based on HRSA’s previously announced methodology, with “Base Payments” available to all providers and “Bonus Payments” targeted to safety net providers. Roughly 75% of Phase 4 payments will be made as Base Payments, covering a percentage of reported lost revenue and Covid-19 expenses. Amounts will differ by provider: 

  • 45% of the reported amount for small providers (revenue under $10 million)
  • 25% of the reported amount for medium providers (revenue between $10 million and $100 million)
  • 20% of the reported amount for large providers (revenue over $100 million).

Providers’ reported lost revenues and Covid-19 expenses will be statistically adjusted to address outliers, new providers, and other limits, as in Phase 3 of the PRF. Furthermore, prior PRF payments from Phases 1 or 2 of the PRF will be deducted from the Phase 4 award, if they were not already deducted during the calculation of the provider’s Phase 3 distribution.
 
The remaining 25% of Phase 4 payments will be made as Bonus Payments, based on Medicare, Medicaid, and Children’s Health Insurance claims data from January 1, 2019 through September 30, 2020. This $9 billion tranche is only a portion of the $17 billion allocated to the Phase 4 General Distribution Provider Relief Fund allocation. The remaining amount will be released in 2022 upon HRSA’s review of remaining applications. 
 
Additional details on the Phase 4 distribution methodology can be found here.

Legislative Updates

Manchin Announces He Will Not Support Current Version of Build Back Better Act
On December 19th, Senator Joe Manchin (D-WV) issued a statement on the Build Back Better Act, saying that he “cannot vote to move forward” on the proposal. Manchin cited his continuing concerns about inflation, the cost of the bill, and certain energy-related provisions. Democrats will be unable to move forward with the bill without his support. The White House issued a response criticizing Manchin for “a sudden and inexplicable reversal in his position.”

Senate Finance Committee Chairman Ron Wyden (D-OR) subsequently released a statement indicating that Democrats will continue to look for a “path forward” for at least some of the priorities in the bill. The latest Senate Finance Committee version of the bill’s text, released December 11th, already differed from the House bill in certain ways, including the omission of Medicaid Disproportionate Share Hospital (DSH) cuts in non-expansion states and minimum nursing home staffing requirements.

Congress Passes Legislation to Raise the Debt Ceiling
On December 14th, Congress approved legislation (S.J. Res 33) to raise the debt ceiling by $2.5 trillion. The measure passed almost entirely on party lines in the House (221-209) and the Senate (50-49), with only one Republican, Rep. Adam Kinzinger (R-IL) voting in favor. The vote followed a deal to allow this specific bill to pass with a simple majority vote, instead of a 60-vote threshold. The bill’s passage means that the debt limit issue is not expected to be raised again until after the 2022 elections. President Biden signed the bill into law on December 16th.

Regulatory Updates

CMS Finalizes Second FY 2022 Hospital Inpatient PPS Rule on GME
On December 17th, CMS issued the second part of the fiscal year (FY) 2022 Medicare Hospital Inpatient Prospective Payment System (PPS) rule. This rule enacts additional policies related to Medicare graduate medical education (GME) funding that were passed in the 2020 year-end omnibus spending bill. These include: 

  • Adding 200 new Medicare-funded physician residency slots per year for five years, distributed across qualifying hospitals;
  • Allowing rural teaching hospitals participating in an accredited rural training track to receive increases to their resident caps; and
  • Removing the restriction on funding for new medical residency training programs established by hospitals who have previously hosted short-term rotating residents from other programs.

CMS will also accept comments on certain GME issues, including on health equity issues and the review process for resident cap resets. Specifically, CMS seeks comment on how it should account for care provided outside of a Health Professional Shortage Area (HPSA) to HPSA residents and on alternative approaches it should use to consider health disparities in prioritizing funding for additional cap slots.
 
The rule also finalizes policies regarding the organ procurement process and organ procurement organizations (OPOs). In particular, CMS codified its procedures around billing requirements for donor community hospitals and transplant hospitals, but has withdrawn its proposed changes around counting organs.
 
Comments will be accepted on the final rule through February 25, 2022. A fact sheet is available here, and the full text of the rule is available here.
 
