Healthcare Law Blog

Shaping the World of Healthcare Law

On August 14, 2023, the Centers for Medicare & Medicaid Services (CMS) released guidance on changes to the Accountable Care Organization Realizing Equity, Access, and Community Health (ACO REACH) Model starting in performance year 2024 (PY2024). The changes came about in response to stakeholder and participant feedback. All ACO REACH participants should familiarize themselves with the upcoming changes.
Continue Reading CMS Announces Changes to ACO REACH Model

As we previewed in our previous blog article, the California Department of Health Care Access and Information (HCAI) hosted a live public workshop on August 15, 2023 for in-person and virtual attendees to make comments and pose questions regarding the proposed regulations governing the Office of Health Care Affordability’s (OHCA) review authority for certain healthcare transactions.
Continue Reading Public Workshop for OHCA’s Proposed Regulations Sparks Lively Discussion Among Industry Stakeholders

The status of the independent dispute resolution (IDR) process under the No Surprises Act (NSA) is ever-evolving. Providers are waiting on the sidelines as cases weave their way through the court system. While the IDR process is currently on hold, it is incumbent on providers, payors, and individuals to remain vigilant and stay abreast of the forthcoming changes.
Continue Reading Sheppard Mullin Webinar – No Surprises Act: Litigation Update and Recent Guidance

On September 1, 2023, the Centers for Medicare and Medicaid Services (CMS) issued a long-awaited proposal to establish new federal minimum staffing standards for long-term care facilities.[1] If the proposed rule is finalized, CMS estimates that approximately 75% of all nursing homes would have to “strengthen staffing in their facilities” in order to meet the new requirements.[2]
Continue Reading Long Term Care Facilities Face Mandatory Minimum Staffing Requirements

On August 24, 2023, the United States District Court for the Eastern District of Texas again largely ruled in favor of the Texas Medical Association and other plaintiffs (including air ambulance providers) and vacated certain regulations[1] and related guidance concerning how the “Qualified Payment Amount” (“QPA”) – one of the factors in the arbitration of out-of-network disputes – is calculated under the No Surprises Act (the “Act”).[2] The Court also vacated certain rules specific to the QPA and Federal Independent Dispute Resolution (“IDR”) process for out-of-network air ambulance services.
Continue Reading Another No Surprises Act Update: Texas Court Vacates Rules and Guidance Related to the “Qualified Payment Amount”

The intersection of patient satisfaction and quality of care is central to healthcare today, and a provider’s level of cultural competence can significantly impact his/her performance in both areas. Recent focus on diversity, equity, and inclusion initiatives in healthcare has impacted how policymakers are approaching related issues, such as cultural competence in patient care.[1] Some state governments have determined that a provider’s ability to deliver culturally competent care is an essential component to promoting effective and efficient healthcare delivery.[2] For example, Nevada, Oregon, Connecticut, New Jersey, California, Washington, New Mexico, and the District of Columbia each require some
Continue Reading Get Prepared – Newly Mandated Cultural Competency Training for Illinois Healthcare Providers

On August 21, 2023, the New York State Office of the Medicaid Inspector General (OMIG) announced updates to the Medicaid overpayment self-disclosure program, which now includes an abbreviated process for reporting and explaining overpayments that are considered routine or transactional in nature and have been already voided and adjusted.
Continue Reading New York Medicaid Providers Now Have Two Pathways to Self-Disclose Overpayments to the Office of the Medicaid Inspector General

Nearly three months after hearing oral arguments, a divided Fifth Circuit panel issued its decision in Alliance for Hippocratic Medicine v. FDA, upholding the U.S. Food and Drug Administration’s (“FDA”) underlying approval of Mifepristone in 2000, but reinstating the limitations and restrictions under the pre-2016 protocol. Despite rejecting Judge Matthew Kacsmaryk’s blanket suspension of the drug’s approval, the federal appeals court found that the FDA overstepped its authority in expanding access and loosening restrictions on the drug in 2016 and 2021. Specifically, the Fifth Circuit agreed with the lower court’s ruling to invalidate the FDA’s modifications that increased the
Continue Reading Fifth Circuit Rules to Reinstate Abortion Pill Restrictions

