Weekly Health Care Policy Update – August 15, 2022

In this update: 

• Legislative Updates
  • House Passes Inflation Reduction Act
  • President Biden Signs the PACT Act
• Federal Agencies
  • CDC Streamlines Covid-19 Guidance
  • HHS Issues Semiannual Regulatory Agenda
  • FDA Authorizes Modified Administration Method for Monkeypox Vaccine
  • CMS Publishes Final Rule Removing Prior Authorization for Some Orthopedic Procedures
  • HRSA Awards Nearly $90 Million to Health Centers
• New York State Updates
  • DOH to Hold Webinar on Required $3,000 Health Workforce Bonuses on August 19^th
  • DOH Releases New Attestation Form for Medicaid Beneficiaries Enrolled in Qualifying Clinical Trials
  • DOH Releases Updated Billing Guidance for Postpartum Maternal Depression Screening
  • DOH Updates E&M Fees for Physicians, Nurse Practitioners, and Midwives
  • DOH Releases Updated Medicaid Pharmacy Guidance and Announces Webinar on Medicaid Pharmacy Benefit Transition
• Funding Opportunities
  • NYC ACS Releases Concept Paper for the Provision of Skills Training for Parents with I/DD
  • HRSA Issues Additional FY 2023 FQHC Service Area Competition

Legislative Updates

House Passes Inflation Reduction Act
On August 12^th, the House of Representatives passed the Inflation Reduction Act (H.R. 5376) by a party-line vote of 220-207. The Act is unchanged from the version that was passed by the Senate last week. As such, the health care policy aspects of the bill pertain to prescription drug pricing, the extension of the enhanced American Rescue Plan (ARP) subsidies for Exchange coverage, and certain other issues, including establishing vaccines as a mandatory benefit in Medicaid. SPG summarized these provisions in more detail in last week’s update. President Biden has said he will sign it into law this week.
 
President Biden Signs the PACT Act
On August 10^th, President Biden signed the Sergeant First Class Heath Robinson Honoring our Promise to Address Comprehensive Toxics (PACT) Act. The bill will offer more timely benefits and services to more than 5 million veterans who have been affected by toxic exposures while serving in the military. Major provisions of the bill include:

• Expanding access to Department of Veterans Affairs (VA) health care services for veterans exposed during their military service. For post-9/11 combat veterans, the bill extends the period of time they have to enroll in VA health care from five to ten years post-discharge. For those combat veterans who do not fall within that window, the bill also creates a one-year open enrollment period.
• Codifying VA’s new process for evaluating and determining presumption of exposure and service connection. The new process will allow for such presumption when the evidence of a military environmental exposure and the associated health risks are strong in the aggregate but hard to prove on an individual basis.
• Removing the need for certain veterans and their survivors to prove service connection if they are diagnosed with one of 23 specific conditions. The list includes 11 respiratory related conditions, along with several forms of cancer, including reproductive cancers, melanoma, pancreatic cancer, kidney cancer, and brain cancers such as glioblastoma. Survivors of veterans who died due to one of these conditions may now also be eligible for benefits.

More information on the PACT Act is available here.

Federal Agencies

CDC Streamlines Covid-19 Guidance
On August 11^th, the Centers for Disease Control and Prevention (CDC) updated its Covid-19 guidance. The guidance includes the following changes:

• Individuals who have been exposed to Covid-19 should wear a high-quality mask for 10 days and get tested on day 5, but no longer need to quarantine, even if such individuals are not up to date with vaccines.
• Individuals who have tested positive for Covid-19 should still stay home for at least the first 5 days and isolate from others in the home. If after 5 days, an individual is fever-free for 24 hours without the use of medication and symptoms are improving, the individual can end isolation. 
  • Individuals who leave isolation on day 5 should wear a mask through day 10 or test negative twice over 48 hours before they stop wearing a mask.
  • Individuals who had moderate or severe illness should isolate through at least day 10.
  • If after isolation, symptoms worsen again, individuals should restart isolation at day 0.
• Screening testing of asymptomatic individuals without known exposure is no longer recommended in most community settings, but might be considered in settings like long-term care facilities, correctional facilities, and homeless shelters.
• “Test-to-stay” policies for schools are no longer recommended after exposure, but widespread testing during outbreaks or periods of high viral prevalence should be considered.
• Physical distance is now just one component of an overall protection strategy, instead of a specific guideline, and should be taken into account with other factors like community transmission and ventilation.