CMS Releases Next Gen ACO Model Beneficiary and Provider Data
On December 14th, CMS announced the availability of new Research Identifiable Files that contain data from the Next Generation (Next Gen) Accountable Care Organization (ACO) Model for Performance Year 4. CMS released two files: one containing enrollment data for beneficiaries in the Next Gen Model and a second containing identifying information about the providers participating in the Model.
 
Like the Medicare Shared Savings Program (MSSP) ACOs, the Next Gen Model tests whether financial incentives, along with better patient engagement and care management, improve outcomes and lower costs for Medicare fee-for-service beneficiaries. The Next Gen Model was launched in 2016 as the successor to the Pioneer ACO model, offering a higher-risk, more advanced ACO model than the MSSP. There are currently 35 ACOs participating in the Next Gen program, which is scheduled to sunset at the end of 2021.
 
More information on the Next Gen Model can be found here. The new data files can be found here and here. 
 
CMS Releases 2020 National Health Expenditure Data, Showing 9.7% Increase
On December 15th, the CMS Office of the Actuary released a 2020 edition of the National Health Expenditures report estimating that total health care expenditures in the U.S. increased by 9.7% in 2020 to $4.1 trillion. Health spending rose primarily due to the federal response to the Covid-19 pandemic, including the Provider Relief Fund, Paycheck Protection Program, and federal public health spending. Excluding such programs, the report finds that growth was only 1.9%, down from the 4.3% increase in 2019.
 
Sorted by payer, private health insurance spending decreased by 1.2%, to $1.15 trillion, while Medicare spending increased by 3.5% to $830 billion and Medicaid spending increased by 9.2% to $671 billion. Total spending on hospitals increased by 6.4% to $1.3 trillion, a similar increase to that in 2019 (6.3%).
 
The full data is available here. The CMS press release is available here.
 
FDA Removes Restriction on Access to Abortion Pills
On December 16th, the Food and Drug Administration (FDA) issued a modification to the Risk Evaluation and Mitigation Strategy (REMS) for mifepristone. Mifepristone may be used with misoprostol to end an early pregnancy. Previously, the REMS included an in-person dispensing requirement, requiring patients to physically travel to certain healthcare settings authorized to dispense the medication. The FDA removed the in-person dispensing requirement, allowing patients to obtain the medication by mail, and added a requirement that dispensing pharmacies be certified.
 
Information from the FDA on mifepristone is available here and questions and answers are available here.
 
Treasury Plans to Issue Rule on Family Glitch
The Biden Administration’s Fall 2021 Unified Regulatory Agenda includes plans for the Department of the Treasury to issue a proposed regulation entitled “Guidance Under Section 36B Regarding the Premium Tax Credit.” This rule would reconsider current regulations regarding the Affordable Care Act (ACA), in particular, the so-called “family glitch.” Current Treasury guidance denies ACA premium tax credits to any individual who is eligible for affordable individual (self-only) coverage through their employer, even if coverage for that individual’s family would not be considered affordable. The Treasury is expected to issue a reinterpretation that would expand coverage to such families, which could cover an additional 5 million Americans.
 
The Unified Agenda notice is available here.
 
Senate HELP Committee Holds Confirmation Hearings for FDA Nominee Robert Califf
On December 14th, the Senate Health, Education, Labor, and Pensions (HELP) Committee held a hearing on the nomination of Dr. Robert Califf to serve as Commissioner of the Food and Drug Administration (FDA). Dr. Califf, a cardiologist, previously served as the 22ndFDA Commissioner during the Obama Administration. During his testimony, Dr. Califf identified his top two priorities as: (1) a digital, modernized platform for future public health emergencies, including related workforce development, and (2) a better system for generating evidence for post-market research on accelerated approvals. In their questioning, Senators focused heavily on the FDA approval process, with a particular focus on expedited drug development, as well as what authorities FDA can leverage to lower drug prices. Senators also discussed pandemic response, including questions about Covid-19 testing availability, pharmaceutical supply chain, and the opioid crisis, during which Dr. Califf committed to reviewing opioid procedures.
 
The Committee is expected to approve Dr. Califf’s nomination, though Senators Joe Manchin (D-WV) and Bernie Sanders (I-VT) have said they will oppose the nomination, due to Califf’s ties to the drug industry and the FDA’s role in the opioid crisis. Several Republicans, including Senators Richard Burr (R-NC), Susan Collins (R-ME), Tommy Tuberville (R-AL) and Roger Marshall (R-KS) have expressed support for the nomination. The full Senate is expected to vote early next year. In 2016, Califf was confirmed by a vote of 89-4.
 
