Weekly Health Care Policy Update – July 15, 2022

In this update: 

• Covid-19 Updates
  • FDA Authorizes Pharmacists to Prescribe Paxlovid
  • Cross-Agency Effort Seeks Public Input on Long Covid Workplace Challenges
  • FDA Issues EUA for Novovax Covid-19 Vaccine
• Administration Update
  • Biden Signs Executive Order on Protecting Access to Reproductive Care
• Congressional Update
  • Manchin Indicates Support for Health Care-Only Package
• Federal Agencies
  • CMS Releases CY 2023 Medicare PFS Proposed Rule
  • HRSA Opens 2022 Million Hearts Hypertension Control Challenge
  • CMMI Finds Implicit Bias in Three Payment Models
  • CMS Issues EMTALA Guidance Related to Abortion Services
  • HRSA Awards $155 Million to 72 Teaching Centers
• Other Updates
  • MACPAC to Hold Meeting on Medicaid Redeterminations
  • AHRQ Study Shows Drop in Hospital Adverse Events Pre-Pandemic
• New York State Updates
  • Governor Hochul Extends NYS Covid-19 Emergency Declaration
  • OSC Releases State Fiscal Year 2022-23 Enacted Budget Financial Plan Report
  • OMH Releases Billing Guidance Documents for BH Carve-In to MAP, Will Hold Webinar July 27^th
  • OMIG Releases Proposed Rule Updating Fraud, Waste, and Abuse Requirements
  • DOH Announces CMS Approval of Children’s Waiver Renewal Application
  • OMH Notifies Medicaid Managed Care Plans Regarding 5.4% COLA
  • Governor Hochul Announces Funding for Reproductive Health Care Providers to Strengthen Security
  • DOH Highlights New Medicaid Perinatal Care Standards and Expanded List of Lactation Services Certifications in Medicaid Update

COVID-19 Updates

FDA Authorizes Pharmacists to Prescribe Paxlovid
On July 6^th, the Food and Drug Administration (FDA) revised the Emergency Use Authorization (EUA) for Paxlovid to authorize state-licensed pharmacists to prescribe Paxlovid to eligible patients, with some limitations. In a press release, FDA indicated it hoped this change would help expand access to timely treatment for eligible patients, recognizing that Paxlovid treatment must be initiated within five days of symptom onset. FDA urges patients to first consider seeking care from their regular health care provider or a Test-to-Treat location.
 
Under the revised EUA, state-licensed pharmacists may prescribe Paxlovid to eligible patients except when: 

• Sufficient information is unavailable to assess renal and hepatic function;
• Sufficient information is unavailable to assess potential drug interaction;
• Modification of other medication is necessary to address a potential drug interaction; or
• Paxlovid is not an appropriate therapeutic option.

If any of the above circumstances apply, pharmacists may not prescribe Paxlovid and should refer the patient for a clinical evaluation with a physician or other provider licensed or authorized under state law to prescribe drugs.
 
A press release is available here. The updated Paxlovid EUA is available here.
 
Cross-Agency Effort SeeksPublic Input on Long Covid Workplace Challenges
On July 12^th, the Department of Labor, the Centers for Disease Control and Prevention, and the U.S. Surgeon General invited the public to offer ideas on how federal agencies can identify and respond to workplace challenges related to long Covid, including reducing the employment and financial impacts of the condition. The request seeks input in five key areas: 

• Challenges workers face as they cope with symptoms;
• Support for workers with long Covid from their employer;
• Ways to inform workers and employers about long Covid;
• Organizations to engage to develop solutions for those affected by long Covid; and
• Obstacles to obtaining disability benefits that workers with long Covid face.

The agencies are seeking input via a virtual crowdsourcing tool, found here.
 
FDA Issues EUA for Novovax Covid-19 Vaccine
On July 13^th, the FDA issued an Emergency Use Authorization (EUA) for the Novavax Covid-19 vaccine, a protein-based vaccine that can be stored in standard refrigeration. The two-dose vaccine is approved for individuals aged 18 years of age and older. In studies that preceded the omicron and delta waves, the vaccine was 90.4% effective in preventing mild, moderate, or severe COVID-19. In a subset of participants 65 years of age and older, the vaccine was 78.6% effective. Novovax has said that the vaccine shows “broad” immune response to Omicron subvariants BA.4 and BA.5. The fact sheet for health care providers administering the vaccine will include a warning that clinical trial data provided evidence for increased risk of myocarditis following administration of the vaccine.
 
