CMS finalizes 2025 Medicare Advantage rule: 11 key updates

https://www.beckerspayer.com/policy-updates/cms-finalizes-2025-medicare-advantage-rule-11-key-updates.html

CMS issued its final 2025 Medicare Advantage and Part D rule April 4, setting new standards around marketing, broker payments, and prior authorization.

Here are 11 things to know about CMS’ final rule: 

1. CMS set a fixed amount that agents and brokers can be compensated by MA plans, regardless of the plan a beneficiary enrolls in. The agency increased the final fixed amount by $100, compared to the proposed $31.
2. Personal beneficiary data collected by a third-party marketing organization for marketing or enrollment purposes may only be shared with another TPMO when prior written consent is given by the enrollee.
3. Insurers are generally prohibited from paying TPMOs volume-based bonuses for steering a certain number of enrollees to health plans. 
4. CMS is adding behavioral network adequacy evaluation standards to include providers specializing in mental health and addiction issues.
5. Plans are required to issue a mid-year notice to enrollees, informing them of any supplemental benefits they have access to in their plan that they have not used.
6. MA plans must analyze their utilization management policies and procedures from a health equity perspective, including having one member of the UM committee with expertise in health equity and an annual health equity analysis of prior authorization policies.
7. There are new restrictions on the marketing of supplemental benefits for chronically ill enrollees, requiring plans to disclose that these benefits are only available to beneficiaries with certain diagnoses, not all Medicare beneficiaries. 
8. Independent contractors will review untimely fast-track appeals of an MA plan’s decision to terminate services in a skilled nursing or outpatient rehab facility, and for home health services.
9. The rule reduces the number of plans able to enroll beneficiaries dually eligible for Medicare and Medicaid outside of the open enrollment period. This will crack down on year-round aggressive marketing of D-SNP plans, CMS said. 
10. MA plans will be limited in how much information they can request from CMS when appealing risk adjustment data validation audits.
11. Part D sponsors will have more flexibility around formulary substitutions of biosimilars with interchangeable generic products.

Read the full rule here.

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Hospitals Cash In on a Private Equity-Backed Trend: Concierge Physician Care

https://www.medpagetoday.com/hospitalbasedmedicine/generalhospitalpractice/109518

Pricey membership fees for easier access to doctors becoming more common

Nonprofit hospitals created largely to serve the poor are adding concierge physician practices, charging patients annual membership fees of $2,000 or more for easier access to their doctors.

It’s a trend that began decades ago with physician practices. Thousands of doctors have shifted to the concierge model, in which they can increase their income while decreasing their patient load.

Northwestern Medicine in Chicago, Penn Medicine in Philadelphia, University Hospitals in the Cleveland area, and Baptist Health in Miami are among the large hospital systems offering concierge physician services. The fees, which can exceed $4,000 a year, are in addition to copayments, deductibles, and other charges not paid by patients’ insurance plans.

Critics of concierge medicine say the practice exacerbates primary care shortages, ensuring access only for the affluent, while driving up healthcare costs. But for tax-exempt hospitals, the financial benefits can be twofold. Concierge fees provide new revenue directly and serve as a tool to help recruit and retain physicians. Those doctors then provide lucrative referrals of their well-heeled patients to the hospitals that employ them.

“Hospitals are attracted to physicians that offer concierge services because their patients do not come with bad debts or a need for charity care, and most of them have private insurance which pays the hospital very well,” said Gerard Anderson, PhD, a hospital finance expert at Johns Hopkins University in Baltimore. “They are the ideal patient, from the hospitals’ perspective.”

Concierge physicians typically limit their practices to a few hundred patients, compared with a couple of thousand for a traditional primary care doctor, so they can promise immediate access and longer visits.

“Every time we see these models expand, we are contracting the availability of primary care doctors for the general population,” said Jewel Mullen, MD, MPH, of Dell Medical School at the University of Texas at Austin and a former commissioner of the Connecticut Department of Public Health. She noted that concierge doctors join large hospital systems because of the institutions’ reputations, while hospitals sign up concierge physicians to ensure referrals to specialists and inpatient care. “It helps hospitals secure a bigger piece of their market,” Mullen said.