Biden Administration Releases Executive Order on Improving Federal Government Customer Experience
On December 13th, the Biden Administration released an Executive Order titled, “Transforming Federal Customer Experience and Service Delivery to Rebuild Trust in Government.” The Executive Order includes 36 customer experience improvement commitments across 17 Federal agencies. Through the initiative, the Administration will work to identify and define critical services that meet customers’ needs and expectations, assess performance delivery and report it publicly, and incorporate customer feedback during each interaction. Notable items include: 

  • “Personalized online tools” to help Medicare recipients with managing their health care, saving money on drugs, and customer support;
  • Improving enrollment processes for low-income families with a direct certification process and a “no wrong door” approach to benefits;
  • Automated access to electronic health records for women seeking maternal care;
  • Strengthened requirements for maternal health quality measurement; and
  • An “increased ability” to use telehealth.

In addition, the Order designates 35 High Impact Service Providers and federal agencies as key service providers. These providers will be required to meet requirements to modernize programs, reduce administrative burdens, and pilot new online tools and technologies to provide a simple, seamless, and secure customer experience.
 
The Executive Order can be found here. The list of Designated High Impact Service Providers can be found here.

Other Updates

Wyden Sends Letter to HHS on Part B Premium Increase
On December 13th, Senate Finance Committee Chairman Ron Wyden sent a letter to Secretary of Health and Human Services (HHS) Xavier Becerra encouraging the agency to use its authority to reduce the planned increase in Medicare Part B premiums scheduled to begin in January. As announced earlier this year, Part B premiums are scheduled to increase from $148.50 to $170.10, a nearly $22 increase. HHS has attributed half of the increase to the need to potentially cover Aduhelm, Biogen’s newly-approved Alzheimer’s drug. HHS has said that the increase should be covered by a cost-of-living increase to Social Security checks. The letter argued that Medicare has not yet developed a formal policy for covering Aduhelm, justifying a lower up-front premium at this time. Senators Sanders (I-VT), Hassan (D-NH), Rosen (D-NV), Van Hollen (D-MD), Kelly (D-AZ) and Reed (D-RI) have expressed similar concerns.
 
The letter can be found here.

HHS OIG Releases Report on Medicare Beneficiary Use of Medication for Opioid Use Disorder
On December 16th, the HHS Office of the Inspector General (OIG) published a report entitled “Many Medicare Beneficiaries Are Not Receiving Medication to Treat Their Opioid Use Disorder.” According to the report, roughly 1 million Medicare beneficiaries were diagnosed with an opioid use disorder in 2020, but fewer than 16% of them received medication to treat the disorder. Even worse, fewer than half of beneficiaries who received medication to treat their opioid use disorder also received behavioral therapy. Beneficiaries in Florida, Texas, Nevada, and Kansas were least likely to receive medication for an opioid use disorder, and Asian/Pacific Islander, Hispanic, and Black beneficiaries were less likely than White beneficiaries to receive medication.
 
The full report can be found here.
 
MedPAC Commissioners Approve Several Recommendations for March Report to Congress
On December 9th and 10th, the Medicare Payment Advisory Commission (MedPAC) held its monthly public meeting, during which commissioners reviewed and made recommendations to update Medicare’s fee-for-service payment policies. Some highlights include: 

  • MedPAC recommended that Congress update payments to acute care hospitals for FY 2023 by the amount determined under current law, estimated to be 2%.
  • Despite concerns about workforce impact, MedPAC recommended a calendar year 2023 update to payments made under the Physician Fee Schedule by the amount determined under current law, which is 0% (no update). In addition, MedPAC recommended that the Secretary require clinicians to use a claims modifier to identify audio-only telehealth visits.
  • MedPAC recommended that HHS should eliminate the 2% update to the conversion factor for ambulatory surgery center (ASC) payments in 2023 and require ASCs to report cost data to CMS.

A transcript of the meeting and slides presented by staff are available here.

MACPAC Holds Monthly Public Meeting
On December 9th and 10th, the Medicaid Access and Payment Advisory Commission (MACPAC) convened for its monthly public meeting. The meeting opened with a presentation and discussion of state-directed payments in Medicaid, with Commissioners agreeing on the need for greater transparency in such payments and noting that more analysis is needed before the Commission could recommend an upper payment limit.
 
