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Michigan Association of Health Plans Asks DIFS To Clarify Gene And Cell Therapy Coverage Requirements


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MAHP Executive Director Dominick Pallone queried Anita Fox, director of the Michigan Department of Insurance and Financial Services, two days ago, in response to the regulatory bulletin that Fox issued on January 9th. The underlying case which impelled this MAHP query was covered in Insurance Executives Refused to Pay for the Cancer Treatment That Could Have Saved Him. This Is How They Did It.  

https://www.crainsgrandrapids.com/news/health-care/priority-health-case-sparks-debate-over-insurance-coverage-of-high-cost-therapies/

Priority Health case sparks debate over insurance coverage of high-cost therapies
By Mark Sanchez - January 25, 2024

The industry trade association for health plans in Michigan wants greater clarity on how exactly state regulators view high-cost gene and cell therapies and their mandated coverage.

In a response to a regulatory bulletin saying they must cover expensive gene and cell therapies, the Michigan Association of Health Plans notes that when the state Legislature enacted a law in 1989 that requires health insurers to cover cancer drugs, the new generation of gene and cell therapies had not yet been developed.

The bulletin followed a November report from ProPublica that detailed how Priority Health denied coverage to a Sparta man who had an aggressive form of lymphoma. Forrest VanPatten died Feb. 17, 2020 at the age of 50 while awaiting a response from an independent medical reviewer on an appeal of Priority Health’s denial, according to the report.

“It is the opinion of MAHP that gene therapies could not have been intended to be included by the Legislature (in the state law) because gene therapies did not exist when the Legislature enacted its statute,” association Executive Director Dominick Pallone wrote in a letter this week to Anita Fox, director of the Michigan Department of Insurance and Financial Services.

“We need to better understand how gene therapies and cell therapies fit within the existing benefit mandate and what we can do to work with the department on what the intention is so that we can remain compliant,” Pallone told Crain’s Grand Rapids Business.

The MAHP’s Jan. 24 letter responded to the regulatory bulletin that Fox issued Jan. 8 reminding health insurers of the state law that requires coverage for cancer therapies that have been approved by the U.S. Food and Drug Administration. Health insurers may not deny coverage for genetic therapies or immunotherapies that meet criteria in the state law, Fox wrote in the bulletin.

DIFS rejects “any assertion that insurers are only required to cover medical treatments that existed before specific provisions in the law were enacted” and “is reviewing industry questions and will provide additional guidance to insurers as necessary,” according to a department spokesperson.

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The 34-year-old state law requires coverage for cancer drugs if a patient’s doctor orders an approved therapy and if current “medical literature substantiates its efficacy and recognized oncology organizations generally accept the treatment,” according to the DIFS bulletin. That includes CAR-T, an expensive form of cell therapy used to treat cancer.

“The Department of Insurance and Financial Services will disapprove any health insurance policy form that limits or restricts coverage for cancer therapies, including genetic therapies or immunotherapies, including but not limited to CAR-T,” and that meet the state law’s criteria, Fox wrote in the bulletin.

“The Michigan Department of Insurance and Financial Services is committed to protecting Michiganders by ensuring that health insurers are following all state and federal laws and regulations,” Fox said in a statement emailed to Crain’s Grand Rapids Business.

In responding to the bulletin, and as with any issue involving health care, the MAHP seeks to “position ourselves at the table” for a discussion on how the state insurance code treats costly gene and cell therapies, as well as other costly medical advances and their affordability, Pallone said.

Pallone considers the issue an example in whcih state law and regulation have not kept up with medical advances. That’s why the MAHP generally opposes writing specific medical treatments into state law.

“We always encourage the conversation on any piece of our insurance code. Is it up to date? Is it the right language reflecting modern medicine, modern times?” Pallone told Crain’s Grand Rapids Business. “When you codify medicine, and medicine changes, then it needs frequent updates. So, we tend to default to ‘don’t codify medicine’ because we know it’s going to change. There’s going to be some new breakthrough. There’s going to be something that somebody never envisioned.

