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Federal Trade Commission Proposes New Rule for Personal Health Record Vendors

On June 9, 2023, the Federal Trade Commission (“FTC”) proposed amendments to a regulation applicable to vendors of personal health records (“PHRs”) and related entities who store data about U.S. citizens or residents. The Health Breach Notifi… Read More
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DEA and SAMHSA Extend COVID-19 Telemedicine Flexibilities for Prescribing Controlled Medications until November 2023 while Considering Public Comments

The Drug Enforcement Administration (DEA) jointly with the Substance Abuse and Mental Health Services Administration (SAMHSA) published a temporary rule, effective May 11, 2023, extending flexibilities for the prescribing of controlled substances thr… Read More
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The Beginning of the End – The Public Health Emergency Has an End Date

On January 30, 2023, the Biden Administration announced its intent to end the COVID-19 public health emergency (“PHE”) on May 11, 2023. With the end of the PHE comes the end of federal regulatory waivers and flexibilities that have in some instan… Read More
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Categories: Client Advisory

Virginia Department of Health Office of Licensure and Certification Releases a New Licensing Application Portal

On January 3, 2023, the Virginia Department of Health (VDH) Office of Licensure and Certification (OLC) launched Phase I of a new online application portal.[1] The new VDH OLC Portal is available on OLC’s website at https://www.vdh.virginia.gov/lic… Read More
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Categories: Client Advisory

Time to Tighten the ROP - CMS Issues Revised Guidance on Requirements of Participation for Long-Term Care Facilities Effective October 24, 2022

The Centers for Medicaid and Medicare Services (“CMS”) published revised guidance on the Requirements of Participation (“ROP”) and standards for Long-Term Care (“LTC”) facilities on June 29, 2022. The updated guidance clarifies and correc… Read More
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Categories: Client Advisory

CMS Finalizes New Value Based Arrangement and Cybersecurity Exceptions and New Guidance for Complying with Stark Law

On November 20, 2020, the Centers for Medicare & Medicaid Services (CMS) published its Final Rule updating the physician self-referral law (“Stark Law”) located at 42 CFR 411. Originally proposed in 2018, the Final Rule establishes new except… Read More
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Categories: Client Advisory

Enhanced HIPAA Enforcement Actions in 2020 and Beyond: Health Care Providers of All Sizes Need to Be Prepared

As the COVID-19 pandemic has continued, health care providers have adjusted to a new reality of providing health care services to patients through telehealth and other means designed to mitigate the spread of the virus. With these new practices come… Read More
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Categories: Client Advisory

Virginia’s New Independent Contractor Laws: Implications for Health Care Providers

Introduction During the 2020 session, the Virginia General Assembly enacted several new laws addressing the evolving employer-worker relationship in a gig economy. Although the appropriate classification of workers as independent contractors versus e… Read More
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Categories: Client Advisory

CMS “Breaks Through” Medicare Coverage Delay and Defines “Reasonable and Necessary” in Proposed Rule

Introduction On September 1, 2020, CMS published a new proposed rule that would create a streamlined Medicare coverage pathway for new and innovative medical devices that are deemed “breakthrough” by the Food and Drug Administration (“FDA”).… Read More
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HHS Final Rule Concerning Confidentiality of Substance Use Disorder Patient Records Adopted; CARES Act Changes to Follow

In August 2019, the Department of Health and Human Services (“HHS”) proposed a new rule that would amend provisions of 42 CFR Part 2 governing the confidentiality of substance use disorder patient records. Shortly thereafter, Mellette PC publishe… Read More
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Categories: Client Advisory