CMS Mulls Opposition to Downsizing Part D Protected Drug Classes

Targeted Therapies in OncologyMarch 2019
Volume 8
Issue 4

The healthcare community is still awaiting a response from the Centers for Medicare & Medicaid Services to the opposition of the agency’s proposal to substantially revise the Medicare Part D protected drug classes.

The healthcare community is still awaiting a response from the Centers for Medicare & Medicaid Services (CMS) to the opposition of the agency’s proposal to substantially revise the Medicare Part D protected drug classes.

Protection of the 6 drug classes within the Part D prescription drug plan, which include antineoplastics such as chemotherapies, was instituted in 2006 to ensure that commercial health plan sponsors of the newly launched Medicare Part D program would make these drugs available to patients.

CMS contends that the protected-class categories were not intended to be permanent and that the protected status has caused the costs of these drugs to be higher for Part D coverage than for private plans. CMS states that the discounts on these drugs for private plans are in the range of 20% to 30%, versus 6% for Part D participants. “The protected class policy is in need of an update to ensure that beneficiaries who depend on these drugs are getting the same discounts that other beneficiaries get,” wrote Alex Azar, secretary of the Department of Health & Human Services (HHS), and Seema Verma, administrator of CMS, in a November statement.1,2

Approximately 60 patient advocacy groups have joined the American Cancer Society Cancer Action Network’s (ACS CAN) campaign to stop Medicare Part D health plans from scaling back coverage for these protected-class drugs, which also include anticonvulsants, antidepressants, antipsychotics, antiretrovirals, and immunosuppressants.3 The groups argue that the protections ensure patient access to a wide variety of nontherapeutically equivalent drugs within each class, which is essential because some available drugs work better than others for different patients, and doctors and patients need a choice, especially for chemotherapies. Without the protections, some of these drugs might drop off formularies, or step requirements and prior-approval processes could make accessing them more difficult, opponents argue.

A case in point, they say, is reflected in the subclass of antineoplastics known as tyrosine kinase inhibitors, “which have been developed to treat cancer, but each drug within this category may target a different mutation that is relevant to a small subcategory of patients with a given disease,” ACS CAN wrote in opposition to the proposed revision. The proposal for change was released by CMS in November 2018. The requirement to cover protected drug classes significantly lessens Part D plan sponsors’ negotiating power with drug providers such as manufacturers, according to CMS.

Opponents of the proposed change contend that within the existing protected-class framework, Part D plans can tier drugs, which does provide a form of leverage, and can allow management of these classes of drugs for savings.4They argue that “generic utilization for drugs within the 6 protected classes is higher than [that of] other drug classes (92% vs 84%).”

A similar effort to revise the protected-classes provision of Part D was attempted in 2014 but abandoned owing to contention among stakeholders. Verma and Azar have revived the effort under the drug-price—reduction banner raised by President Donald Trump in his “blueprint” for change. “HHS has been hard at work to make the president’s vision a reality—because the status quo is simply unacceptable,” Azar and Verma wrote.

Under the proposed revision to Part D, Part D plan sponsors would be required to keep a minimum of 2 drugs in their formularies for each of the 6 protected classes starting in 2020. CMS would allow the plans to exclude the remaining drugs with price increases greater than the rate of inflation, as well as new drug formulas that are not a significant innovation over the original products. The proposal also notes that plans would be allowed to exclude a newer formulation of an older drug, even if the older version is no longer on the market.

Additionally, the plans would be permitted to implement prior authorization or step therapy, the practice of using the most cost-effective drug therapy first and progressing to more costly or risky therapies only if needed. According to Azar and Verma, plan sponsor step therapy requirements would be fenced in by patient protections, which would include a CMS review on an annual basis and expedited appeals through which physicians could recommend an exception.

Opponents say that these reviews would be time-consuming and potentially perilous for patients whose health conditions require immediate action. “Such policies may unnecessarily impede patient access to needed cancer care and lead to irreversible disease progression and other significant health risks,” the American Society of Clinical Oncology (ASCO), which has joined the protest, said in a January 18th statement.5

The Community Oncology Alliance has joined the struggle to prevent the policy change. Ted Okon, MBA, the group’s executive director, said that care decisions based on cost are ultimately bad for patients and run counter to the principles of good medicine.

“When it does not work, and the patient goes to the hospital because they are not getting the appropriate treatment, it is going to cost more. It is a very short-term strategy,” he said.

In an interview with Targeted Therapies in Oncology, Jeffery C. Ward, MD, said that downsizing the protected-class policy would lead to negative health outcomes, increased costs for Medicare Part D health plans through increased morbidity, and higher beneficiary cost sharing. Starting patients on less-than-ideal drugs is a bad idea, he said.

“With step therapy, for example, the cheaper drugs [used] may be more toxic,” said Ward, a medical oncologist at the Swedish Cancer Institute and the current chair of ASCO’s Government Relations Committee. “With toxicities come increased supportive care costs [including] expensive emergency department visits and hospitalizations.”

Similarly, ACS CAN said the requirements for step therapy and prior authorization would create unnecessary administrative challenges for physicians. The group said physicians report that prior authorization is behind most care delays, and these administratively burdensome processes are linked to patients abandoning prescribed treatments.3

Okon contended that “eliminating the protected classes would allow third-party entities to make the treatment decisions. They are going to include drugs that get the best deal for them, and it is questionable [whether] it will ever save money for Medicare or Medicaid patients.”


  1. Proposed changes to lower drug prices in Medicare Advantage and Part D. US Department of Health & Human Services website. proposed-changes-lower-drug-prices-medicare-advantage-part-d.html. Published November 26, 2018. Accessed February 25, 2019.
  2. CMS takes action to lower prescription drug costs by modernizing Medicare [news release]. Baltimore, MD: US Centers for Medicare & Medicaid Services; November 26, 2018. drug-costs-modernizing-medicare. Accessed February 6, 2019.
  3. ACS CAN and nearly 60 patient advocacy groups send letter raising alarm over changes to Medicare Part D cancer drug coverage [news release]. Washington, DC: American Cancer Society Cancer Action Network; January 28, 2019. raising-alarm-over-changes. Accessed February 25, 2019.
  4. Medicare’s six protected classes explained. website. fightcancer. org/policy-resources/medicare%E2%80%99s-six-protected-classesexplained. Published July 20, 2018. Accessed February 25, 2019.
  5. ASCO joins groups urging Congress to reject proposed changes to Medicare Part D. American Society of Clinical Oncology website. asco-in-action/asco-joins-groups-urging-congress-reject-proposedchanges- medicare. Published January 18, 2019. Accessed February 25, 2019.
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