The Novovax vaccine is the fourth Covid vaccine to be made available in the United States, but is already in use in 170 other countries. The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will meet on July 19^th to weigh in on whether to recommend the vaccine.
 
More information is available here.

Administration Update

Biden Signs Executive Order on Protecting Access to Reproductive Care
On July 8^th, President Biden signed an Executive Order directing the Secretaries of Health and Human Services (HHS) and Homeland Security and the Attorney General to identify potential actions to protect access to abortion, including medication abortion.
 
While the Order is wide-ranging, it does not establish new policies or carry the force of law. It generally directs members of the President’s cabinet to explore and identify any regulatory or administrative authority that they may be able to apply. In particular, it directs HHS to provide a report to the President within 30 days identifying potential actions it may take to: 

• Protect and expand access to abortion care and the full range of reproductive health services;
• Increase outreach and education about such access; and
• Ensure that all patients receive the full protection of emergency medical treatment (including patients experiencing miscarriage and other pregnancy complications) provided under federal law.

The Order also directs the Attorney General, the Secretary of Homeland Security, and other federal agencies to explore ways to address privacy, safety, and security risks related to the provision of reproductive health care.
 
The Executive Order is available here and a Fact Sheet is available here.

Congressional Update

Manchin Indicates Support for Health Care-Only Package
On July 14^th, Senator Joe Manchin (D-WV) indicated that he would be willing to support a narrow legislative package focused on health care. Manchin stated that he would not support the climate and tax proposals that were under negotiation due to his concerns about the June inflation report, but would continue to support the current Senate proposal for prescription drug legislation. That legislation would introduce a $2,000 cap on out-of-pocket costs for Medicare Part D, enable Medicare to negotiate the price of certain drugs, and apply a tax to drugs whose prices increase faster than inflation. The Congressional Budget Office (CBO) has estimated it would produce savings of $288 billion over 10 years. Manchin said he would support using $40 billion of the savings to extend the American Rescue Plan’s (ARP) enhanced premium tax credits for two years, and using much of the rest of the savings deficit reduction. Manchin left the door open to reopening discussions if inflation figures improved next month. It remains unclear whether the rest of the Democratic caucus will accept the narrowed proposal. If passed through reconciliation, the proposal would need to be passed at the latest by the end of September, although it would be expected to move significantly sooner. 
 
The CBO score of the prescription drug pricing bill is available here.

Federal Agencies

CMS Releases CY 2023 Medicare PFS Proposed Rule
On July 7^th, the Centers for Medicare & Medicaid Services (CMS) released a proposed rule to update the Medicare Physician Fee Schedule (PFS) for calendar year (CY) 2023. The PFS includes payment rates for about 8,000 services, defined by their Healthcare Common Procedure Coding System (HCPCS) codes. PFS rates are based on three components called Relative Value Units (RVUs) that reflect practitioner work, practice expense (PEs), and liability insurance. Each of the RVU components is adjusted by a geographic index specific to that component. The components are summed and then multiplied by a conversion factor to produce a dollar amount. The proposed CY 2023 conversion factor is $33.08, a decrease of $1.53, or about 4.4%, from last year’s conversion factor. This decrease is accounted for by several factors: 

• The statutory update, under current law, of 0% for CY 2023;
• The expiration of the temporary 3% increase to the conversion factor for CY 2022, which was passed at the end of 2021; and
• Required budget neutrality adjustments to account for RVU changes.

In addition to establishing the 2023 rates for Medicare physician payment, the rule contains several other major components, which are detailed further in the below subsections: 

• New billable codes and clinical flexibilities to expand access to behavioral health (BH) and other types of care;
• A proposed new calculation for the Medicare Economic Index (MEI), which is used to estimate input price costs of providing physician services and would change the relative distribution of RVUs;
• Changes to the parameters of the Medicare Shared Savings Program (MSSP) Accountable Care Organization (ACO) model; and
• Several requests for comments, including on global surgical package valuation, on how CMS should update practice expense data, and on how CMS can improve access to high-value, potentially underutilized services.