Concierge physicians typically promise same-day or next-day appointments. Many provide patients their mobile phone number.

Aaron Klein, DO, who oversees the concierge physician practices at Baptist Health, said the program was initially intended to serve donors.

“High-end donors wanted to make sure they have doctors to care for them,” he said.

Baptist opened its concierge program in 2019 and now has three practices across South Florida, where patients pay $2,500 a year.

“My philosophy is: It’s better to give world-class care to a few hundred patients rather than provide inadequate care to a few thousand patients,” Klein said.

Concierge physician practices started more than 20 years ago, mainly in upscale areas such as Boca Raton, Florida, and La Jolla, California. They catered mostly to wealthy retirees willing to pay extra for better physician access. Some of the first physician practices to enter the business were backed by private equity firms.

One of the largest, Boca Raton-based MDVIP, has more than 1,100 physicians and more than 390,000 patients. It was started in 2000, and since 2014 private equity firms have owned a majority stake in the company.

Some concierge physicians say their more attentive care means healthier patients. A study published last year by researchers at the University of California (UC), Berkeley and the University of Pennsylvania in Philadelphia found no impact on mortality ratesWhat the study did find: higher costs.

Using Medicare claims data, the researchers found that concierge medicine enrollment corresponded with a 30-50% increase in total healthcare spending by patients.

For hospitals, “this is an extension of them consolidating the market,” said study co-author Adam Leive, PhD, of UC Berkeley. Inova, a healthcare services company in Fairfax, Virginia, one of the state’s largest tax-exempt hospital chains, employs 18 concierge doctors, who each handle no more than 400 patients. Those patients pay $2,200 a year for the privilege.

George Salem, 70, of McLean, Virginia, has been a patient in Inova’s concierge practice for several years along with his wife. Earlier this year he slammed his finger in a hotel door, he said. As soon as he got home, he called his physician, who saw him immediately and stitched up the wound. He said he sees his doctor about 10 to 12 times a year.

“I loved my internist before, but it was impossible to get to see him,” Salem said. Immediate access to his doctor “very much gives me peace of mind,” he said.

Craig Cheifetz, MD, a vice president at Inova who oversees the concierge program, said the hospital system took interest in the model after MDVIP began moving aggressively into the Washington, D.C., suburbs about a decade ago. Today, Inova’s program has 6,000 patients.

Cheifetz disputes the charge that concierge physician programs exacerbate primary care shortages. The model keeps doctors who were considering retiring early in the business with a lighter caseload, he said. And the fees amount to no more than a few dollars a day — about what some people spend on coffee, he said.

“Inova has an incredible primary care network for those who can’t afford the concierge care,” he said. “We are still providing all that is necessary in primary care for those who need it.”

Some hospitals are starting concierge physician practices far from their home locations. For example, Tampa General Hospital in Florida last year opened a concierge practice in upper-middle-class Palm Beach Gardens, a roughly 3-hour drive from Tampa. Mount Sinai Health System in New York City runs a concierge physician practice in West Palm Beach.

NCH Healthcare System in Naples, Florida, employs 12 concierge physicians who treat about 3,000 patients total. “We found a need in this community for those who wanted a more personalized healthcare experience,” said James Brinkert, regional administrator for the system. Members pay an annual fee of at least $3,500.

NCH patients whose doctors convert to concierge and who don’t want to pay the membership fee are referred to other primary care practices or to urgent care, Brinkert said.

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The War on Drugs Is Also a War on Pain Patients

https://www.cato.org/blog/war-drugs-also-war-pain-patients

In a March 22 opinion column in the New York Times entitled “The DEA Needs to Stay Out of Medicine,” Vanderbilt University Medical Center associate professor of anesthesiology and pain management Shravani Durbhakula, MD, documents powerfully how patients suffering from severe pain—many of them terminal cancer patients—have become collateral casualties in the government’s war on drugs.

