In her practice, Kathleen A. Reed has counseled a variety of health care providers, including hospitals, home health agencies, hospices, nursing homes, pharmacies, durable medical equipment suppliers and individual practitioners. Her practice encompasses many aspects of health care law, with particular emphasis on reimbursement, pharmacy and drug control and resale issues, fraud and abuse, scope of practice, licensure and regulatory matters and patient care issues. Ms. Reed has also provided counsel on compliance with Medicaid and Medicare requirements for participation and reimbursement and has assisted clients appeal adverse Medicare and Medicaid reimbursement decisions. She has also counseled health care clients on general corporate matters. Prior to her legal career, Ms. Reed practiced as a Registered Nurse in a variety of health care settings, including critical care, medical and surgical nursing, and home care.

On January 13, 2022, the United State Supreme Court upheld the Department of Health and Humans Services (“HHS”) Centers for Medicare and Medicaid Services (“CMS”) COVID-19 vaccine mandate for staff working at Medicare-participating health care facilities. HHS/CMS had issued an interim final rule on November 5, 2021, that incorporated a vaccine mandate into the health and safety regulations (e.g., conditions and requirements of participation) that apply to 15 types of facilities and agencies that participate in Medicare. The interim rule required these facilities and agencies to adopt policies and procedures mandating COVID-19 vaccination for all staff, except in cases of religious or medical exemption or delay, by stated deadlines.
Continue Reading U.S. Supreme Court Upholds the CMS COVID-19 Vaccine Mandate

Health plans and insurers will have a little more time to comply with some of the multitude of new requirements under the Consolidated Appropriations Act (“CAA”). On August 20, 2021, the Departments of Labor, Health and Human Services, and the Treasury (the “Departments”) issued an FAQ updating plans and issuers on critical enforcement guidance for several CAA transparency measures. The Departments have acknowledged that plans and issuers are struggling to comply with the litany, and complexity, of transparency requirements the CAA imposes, going so far as to note that compliance with some requirements by initial enforcement dates “is likely not possible.”

Continue Reading Important Enforcement Updates on No Surprises Act and Transparency Requirements

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.

Continue Reading New COVID-19 Vaccine Requirements for Nursing Homes

In support of Lucido’s investigation, Republicans in both houses of Michigan’s legislature have introduced bills to provide funds for county prosecutors for further investigation. Specifically,  Senate Bill 27, which the Senate already passed on a party line vote, appropriates $1.25 million for grants of up to $250,000 to prosecutors.  House Bill 4589, which was introduced on March 25, 2021, appropriates $5 million to the “Prosecuting Attorneys Coordinating Council” for similar purposes. While it is unlikely either bill will become law, as they would require Governor Whitmer’s approval, Lucido’s efforts could have significant ramifications for the industry and, given the current political environment, are likely to spur “copy-cat” initiatives by prosecutors around the state and perhaps the nation.

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

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

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

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

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.
Continue Reading A Critical Resource: Get to Know Your Local Health Department

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.
Continue Reading Michigan to License Remote Pharmacies