By BILLEE LIGHTVOET WARD, ESQ.
Dickinson Wright

The Food and Drug Administration (FDA) regulates foods and beverages, drugs and medical devices, biologics, dietary supplements, tobacco products, veterinary products, and cosmetics. Although these various product categories may appear to be clearly cut, the fact of the matter is that a product can very easily cross over from one product category to a different one as a result of issues such as in intended use, composition, labeling content or other claims, or other such issues that may seem to be inconsequential. At the earliest possible stage of product development, it is important to evaluate the identity of the product based on these and [Read More]

Lansing Lines is presented in cooperation with MIRS, a Lansing-based news and information service.

DHHS Budget Asks: From Detroit Project To Chromotherapy Glasses

During the only House committee hearing over the two weeks of legislative spring break, Rep. Christine Morse (D-Kalamazoo)’s Appropriations subcommittee on Health and Human Services heard funding requests for everything from a new Detroit affordable housing and childcare campus to chromotherapy glasses.

Morse held the hearing to take public comment, which she said would be used to influence the budget-crafting process.

Among the requests heard was a $2.498 million ask to break ground on a combined housing and childcare project in downtown Detroit through MiSide, a Detroit-based nonprofit providing families [Read More]

This story was originally published by ProPublica.

By ROBIN FIELDS & MAYA MILLER
Spurred by a ProPublica story about an insurer that denied coverage of the only therapy that could have saved the life of a 50-year-old father of two, a Michigan lawmaker a bill early this month requiring health plans in the state to cover cutting-edge cancer treatments.

In February 2020, Forrest VanPatten died fighting Priority Health, one of Michigan’s largest health insurers, over its refusal to pay for CAR-T cell therapy, his last-chance treatment. The therapy works by genetically reengineering patients’ own cells, then infusing them back into the body to beat back their disease.

Michigan has long required insurers to [Read More]

By SUSAN ADELMAN, MD
On Oct. 19, 2023, the Free Press announced that Henry Ford Health and Ascension Michigan would form a joint venture. This will join Ascension’s Southeast Michigan hospitals with the Ascension Genesys Hospital in Grand Blanc and the Henry Ford hospitals, creating a system with more than 550 sites of care.  Among the eight Ascension hospitals are two Providence Hospitals, St. John Hospital, two Macomb Oakland Hospitals, River District Hospital, and the Brighton Center for Recovery. Joining them will be five Henry Ford hospitals and Health Alliance Plan. This all must pass antitrust review, but I cannot recall any of the mergers in Michigan failing to get approval.

Remember, [Read More]

By EWA MATUSZEWSKI
I believe we witnessed a breakthrough in getting the role of the community health worker (CHW) into the vernacular of common healthcare terms. That’s because I saw a news story about CHWs on local television – not a healthcare special or a “news hour” but standard local news programming. Thank you, Henry Ford Cancer Institute, for sharing with WDIV (the local NBC affiliate in Detroit,) how your mobilization of healthcare workers in the hospital setting is putting patients and their families at ease by helping navigate some of the non-clinical aspects of illness, hospital stays and care coordination.

The timing of the local news piece couldn’t have been better [Read More]

By JENNIFER COLAGIOVANNI
Wachler & Associates, P.C.

Nearly four years after the COVID-19 pandemic began, healthcare providers continue to see payor audits and demands for repayment of services provided during the pandemic, primarily related to COVID-19 testing and lab services, as well as for evaluation and management (E/M) office and telehealth visits. Despite the fact that these services served a critical public health function during the pandemic, constantly changing and often unclear guidelines governing coverage and documentation of these services have created fertile ground for payors to allege after-the-fact that providers were not entitled to payment.

The audit issues asserted by payors tend to relate to the process used by the provider rather [Read More]

By ANDREW L. SPARKS
Dickinson Wright

The Families First Coronavirus Response Act (FFCRA) was enacted in March 2020 as part of the government’s response to the COVID-19 pandemic. The FFCRA, among other things, provided funds for diagnostic testing and services for people without insurance for COVID-19. These funds were distributed through the COVID-19 Claims Reimbursement to Health Care Providers and Facilities for Testing, Treatment, and Vaccine Administration for the Uninsured Program (HRSA uninsured program). Providers seeking reimbursement under the HRSA uninsured program were required to enroll as a provider participant and check to ensure that patients were uninsured.

The HRSA uninsured program paid out more than $24.5 billion in claims. With the passage [Read More]

Lansing Lines is presented in cooperation with MIRS, a Lansing-based news and information service.

Organ Donor Education May Be Mandatory Part Of 9th Grade

A pandemic-era change to Michigan’s driver’s training program means new drivers may wait in fewer Secretary of State lines, but reworked visit schedules means they will also be asked to opt in as an organ donor before completing an educational segment about the registry.

The solution? Rep. Felicia Brabec (D-Ann Arbor) proposed the creation of an hour-long organ donor education program for Michigan’s ninth graders.

Patrick Wells-O’Brien, vice president of communications and external relations for non-profit registry Gift of Life Michigan, said Michigan is in the middle of the [Read More]

Missing from the Gretchen Whitmer’s State of the State address late last month were her calls for paid family leave and prescription drug affordability – both items she wanted to see get done before the end of last year.

Whitmer’s August 2023 “What’s Next?” Address highlighted proposals she wanted moved in Lansing during the first year of a Democratic-led House, Senate and executive office in 40 years.

The “clean energy” by 2040 proposal and the elimination of numerous state abortion regulations were both endorsed by the governor in her August speech and passed before mid-November. Whitmer’s priorities for paid family leave and a prescription drug affordability board were left behind, and didn’t [Read More]

By ROBIN FIELDS & MAYA MILLER
ProPublica/Co-published with The Capitol Forum

In a victory for many cancer patients in Michigan, the state’s top insurance regulator told health plans last month that they cannot deny coverage for clinically proven cancer treatments, and she made it clear for the first time that this includes cutting-edge genetic and biologic therapies.

The move follows weeks of questions from ProPublica and pressure from state lawmakers after the news organization reported in November that an insurer there refused to pay for the only treatment that could save the life of Forrest VanPatten, a 50-year-old father of two, even though a state law requires insurers to pay for proven cancer drugs.

Internal [Read More]