“It’s really hard to codify that in a static piece of statute and expect that it’s still relevant.”

The MAHP also asked whether the state regulatory agency requires health plans “who are selling full-risk commercial products that must be approved by DIFS before they can be sold, to cover all oncology drugs, and cellular and gene therapies without regard to FDA safety guidance so long as the aforementioned conditions are met?”

ProPublica’s story in November reported that Priority Health questioned the effectiveness of CAR-T and claimed that the cell therapy is not a drug, meaning the health plan technically did not have to include it in coverage under the state law.

In a statement to Crain’s Grand Rapids Business, a Priority Health spokesperson wrote that “after ongoing clinical evaluations, the medical community demonstrated continued clinical improvements from the treatment, and we began covering CAR-T Cell therapy several years ago.”

The spokesperson did not respond to questions about when exactly it started that coverage.

“The health and safety of our members is always our top priority,” the spokesperson for Priority Health said. “The constant progression and accumulation of scientific evidence is part of our process. We are committed to finding new ways to make medical innovations more affordable and accessible as quickly as possible.”


   
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The DIFS regulatory bulletin that Anita Fox issued on January 9th:

https://www.michigan.gov/difs/news-and-outreach/press-releases/2024/01/09/difs-highlights-important-consumer-protection-for-cancer-patients

DIFS Highlights Important Consumer Protection for Cancer Patients

Media Contact: Laura Hall, 517-290-3779, DIFS-press@michigan.gov

Consumer Hotline: 877-999-6442, Michigan.gov/DIFScomplaints

FOR IMMEDIATE RELEASE: January 9, 2024

(LANSING, MICH) To help ensure that life-saving cancer treatments are accessible and affordable for Michiganders, Michigan Department of Insurance and Financial Services (DIFS) Director Anita Fox took action to remind Michigan’s health insurers that they may not exclude coverage for cancer therapies, including genetic therapies or immunotherapies, that meet the coverage requirements listed in state law.

“The Michigan Department of Insurance and Financial Services is committed to protecting Michiganders by ensuring that health insurers are following all state and federal laws and regulations,” said Director Fox. “Michiganders should also know that they have the right to appeal and file a complaint with DIFS if they believe their health insurer is improperly denying or limiting coverage for health care services, including cancer treatment. More information about this process is available on the DIFS health insurance website or by calling the DIFS Call Center at 877-999-6442, Monday through Friday from 8 a.m. to 5 p.m.”

As affirmed in a newly issued DIFS bulletin, Michigan law prohibits health insurers from denying coverage for cancer treatments, including genetic and immunotherapies when certain criteria are met, including that the treatment is ordered for a specific cancer and the treatment is approved by the United States Food and Drug Administration for cancer therapy, even if it is not approved for the specific cancer being treated.

Under Michigan’s Patient's Right to Independent Review Act (PRIRA), patients have the right to appeal, first to their insurer and then to DIFS, if they disagree with a denied health insurance claim. If DIFS finds that an insurer that has improperly denied coverage, the insurer will be ordered to cover the denied services. In addition, the insurer may be referred for enforcement action or a market conduct examination, which may result in penalties or other regulatory actions under the Michigan Insurance Code. Michiganders with self-funded group health plans offered by some large employers should contact their insurer or employer to learn how to appeal an insurance denial.

Michiganders who still need health insurance for 2024 can take advantage of the Health Insurance Marketplace open enrollment, which continues until January 16, with coverage starting on February 1. You may qualify for savings, and many Michiganders are able to find a health plan for less than $10 per month. More information is available on the DIFS health insurance website. In addition, free local enrollment help is available at LocalHelp.HealthCare.gov.

The mission of the Michigan Department of Insurance and Financial Services is to ensure access to safe and secure insurance and financial services fundamental for the opportunity, security, and success of Michigan residents, while fostering economic growth and sustainability in both industries. In addition, the Department provides consumer protection, outreach, and financial literacy and education services to Michigan residents. For more information, visit Michigan.gov/DIFS or follow the Department on Facebook, Twitter, or LinkedIn.


   
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