Next, Commissioners considered existing criteria regarding a qualified residence under the Money Follows the Person demonstration, but were unable to reach consensus on whether such criteria should be maintained or expanded to meet the definition used by Medicaid home- and community-based services more generally. In other sessions, Commissioners supported a recommendation to create new behavioral health electronic health record standards and certifications at the federal level and noted inadequacies and limitations in the current systems for monitoring Medicaid beneficiaries’ access to care.
 
A summary of the meeting and the presentation materials are available here.

Congressional Hearings

No hearings are scheduled next week. The House and Senate are in recess for the remainder of the year.

New York State Updates

HERO Act Designation Extended Through January 15, 2022
On December 15th, the New York State Department of Health (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 6th, 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 January 15, 2022.
 
The Commissioner’s designation is available here and additional details on the HERO Act are available here.
 
Assemblyman Richard Gottfried Announces Retirement
On December 13th, New York State Assemblyman Richard Gottfried announced that he would not seek re-election next November and will retire at the end of 2022. Assemblyman Gottfried, who was first elected in 1970 and who has served as the Health Committee Chair since 1987, is the longest serving legislator in New York State history. As Health Committee Chair, Gottfried has been a longtime advocate for the New York Health Act (A4738A/S4840), which would create a universal, single-payer health insurance plan for New York State.
 
The press release is available here.
 
DOH Issues Guidance Documents on Regulatory Changes to PCS and CDPAS
On December 13th, DOH issued an administrative directive (here) and policy document (here) regarding regulatory changes impacting Personal Care Services (PCS) and Consumer Directed Personal Assistance Services (CDPAS) that are effective as of November 8, 2021. The documents provide guidance on the following aspects of the regulatory changes: 

  • Eliminating the requirement for managed care plans to notify home care recipients about CDPAS annually;
  • Requiring consumers/designated representatives to work with only one fiscal intermediary (FI) at a time;
  • Defining additional responsibilities of designated representatives; 
  • Changing the routine reassessment timeframe; 
  • Ordering practitioners for PCS and CDPAS;
  • Codifying supervision and cueing; and
  • Updates to the requirements for the continuation, denial, reduction or discontinuation of services. 

The updated CDPAS consumer/designated representative agreement is available here. Templates for outreach to CDPAS consumers working with more than one FI are available in the policy document.
 
Questions may be submitted to independent.assessor@health.ny.gov.

DFS Issues Circular Letter on Surprise Billing Process

On December 17th, the New York State Department of Financial Services (DFS) issued a Circular Letter to Article 42, 43, and 44 regulated insurers and providers regarding the implementation of the federal No Surprises Act and its effect on New York’s existing surprise billing rules. The existing New York independent dispute resolution (IDR) process will continue to operate, with certain modifications, effective January 1, 2022:

  • Types of Providers: The New York IDR process currently applies only to bills from physicians (not all providers) who are non-participating providers of emergency services in hospital facilities and ASCs. New York’s process will be expanded to cover disputes covering all such providers.
  • Types of Services: The No Surprises Act defines “visit” to cover eligible services that may be covered by the federal IDR process, including “equipment and devices, telemedicine services, imaging services, laboratory services, preoperative and postoperative services,” and other services specified by HHS, regardless of whether the provider of the services is at the facility. New York’s process will be expanded to include all such services provided on an emergency basis.
  • Safety Net Exemption: New York’s current exemption from the IDR process for a defined set of “safety net hospitals” (with at least 60% Medicaid, dual, or uninsured inpatient payer mix) will be removed.
  • Exempt CPT Codes: New York’s current exemption for certain CPT codes if the amount billed is under a threshold (currently $714.64) will be removed. 
  • No Increases in Cost-Sharing: New York’s IDR process currently allows for the possibility of the patient’s cost-sharing increasing if the IDR entity determines that a higher amount is due than the issuer paid. This provision will be removed, so cost-sharing must be calculated based on the issuer’s original payment amount (although patients will be due a refund if the IDR determines a lower amount is due).
  • Patient Choice to Waive Protections: Although the No Surprises Act allows patients to waive their balance billing protections, New York’s IDR does not, and will continue not to include such an option. 
  • Assignment of Benefits Form: New York’s IDR process currently requires an insured to sign an assignment of benefits form to activate their balance billing protections. This requirement will be removed. Regardless of assignation, issuers must send initial notices related to surprise bills directly to providers.
  • Air Ambulances: Air ambulances will be not be included in New York’s IDR process. They will be subject to the federal IDR process per the No Surprises Act.
  • Disclosure Requirements: Providers and plans must comply with the No Surprises Act’s disclosure requirements, such as providing notice of balance billing protections on their public-facing websites.

