No 'Step Therapy,' American College of Rheumatology Tells CMS

The American College of Rheumatology (ACR) is the latest in a string of professional organizations and patient advocacy groups to oppose a policy by the Centers for Medicare & Medicaid Services (CMS) to allow Medicare Advantage plans the option of requiring step therapy for Part B drugs.

The new policy, released last month by CMS, has caused a ripple of negative reactions throughout the medical community, along with patient advocacy groups and even some industry organizations, such as the Pharmaceutical Research and Manufacturers of America (PhRMA).

CMS is labeling the move as a way to drive down drug costs by motivating pharmaceutical companies to come to the negotiating table.

Many professional organizations aren't buying it. Oncology groups have already voiced their concern, with the Community Oncology Alliance (COA) calling it a "dangerous nightmare for cancer patients," and sees it as a step toward the government's dictating what cancer treatments Medicare recipients can or cannot receive.

Now, ACR has also released a statement outlining the potential detrimental effect the policy would have on patient care and the ability of a physician to prescribe appropriate treatment.

Although ACR supports the goal of reining in the cost of medications, they have "long opposed step therapy and other utilization management techniques that undermine the clinical judgement of providers, delay access to needed treatments and put our patients' health at unnecessary risk," according to a press release.

ACR representatives recently met with US Department of Health and Human Services (HHS) Secretary Alex Azar to discuss the new policy and voice the issues that they have with a requirement for step therapy.

"Secretary Azar expressed the goal of maintaining adequate care for patients," David Daikh, MD, PhD, president of the ACR, who attended the meeting with the HHS secretary, told Medscape Medical News. "He also acknowledged that it will require additional administrative work for providers despite CMS's expressed goal of reducing provider burden."

Daikh noted that Azar appeared receptive to the need to avoid putting patients who are currently receiving effective care through unnecessary medication changes and switching protocols.

"We also advocated that if a patient achieved clinical remission on a medication and was able to stop therapy, that the patient not be required to go through all of the preceding step therapies they had failed in the past if their disease becomes active again," said Daikh, who is also rheumatology division chief at the San Francisco Veterans Affairs Medical Center and director of the rheumatology fellowship program at the University of California, San Francisco.

Fail First

Step therapy, sometimes referred to as "fail first" therapy, generally requires a patient to begin treatment with the most cost-effective drug option and then move on to the costlier treatments if cheaper ones fail. Medicare Advantage plans, which are private for-profit health insurance plans that provide Medicare benefits to 20 million beneficiaries, were explicitly forbidden by the Obama administration in 2012 from requiring step therapy. The new CMS policy will rescind that prohibition.

Under the new policy, not only are Medicare Advantage plans obligated to require step therapy, but for those that decide to go that route, it would be applicable only to new prescriptions beginning in January 2019. Medicare enrollees would also have the choice to switch to an Advantage plan that does not use step therapy or opt out of the Advantage plans entirely and return to fee-for-service. The plans that offer step therapy have to tie it to new patient-centered care coordination services that include discussing medication options, providing educational material and information about medications, and implementing adherence strategies.

Another problem stems from the complicated way that the current healthcare system operates, explained Herbert S.B. Baraf, MD, senior member and managing partner of Arthritis and Rheumatism Associates, and a clinical professor of medicine at the George Washington University School of Medicine in Washington, DC.

Pricing is all over the place, depending on individual negotiations, rebates for specific drugs, and other factors. "The steps are not standard and are set by Medicare Advantage Plans," he told Medscape Medical News. "Each plan sets its own steps because it is doing its own negotiations on price or rebate, so they will all come up with something different."

He added that the steps are not based only on the appropriateness of the drugs but on cost. "The plans cut a deal with pharma and PBMs [pharmacy benefit managers], and the CMS policy doesn't fix the rebate system," Baraf explained. "CMS wants to save money, but this policy does something very different."

"It's providing a benefit to the Medicare Advantage plans in that they can generate more profit," he added. "That's why the steps are there and are set for an economic benefit.

"To really cut cost, the government needs to negotiate prices, remove the opaqueness surrounding pricing, and increase transparency," he said.

Burden on Patient/Provider

At the meeting with the HHS secretary, Daikh said they also discussed the burden that the new policy would put on both providers and patients. "Step therapy means that physicians have to prescribe a specific medication for a given condition and the patient has to fail that therapy before a different therapy will be approved," he said. "However, there are many reasons that arise for why a specific medication is not appropriate for an individual patient."

Allowing step therapy for Medicare Advantage plans will mean that for every one of these cases, the physician will need to fill out and submit additional paperwork to obtain the needed medication for their patient. "To reduce this burden and more importantly, to help ensure that step therapy is not applied inappropriately, we suggested that if step therapy guidelines are to be introduced that they are designed in accordance with established treatment pathways."

An example would be evidence-based treatment guidelines that professional organizations like the ACR have already put in place. "Secretary Azar and his staff responded that they expect Medicare Advantage plans to adopt such pathways, but we will have to see if this in fact happens," Daikh said.

However, Azar has given no indication when he will get back to the medical community regarding their input.

Baraf noted that the new policy will further "twist the patient in knots" and make it increasingly more difficult to get patients appropriate therapy. "Medicare Advantage contractors will figure out a way to bring more money to their bottom line by tweaking their formulary," he said. "We need to protect the patient and the sanctity of medicine, but that is being thwarted by commercial interests under the guise of saving money."

More CMS Woes

The ACR has also responded to a related CMS plan that will allow Medicare Part D plan sponsors to implement indication-based formulary designs, which essentially allow plans to select drugs for their formularies based only on the disease indications they want to use.

"While we appreciate the agency's efforts to make prescription medications more affordable, we have serious concerns about a new CMS guidance," ACR said in a release. "These changes are a departure from current policy, which requires plans to cover each on-formulary drug for all indications that are approved by the FDA. It takes clinical decision making out of the hands of providers and puts insurance companies in control of patient treatment plans."

In addition, these proposed changes will exacerbate many of the access issues patients already face, such as step therapy. But unlike step therapy, ACR notes, which often delays the implementation of effective therapies, this new proposal would actually remove certain therapeutics from the formulary, leaving patients without access to prescribed treatments.

Thus, the ACR calls on CMS not to move forward with this plan "or at a minimum to clarify the process for allowing exemptions for patients for whom a specific therapy is medically necessary. This process should be straightforward and not place an undue burden on the physician or patient in gaining access to needed medications."

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