Decrying the Drug Enforcement Administration’s progressive tightening of opioid manufacturing quotas, Dr. Durbhakula writes:

In theory, fewer opioids sold means fewer inappropriate scripts filled, which should curb the diversion of prescription opioids for illicit purposes and decrease overdose deaths — right?

I can tell you from the front lines that that’s not quite right. Prescription opioids once drove the opioid crisis. But in recent years opioid prescriptions have significantly fallen, while overdose deaths have been at a record high. America’s new wave of fatalities is largely a result of the illicit market, specifically illicit fentanyl. And as production cuts contribute to the reduction of the already strained supply of legal, regulated prescription opioids, drug shortages stand to affect the more than 50 million people suffering from chronic pain in more ways than at the pharmacy counter.

Dr. Durbhakula provides stories of patients having to travel long distances to see their doctors in person due to DEA requirements about opioid prescriptions. However, despite their efforts, they find that many of the pharmacies do not have the opioids they require because of quotas. She writes:

Health care professionals and pharmacies in this country are chained by the Drug Enforcement Administration. Our patients’ stress is the result not of an orchestrated set of practice guidelines or a comprehensive clinical policy but rather of one government agency’s crude, broad‐​stroke technique to mitigate a public health crisis through manufacturing limits — the gradual and repeated rationing of how much opioids can be produced by legitimate entities.

In the essay, Dr.Durbhakula does not question or challenge the false narrative that the overdose crisis originated with doctors “overprescribing” opioids to their pain patients.

Unfortunately, Dr. Durbhakula’s proposed policy recommendations would do little to advance patient and physician autonomy. She would merely transfer control over doctors treating pain from the cops to federal health bureaucracies and let those agencies set opioid production quotas. For instance, she claims, “It’s incumbent on us [doctors] to hand the reins of authority over to public health institutions better suited to the task.”

No. The “reins of authority” belong in the hands of patients and doctors.

Dr. Durbhakula suggests that “instead of defining medical aptness, the DEA should pass the baton to our nation’s public health agencies” and proposes that the Centers for Disease Control and Prevention and the Food and Drug Administration “collaborate” to “place controls on individual prescribing and respond to inappropriate prescribing.” She elides the fact that these public health agencies will “respond” to doctors or patients who don’t comply with their regulations by calling the cops.

To be sure, Dr. Durbhakula has good intentions. But replacing actual cops—the DEA—with federal health agencies that can order those cops to arrest non‐​compliant doctors and patients is like rearranging the deck chairs on the Titanic. True, her proposed new pain management overlords would have greater medical expertise, but they would still reign over doctors and patients and assault their autonomy. And, as we learned during the COVID-19 pandemic, they will not be immune to political pressures and groupthink.

While her policy prescriptions may be flawed, Dr. Durbhakula deserves praise for having the courage to point out that the war on drugs is also a war on pain patients. Alas, courageous doctors are in short supply these days. Most doctors keep their heads down and follow the cops’ instructions.

After I read her essay, I wrote the following (unpublished) letter to the editor of the New York Times:

Dear Editor—

Kudos to Dr. Durhakula for speaking out against the Drug Enforcement Administration’s intruding on doctors’ pain treatment (“The DEA Needs to Stay Out of Medicine,” March 22, 2024). As my colleague and I explained in our 2022 Cato Institute white paper, “Cops Practicing Medicine,” for more than 100 years, law enforcement has been increasingly surveilling and regulating pain management.

The DEA maintains a schedule of substances it controls, and it categorizes them based on what the agency determines to be their safety and addictive potential. The DEA even presumes to know how many and what kind of controlled substances—from stimulants like Adderall to narcotics like oxycodone—the entire US population will need in future years, setting quotas on how many each pharmaceutical manufacturer may annually produce.

