CMS Reverses Course: 'Protected' Drug Classes Still Covered

Alicia Ault

May 17, 2019

The federal government has backed off a proposal that would have let Medicare Part D prescription drug plans deny coverage for therapies in six "protected" classes of drugs, including those for cancer and psychiatric conditions.

While that is seen as a win for many consumers, patients, and physician groups, the Centers for Medicare & Medicaid Services' (CMS) May 16 final rule on drug coverage policies also codified a policy that's been in effect since January that allows step therapy for Part B drugs prescribed for Medicare Advantage patients.

Part B drugs include a wide variety of injectable and infusible drugs, including IV cancer therapies, IV immune globulin, antigens, injectable osteoporosis drugs, and rheumatoid arthritis therapies. Some oral cancer therapies may also be covered under Part B.

Ted Okon, executive director of the Community Oncology Alliance, told Medscape Medical News that the step therapy policy has already been causing disruptions in care and may lead to poor and perhaps dangerous outcomes for cancer patients.

Monica M. Bertagnolli, MD, FACS, FASCO, president of the American Society of Clinical Oncology (ASCO), also said in a statement that ASCO was disappointed in CMS codifying the Part B policy.

"Step therapy requires patients to try and fail to have a desired clinical outcome on a lower cost medication before they can access the medication prescribed by their health care provider," she said. "This not only delays patient access to proper treatments, it potentially leads to irreversible disease progression and other significant patient health risks."

The American College of Rheumatology has also objected to the policy in a statement, saying that the policy will not only impact patient care, but it will also add to physicians' administrative burden.

Protected Classes Still Protected

The final rule reverses a proposal made in November that would have allowed Part D plans to exclude coverage of a drug from six "protected" classes — antidepressants, antipsychotics, anticonvulsants, immunosuppressants for treatment of transplant rejection, antiretrovirals, and antineoplastics — if the increase in the drug's price was greater than inflation or if CMS determined that the drug was not a significant innovation over the original product.

The reversal is likely an acknowledgement of the opposition from physician and patient organizations.

In a statement, CMS said it "appreciates the feedback received on this issue and has chosen not to finalize the proposed changes to its protected classes policy at this time, but rather is codifying existing policy."

But, said the statement, "the administration remains concerned that prescription drug companies are offering seniors in Medicare substantially smaller discounts for protected class drugs than are offered in the commercial market," which means that Medicare beneficiaries are paying more. CMS said it would continue to address the problem of high drug prices.

Under the policy in place since 2006, Part D plans will still be required to include on formularies all drugs in the six classes. Part D sponsors will also continue to only be allowed to impose prior authorization and step therapy for new starts in five of the six classes; no prior authorization or step therapy is allowed for antiretrovirals.

American Medical Association (AMA) President Barbara L. McAneny, MD — an oncologist — praised the CMS reversal in a statement. "Seriously ill patients who faced the prospect of new hurdles to accessing their medication can breathe a sigh of relief now that the Trump administration has discarded the proposal.... The AMA and other patient champions detailed the potential effects of the policy, and we're grateful the administration listened," she said.

ASCO’s Bertagnolli also applauded the agency for heeding its — and other organizations' — concerns. "While we support efforts to control drug prices, optimal cancer care requires patient access to the most medically appropriate drug, at the most opportune time, based on the highest quality evidence," she said.

Lisa Lacasse, president of the American Cancer Society Cancer Action Network, also said in a statement that CMS had responded appropriately to patients' concerns. And she agreed with ASCO that cancer care is not a one-size-fits-all treatment.

"Cancer care often requires specialized treatment targeted at a patient's specific tumor, and these treatments are rarely interchangeable," she said. "We will closely monitor implementation of this rule, working to make sure all cancer patients have timely access to the therapies best suited to treat their disease."

"Inhumane" Step Therapy

The final rule gives full regulatory force to the CMS policy that began this year allowing Medicare Advantage (MA) plans to use step therapy, which CMS said "will better enable MA organizations to ensure that Medicare beneficiaries pay less overall or per unit for Part B drugs."

Medicare Advantage enrolls about a third of all beneficiaries, some 19 million individuals. Step therapy can only be used for new starts of medication and must be reviewed and approved by the plan's pharmacy and therapeutics committee, said CMS. Medicare enrollees have the choice to go to an Advantage plan that does not use step therapy or to go back to fee-for-service, but clinicians may find it harder to prescribe their first choice.

The Community Oncology Alliance's Okon told Medscape Medical News that patients are already encountering difficulties, citing a case where a Humana MA plan insisted that a multiple myeloma patient first try a therapy that was contraindicated.

"Step therapy in cancer is nothing short of inhumane," Okon said, adding that the policy was only about "cutting costs and cutting costs at the expense of the patient."

The Pharmaceutical Care Management Association (PCMA), the pharmacy benefit management industry's trade group, however, praised the step therapy plan when it was first issued, calling it in a statement, "an important step toward reducing costs for the program and beneficiaries."

CMS said that when patients request coverage of, or appeal a denial of, a Part B drug, the plan has to act more quickly than currently required under Part D rules.

Okon said that appeals are small consolation to individuals with cancer. "That's the last thing you want to have to go through," he said.

Real-Time Cost Data

The final rule also requires — by January 2021 — Part D plans to incorporate into electronic health records tools that let prescribers know when lower-cost alternative therapies are available under the beneficiary's prescription drug benefit.

Also by that time, CMS will require the Part D Explanation of Benefits sent to patients to include drug price increases and lower cost therapeutic alternatives, with an aim of letting Medicare beneficiaries "know about possible ways to lower their out of pocket costs by considering a lower cost medication," according to CMS.

"Today's rule requires Part D plans to adopt tools that provide clinicians with information that they can discuss with patients on out-of-pocket costs for prescription drugs at the time a prescription is written," said CMS Administrator Seema Verma, in a statement.

"By empowering patients with information on the cost of their prescription drugs, today's rule will ensure that pharmaceutical companies have to compete on the basis of price," she said.

The rule also finalizes the policy that Part D plans cannot prevent or penalize a pharmacy from disclosing a lower cash price to an enrollee.

Finally, the agency had proposed to re-define the "negotiated" price as the lowest possible amount paid to a pharmacy. That negotiated price is used to calculate beneficiary cost-sharing and adjudicate the Part D benefit.

The agency said it would not move forward at this time, due, in part, to some 4000 comments it received.

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