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Homeostasis: Health Care Law Blog

Homeostasis: Health Care Law Blog

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Michigan to License Remote Pharmacies

Remote Pharmacy Legislation

In an attempt to improve access to pharmacy services in rural areas, the Michigan legislature recently enacted Public Act  4  of 2020 (“PA 4”), permitting licensure of  “remote pharmacies” in Michigan. Effective April 26, 2020, a “parent pharmacy” licensed and located in Michigan may  obtain a license for a “remote pharmacy,”  provided there is no licensed pharmacy within a 10 mile radius of the remote pharmacy location. The 10-mile rule does not apply if the remote pharmacy is located at a licensed hospital or mental health facility. The Board of Pharmacy may waive the mileage requirement upon application if the parent pharmacy demonstrates that the proposed remote pharmacy location is in an area where access to pharmacy services is limited, and there are compelling circumstances that justify the waiver. The parent pharmacy and the remote pharmacy must both be located in Michigan, and be under common ownership.  Read More ›

Cybersecurity Attacks: The Importance of Compliance With the Standards

Recent ransomware attacks illustrate the importance of compliance with the HIPAA required and addressable security standards. In its December 2, 2019 Fall 2019 Cybersecurity Newsletter, the Office of Civil Rights (OCR) discussed ransomware attacks and ways to recognize, prevent, mitigate and recover from an attack. Read More ›

Health Care Industry Employers Time to Redouble Efforts to Avoid Claims of Disability Discrimination (Part 1)

The Americans with Disabilities Act (ADA) is a federal law that prohibits discrimination against individuals with disabilities. Title I of the ADA covers employment by private employers with 15 or more employees as well as state and local government employers of the same size. Read More ›

Resident Discharge From a Michigan HFA: A Reminder

In Michigan, licensed homes for the aged are a sort of regulatory hybrid, wedged in between heavily regulated skilled nursing facilities and unlicensed assisted living facilities. That middle ground is apparent in the degree to which the Michigan Department of Licensing and Regulatory Affairs (“LARA”) is involved in the facility’s relationship with its residents during discharge situations. Although a licensed home for the aged (“HFA”) is not subject to the detailed procedures for involuntary discharge that apply to skilled nursing facilities, HFAs are not free to approach the eviction process like the typical commercial senior housing landlord. Rather, a licensed HFA must ensure it has met LARA’s discharge requirements before even beginning the eviction process. If not, all its efforts may be for naught. Read More ›

Office of Civil Rights Fines Dental Practice for Disclosure of PHI on YELP

The Office of Civil Rights of the Department of Health and Human Services (“OCR”) settled a HIPAA violation with a Texas-based dental practice based on the practice’s inappropriate disclosures of PHI on YELP. Read More ›

HHS Proposes Anti-Kickback Statute and Stark Law Revisions Protecting Value-Based Arrangements and Care Coordination

On October 9, 2019, the U.S. Department of Health and Human Services (“HHS”), Office of Inspector General (“OIG”) issued a Notice of Proposed Rulemaking to update the safe harbors to the federal Anti-Kickback Statute (“AKS”) and the Civil Monetary Penalties Law (“CMP Law”) related to the prohibition on beneficiary inducements. Read More ›

CMS Issues New Reporting Requirements for Providers and Suppliers

Authored by David Padalino

On September 10, 2019, the Center for Medicare & Medicaid Services (“CMS”) announced its Final Rule applying new reporting requirements for enrolled, and prospective, providers and suppliers. Medicare, Medicaid, and CHIP providers and suppliers will need to disclose their affiliations with organizations that have uncollected debts, are subject to a payment suspension under a federal health care program, have been excluded by the OIG, or had their Medicare, Medicaid, or CHIP billing privileges denied or revoked (“Disclosable Events”). Read More ›

Eleventh Circuit Rejects Expert Challenge to Clinical Judgment Decision in Hospice False Claims Act Litigation

On September 9, 2019, the U.S. Court of Appeals for the Eleventh Circuit issued an important decision for health care providers, especially those in the hospice industry. In U.S. v. AseraCare, Inc., No.16-13004, Slip. Op. (11th Cir. September 9, 2019), the Court held that a “reasonable disagreement between medical experts” about prognosis for a terminally ill patient, without more, cannot establish falsity. Slip. Op. at 3. The case began in 2008 as a qui tam action when former AseraCare company employees filed a False Claims Act lawsuit alleging that AseraCare submitted documents that falsely certified some Medicare patients were “terminally ill” and eligible for hospice care. The Government intervened. While the Eleventh Circuit remanded to the District Court to review its ruling in favor of AseraCare, the Eleventh Circuit upheld the lower court’s ruling that differing medical opinions do not qualify as “objective” evidence of falsity required by the False Claims Act.

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DHHS Issues Proposed Rule Amending 42 CFR Part 2

On August 22, 2019, the Substance Abuse and Mental Health Services Administration of the United States Department of Health and Human Services (“SAMHSA”) issued a proposed rule amending the Confidentiality of Substance Use Disorder Patient Records regulations set forth at 24 CFR Part 2. These regulations were initially implemented to provide heightened protection of patient records covering the treatment of substance use disorder (“SUD”) provided by certain federally funded programs (“Part 2 programs”). Read More ›

CMS Repeals Prohibition on Pre-Binding Arbitration for Long-Term Care Providers

On July 16, 2019, the Centers for Medicare & Medicaid Services (CMS) announced its final rule updating regulations pertaining to the use of arbitration agreements by long-term care facilities. Significantly, the final rule reversed CMS’s prior ban on pre-dispute arbitration agreements, imposed in CMS’s October, 2016 “Reforms of Requirements for Long-Term Care Facilities” final rule. Despite the repeal of the ban, the final rule continues to prohibit long-term care facilities from requiring a resident to sign an arbitration agreement as a condition of admission to, or receipt of care at, the facility.  Read More ›