The DEA restricts pain management based on the flawed assumption that what they consider to be “overtreatment” caused the overdose crisis. However, as my colleagues and I showed, there is no correlation between the opioid prescription rate and the rate of non‐​medical opioid use or opioid addiction. And, of course, as fear of DEA reprisal has caused the prescription rate to drop precipitously in the last dozen years, overdose deaths have soared as the black market provided non‐​medical users of “diverted” prescription pain pills first with more dangerous heroin and later with fentanyl.

Researchers at the University of Pittsburgh School of Public Health found that overdose fatalities have been rising exponentially since at least the late 1970s, with different drugs predominating during various periods. Complex sociocultural, psychosocial, and socioeconomic forces are at the root of the overdose crisis, requiring serious investigation. Yet policymakers have chosen the lazy answer by blaming the overdose crisis on doctors treating pain.

When cops practice medicine, overdoses increase, drug cartels get richer, and patients suffer.

Sincerely,

Jeffrey A. Singer, MD, FACS

Senior Fellow, Cato Institute

When cops practice medicine, overdoses increase, drug cartels get richer, and patients suffer.

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Be cautious in signing up for Medicare-c (Advantage) prgms,  These programs are provided by FOR PROFIT INSURANCE COMPANIES. An increasing number of large healthcare corporations are canceling their contracts with Medicare-C programs. Patients in these programs may find themselves having to change primary healthcare providers, hospitals, and other providers that they have a relationship with.

Hospitals’ Medicare Advantage problem hits an inflection point

https://www.beckershospitalreview.com/finance/hospitals-medicare-advantage-problem-hits-an-inflection-point.html

As Medicare Advantage enrollment climbs to nearly 34 million people and the federal government implements new insurance policies, the scene has been set for tensions between hospitals and payers to intensify.

“The relationship between hospitals and managed care is strained at best right now,” Chip Kahn, president and CEO of the Federation of American Hospitals, told Becker’s. “[Insurers] are finding every way to not pay for the care that Medicare beneficiaries should receive. I don’t know how the issue gets worse — we’re at a critical stage, and I think CMS is sending those signals.” 

On April 1, CMS finalized a slight decrease in MA benchmark payments for 2025. The agency has also enacted stricter prior authorization rules this year and cracked down on when MA plans must cover inpatient care.

The health insurance industry has said the new rates will “put even more pressure on the benefits and premiums” of MA beneficiaries, a warning that individual insurers echoed in recent months.

“Payers know that they’re going to have to cut supplemental benefits, and premiums may even have to go up, but I wouldn’t want to be the first one to do it,” Scott Ellsworth, founder and president at Ellsworth Consulting, told Becker’s.

Mr. Ellsworth is a former senior insurance executive, overseeing large divisions at Centene, Optum and a BCBS plan throughout his career.

“Seniors have seen their benefits get better every year, but now we’re at an inflection point and the free lunch is over,” he said. “There is going to be a sharing of the pain. Providers have disproportionately shared the pain and now you’re seeing many of them say ‘enough is enough, we’re out.'” 

In 2023, Becker’s reported on at least 15 hospitals and health systems nationwide that dropped some or all of their Medicare Advantage contracts. Among the most commonly cited reasons are excessive prior authorization denial rates and slow payments from insurers. Some systems have noted that most MA carriers have faced allegations of billing fraud from the federal government and are being probed by lawmakers over their high denial rates.

“It’s become a game of delay, deny and not pay,” Chris Van Gorder, president and CEO of San Diego-based Scripps Health, told Becker’s in September. “Providers are going to have to get out of full-risk capitation because it just doesn’t work — we’re the bottom of the food chain, and the food chain is not being fed.” 

Scripps terminated MA contracts in January for its integrated medical groups, citing an annual loss of $75 million on its contracts with insurers.

In March, Bristol (Conn.) Health announced it was eliminating 60 positions, 21 of which are occupied and will result in layoffs. Its CEO laid blame on Medicare Advantage, saying, “All the nice-to-haves are being taken out by the lack of insurance payment and the lack of reimbursement.”  

