» Client Advisory
Federal Trade Commission Proposes New Rule for Personal Health Record Vendors
June 13th, 2023
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
Read More
Categories: Client Advisory
DEA and SAMHSA Extend COVID-19 Telemedicine Flexibilities for Prescribing Controlled Medications until November 2023 while Considering Public Comments
June 2nd, 2023
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
Read More
Categories: Client Advisory
The Beginning of the End – The Public Health Emergency Has an End Date
April 17th, 2023
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
Read More
Categories: Client Advisory
Virginia Department of Health Office of Licensure and Certification Releases a New Licensing Application Portal
February 6th, 2023
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
Read More
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
July 22nd, 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
Read More
Categories: Client Advisory
CMS Finalizes New Value Based Arrangement and Cybersecurity Exceptions and New Guidance for Complying with Stark Law
February 2nd, 2021
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
Read More
Categories: Client Advisory
Enhanced HIPAA Enforcement Actions in 2020 and Beyond: Health Care Providers of All Sizes Need to Be Prepared
January 4th, 2021
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
Read More
Categories: Client Advisory
Virginia’s New Independent Contractor Laws: Implications for Health Care Providers
October 9th, 2020
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
Read More
Categories: Client Advisory
CMS “Breaks Through” Medicare Coverage Delay and Defines “Reasonable and Necessary” in Proposed Rule
September 8th, 2020
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
Read More
HHS Final Rule Concerning Confidentiality of Substance Use Disorder Patient Records Adopted; CARES Act Changes to Follow
July 21st, 2020
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
Read More
Categories: Client Advisory