CMS urges limits on Part D drug changes

Doctors and other patient advocates welcomed the agency's formulary guidance but warned that drug plans might disregard the advice.

By David Glendinning, amednews staff. May 22/29, 2006.

Washington -- The Centers for Medicare & Medicaid Services has stepped in to head off what some physicians were worrying would be a major "bait and switch" by some insurers offering Medicare drug plans.

Under voluntary guidance recently issued by CMS, the government states that plans deciding during the middle of the year to stop covering certain drugs should continue for the remainder of the year to pay for the medications for enrollees who already are taking them. Medicare statute allows insurers to drop medications from their formularies or move them into nonpreferred status as long as they receive CMS approval and give 60 days notice before making the change.

Formulary changes
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The original policy had provoked criticism from physicians, lawmakers and consumer advocates who said plans could offer an attractive array of covered drugs during the enrollment period and then jettison the more expensive therapies after many people already had signed up.

Medicare beneficiaries are allowed to change their drug plans only once a year, during an open enrollment period that begins each fall and that affects coverage for the following calendar year. Democratic lawmakers have been working on legislation that would prevent seniors from having their covered drugs dropped.

The CMS announcement is a welcome development for doctors, said AMA Trustee Edward L. Langston, MD, a family physician in Lafayette, Ind.

"We were trying to get CMS to say that if you're signed up for the program and you're on a covered medication, you ought to be able to continue it through the end of the year," he said. "So from the AMA's perspective, this is a very appropriate directive. It does answer the question of whether they can bait and switch."

Medicare beneficiaries may switch Part D drug plans only during open enrollment every fall.

Without such assurances, physicians and their patients could be forced to scramble to find covered alternatives to medications that insurers unexpectedly drop from coverage. Many seniors and disabled people with multiple chronic conditions and complex drug regimens risk endangering their recovery if they stop taking drugs after such a formulary deletion, Dr. Langston said.

Medicare patients taking expensive therapies for mental health conditions and other serious ailments are at particular risk if drug plans make midyear changes, but all beneficiaries who take numerous regular medications are vulnerable, said Leslie Fried, director of the Medicare Advocacy Project. The project is a collaboration between the Alzheimer's Assn. and the American Bar Assn.'s Commission on Law and Aging.

"A lot of people with Alzheimer's disease and older people in general have multiple chronic conditions and are on multiple medications, and trying to get them to a point where they're stable is like building a house of cards," she said. "If one of these cards is removed from the house, there's concern that that person will become instable."

Seeing what plans will do

The CMS guidance does not guarantee that all beneficiaries and their physicians will be immune from midyear drug benefit changes. The exemption will not apply to patients who have not been taking the drugs in question or who sign up after the change takes effect. Plans also can receive approval for midyear "maintenance" changes to formularies when a new generic comes on the market or when safety or efficacy studies show that another drug in a particular class might be a more appropriate one to cover.

America's Health Insurance Plans offered support for the CMS statement about continuity of care and said it would recommend that its members follow the advice.

CMS has had more than 1,000 requests from drug plans to change drugs in Part D formularies.

"Today's announcement gives beneficiaries the peace of mind of knowing that they will be able to continue to receive their Part D formulary drugs throughout the year while preserving flexibility needed in plan formularies to maximize the value of the drug benefit when safety concerns are raised or generic equivalents come to market," said Karen Ignagni, AHIP's president and CEO.

But some patient advocates are worried that certain plans could disregard the voluntary guidance.

CMS says it will be diligent in prodding plans to do the right thing. Federal officials might reject a plan's application for a formulary change if it has even the appearance of being an underhanded technique, the guidance states. The agency would not reveal details about the formulary change requests that have come in so far, but a CMS spokesman said the number already has exceeded 1,000.

Dr. Langston said the AMA would be diligent in putting pressure on federal officials to act on insurers that violate the spirit of the law, whether that action involves cutting off plans from future participation in Medicare or other such administrative moves.

"We can monitor this, and if we see that a few plans are in fact baiting and switching, we ought to share that with beneficiaries and make it a public issue," he said. "If we have to help be the watchdog on this, then that's what we'll do."

ADDITIONAL INFORMATION:

Formulary changes

Plans that offer Medicare drug benefits under Part D can alter their lists of approved drugs in four different ways. Insurers may:

Expand the number of covered drugs, place drugs in a more-preferred tier or lift utilization management requirements at any time.
Replace brand-name drugs with new generics or make changes based on new safety or efficacy information, provided they give 60 days notice and receive approval from the Centers for Medicare & Medicaid Services.
Remove drugs from coverage, move them to a less-preferred tier or add utilization management requirements, provided they give 60 days notice and receive CMS approval.
Change therapeutic categories and classes in formularies only at the beginning of each plan year, except to account for newly approved drugs or therapeutic uses.

Source: Centers for Medicare & Medicaid Services