New Billable Codes and Clinical Flexibilities
CMS proposes the following actions to increase access to behavioral health services: 

• An exception to supervision requirements to allow BH services to be provided under general supervision, rather than direct supervision, of a physician, when provided by auxiliary personnel on an “incident to” basis. Specifically, this includes licensed professional counselors (LPCs) and licensed marriage and family therapists (LMFTs), who may not otherwise be paid under the PFS; and
• Creation of a new code, GBHI1, to allow clinical psychologists or clinical social workers to bill Medicare for care management services for BH conditions.

CMS also proposes: 

• New codes and valuations for chronic pain management services, which would establish a monthly bundled code to facilitate overall care for chronic pain;
• Updates to colorectal cancer screening policies to match recent recommendations by reducing the minimum age limit to 45 years and to include follow-up colonoscopies after a positive non-invasive test as a colorectal screening test which may be covered without cost-sharing;
• A new code for audiologists to bill for direct access to existing services without a physician referral;
• A policy to expand Medicare’s coverage of dental services to include services “inextricably linked to, and substantially related and integral to the success of” otherwise covered medical services. For example, CMS believes a patient who is scheduled for an organ transplant but has an oral infection may require dental services to address the infection in order to safely carry out the transplant.

Update to the Calculation of the MEI
Although the MEI is no longer used to set the conversion factor, CMS still uses it as a component of setting geographic price adjustments and of maintaining relativity between work and PE RVUs. The current MEI therefore determines that in total, work RVUs represent about 51% of costs, PE RVUs represent 45%, and malpractice RVUs represent 4%. The existing MEI has not been rebased and revised since 2014, and CMS proposes to do so starting in 2024.
 
Under CMS’s proposal, the revised MEI would result in a shift to about 47% work RVUs, 51% PE RVUs, and 1% malpractice. This would generally result in significant changes on the relative distribution of RVUs which would mostly disfavor facility-based billing. If implemented immediately, facility-based charges would go down by 4% while non-facility charges would increase by 2%, with significant variation in impact across specialties. CMS is proposing not to make an immediate change and to use the current MEI for CY 2023, but to consider making this change for CY 2024. 
 
Changes to the Parameters of the MSSP Program
CMS seeks to encourage more participation in MSSP and is proposing various changes that it hopes will increase the number of ACOs, the number of beneficiaries assigned to an ACO, and the enrollment of higher-spending populations in particular. CMS states that “without modification, [MSSP] is at high risk of increasing overall Medicare spending” because “ACOs serving patients with low spending will likely continue to dominate the roster of ACOs making the transition to risk.”
 
These include: 

• To provide upfront capital for ACOs serving underserved populations, CMS proposes to provide advance incentive payments (AIPs) to low-revenue ACOs that are new to the MSSP and do not have existing experience with performance-based risk Medicare payments. These payments would include a one-time fixed payment of $250,000 and eight per-member (up to 10,000 members) quarterly payments of up to $45 based on a risk score calculated from the ACO’s attributed beneficiaries’ dual eligibility status and geography.
• CMS proposes to extend the upside-only runway for new MSSP entrants by allowing them to sign up for one 5-year Level A agreement before entering the current glide path (which allows an additional 2 years at Level B before transitioning to downside risk).
• CMS proposes to allow ACOs to continue in Level E of the BASIC track indefinitely, rather than requiring them to transition to the ENHANCED track.

CMS also seeks to strengthen incentives for successful ACOs to remain in the program, which is affected by benchmarking rebasing and by the so-called “rural glitch”. CMS envisions moving to an “administratively set benchmark” in the long term, but currently proposes to revise the benchmarking methodology starting in 2024 by: 

• Introducing a “three-way blend” of the existing national and regional growth factors as well as a new prospective administrative growth factor. The administrative component would be set in advance of an ACO’s 5-year agreement period, and would therefore provide a degree of certainty to the ACO and reduce the impact of national and regional changes;
• Reinstituting a “prior savings adjustment” that will add savings achieved by an ACO across the past three years back into the ACO’s benchmark in future years; and
• Reducing the maximum negative impact of a regional adjustment from 5% to 1.5%, and reducing the level further for ACOs serving underserved populations.

