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Homeostasis: Health Care Law Blog

Posts by Kathleen A. Reed

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Photo of Homeostasis: Health Care Law Blog Kathleen A. Reed
Senior Counsel
kreed@dykema.com
734-214-7661
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Showing 20 posts by Kathleen A. Reed.

New COVID-19 Vaccine Requirements for Nursing Homes

On May 13, 2021, the Centers for Medicare and Medicaid Services (“CMS”) published an interim final rule with comment period addressing COVID vaccine education, administration, and reporting requirements for nursing homes. Designed to reduce the spread of COVID-19, the rule updates the existing infection control requirements that nursing homes must meet to participate in the Medicare program, found at 42 C.F.R § 483.80. The effective date for the new rule is May 21, 2021, and Michigan’s state survey and certification staff have advised that they will begin enforcement of the new rule on June 14, 2021. Read More ›

Long Term Care Facilities Should Prepare for County Investigations Into COVID Deaths

Earlier this month, Peter Lucido, the Macomb County Prosecutor, who was also a former Republican State Senator and State Senate Majority Whip, announced a plan to investigate COVID-19 deaths in Macomb County nursing homes to determine whether Executive Order 2020-50, which was issued in April 2020 by Governor Gretchen Whitmer, and is no longer in effect, was responsible for those deaths. Prosecutor Lucido made a form available to families of former nursing home residents to collect information from the facility and then share with Macomb County law enforcement officials.  Read More ›

The Ten Year Wait is Over: HRSA Releases 340B Dispute Resolution Final Rule

The 340B Program, named after its section within the 1992 Public Health Service Act, allows covered entities to stretch their scarce federal resources as far as possible, by setting  a ceiling price on the sale of covered outpatient drugs from participating pharmaceutical manufactures to covered entities. With the passage of the Patient Protection and Affordable Care Act in 2010, 340B’s oversight agency, the Health Resources and Services Administration (“HRSA”) within the Department of Health and Human Services (“HHS”), was directed to establish an administrative dispute resolution (“ADR”) process. Covered entities and pharmaceutical manufactures would then use the ADR process to settle claims such as drug overcharging, diversion, or duplicate discounts. It took ten years, but HHS has finally taken action. Read More ›

Michigan Governor’s Executive Order 2020-30 Expands Health Care Professionals’ Scope of Practice and Lifts Certain Licensure Restrictions

On March 29, 2020, Michigan Governor Gretchen Whitmer issued Executive Order 2020-30  (“E.O. 2020-30”) temporarily lifting certain licensure and scope of practice restrictions for health care professionals practicing at health care facilities in response to the COVID-19 public health emergency.  E.O. 2020-30 contains the following provisions, which are effective immediately through the end of the COVID-19 public health emergency. Read More ›

CARES: Implications for the Healthcare Industry

On March 25, the Senate passed the Coronavirus Aid, Relief, and Economic Security Act (“CARES”). The House is expected to vote on the legislation on March 27, 2020. The following is a summary of the significant provisions impacting the health care industry. Read More ›

Michigan Governor Issues Executive Order 2020-13 to Enhance Operational Capacity and Efficiency of Health Care Facilities

On March 17, 2020, Michigan Governor Gretchen Whitmer issued Executive Order 2020-13 (COVID-19) (“E.O. 2020-13”) designed to enhance the operational capacity and efficiency of health care facilities in response to the COVID-19 public health emergency. Executive Order 2020-13 contains the following six directives: Read More ›

Prescribers May Forego In-Person Medical Exam When Prescribing Controlled Substances via the Internet During COVID-19 Public Health Emergency

Under the federal Ryan Haight Act (the “Act”), prescribers must ordinarily perform an in-person medical evaluation of a patient before using the Internet to prescribe controlled substances for that patient. The Act contains an exception to the in-person evaluation requirement when prescribing is done via the “practice of telemedicine,” as defined in the Act. The Act’s definition of telemedicine includes the practice of medicine by means of an acceptable telecommunication system during a public health emergency declared by the Secretary of Health and Human Services (the “Secretary”), with the concurrence of the federal Attorney General through the Drug Enforcement Administration (“DEA”). Read More ›

A Critical Resource: Get to Know Your Local Health Department

Administrative and clinical staff in nursing facilities around the country are under tremendous stress trying to deal with the COVID-19 pandemic. Facilities are getting barraged from all sides with information from experts and questions from residents and their families. In this period of uncertainty, do not overlook an important ally and resource right in your backyard—your local health department. The medical director at your health department is the epidemiology expert in your community, and is an invaluable resource for how pubic health issues are best addressed in your specific community, with your specific population. Read More ›

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 ›

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 ›