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Homeostasis: Health Care Law Blog

Posts by Kathleen A. Reed


Photo of Homeostasis: Health Care Law Blog Kathleen A. Reed
Senior Attorney
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Showing 12 posts by Kathleen A. Reed.

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 ›

The New Hazardous Waste Pharmaceuticals Rule: A Few Practical Steps to Prepare

On February 22, 2019, the federal Environmental Protection Agency (EPA) issued a final version of the hazardous waste pharmaceuticals rule. The new rule was promulgated under the federal Resource Conservation and Recovery Act (“RCRA”), that provides for significant civil and criminal penalties for violation. According to the EPA, the new rule is a “better fit” for healthcare organizations managing hazardous waste pharmaceuticals (HWPs) because it reduces overlapping regulation by the FDA and the DEA, and it provides regulatory clarity and national consistency on the application of federal environmental law to the reverse distribution and reverse logistics processes used in the healthcare industry. The updated rule also protects the environment by prohibiting the sewering (i.e., pouring down the drain or flushing down the toilet) of all HWPs effective August 21, 2019.   Read More ›

Developments in Michigan Controlled Substance Regulation: New MAPS Communication Capabilities

NEW MAPS CapabilitiesThe Michigan Department of Licensing and Regulatory Affairs (“LARA”) announced the launch of two new communication capabilities in MAPS, available on July 18, 2019: Read More ›

Developments in Michigan Controlled Substance Regulation: New Exceptions for Hospice Patients

New Hospice ExceptionsMotivated by concerns that the requirements of Michigan controlled substance (“CS”) laws might result in hospice patients being denied timely access to necessary pain control drugs in their final days, the Michigan legislature amended the CS laws to benefit hospice patients, effective July 8, 2019. Two new exceptions give providers more flexibility under the bona fide prescriber-patient relationship requirement and the Michigan Automated Prescription System (“MAPS”) query requirement, both explained below, for meeting the pain control needs of hospice patients. Read More ›

Michigan Medicaid Issues New Requirements for Nurse Practitioner and Clinical Nurse Specialist Collaboration Agreements

Medicaid Bulletin MSA 19-10

Enrollment and Reimbursement for Clinical Nurse Specialists

On May 1, 2019, the Medical Services Administration of the Michigan Department of Health & Human Services (“MDHHS”), which administers the Michigan Medicaid program, issued Bulletin MSA 19-10 (the “Bulletin”), setting out new general information regarding enrollment, billing and reimbursement for a Clinical Nurse Specialist (“CNS”). CNS is a relatively new category of specialty certification available to a registered nurse (“RN”) in Michigan (Click here to access Bulletin MSA 19-10). The CNS Medicaid enrollment and coverage provisions essentially mirror those that apply to a Nurse Practitioner (“NP”), a long-established specialty certification for RNs in Michigan. Both NPs and CNSs, along with specialty certified nurse midwives (“CNM”), fall within the category of Advanced Practice Registered Nurse or APRN, which have an expanded independent scope of practice under recent amendments to the Michigan Public Health Code (“Code”). Read More ›

Bona Fide Prescriber-Patient Relationship Requirement for Controlled Substance Prescribing Effective January 4, 2019

Bona Fide Relationship Requirement LawPublic Act 247 of 2107, MCL § 333.7303a(2), requires that except as provided in exceptions detailed in administrative rules, a prescriber must be in a bona fide prescriber-patient relationship with a patient before prescribing a schedule 2-5 controlled substance (“CS”). The Michigan legislature delayed the effective date of the bona fide prescriber-patient relationship requirement to the earlier of (a) March 31, 2019, or (b) the date administrative rules describing the exceptions to the requirement are promulgated. Public Act 247 also requires the prescriber to provider certain follow-up care to the patient to monitor the efficacy of the CS in treating the patient’s medical condition. Failure to comply with the bona fide relationship requirement is considered professional misconduct and may subject the prescriber to professional discipline. Read More ›

Reminder: 7-Day Rule for Opioid Prescribing for Acute Pain Starts July 1, 2018

Only a few days remain before the 7-day rule for opioid prescribing goes into effect in Michigan. Beginning July 1, 2018, a prescriber who is treating a patient for acute pain shall not prescribe more than a 7-day supply of an opioid within a 7-day period. Acute pain is defined by statute as the normal, predicted physiological response to a noxious chemical, thermal, or mechanical stimulus that is typically associated with invasive procedures, trauma, and disease, and that usually lasts for a limited timeRead More ›

Michigan Department of Licensing and Regulatory Affairs Finalizes “Opioid Start Talking” Form for Mandatory Use with Opioid Prescriptions Starting June 1, 2018

Public Act 246 of 2017 includes two separate requirements for prescribers to obtain a patient’s signature certifying the receipt of information about opioids prior to prescribing a controlled substance containing an opioid for the patient. The first is a requirement that a prescriber use a “Start Talking” informed consent-type form when prescribing an opioid for a minor, with some exceptions. The second is a requirement that a patient sign a form approved by the Michigan Department of Licensing and Regulatory Affairs (“LARA”) certifying the receipt of certain opioid information from a licensed health professional prior to having an opioid prescribed for the patient (minor or adult) for other than for inpatient use. Both requirements go into effect June 1, 2018. Read More ›

Michigan Legislature Delays Effective Date of New Bona Fide Patient Relationship Requirement for Controlled Substance Prescribing to March 31, 2019

The recently-passed Michigan opioid and controlled substance legislation includes a requirement that a prescriber have a “bona fide” patient relationship with an individual prior to prescribing a controlled substance (“CS”) for that person, and includes some follow-up care requirements. In response to prescribers’ concerns about how to satisfy this requirement when covering their colleagues’ patients during off hours, or writing orders for home care or hospice patients, the Michigan legislature passed HB 5678, delaying the effective date of the requirement one year to March 31, 2019, or the earlier date on which LARA publishes rules regarding the requirement. The original legislation contains a provision permitting LARA, in consultation with the Boards of Medicine, Osteopathic Medicine and Surgery, Dentistry, Nursing, Optometry and Podiatry, and the Physician’s Assistant Task Force, to promulgate rules describing when a bona fide patient relationship is not required, and possible alternative requirements. The governor is expected to sign the legislation. Read More ›