CMS also proposes several changes related to quality reporting, including: 

• Creating a “health equity adjustment” to quality scores for ACOs that report all-payer electronic Clinical Quality Measures (eCQMs) or Merit-Based Incentive Payment System (MIPS) CQMs. The adjustment would be calculated based on their quality performance on each of the six measures in the APM Performance Pathway (APP) set, multiplied by an “underserved multiplier” and then capped at 10 bonus points; and
• Reinstating the “sliding scale” approach to shared savings and losses for ACOs, based on their health equity adjusted quality score;

Requests for Comments
CMS is seeking public comment on a variety of issues in this proposed rule, including: 

• Valuation of global surgical packages, related to concerns that the packages are not representative of E/M services actually delivered;
• How CMS should conduct updates to practice expense data, because CMS intends “to move to a standardized and routine approach to valuation of indirect PE” and seeks feedback on what that should entail; and
• A Request for Information (RFI) on potentially underutilized services, and in particular what services are underutilized and how CMS may encourage further utilization among potentially underserved communities.

Other
CMS also proposes to: 

• Enact various policies related to Medicare telehealth that implement 2021 year-end legislation around the expiration of the Covid-19 public health emergency (PHE), including: 
  • Extend the availability of several services temporarily available through telehealth under the PHE until the end of CY 2023 on a Category III basis;
  • Extend telehealth flexibilities that are in place during the PHE until 151 days after the PHE ends; and
  • Delay the in-person visit requirements for mental health visits furnished by rural health clinics and federally qualified health clinics via telecommunications technology until 152 days after the end of the PHE.
• Require manufacturers of certain single-dose container or single-use package drugs to provide refunds for discarded amounts, as required by the Infrastructure Investment and Jobs Act;
• Adopt most of the changes in coding and document for Other Evaluation and Management (E/M) visits approved by the AMA CPT Editorial Panel effective January 1, 2023;
• Delay the split (or shared) visits policy finalized in CY 2022 with regard to the definition of the substantive portion for one year, with a few exceptions.
• Revise the methodology for pricing the drug component of the methadone weekly bundle and the add-on code for take-home supplies of methadone to help stabilize the price for methadone, and other proposed policy changes to opioid treatment program (OTP) payments;
• Change policies and definitions on skin substitute products;
• Refine the payment amount for preventive vaccine administration under Medicare Part B;
• Revise the Clinical Laboratory Fee Schedule (CLFS); and
• Make a series of changes to the Medicare Ground Ambulance Data Collection System.

Finally, CMS proposes a number of changes to the Quality Payment Program focused on continuing to develop new Merit-based Incentive Payment System (MIPS) Value Pathways (MVPs). As such, CMS proposes limited changes in traditional MIPS to provide clinicians continuity and consistency while they gain familiarity with MVPs.
 
The proposed rule is available here. Comments will be accepted through September 27^th.
 
In conjunction with the proposed rule, CMS released a series of fact sheets including on the PFS proposed rule (available here), on the proposed changes to the CY 2023 Quality Payment Program (available here), and on the proposed changes to the Medicare Shared Savings Program (available here). CMS also published a blog outlining its proposed behavioral health changes (available here).
 
HRSA Opens 2022 Million Hearts Hypertension Control Challenge
On July 5^th, the Health Resources and Services Administration (HRSA) opened applications for the Centers for Disease Control and Prevention (CDC)’s 2022 Million Hearts Hypertension Control Challenge. The challenge “identifies and spotlights health care professionals, practices, and systems that have achieved nationally laudable hypertension control rates.” The challenge seeks health professionals and practices that have achieved hypertension control rates (blood pressure reading below 140 mm Hg/90 mm Hg) among 80% of their hypertensive population aged 18–85 years.
 
The application form is available here. Applications are due September 7^th. Previous Challenge Champions can be found here. More information about the challenge is available here.
 
CMMI Finds Implicit Bias in Three Payment Models
On July 5^th, the Centers for Medicare and Medicaid Innovation (CMMI) published a blog post in Health Affairs detailing its work to review ways in which implicit bias may have affected existing experimental payment and service delivery models, and whether such bias led to the exclusion of certain beneficiary groups from the models. CMMI specifically studied three models: 

• The Kidney Care Choices (KCC) Model;
• The Comprehensive Care for Joint Replacement (CJR) Model; and
• The Million Hearts Cardiovascular Risk Reduction Model.

It evaluated bias concerns in six areas: 

• Criteria for provider and beneficiary eligibility and selection
• Beneficiary attribution
• Risk assessment and screening tools
• Provider tools likely to be employed
• Payment design and risk-adjustment algorithms; and
• Model and evaluation design.