In January, the Healthcare Financial Management Association released a survey of 135 health system CFOs, which found that 16% of systems are planning to stop accepting one or more MA plans in the next two years. Another 45% said they are considering the same but have not made a final decision. The report also found that 62% of CFOs believe collecting from MA is “significantly more difficult” than it was two years ago.

“Medicare Advantage net reimbursement right now is terrible for hospitals — our clients average about 85 cents on the dollar, and it’s only getting worse,” Mr. Ellsworth said. “MA is a race to the bottom and I would argue that we’ve hit that bottom. Payers are going to struggle with this too, but no one wants to be the first to blink.”

Medicare Advantage denials increased almost 56% for the average hospital from January 2022 to July 2023, according to data from a joint American Hospital Association and Syntellis report. The denials and inconsistent reimbursement led to a 28% drop in hospital cash reserves.

Both Mr. Ellsworth and Mr. Kahn noted that it isn’t feasible for most health systems to completely walk away from Medicare Advantage given that it now makes up more than half of the Medicare population. Instead, many hospitals are paring down contracts and looking for payer partners that align best with their financial objectives. Some systems are even exploring launching their own MA plan built in tandem with one insurer. Others have partnered with grocers or other health systems.

“We will ultimately pick a couple of partners going forward, and I think a lot of health systems are going to do this,” Will Bryant, CFO of Chapel Hill, N.C.-based UNC Health, told Becker’s in November. “They’re going to be the partners who act like partners and not who deny care in order to bolster their billions of dollars of quarterly earnings.”

Sachin Jain, MD, CEO of SCAN Group — one of the nation’s largest nonprofit Medicare Advantage companies — cautioned hospitals that dropping MA plans is a short-term trend that is “going to backfire in a big way for these large health systems.”

“You’re a nonprofit system saying you’re no longer going to accept the insurance that low-income people actually have,” he said. “We’ll see how that works out for you.” 

Dr. Jain said any public policy program is going to create unintended consequences, adding, “What I would say to anybody who’s critical about the program is that you’re right, but let’s fix that.”  

Former CMS Administrator, Don Berwick, MD, told Becker’s in February that the battle between hospitals and Medicare Advantage is a “manifestation of an underlying broken system in which everyone that gives care wants to give more, and everyone that pays for care wants to pay less.”

“To me, the untold story yet is about the physicians and nurses who don’t feel directly tied to ongoing Medicare Advantage trends, but they are certainly immersed in a changing financial landscape,” Dr. Berwick said. “As venture capital, private equity and ownership of healthcare by private interests increases, it changes their worlds, what it’s like to practice, their feelings about themselves, and the degrees of freedom they have to care for their patients. That chicken is going to come home to roost.”

Despite the tensions with hospitals, the MA program has bipartisan support in Congress and a 95% quality satisfaction rating among enrolled members in 2023. There are about 4,000 MA plans being offered this year nationwide, and MA members spend an average of $2,434 less on out-of-pocket costs and premiums per year compared to traditional Medicare enrollees.

“Medicare Advantage is very important, especially for low-income seniors,” Mr. Ellsworth said. “Hospitals need to acknowledge the reimbursement problem and proactively address their relationships [with payers] head-on.”

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All police states have a modus operandi by which they can be recognized. One of those is the absolute and unreasonable, almost random, destruction of people selected to be an “example” to terrify the population. The most educated physician in American history, Dr. Xiulu Ruan, is still languishing in prison because, while the DEA has no right to dictate the practice of medicine, they have the unconstrained power to destroy those who do not toe the party line. And if the government has its way… Dr. Meredith Norris is next.

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Payback: Tracking the Opioid Settlement Cash

The Tobacco Money Settlement is running out soon. Just about EVERYONE has their HAND OUT for some of the Opioid Settlement Money. From bureaucraties that had employees who are/were dealing with addiction and wants to recoup the money paid out for treating those employees, to Grandparents raising their Grandkids because their parents OD’d and they want financial assistance in raising their Grandkids.  Doesn’t Social Security pay kids $$ when a parent dies?

