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Homeostasis: Health Care Law Blog

Homeostasis: Health Care Law Blog


What to Do When Guidance Doesn’t Seem to Guide

On June 14, 2018, the U.S. Department of Health and Human Service’s Office for Civil Rights (OCR) issued guidance to the clinical research community about the proper content of HIPAA authorizations to use Protected Health Information (PHI) for future clinical research.

The Guidance was mandated by the federal 21st Century Cures Act (Cures Act), which among other things, encourages finding cures for disease and injury through scientific research. The Cures Act required OCR to address three points:

  • What information will satisfy the “purpose” provision of a HIPAA authorization when the plan is for PHI to be used for future research that may not even be contemplated at the time the authorization is signed—e.g. when PHI will be placed in a research database or repository for use in as yet unspecified future research protocols?
  • What is a sufficient expiration date or event for a HIPAA authorization for future research?
  • What information must the authorization provide about the individual’s right to revoke the authorization and the mechanisms to accomplish revocation?
 Read More ›

Covenant FN 40: A Silver Lining for Health Care Providers?

The Covenant Med. Ctr., Inc. v. State Farm Mut. Auto. Ins. Co., decision last year posed new problems for health care providers seeking to litigate no-fault benefit payment disputes against insurance companies. The Michigan Supreme Court held that providers could no longer bring direct causes of action against no-fault insurance companies for payment denials or underpayments because the no-fault statute does not mention any such cause of action. However, Footnote 40 of the Court’s opinion offered another option: the health care provider can enforce an assignment of past or present—not future—benefits from the patient. If the patient signs an assignment of benefits form at the time of each service, the health care provider can bring an action against the no-fault insurer on behalf of the patient. It remained unclear though how Michigan courts would interpret this footnote and whether the courts would impose additional restrictions on providers’ use of assignments to litigate payment disputes with no-fault insurers. Recent case law clarifies how providers may use Footnote 40. Read More ›

New Federal Right To Try Act Poses Practical and Ethical Dilemmas for Physicians

On May 30, 2018, the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 (“Right To Try Act,” or “Act”) became the law of the land. See 115 P.L. 176; 132 Stat. 1372; 2018 Enacted S. 204. Proponents herald it as a new era for terminally ill patients for whom standard treatments have not worked. Critics assail it as an assault on the authority of the U.S. Food and Drug Administration (FDA) and a sham that adds little to patients’ existing options.

What does the Act mean for physicians providing care to terminally ill patients? Like many of its state-based existing counterparts, the Act raises practical problems and exacerbates ethical dilemmas that physicians face as they balance their obligation to support their patients against their obligation to avoid futile and even harmful interventions. 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 ›

Forecasting Turbulence for Health Care Providers

Bankruptcies and other debt restructuring activities for health care providers are on the rise, and recent headlines related to the industry suggest further stormy weather ahead. Please join Dykema attorneys Mark Andrews and Lea Courington as they discuss the intersection of healthcare and insolvency. What is the current state of the industry? Why are nursing homes, hospitals and other healthcare institutions in financial trouble? What factors are changing reimbursement rates? What effect does litigation have on the success or failure of the nursing home industry? What market forces are at play in consolidating some aspects of the industry? The speakers will also discuss recent cases, regulatory restrictions on reimbursements, disruptive technology, tort claims and qui tams, and the anatomy of a bankrupt healthcare company. Read More ›

Highlights of Tax Reform Applicable to Healthcare Organizations

The Internal Revenue Code recently received its most significant overhaul in decades by the Tax Cuts and Jobs Act of 2017 (2017 Tax Act). Below is a brief summary of the 2017 Tax Act’s impact on healthcare organizations. Additional guidance is expected to be forthcoming from the IRS on many of these topics. Read More ›

Proposed Options for Implementing the Human Subject Protections of the Research Common Rule

The U.S. Department of Health and Human Services (DHHS), along with 15 other federal agencies, proposes to delay the effective date of sweeping changes promulgated last year regarding protection of human subjects in federally funded research outside of FDA jurisdiction, known as the “Common Rule.” See 83 FR 17595, dated April 20, 2018. The proposal is intended to do three things: (a) give the research community additional time to comply with the numerous new requirements in the new Common Rule; (b) give DHHS and other federal agencies time to issue sub-regulatory guidance; and (c) offer burden-reducing flexibility to research institutions in certain instances. Comments on the proposed rule are due by May 21, 2018. Read More ›

CMS Clarifies Role and Responsibilities of Hospice Medical Directors and Other Hospice Physicians

After a series of CMS surveys caused confusion in the hospice industry regarding the role and responsibilities of the medical director, CMS Region V issued much-needed clarification. CMS Region V, which covers hospices in the states of Illinois, Indiana, Michigan, Minnesota, Ohio, and Wisconsin, clarified that: Read 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 ›

Tick Tock, Watch the Clock for Submission of Nursing Facility Resident Satisfaction Survey Information to Michigan Medicaid

Michigan nursing facilities (NFs) participating in Medicaid can receive higher Quality Measure Incentive (QMI) payments if they promptly submit resident satisfaction survey data and documentation to the Michigan Department of Health and Human Services, Medical Services Administration (MSA). Don’t be lulled into complacency about submitting this data and documentation because you may have heard that the supplemental QMI program has not yet been approved by the federal Centers for Medicare and Medicaid Services (CMS). Read More ›