CMMI’s findings, by model, included: 

• KCC Model: The use of a race-adjusted estimated glomerular filtration rate (eGFR) as part of beneficiary alignment for the model may have erroneously elevated Black beneficiaries’ kidney function, and incorrectly assessed them as not meeting the medical eligibility criteria for the model.
• CJR Model: The model’s target price is not initially adjusted for factors associated with higher costs such as race or socioeconomic status, and CMMI found that beneficiaries receiving joint replacements under the model were less medically complex, and less likely to be dual eligible, than those receiving joint replacements at the same hospitals before model implementation. This raises concerns about selection bias, and prompted CMS to revise the risk-adjustment formula used to set the target price.
• Million Hearts Cardiovascular Risk Reduction Model: The Model uses the Atherosclerotic Cardiovascular Disease (ADCVD) Risk Calculator to determine eligibility for the model, a tool that may underestimate risk in patients from certain racial and ethnic groups with lower socioeconomic status (SES), while overestimating risk for individuals with higher SES. The model therefore may have systematically underestimated ten-year ASCVD risk for certain groups, excluding them from the model.

Moving forward, CMMI intends to engage in more systematic evaluations of its programming and to develop a step-by-step guide to screen for and mitigate bias in models before implementation.

The blog post is available here.
 
CMS Issues EMTALA Guidance Related to Abortion Services
On July 11^th, CMS issued clarifying guidance regarding the application of the Emergency Medical Treatment and Active Labor Act (EMTALA) to reproductive care, which indicates that in emergency situations, EMTALA authorizes providers to perform any medically necessary “stabilizing treatment”, including abortion, regardless of state laws.
 
The guidance reminds providers that EMTALA requires that “all patients receive an appropriate medical screening examination, stabilizing treatment, and transfer, if necessary, irrespective of any state laws or mandates that apply to specific procedures.” It notes that emergency medical conditions involving pregnant patients, such as ectopic pregnancy, complications of pregnancy loss, or emergent hypertensive disorders, may require such treatment.
 
The letter indicates that any hospital who denies abortions or other care necessary under EMTALA may face penalties, including the termination of a hospital’s Medicare provider agreement and/or the imposition of civil monetary penalties. It also threatens civil monetary penalties against an individual physician found in violation of EMTALA, as well as exclusion from Medicare and State health programs.
 
The full letter is available here.
 
HRSA Awards $155 Million to 72 Teaching Centers
On July 6^th, HRSA announced the award of over $155 million to 72 teaching health centers that operate primary care medical and dental residency programs. The awards focused on supporting residents in primary care residency training programs to meet the medical and mental health care needs of rural and underserved communities. HRSA awarded $135 million to existing and new teaching health centers to support additional resident positions and $20 million to existing Teaching Health Center Graduate Medical Education residency programs to continue resident training in the upcoming academic year. Awardees in New York include the Sunset Park Health Council in Brooklyn, Long Island FQHC in East Meadow, and the Institute for Family Health in Harlem and Mid-Hudson.
 
A full list of award recipients is available here. More information is available here.

Other Updates

MACPAC to Hold Meeting on Medicaid Redeterminations
On July 27^th at 1:30pm, the Medicaid and CHIP Payment Access Commission (MACPAC) will hold a special meeting to discuss challenges that state Medicaid programs may face when the Covid-19 public health emergency ends and Medicaid eligibility redeterminations begin. MACPAC was not officially scheduled to meet again until its September meeting.
 
More information on the virtual meeting is available here.
 
AHRQ Study Shows Drop in Hospital Adverse Events Pre-Pandemic
On July 12^th, the Agency for Healthcare Research and Quality (AHRQ) published a report in JAMA showing that rates of in-hospital adverse events for heart attack, heart failure, pneumonia, and major surgical procedures fell significantly in the U.S. from 2010 to 2019. The study reviewed data from over 3,100 hospitals and nearly 245,000 patients, and looked at 21 adverse events including infections, adverse medication events, or post-procedure events such as cardiac problems. Overall, adverse event rates fell 36 percent for heart attack patients, 31 percent for heart failure patients, 39 percent for pneumonia patients, 36 percent for major surgery patients, and were unchanged for patients representing all other conditions. Once adjusted for changes in patient populations and hospitals included in the study, overall rates went down 41 percent for heart attack patients, 27 percent for heart failure patients, 36 percent for pneumonia patients, 41 percent for major surgery patients, and 18 percent for patients with all other conditions.
 