HHS Issues Semiannual Regulatory Agenda
On August 8^th, the Department of Health and Human Services (HHS) published its Fall 2022 Semiannual Regulatory Agenda, which provides an inventory of rulemaking actions currently under development throughout HHS. The Agenda lists various rules by their stage of development (proposed, final, long-term, or completed), although it is not a comprehensive list of all potential rules under consideration.
 
Most rules that are under the Centers for Medicare and Medicaid Services (CMS) have already been published in the Federal Register, except for the following: 

• Administrative Simplification: Modifications to NCPDP Retail Pharmacy Standards, projected for September 2022;
• Medicare Advantage and Medicare Prescription Drug Benefit Program Payment Policy (which “would codify long-established Medicare Advantage and Part D payment policies that are outside the scope of the annual Advance Notice/Rate Announcement”), projected for December 2022; and
• Transitional Coverage for Emerging Technologies, projected for April 2023.

Additionally, finalization of the Omnibus Covid-19 Health Care Staff Vaccination rule is listed as “long-term”, with the review of public comments still underway.
 
The full Agenda is available here.

FDA Authorizes Modified Administration Method for Monkeypox Vaccine
On August 9^th, the Food and Drug Administration (FDA) announced that it had granted Emergency Use Authorization (EUA) for an alternative dosing regimen of the JYNNEOS monkeypox vaccine. The EUA now allows for 0.1 ml of the JYNNEOS vaccine to be administered intradermally as opposed to 0.5 ml of the vaccine subcutaneously, which will greatly increase the available supply. A 2015 study demonstrated that this method, given on the same two-dose schedule 28 days apart, produced an immune response that was similar to subcutaneous dosing, although it does require a different type of needle. Individuals who received their first dose subcutaneously can receive their second dose intradermally or subcutaneously. The FDA also authorized JYNNEOS for individuals younger than 18 years of age who are at high risk of monkeypox infection, using the standard dosing route.
 
More information is available here.

CMS Publishes Final Rule Removing Prior Authorization for Some Orthopedic Procedures
On August 9^th, CMS published a final rule updating the Master List of Durable Medicare Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Conditions of Payment. The rule also suspends the DMEPOS prior authorization requirement for certain items for which the two-day expedited review would delay care and risk the health or life of the beneficiary. Specifically, CMS suspended prior authorization requirements indefinitely in circumstances where the “item was furnished urgently” (claims for HCPCS codes L0648, L0650, L1832, L1833, and L1851 that are billed using modifier ST), or where the item is “needed immediately due to medical necessity or because…[it is] furnished as part of a therapy session” (claims for HCPCS codes L0648, L0650, L1833, and L1851 billed with modifiers KV, J5, or J4). Prior authorization will continue for items not covered by the final rule. This policy has already been in effect since April 13^th, but this rule formally finalizes these changes.
 
The rule is available here.
 
HRSA Awards Nearly $90 Million to Health Centers
On August 8^th, the Health Resources and Services Administration awarded nearly $90 million to 1,354 community health centers to advance health equity through better data collection and reporting. The funding is specifically intended to “strengthen efforts to eliminate inequities in Covid-19 care and outcomes within communities of color and other underserved populations” through data modernization to better identify and respond to specific needs and help prepare for future public health emergencies. In New York, 65 health centers received roughly $65,000 each, for a total of roughly $4.2 million.
 
More information, including a map of funding recipients, is available here.

New York State Updates

DOH to Hold Webinar on Required $3,000 Health Workforce Bonuses on August 19^th
On August 19^th, the New York State Department of Health (DOH) will host two sessions of a webinar to provide information on the Healthcare Worker Bonus (HWB) Program, which requires Medicaid-billing employers to provide State-funded bonuses of up to $3,000 to many of their frontline health care workers and support workers. In general, any organization that receives Medicaid payments and has employees may be required to participate, although they may be exempt if they do not have significant Medicaid volume and are not subject to a certificate of need process. Qualified employers must submit their claims for bonus payments for the first vesting period, covering employees continuously employed from October 2021 through March 2022, by September 2^nd.
 
The webinar will discuss the implementation of the HWB program, including addressing eligibility and requirements and other frequently asked questions. Two sessions of the webinar will be held, the first at 11am (registration here) and the second at 1pm (registration here).
 