Not to mention the bureaucracies that the bureaucrats are creating to manage the distribution of those funds.

The total money that is to be paid out over the next 18 yrs, is but a drop in the bucket as to what the Tobacco Settlement amounted to. What industry is next?

Maybe they will go after the Tobacco wholesalers & retailers that didn’t get “taken to the cleaners” with the original settlement? There is always the Liquor industry, but will they sue those states that only sell liquor thru state-owned stores?

I am sure that they will find some other industry that is selling some legal product that they can fabricate some harm to people or with the current “green mindset”, products that “they” believe is harming our environment.

Maybe these law firms and bureaucrats have created a qazi  Rube Goldberg machine https://en.wikipedia.org/wiki/Rube_Goldberg_machine or a qazi “ATM machine” that never runs out of money!

One thing that no one wants to talk about is all this money that is being paid out or has been paid out from the Tobacco Settlement, These tobacco companies are still around and the price of their products are substantially higher than they were back in 1999, way above what the CPI/COLA increases would suggest.

Same thing with all these Opioid fines and settlements that started in the early 2010 decade and now will continue into the 2040 decade. While the DOJ/DEA & state AG’s are attempting to reduce the number of controlled meds produced and sold.

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Driving down health care costs: Independent pharmacies, patients and lawmakers take steps to rein in PBMs

https://spectrumnews1.com/oh/columbus/news/2024/04/03/pbm-ohio-independent-pharmacy

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Could a chronic pain pt, who lives in Minnesota, could they sue for being denied controlled Rxs to treat their pain, because they are disabled? After all, maintaining and optimizing a pt’s QOL is time-sensitive!

Court Rules Against Pharmacist Who Refused Emergency Contraception Prescription

https://www.medpagetoday.com/pharmacy/pharmacy/10942

Case will be appealed to state Supreme Court or returned to district court

The Minnesota Court of Appeals has ruled that a pharmacist who refused to provide emergency contraceptives to a customer because of his personal beliefs engaged in discrimination.

The three-judge panel ruled Monday that pharmacist George Badeaux engaged in business discrimination in 2019 when he wouldn’t fill a prescription for an emergency contraception that is used to stop a pregnancy before it starts. The customer seeking the prescription said she then traveled about 100 miles (160 kilometers) round trip from the pharmacy in McGregor to another pharmacy in Brainerd, where she filled the prescription.

The customer, Andrea Anderson, later filed a lawsuit claiming discrimination under Minnesota’s Human Rights Act.

“Badeaux’s refusal to dispense emergency contraception because it may interfere with a pregnancy is sex discrimination,” Judge Jeanne Cochran wrote in the ruling.

The appeals court decision means the case will either be appealed to the Minnesota Supreme Court or returned to district court, where a jury in 2022 found the pharmacist had not discriminated but that Anderson was owed $25,000 because of emotional harm. However, Anderson couldn’t collect that money because there was no finding of discrimination.

Jess Braverman — an attorney for Anderson and the legal director of Gender Justice, an advocacy organization for gender equity — said this may be the first ruling in the country to find that a refusal to dispense emergency contraception is a form of sex discrimination. Alison Tanner, senior litigation counsel for reproductive rights and health at the National Women’s Law Center, agreed.

Braverman said the ruling made clear to Minnesota businesses “that you can’t just turn away patients in need of reproductive healthcare.”

Rory Gray, senior counsel at Alliance Defending Freedom, a Christian advocacy group, represented Badeaux and criticized the decision.

“As a devout Christian, George believes every human life has value. As such, George cannot provide or facilitate the use of any potential abortion-causing drugs,” Gray said in a statement. “The court failed to uphold George’s constitutionally protected freedom to act consistent with his beliefs while at work.”

