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Alexandria (Alex) Foster is an associate in the Corporate Practice Group in the firm's Washington, D.C. office and a member of the Healthcare Team.

2024 marked a notable year in AI and healthcare, with AI being top of mind for all healthcare players, including providers, technology companies, developers and regulators. The adoption of AI into clinical settings became more common, as scribe and clinical-decision support products gained popularity and EMR vendors incorporated AI tools into their products. The federal government released guidance, established task forces and implemented the directives of the 2023 Executive Order on AI. Similarly, state regulation began to unfold with some states passing legislation around AI’s use in healthcare.Continue Reading Healthy AI: 2024 Year in Review

On June 10, 2024, the U.S. Supreme Court granted certiorari in Advocate Christ Medical Center v. Becerra[1] for the October 2024 – 2025 term to review a D.C. Circuit Court of Appeals ruling potentially affecting up to $4 billion in federal funding for hospitals.[2] The Supreme Court will determine whether the federal Department of Health and Human Services (“HHS”) properly reimbursed hospitals for providing care to patients receiving financial aid from the Supplemental Security Income Program (the “SSI Program”).[3] Hospitals benefiting from Medicare reimbursement adjustments for treating low-income patients should closely monitor this case, as a favorable ruling for the plaintiffs may impact how hospitals are reimbursed for similar claims in the future.Continue Reading SCOTUS to Review Case Impacting Medicare Reimbursement for Hospitals Treating Low-Income Patients

On April 4, 2024, the Centers for Medicare & Medicaid Services (“CMS”) issued the contract year 2025 (CY2025) Medicare Advantage and Part D final rule (the “Final Rule”). In addition to finalizing its CY2025 proposed rule, CMS also addressed several key provisions that remained from the CY2024 proposed rule. According to CMS’ Fact Sheet, the Final Rule builds on existing Biden-Harris Administration policies to strengthen protections and guardrails, promote healthy competition, and ensure Medicare Advantage and Part D plans best meet the needs of enrollees. The Final Rule also promotes access to behavioral health care providers, promote equity in coverage, and improve supplemental benefits.Continue Reading CMS Issues CY2025 Medicare Advantage and Part D Final Rule

The U.S. Department of Health and Human Services (HHS) and the Substance Abuse and Mental Health Services Administration (SAMHSA) recently released the long anticipated Final Rule to revise the Confidentiality of Substance Use Disorder (SUD) Patient Records regulations at 42 C.F.R. Part 2 (Part 2).Continue Reading HHS Announces 42 Part 2 Final Rule to Align with HIPAA

On November 6, 2023, the Centers for Medicare and Medicaid Services (“CMS”) released the contract year 2025 proposed rule for Medicare Advantage (“MA”) organizations and Part D sponsors (the “Proposed Rule”). The Proposed Rule covers an array of regulatory topics including the Star Ratings program, marketing and communications, agent and broker compensation, health equity, dual eligible special needs plans (“D-SNPs”), utilization management, network adequacy, and access to biosimilars.Continue Reading CMS Promotes Competition, Transparency, Health Equity and More in the CY2025 Medicare Advantage and Part D Proposed Rule

California is taking steps through Assembly Bill 254 (the “Bill”), approved by the State’s Governor on September 27, 2023, to ensure that patient information collected through reproductive or sexual health applications enjoys protections under the Confidentiality of Medical Information Act (the “CMIA”).[1] In addition to applying to providers and plans, the CMIA applies to businesses that offer software or hardware to consumers, such as mobile applications, which maintain medical information for the purpose of enabling management of such medical information or to otherwise support diagnosis, treatment, or management of a medical condition.[2] As a result, software and application developers may need to consider the CMIA with respect to their obligations relating to this particular data. In addition to certain confidentiality requirements, the CMIA also prohibits certain marketing uses and disclosures and requires breach notification in certain qualifying instances.Continue Reading California Moves to Protect Medical Information Collected Through Reproductive and Sexual Health Applications

The Office of Inspector General (“OIG”) within the U.S. Department of Health and Human Services (“HHS”) is responsible for detecting and preventing fraud, waste, and abuse in federal health care programs. The OIG has authority to enforce the federal Anti-Kickback Statute (“AKS”) and the Beneficiary Inducements Civil Monetary Penalty law (“CMPL”). One of the ways that the OIG utilizes its enforcement authority is through the issuance of advisory opinions. Continue Reading OIG 2022 Advisory Opinions: Year in Review

On April 12, 2023, OCR issued a Notice of Proposed Rulemaking (“NPRM”) to strengthen HIPAA’s protections around reproductive health care privacy. The NPRM responds to President Biden’s Executive Order 14076, which directed HHS to consider ways to strengthen privacy protections for reproductive health care services, following the Supreme Court’s rule in Dobbs v. Jackson Women’s Health Organization, overturning Roe v. Wade and ultimately resulting in renewed concern over patient privacy and reproductive healthcare.Continue Reading OCR Announces Proposed Rulemaking to Strengthen Reproductive Health Privacy

The Centers for Medicare & Medicaid Services (“CMS”), on behalf of the U.S. Department of Health and Human Services (“HHS”), recently issued a proposed rule to adopt standards under the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) for “health care attachment” transactions (the “Proposed Rule”). The Proposed Rule would implement requirements of HIPAA’s administrative simplification regulations, which are intended to support healthcare claims and prior authorization transactions while also introducing a standard format for electronic signatures to be used in conjunction with health care attachments.Continue Reading CMS’s Administrative Simplification Rule Aims to Increase Efficiency and Standardization for Health Care Attachments