The Circular Letter is available here.

DOH Releases Guidance on Medicaid Coverage of At-Home Covid-19 Tests
Effective December 13th, New York State Medicaid will cover “at-home” Covid-19 diagnostic and screening tests with no member cost sharing. Coverage will be provided under both fee-for-service and managed care for FDA-authorized over-the-counter Covid-19 tests kits that are used in accordance with CDC recommendations for antigen collection.
 
Patients may be symptomatic or asymptomatic and do not require medical observations for self-collection. However, a fiscal order by a Medicaid-enrolled practitioner for the over-the-counter tests is required. A fiscal order may only include one test kit (each kit may contain two tests) and only one test kit may be ordered per week.
 
The at-home Covid-19 testing coverage guidance is available here.  
 
CMS Approves New York State SPA for Intermediate Care Facility Add-on Payments
On December 8th, the Centers for Medicare and Medicaid Services (CMS) approved New York State’s State Plan Amendment (SPA) including add-on payments for Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICF/IDD) providers as a result of enacted legislation increasing the minimum wage. The payment adjustments are effective January 1, 2017. The SPA also makes provisions for ICF/IDD ownership and control payments for specified circumstances effective August 1, 2017.
 
The SPA is available here and the CMS approval letter is available here.
 
DOH Issues Notice Regarding Forthcoming Children’s HCBS Rate Enhancements
On December 15th, DOH issued a notice (available here) to plans and providers regarding anticipated rate enhancements for Children’s Home and Community-Based Services (HCBS). The Children’s HCBS package is available to enrollees in the consolidated Children’s 1915(c) waiver and to eligible children in the 1115 waiver. The State’s enhanced HCBS spending plan under the American Rescue Plan includes a 25 percent rate increase for HCBS provided to children in Medicaid fee-for-service and managed care, to assist providers in building capacity to meet increased demand for HCBS due to the Covid-19 pandemic.
 
Although enhancements are planned for other related services, this notice concerns only the Children’s HCBS service package, which includes services like Community Habilitation, Day Habilitation, Respite, Prevocational Services, and Palliative Care. Upon final approval from CMS and updates to the eMedNY system, Medicaid fee-for-service payments to HCBS providers and non-risk payments to plans will be retroactively adjusted for services delivered on or after April 1, 2021. The rate enhancement will be in effect through September 30, 2022.
 
Questions may be submitted to BH.Transition@health.ny.gov.
 
DFS Fines Three Health Plans for Mental Health Parity Violations
On December 15th, DFS announced that it had secured $3.1 million in penalties from health insurance plans that were not compliant with state and federal cost-sharing requirements for mental health and substance use disorder parity. DFS reviewed the mental health and substance use disorder parity reports that insurers are required to submit every two years and found that three plans sold policies that required consumers to pay a copayment or coinsurance for mental health and substance use disorder benefits that was not permitted under the law.
 
Of the penalties, about $0.5 million will be returned to consumers, $2.3 million will support the Behavioral Health Parity Compliance Fund, which provides funding for initiatives supporting parity implementation and enforcement on behalf of consumers, and the remaining $0.4 million will go to the General Fund.
 
The DFS press release is available here.
 
Governor Hochul Signs Several Health Care-Related Bills
Over the past week, Governor Hochul signed the following health care-related legislation: 

  • A6429B/S5606B requires hospitals to distribute literature created by the Commissioner of Health to patients at high risk of sickle cell disease.
  • A5364/S4998 extends through March 31, 2024 the statutory authority for the Office for People with Developmental Disabilities (OPWDD) care demonstration program, which offers additional state-provided community-based services to some individuals with intellectual/developmental disabilities.
  • A4662/S1201A requires DOH, in consultation with the Department of Education, to maintain a schedule for when training programs offer competency exams to qualified home care services workers who reside outside New York State.