Anderson tried unsuccessfully to buy the emergency contraception, called Ella, at the drug store. The store previously was owned by Aitkin Pharmacy Services, and an attorney for the business did not immediately respond to requests for comment by phone and email.

Gender Justice appealed the jury’s ruling last year, arguing that Badeaux discriminated against Anderson on the basis of her sex when he refused to fill her prescription for a drug that is only prescribed to women.

In 2015, Badeaux refused to dispense Plan B, a different type of emergency contraception, to a woman, resulting in a complaint to the pharmacy’s owner, the judges wrote. The owner and Badeaux then developed a plan for dispensing emergency contraception, which involved getting another pharmacist to come in to fill the prescription the same day or the next day, or transferring the prescription elsewhere.

Tanner, at the National Women’s Law Center, said the Monday ruling “is important because there should be no reason that folks who are in need of emergency contraception are delayed access to that care. It is a time-sensitive medication.”

Since the U.S. Supreme Court ended constitutional protections for abortion in 2022, some states have expanded access to emergency contraceptives and birth control while other states have restricted access and enacted abortion bans.

Dozens of universities across the country now carry emergency contraceptives in vending machines according to the American Society for Emergency Contraception. Some, such as the University of Tulsa in Oklahoma, are in states where abortion is largely banned

Although Minnesota has protected abortion access neighboring states have banned or severely restricted the procedure.

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Bill that would allow medical professionals to deny care based on conscience clears hurdle in House

https://www.newsfromthestates.com/article/bill-would-allow-medical-professionals-deny-care-based-conscience-clears-hurdle-house

House Bill 303, which would allow medical professionals to refuse medical service based on conscience, passed second reading 65-35 in the House on Monday.

“I’d like my health care provider to have a conscience,” said Rep. Steve Gunderson, R-Libby, in support of the bill.

Sponsor Rep. Amy Regier, R-Kalispell, said on the floor that the bill, which will need to pass third reading before heading to the Senate, was aimed not at particular persons, but at procedures, as she had in committee. She listed objections “concerning lifestyle, elective procedures and treatments,” like assisted suicide, gene editing, dispensing marijuana or opioids and abortion.

However, several Democrats spoke in opposition to the bill, the first being Rep. Zooey Zephyr, D- Missoula, the first trans woman elected to the statehouse who serves on the House Judiciary Committee where the bill was heard last week. Medical professionals and organizations had opposed it in committee.

Zephyr said Regier’s characterization the bill was focused on procedures and not people doesn’t accurately reflect its broad language, including definitions for health care service that span from research to any service performed or provided by a medical practitioner.

Zephyr spoke to the impact the bill could have on the trans community, as she and advocates did in committee. She said that the likely consequence would be denial will be based on diagnosis.

“That is inherently discriminatory, because you cannot parse my diagnoses from who I am,” she said. “To deny me based on my diagnosis of gender dysphoria is to deny me based on my being a trans woman.”

Proponents said the bill allows medical professionals to live their values, with Regier citing it as a way to help retain healthcare workers in the state.

Rep. Jerry Schillinger, R-Circle, said in an “oftentimes profit driven world,” healthcare providers who hold traditional values need protection.

Rep. Laura Smith, D-Helena, said she was rising in opposition to the bill due to the impact on parental rights. She said parents would have less ability to advocate for family members in the hospital, giving the example of a family advocating for an unconscious patient where medical staff initially denied a procedure to help her breathe due to concerns over suffering. In Smith’s telling, the young girl made a full recovery after the family pushed for care.

“I think we all have to be honest with ourselves that this is not something that couldn’t fall upon any of us in our lives, our kids or our grandkids,” Smith said.

Rising as a proponent, Rep. Kerri Seekins-Crowe, R-Billings, said her healthcare provider stopped providing service to her after a vote she had taken during the 2021 session on wolves.

“And even though it was a blow to me, because I really did like the healthcare I was getting from her, I really do believe …that she has the right to not to give me care if she believes that strongly,” she said. “Her oath of ‘do no harm,’ she can no longer uphold that if that’s what she believed in.”

