Department of Health & Human Services

The Department of Health and Human Services Office of Inspector General (OIG) recently announced changes to its process for informing healthcare industry stakeholders of new or updated Compliance Program Guidance (CPG). Historically, sector-specific CPG has been published in the Federal Register. Going forward, the OIG will publish all current and updated CPG on its website.Continue Reading OIG’s Modernization of Compliance Program Guidance: What to Expect

The growth of private equity and other financial sponsor investments in the health care industry has led many states across the country to adopt expansive oversight authority over health care transactions. With the enactment of New York State’s budget for the State Fiscal Year 2023-2024, signed into law on May 3, 2023, the movement for more oversight in New York is coming this summer.Continue Reading New Notice and Public Disclosure Requirements for Material Health Care Transactions in New York

On April 17, 2023, the Centers for Medicare & Medicaid Services (“CMS”) released the U.S. Department of Health and Human Services (“HHS”) Notice of Benefit and Payment Parameters for 2024 Final Rule (the “Notice”) that includes standards for issuers and Marketplaces, and requirements for agents, brokers, web-brokers and others. The Notice implements various changes previously proposed by CMS, including (i) requiring provider networks to comply with network adequacy standards and delaying the implementation of appointment wait time standards, (ii) standardizing plan options, (iii) adding special enrollment periods to increase ease of obtaining coverage, (iv) strengthening markets, and (v) bolstering program integrity.Continue Reading CMS Releases Notice of Benefit and Payment Parameters for 2024 Final Rule

In February, when the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) delivered two annual reports to Congress for the 2021 calendar year as mandated by the HITECH Act, several notable takeaways were exposed. By providing data on enforcement actions and insight into areas of noncompliance, the reports assist HIPAA entities to mitigate risk, prioritize compliance efforts, and promote industry accountability.Continue Reading HHS OCR Delivered Annual Reports to Congress

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

Social determinants of health (“SDOH”) consider the non-clinical factors that can profoundly impact an individual’s well-being. They are extensive and often overlap, including housing instability, food insecurity, the inability to afford and obtain medications and more. Research has indicated that healthcare systems that connect patients to basic resources have observed improvements in population health metrics, fostered trust with their patient base, and experienced reduced hospitalization costs.Continue Reading CMS Augments “In Lieu Of Services” Medicaid Guidance to Support State Medicaid Managed Care Efforts to Address Social Determinants of Health

On December 21, 2022, the Department of Health and Human Services (“HHS”) issued a proposed rule aimed at advancing health equity and mitigating health disparities while minimizing administrative burden. The HHS Notice of Benefit and Payment Parameters for 2024 (“Proposed Rule”) would streamline ACA health plan selection, simplify marketplace enrollment, and expand access to care for low-income and medically underserved consumers through revision of network adequacy and essential community provider (“ECP”) standards. These proposed changes came in the midst of a record-breaking ACA Marketplace enrollment period, highlighting the increased demand for affordable health care coverage.Continue Reading HHS Proposes Health Insurance Market Reforms for 2024

The COVID-19 Public Health Emergency (“PHE”) led to a rapid expansion in the utilization of telehealth. Now, almost three years later, governmental entities have focused their attention on telehealth services and the potential for fraud and abuse. In July 2022, the Department of Health and Human Services Office of Inspector General (“OIG”) issue a Special Fraud Alert alerting practitioners to exercise caution when entering into arrangements with telemedicine companies. The issuance of this report is a significant step and reinforces the government’s interest in scrutinizing telehealth arrangements. The Department of Justice (“DOJ”) and the Drug Enforcement Agency (“DEA”) have also launched several high-profile investigations that the industry is monitoring closely. Telehealth providers should carefully review and update their practices given the heightened enforcement climate.Continue Reading Recent Developments in Telehealth Enforcement

On December 5, 2022, the Department of Health and Human Services (“HHS”), Office of Inspector General (“OIG”), released their Semiannual Report to Congress for the period beginning on April 1, 2022, and ending on September 30, 2022 (the “Semiannual Report”).[1]Continue Reading OIG Shines a Spotlight on Nursing Homes, Opioid Misuse, and Health Equity in the FY2022 Semiannual Report

The U.S. Department of Health and Human Services (“HHS”) has announced proposed changes (the “Proposed Rule”) to 42 C.F.R. Part 2 (“Part 2”). While the Health Insurance Portability and Accountability Act (“HIPAA”) governs the privacy and security of protected health information generally, Part 2 specifically governs the medical records of federally assisted substance use treatment programs (“SUD Records”).Continue Reading Proposal to Overhaul Privacy Law Governing Substance Use Disorder Treatment Records