On July 13, 2023, the Centers for Medicare & Medicaid Services (“CMS”) issued its proposed rule (the “Proposed Rule”) for the 2024 Medicare Physician Fee Schedule (“PFS”). The Proposed Rule, which was issued in the Federal Register on August 7, 2023,  includes updated payment rates, changes to reimbursement for services related to health equity and social determinants of health, increases to payment for cancer care support, and changes to enrollment for mental health providers. CMS projects that the Proposed Rule will lead to growth in the Medicare Shared Savings Program (“MSSP”).
Continue Reading CMS Announces Proposed Rule for 2024 Medicare Physician Fee Schedule

On August 3, 2023, the United States District Court for the Eastern District of Texas once again ruled in favor of the Texas Medical Association[1] and vacated portions of the guidance related to (i) the administrative fee for the Independent Dispute Resolution (“IDR”) process created by the No Surprises Act (the “Act”) and (ii) the “batching” of claims for the IDR.[2] The Department of Health and Human Services promptly announced that the IDR process is temporarily suspended and will not be available for out-of-network disputes until further notice.
Continue Reading No Surprises Act Update: Federal IDR Temporarily Suspended After Court Vacates Increased Administrative Fees and Rule for Batching Claims

As the nation prepares for the upcoming 2024 elections, the consequences of the U.S. Supreme Court’s ruling in Dobbs v. Jackson continues to be a significant topic of discussion in numerous states. Since that decision and our first and second posts in this series, a number of noteworthy developments* have occurred at both the federal and state levels, including some states passing laws that prohibit or restrict the availability of abortions. Some of the most recent legal developments are summarized below.
Continue Reading Part 3: An Update on the Federal and State E-Roe-sion or P-Roe-tection of Abortion Rights

As we previewed in our blog article in March on the establishment of California’s new Office of Health Care Affordability (OHCA), OHCA has issued proposed regulations available on the OHCA website, that provide anticipated details on OHCA’s advance review authority regarding certain transactions in the healthcare space.
Continue Reading Update from California’s Office of Health Care Affordability (OHCA): Proposed Regulations re Material Change Transactions and Pre-Transaction Review

As more and more states are enacting privacy laws, organizations in the health care industry may be wondering what the impact these laws will have on them. At this point, there are privacy laws in 12 states, with one more (Delaware) likely to be signed by the governor soon. Those laws are in California, Colorado, Connecticut, Florida, Indiana, Iowa, Montana, Oregon, Tennessee, Texas, Utah, and Virginia. (There is also a new law in Delaware currently pending the governor’s signature). Not all are in effect. Only the laws in
Continue Reading State Privacy Law Roundup: What Health Care Companies Need to Know

Oregon and Delaware have recently joined an increasing number of states enacting comprehensive privacy legislation intended to safeguard consumer[1] personal data by tightening regulation of businesses controlling and processing personal data.[2] Under the recent legislation, Oregon and Delaware intend to provide consumers with knowledge about uses of, and autonomy over, their personal information.[3]
Continue Reading Oregon and Delaware Break Ground in Movement Towards Enactment of Comprehensive Consumer Privacy Laws

On June, 23, 2023, New York City Mayor Eric Adams signed the Healthcare Accountability and Consumer Protection Act (Intro. 844-A). This local law amends the New York City Charter and directs the Mayor to establish an Office of Healthcare Accountability – the first of its kind in the country. Among other things, the NYC Office of Healthcare Accountability will allow New Yorkers to compare costs charged by NYC hospitals for the same services.
Continue Reading New NYC Local Law Promotes Health Care Price Transparency