The full study can be found here.

New York State Updates

Governor Hochul Extends NYS Covid-19 Emergency Declaration
On July 14^th, Governor Hochul issued Executive Order 11.8, which extends New York’s second Covid-19 State Disaster Emergency declaration through August 13^th. The Order continues the implementation of the State’s Comprehensive Emergency Management Plan and the “Surge and Flex” system, which allows the Department of Health (DOH) to limit non-essential elective procedures at health systems with limited capacity. Limited capacity is defined as having below 10% staffed bed capacity available, or as otherwise determined by DOH. The Order also continues the waiver of certain State Finance Law provisions around procurement to expedite purchasing of pandemic-related supplies.   
 
Executive Order 11.8 is available here.
 
OSC Releases State Fiscal Year 2022-23 Enacted Budget Financial Plan Report
On July 6^th, the Office of the New York State Comptroller (OSC) released its State Fiscal Year (SFY) 2022-23 Enacted Budget Financial Plan Report. The report notes that the Financial Plan “projects fiscal stability through the five-year plan period,” but states that “major risks and challenges exist that have the potential to quickly change the current outlook.” While planned disbursements exceed receipts in some years, the surplus General Fund resources accumulated in SFY 2021-22 will be used to balance the budget.
 
Projected growth in the General Fund spending reflects continuing temporary funding for Covid-19 pandemic recovery and the health care and direct workforce in SFY 2022-23, in addition to growth in spending for Medicaid and child care services, among other costs. State Medicaid costs are projected to grow from $18.9 billion to $27 billion in SFY 2026-27, an average annual growth of 9.3 percent. The Report attributes this growth to: 

• Higher service utilization and costs;
• Rising costs of assuming local Medicaid growth;
• Reimbursement of providers to cover minimum wage increases;
• Expiration of enhanced federal funding;
• Increased costs and enrollment growth in managed long-term care;
• Payments to financially distressed hospitals; and
• Increased wages for home care workers.

A variety of one-time expenditures, including Covid-19-related items, continue to impact the budget. On particular, Personal Income Tax receipts are projected to decrease substantially in SFY 2022-23 due to a one-time adjustment related to the State’s pass-through opt-in; without this adjustment, tax receipts would increase by 1.9 percent, “reflecting continued but slower economic growth.” Other one-time funds include General Funding Spending totaling at least $2.2 billion, including $800 million for safety net hospitals and nursing homes in financial distress. In addition, the $1.3 billion for frontline health care and mental hygiene worker bonuses implemented in the Enacted Budget are expected to be non-recurring after SFY 2022-2023. 
 
The report is available here.
 
OMH Releases Billing Guidance Documents for BH Carve-In to MAP, Will Hold Webinar July 27^th
On July 5^th, the NYS Office of Mental Health (OMH) released the following guidance documents for Medicaid Advantage Plus (MAP) plans related to the carve-in of behavioral health (BH) services into the MAP benefit package, which is scheduled to be effective January 1, 2023: 

• NYS MAP Behavioral Health Billing and Coding Manual (available here) outlines the requirements necessary to ensure proper BH claim submission for MAP plans.
• Appendix – MAP Coding Taxonomy for BH Services (available here) provides the coding crosswalk from rate codes to procedures codes and modifiers for MAP plan BH carve-in services.
• OMH Government Rate Table (available here) serves as a reference document for MAP plans for provider-level rate information for OMH outpatient services. 

Questions may be submitted to OMH-Managed-Care@omh.ny.gov.
 
On July 27^th from 10am to 11:30am, DOH and OMH will host a webinar which will provide an overview of the transition, a description of the services being carved-in, and specific billing requirements. The target audience is behavioral health providers serving MAP-enrolled members. Registration is available here.
 
OMIG Releases Proposed Rule Updating Fraud, Waste, and Abuse Requirements
On July 13^th, the NYS Office of the Medicaid Inspector General (OMIG) published a proposed rule in the State Register that would establish new requirements for providers to detect and prevent fraud, waste, and abuse in the Medicaid program. This proposed rule would implement provisions of the SFY 2020-21 Enacted Budget and the Medicaid program integrity reform initiatives of the second Medicaid Redesign Team (MRT II) and aims to align the state compliance program requirement more closely with the standard used at the federal level. The proposed rule, which would replace previous regulations, would: 

• Set forth general requirements for providers to adopt and implement a compliance program;
• Require providers to report, return, and explain overpayments from the Medicaid program, through OMIG’s self-disclosure program; and
• Require all Medicaid managed care plans to adopt and implement fraud, waste, and abuse prevention programs, including requiring plans with a certain number of Medicaid recipients to establish a special investigation unit (SIU).