DOH Releases New Attestation Form for Medicaid Beneficiaries Enrolled in Qualifying Clinical Trials
DOH has released an updated policy to comply with CMS requirements for Medicaid coverage of routine costs associated with qualifying clinical trials. Effective immediately, all Medicaid beneficiaries who are enrolled in a qualifying clinical trial for whom Medicaid reimbursement is requested must have an attestation form completed and signed by the clinical trial’s Principal Investigator and the beneficiary’s health care provider. Once submitted, DOH will review the attestation and make a coverage determination within 72 hours.
 
The CMS guidance on Medicaid coverage of clinical trial costs is available here. The Medicaid attestation form is available here. Additional details are available in the July Medicaid update here. Questions may be sent to MedicaidClinTrials@health.ny.gov.
 
DOH Releases Updated Billing Guidance for Postpartum Maternal Depression Screening
Effective August 1, 2022 for Medicaid fee-for-service (FFS) and October 1^st for Medicaid managed care, postpartum maternal depression screening using a validated screening tool may be reimbursed up to four times (previously up to three times) within the first 12 months after the end of a pregnancy. This reimbursement is in addition to the payment for an Evaluation and Management (E&M) service when maternal depression screening is provided postpartum. Screening may be provided by the maternal health care provider and/or the infant’s health care provider.
 
Additional details, including validated screening tools and billing guidance, are available in the July Medicaid update here.
 
DOH Updates E&M Fees for Physicians, Nurse Practitioners, and Midwives
As authorized by the New York State Fiscal Year 2022-23 Enacted Budget, DOH has benchmarked non-facility fees for E&M codes for physicians, nurses, and midwives to 70 percent of current Medicare rates, effective July 1, 2022. Additionally, the benchmark rate for the Midwife Fee Schedule will increase from 85 percent to 95 percent of the Physician Fee Schedule.
 
Additional details, including links to the impacted fee schedules, are available in the July Medicaid update here. Questions may be sent to FFSMedicaidPolicy@health.ny.gov.
 
DOH Releases Updated Medicaid Pharmacy Guidance and Announces Webinar on Medicaid Pharmacy Benefit Transition
In the July Medicaid Update, DOH included the following pharmacy updates for the Medicaid program: 

• Changes to the Preferred Drug Program (PDP) within the FFS pharmacy program, as recommended by the NYS Medicaid Drug Utilization Review Board;
• Clarification on previous guidance related to Medicaid FFS coverage of Practitioner Administered Drugs (PADs); and
• Clarification on policy regarding authorized practitioner dispensing. 

Additionally, on August 16^th from 1pm-2pm, DOH will be hosting an informational webinar on the pending transition of the Medicaid pharmacy benefit from managed care to FFS. This will be the first in a series of recurring monthly webinars on this topic, which will be open to all interested stakeholders and will include a question-and-answer period at the end of each webinar. Registration for the webinar is available here.
 
The July Medicaid update is available here.

Funding Opportunities

NYC ACS Releases Concept Paper for the Provision of Skills Training for Parents with I/DD
On August 11^th, the New York City (NYC) Administration for Children’s Services (ACS) Developmental Disabilities Unit released a Concept Paper for a forthcoming Request for Proposals (RFP) intended to build on and expand services to parents with a known or suspected intellectual or developmental disability (I/DD). The RFP will seek providers approved by the New York State Office for People with Developmental Disabilities (OPWDD) to offer parenting skills training for parents with known or suspected I/DD, including those with dual diagnoses of I/DD and other clinical needs. Through this concept paper, ACS seeks input from stakeholders, including parents with I/DD, to help inform the upcoming RFP.
 
ACS anticipates awarding over $2.8 million in total funding across three awardees during the three-year program period. Selected providers will be required to each serve a minimum of 75 individuals annually within NYC.
 
The Concept Paper is available in the PASSPort system here by searching “Essential Parenting Supports.” Comments may be submitted to IDD-CP@acs.nyc.gov through September 26^th. ACS anticipates releasing the RFP in the fall of 2022, with proposals due approximately six weeks after release.
 
HRSA Issues Additional FY 2023 FQHC Service AreaCompetition
On August 11^th, HRSA posted a new Service Area Competition (SAC) opportunity for fiscal year (FY) 2023. Through the SAC, organizations may apply to participate in the federally qualified health center (FQHC) program by taking over a grant in an existing service area. FQHCs are typically approved for a three-year period and, if they seek to renew, must reapply to the SAC. For this opportunity, there are additional SACs open in New York City.
 
Applications are due October 11^th. More information is available here.