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This test could be a very slippery slope for this company and any practitioner who uses it and its results. Addiction has substantial underlying mental health issues. Mental health issues are all pretty much subjective health issues and can be various subsets of the total mental health spectrum.

What happens when a pt shows a “positive” test result and is not given or taken off their opioid pain meds, and the pt suffers health consequences for under/untreated pain?

On the other side, the pt shows a “negative” test result and is given opioids for their pain, and they end up becoming an addict because the negative ended up being a false negative.

I suspect that some entity is going to be sued for damages, will it be the pharma or the prescriber who ordered the test?

I hope that the FDA takes the recommendation of its committee of experts and withdraws this test from the marketplace. Of course, FDA is protected by sovereign immunity from being sued for any damages.

Genetic Test for Opioid Addiction Risk Should Be Withdrawn, Experts Tell FDA

https://www.medpagetoday.com/neurology/opioids/109508

Methodology behind AvertD DNA test questioned

A group of 31 physicians and researchers called on the FDA to reverse its decision about AvertD, a test that uses DNA to identify whether adults may have an elevated risk of developing opioid use disorder (OUD).

In a letter to FDA Commissioner Robert Califf, MD, experts in genetics, addiction, psychiatry, public health, and device regulation asked the agency to revoke its recent approval of AvertD, based on research that doesn’t support the methodology used by the test’s sponsor.

The group also sent a letter to Centers for Medicare & Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure asking CMS to deny coverage of AvertD.

The FDA approved AvertD in December 2023. The prescription-only genetic test from SOLVD Health is expected to be on the market soon.

AvertD detects the presence of 15 single nucleotide polymorphisms (SNPs) to help identify people who may have an increased risk of OUD. It’s intended to be used in combination with clinical evaluations and patient assessments when oral prescription opioids are being considered to treat acute pain.

The major risks associated with AvertD are false-negative and false-positive results, the FDA said. Before the agency approved it, an FDA advisory committee voted strongly against an earlier version of AvertD, with false-negative and false-positive test results being a primary concern.

“The FDA seems to believe the test isn’t a very good test but that it’s better than nothing. They’ve got it wrong,” said Andrew Kolodny, MD, an opioid policy expert at Brandeis University in Massachusetts, who signed the letters to the FDA and CMS.

“The problem isn’t that the test has weak specificity and sensitivity,” Kolodny told MedPage Today. “The problem is that it doesn’t work at all. It’s 100% bogus.”

The AvertD test will harm people, Kolodny emphasized. “Patients who test negative, and their clinicians, will be left with a false sense of security, which can result in overuse of opioids and addiction,” he said.

“Patients who test positive will be falsely branded as prone to a highly stigmatized condition,” he continued. “And they may become fearful of taking opioids, even in situations where use is beneficial.”

Genetic tests for opioid addiction have a checkered history. The FDA approval of AvertD last year was an industry first.

Like many genetic tests, confounding is part of the problem, Kolodny and colleagues said. An independent evaluation using methodology like the one used to test AvertD found that the algorithm gave the appearance of predicting genetic risk but was not a true measure of genetic risk, they noted.

“With proper controls for ancestry, genetic predictors from the 15 variants used in AvertD did not predict risk of OUD any better than chance,” they said in their letters to the FDA and CMS.

SOLVD Health said it was aware of the letters to FDA and CMS and is reviewing them.

“We believe the FDA approval of AvertD represents a significant step forward in helping clinicians and patients have informed discussions about opioid-sparing techniques or alternative pain management options, if medically appropriate,” the company said in an email to MedPage Today.

“Consistent with regulatory guidelines and standards, AvertD was clinically validated through a blinded, multicenter study evaluating participants at least 1 year after their initial exposure to prescription oral opioids,” SOLVD noted. “In the hands of physicians, the test results can be a critical tool to help combat opioid use disorder.”

The company also said it is conducting prospective post-market studies to further evaluate the test’s performance in real-world settings.

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