The notice of proposed rulemaking is available here. The proposed regulations may be accessed here. Comments will be accepted through September 11^th.
 
DOH Announces CMS Approval of Children’s Waiver Renewal Application
On July 13^th, DOH issued an announcement that CMS has approved the renewal of the State’s 1915(c) Children’s Waiver for Home and Community-Based Services (HCBS). The five-year renewal is retroactively effective from April 1, 2022 through March 31, 2027. The renewal also includes the following changes to the current program, among others: 

• Changes the title of “Palliative Care: Bereavement” to “Palliative Care: Counseling and Support Services”;
• Changes the title of “Adaptive and Assistive Equipment” to “Adaptive and Assistive Technology”;
• Consolidates Caregiver and Family Supports and Services and Community Self-Advocacy Support into a new service titled “Caregiver/Family Advocacy and Support Services”;
• Removes all references to the Care at Home Waiver;
• Removes the Licensed Practitioner of the Healing Arts (LPHA) form requirement for Medically Fragile and Developmentally Disabled populations;
• Reduces required years of experience for Palliative Care Expressive Therapists from three years to one year;
• Broadens the definition of caregivers eligible for training to include all individuals who supervise and care for members; and
• Includes a temporary 25 percent rate increase, consistent with the DOH spending plan for the enhanced Federal Medical Assistance Percentage (FMAP) for HCBS.

The announcement is available here. Detailed guidance regarding implementation of these changes is forthcoming. Questions may be submitted to bh.transition@health.ny.gov.
 
OMH Notifies Medicaid Managed Care Plans Regarding 5.4% COLA
On July 7^th, OMH released a memorandum to mainstream Medicaid managed care plans, Health and Recovery Plans (HARPs), and HIV Special Needs Plans (HIV SNPs) notifying them of the legislatively mandated 5.4% Cost of Living Adjustment (COLA) increase for OMH-regulated rates, effective April 1, 2022. Plans must complete necessary systems edits to ensure payable claims for services are reimbursed at the newly effective rates and are required to conduct retrospective reconciliation to adjust payment for claims as necessary within 90 days of receipt of this memorandum.
 
The memorandum is available here. Questions may be submitted to BHO@omh.ny.gov.
 
Governor Hochul Announces Funding for Reproductive Health Care Providers to Strengthen Security
On July 7^th, Governor Hochul announced $10 million in total funding to support approximately 200 reproductive health care and abortion services providers improve the security of their facilities and safety of staff and patients. The Request for Proposals (RFP) will be administered by the NYS Division of Criminal Justice Services and will provide up to $50,000 in funding per facility. Funding may be used for new projects that enhance the interior/exterior physical security of the facility and/or provide security training for providers, staff, and/or clients as appropriate.
 
Eligible applicants for funding are public or not-for-profit Comprehensive Family Planning and Reproductive Health Program providers (see list here) or Article 28-certified clinics that provide reproductive health care services (e.g., family planning and medical/surgical abortion services). Eligible applicants may apply for funding to support more than one facility location.
 
The Governor’s press release is available here. The RFP is available here. Applicants are due on August 18^th.
 
DOH Highlights New Medicaid Perinatal Care Standards and Expanded List of Lactation Services Certifications in Medicaid Update
In the June Medicaid Update, DOH highlighted new Medicaid Perinatal Care Standards, which incorporate and replace previously published prenatal care standards. The updated standards, which apply to all Medicaid perinatal care providers and plans that contract with such providers, are effective August 1^st for Medicaid fee-for-service and October 1^stfor Medicaid managed care plans.
 
In the Update, DOH also highlighted that effective July 1^st for Medicaid fee-for-service and September 1^st for Medicaid managed care plans, the list of allowable lactation certifications will be expanded to include those from nationally recognized accrediting agencies.
 
The Medicaid Perinatal Care Standards are available here. The June Medicaid Update is available here.