'Step Therapy' Cost-Cutting Tool Could Limit Drug Selections for Medicare Advantage PatientsKaiser Health News

Starting the coming year, Medicare Advantage plans will be able to add restrictions on expensive, injectable drugs administered by doctors to deal with cancer, rheumatoid arthritis, macular degeneration along with other serious diseases.

Under the brand new rules, these private Medicare insurance plans could require patients to try cheaper drugs first. If those are not effective, then the patients could receive the more expensive medication prescribed by their doctors.

Insurers use such “step therapy” to manage drug costs within the employer-based insurance market plus Medicare’s stand-alone Part D prescription medication benefit, which generally covers medicine purchased at retail pharmacies or with the mail. The new option allows Advantage plans – an alternative choice to traditional, government-run Medicare – to increase that cost-control technique to these physician-administered drugs.

In traditional Medicare, which covers 40 million older or disabled adults, those medications given by doctors are covered under Medicare Medicare part b, including outpatient services, and step treatments are prohibited.

About 20 million individuals have private Medicare Advantage policies, including coverage for Part D and Medicare part b medications.

Some physicians and patient advocates are concerned that the pursuit of lower Medicare part b drug prices could endanger very sick Medicare Advantage patients when they can’t be treated promptly using the medicine which was their doctor's first choice.

Critics from the new policy, area of the administration's efforts to satisfy President Donald Trump’s promise to chop drug prices, say it lacks some crucial details, including how you can determine whenever a more affordable drug isn’t effective.

“Do you have to lose vision before you are allowed to use” medication approved by the Food and Drug Administration, asked Richard O’Neal, v . p . for market access for Regeneron, which makes Eylea, a medicine that's injected into the eye to treat macular degeneration. In 2021, Medicare paid $2.2 billion for Eylea prescriptions for patients in traditional Medicare, a lot more than any other Part B drug, according to government data.

Medicare Advantage insurers spend about $12 billion on Part B drugs, when compared to $25.7 billion traditional Medicare put in 2021 on such drugs. Insurers that adopt the step therapy policy can use it only to new prescriptions – medicine someone hasn’t received previously 108 days.

The alternation in policy gives insurers a brand new bargaining tool: Pharmaceutical makers might want to compete by cutting prices to have their product on the plans' list of preferred lists, allowing patients to get the medicines without step therapy pre-conditions. That “strengthens their negotiating position with the manufacturers,” Medicare chief Seema Verma said when she unveiled the insurance policy recently.

It could also save patients money since they usually pay part of the Part B prescription cost. In addition, Medicare is requiring intends to share the savings with enrollees.

“Competition is a large element in price concessions,” said Daniel Nam, executive director of federal programs at America’s Health Insurance Plans, a business trade group. But insurers haven’t had much leverage to barter affordable prices for these drugs without strategies like step therapy, he said.

Federal nutritionists told insurers inside a memo last month they could substitute a less expensive Medicare part b drug to deal with a medical problem the FDA hasn't approved it for, if insurers can document that it's safe and effective. Yet coverage for a Part D drug is generally denied for a condition that does not have FDA approval, according to the Center for Medicare Advocacy, which helps beneficiaries with appeals.

Several representatives of medical specialty groups recently met with Alex Azar, the secretary of the Department of Health insurance and Human Services, to express their concerns.

Dr. Stephen Grubbs, vice president of clinical affairs at the American Society of Clinical Oncology, was included in this. He explained Azar told then your new step therapy policy will not have a big effect on cancer treatment.

Patients and their physicians who encounter problems getting specific Medicare part b drugs can appeal while using “process we have throughout the Medicare Advantage program and Part D plans,” advised Verma.

Under this technique, if patients don’t wish to follow their insurance plans’ requirements to try a more affordable medication first, they are able to request an exception to step therapy.

“They need their doctor’s support,” said Francine Chuchanis, director of entitlement rights at Direction Home, a place Agencies on Aging organization that serves seniors and people with disabilities in northeastern Ohio. The physician must tell the program why its restrictions should be lifted and provide extensive documentation.

The plans have Twenty four hours to reply to an expedited exception request and 3 days for any regular one. During this time, “individuals are not having their drugs,” said Sarah Jane Blake, a Medicare counselor for New York's StateWide Senior Action Council.

However, Dr. David Daikh, president from the American College of Rheumatology, said plans frequently don't satisfy the 72-hour deadline.

“We raised this point with the secretary and the staff,” he said. “They replied that they felt that there wouldn't be a backlog for this program.”

If a plan denies the exemption, patients can file a “reconsideration” appeal. In this process, patients still can’t obtain medicine unless they pay for it out-of-pocket.

Only a tiny fraction of Medicare Advantage beneficiaries filed a reconsideration appeal this past year. From the 3,498 cases which were decided, just 1 in 10 beneficiaries won decisions fully or partially in their favor, according to Medicare statistics.

“That’s disheartening as you would expect,” said Blake, but she wasn’t surprised. “Beneficiaries are intimidated by the hoops they need to go through and frequently give up trying to purchase the prescriptions given for them.”