On February 8, 2024, the U.S. Department of Health and Human Services (HHS) issued a final rule (Final Rule) updating federal “Part 2” regulations to more closely align the requirements applicable to substance use disorder (SUD) treatment records with the HIPAA privacy rule, and to make certain other changes. The regulations at 42

On June 22, 2023, New York State Public Health Law § 2802-b, added a Health Equity Impact Assessment (HEIA) to the Certificate of Need (CON) process for certain health care facilities. The new requirement comes as part of larger legislative changes to the Public Health Laws passed in 2021. The new HEIA requirement applies to any CON applications submitted on or after June 22, 2023, except there is a partial carve out for Diagnostic and Treatment Centers whose patient population is 50 percent or more Medicaid eligible or uninsured. The Department of Health also issued regulations on June 29, 2023 (10 NYCRR 400.26). The purpose of the HEIA is to understand the health equity impact on a specific project, the impact it may have on medically underserved groups and to ensure community input and assessment are considered. The Department of Health has expressed that their vision is “to have health equity considerations meaningfully impact the planning and execution of health care facility projects.” (NYSDOH, Health Equity Impact Assessment, Webinar Series: Program Documents, September 14, 2023.)Continue Reading New York Implements Health Equity Impact Assessment as New Requirement for Certificate of Need Process

On Wednesday, November 1, the Center for Medicare & Medicaid Services (CMS) released its Home Health Prospective Payment System Rate Update final rule for CY 2024 (the Final Rule). The Rule estimates that the aggregate increase to Medicare home health payments for 2024 will be 0.8 percent, or $140 million. This 0.8 percent increase results from the combined effects of three forecasted rate changes: (1) a 3.0 percent increase to home health payments, (2) a 2.6 percent decrease based on the permanent behavior assumption adjustment, and (3) a 0.4 percent increase resulting from an update to the fixed-dollar loss ratio, which is used to determine outlier payments. The 0.8 percent increase is a departure from the Proposed Rule, which estimated a cut in payments of up to 3 percent.Continue Reading CMS Announces 0.8 Percent Aggregate Home Health Payment Increase in 2024

On October 10, 2023, the federal Drug Enforcement Administration (DEA) issued another extension (Second Temporary Rule) of its pandemic-era telehealth flexibilities “in light of the need to further evaluate the best course of action” with respect to the prescribing of controlled substances via telemedicine. DEA is issuing a limited extension in order to give itself more time to finalize new standards governing tele-prescribing of controlled substances.Continue Reading DEA Further Extends COVID-19 Telemedicine Prescribing Flexibilities through December 31, 2024

On June 26, 2023, Connecticut Governor Ned Lamont signed Public Act No. 23-147, “An Act Protecting Maternal Health.” The Act makes various changes aimed at bolstering health care access and services for maternal and infant health. Key elements of the Act are summarized below.Continue Reading Connecticut Governor Signs Bill Introducing Programs to Improve Maternal Health

This post is co-authored by Seth Orkand, co-chair of Robinson+Cole’s Government Enforcement and White-Collar Defense Team.

On June 1, 2023, the U.S. Supreme Court issued a unanimous opinion in the highest-profile False Claims Act (FCA) case for many years, concluding that a party’s subjective belief as to whether it overcharged Medicare and Medicaid

On May 9, 2023, the Drug Enforcement Administration (DEA) issued a temporary rule that extends pandemic-era flexibilities allowing prescribing of controlled substances based on a telehealth relationship, after receiving in excess of 38,000 comments on its March 1, 2023 proposed rules (previously discussed here) to extend certain of those flexibilities but allow others to end upon expiration of the COVID-19 public health emergency on May 11, 2023.  The Temporary Rule provides the DEA with additional time to assess feedback on its proposed rules for post-pandemic tele-prescribing, and provides practitioners and patients with additional time to utilize pandemic-era flexibilities and to transition away from such flexibilities once final rules are issued.Continue Reading DEA Extends Pandemic Telehealth Prescribing Flexibilities For Up To 18 Months

On April 27, 2023, the Centers for Medicare & Medicaid Services (CMS) released a Notice of Proposed Rulemaking entitled Ensuring Access to Medicaid Services (Proposed Rule) which would, among other things, establish requirements for the amount of Medicaid payment going towards home care worker compensation.Continue Reading CMS Proposes New Rule that Would Require 80 Percent of Payment to Go Toward Home Care Worker Compensation

On May 2, 2023, legislators approved the $229 billion New York State FY 2023-2024 Budget Bill (“the Budget”), which was signed by Governor Hochul on May 3, 2023. Article VII of the Budget touches almost every aspect of the New York healthcare system, including home health, hospitals, laboratories, and reproductive health. It contains wide-ranging provisions that expand access to care, allow clinicians to provide more services, and allocate needed resources to providers. It targets Medicaid in multiple ways, including an extension of the Medicaid Global Cap on system-wide spending growth through FY 2025.[i] Here, we outline some of the key provisions that this Budget contains.Continue Reading New York Enacts Long Negotiated Budget Bill with Sweeping Implications for Health Care

On April 12, 2023, the U.S. Department of Health & Human Services (HHS) released a Notice of Proposed Rulemaking (Proposed Rule) that seeks to enhance safeguards of reproductive health care information through changes to the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule. The proposal is intended to align with President Biden’s Executive Order