Medicare Part D Proposed Rule Triggers AAFP Response

January 28, 2019 03:49 pm News Staff

The AAFP is adamantly opposed to portions of a CMS proposed rule that are bad for patients and for family physicians. One part of the proposal would increase the prior authorization burden on physicians and another would limit some Medicare patients' access to medications prescribed by their physicians.

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The Academy's comments came in a Jan. 25 letter(2 page PDF) to CMS Administrator Seema Verma, M.P.H., and was signed by AAFP Board Chair Michael Munger, M.D., of Overland Park, Kan.

CMS' proposed rule(www.govinfo.gov) titled "Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out-of-Pocket Expenses" was published in the Nov. 30 Federal Register.

The AAFP acknowledged the good intent of the proposed rule, which aims to lower drug prices and reduce out-of-pocket costs for Medicare Part C and D beneficiaries -- but then outlined which policies it supports and which it opposes.

Protected Class Drugs

The letter pointed out that the proposed rule maintains six "protected drug classes" identified as anticonvulsants, antidepressants, antineoplastics, antipsychotics, antiretrovirals and immunosuppressants.

Story Highlights
  • In a letter to CMS, the AAFP raised objections about portions of a proposed rule that would create barriers to certain Medicare Part D drugs.
  • The proposal would, among other things, implement broader use of prior authorization, step therapy and indication-based formulary design for protected class indications.
  • The AAFP's concerns were reinforced in a second letter signed by the AAFP and 142 other medical organizations, which noted that CMS' proposals could cause delayed and improper treatment, undesirable patient outcomes and increased costs to the system.

However, the proposal also offers three exceptions to allow Part D sponsors to more easily negotiate with drug manufacturers.

And that's where the AAFP raised objections.

Notably, one exception would allow Part D plans to "implement broader use of prior authorization, step therapy and indication-based formulary design for protected class indications." In this scenario, Part D sponsors could exclude a protected class drug from the formulary for nonprotected class indications.

Additionally, Part D plans could exclude from their formularies "a protected class drug or biologic that is a new formulation that does not provide a unique route of administration," even if the older formulation is no longer on the market.

Lastly, Part D plans could exclude a protected class drug from a formulary if the drug price "increased beyond a certain threshold relative to the price in a baseline month and year, beyond the rate of inflation."

The Academy pushed back hard, stating that it "opposes any actions that limit a patient's access to medications" prescribed by his or her physician and urged CMS to "prioritize patient access to these essential drugs."

Medicare Advantage

The AAFP was also disappointed with CMS' reaffirmation of Medicare Advantage Plans' current authority to "implement utilization management and prior authorization programs for managing Part D drugs.

Yes, lowering the cost of prescription drugs is important, noted the AAFP.

However, "physicians already face recurrent and burdensome administrative requirements like prior authorizations that create treatment barriers," noted the AAFP.

The letter pointed out that responses from a 2017 AMA physician survey(www.ama-assn.org) showed that 92 percent of respondents attributed delays in patient care to prior authorizations and 78 percent said prior authorizations could lead patients to abandon treatment.

"The AAFP urges the administration to address drug prices, but not by imposing further prior authorizations onto physicians," said the Academy.

Negotiating Prices, Explaining Benefits

The AAFP did throw its support behind a couple of CMS proposals in the rule.

For instance, the AAFP agreed with CMS on taking steps to reduce costs to beneficiaries by defining the term "negotiated price," a step that would essentially do away with post point-of-sale price concessions and lower beneficiary co-payments.

"Ensuring access to affordable medications is an integral part of a family physician's role as an advocate for their patients," said the AAFP.

The letter also highlighted the AAFP's support for CMS' proposal to require Part D plans to include drug pricing information and lower-cost therapeutic alternatives in "explanation of benefits" documents patients receive from their plans.

"The AAFP wholeheartedly supports the policy objective of ensuring beneficiaries are provided with relevant information about the costs of prescription drugs and biological products," said the AAFP.

Reinforcing Concern in Group Letter

In addition to drafting its own strong comment letter to CMS, the AAFP joined 142 other signatories on a Jan. 25 letter(6 page PDF) to the CMS administrator that objected to some of the same sections of the CMS proposed rule -- specifically those that aim to lower drug prices by establishing broad exceptions to Medicare Part D's protected classes policy.

The joint letter leveled significant criticism at the proposed rule's call for stronger utilization management tools such as prior authorization and step therapy for Medicare enrollees already stabilized on a drug treatment within the existing boundaries of the protected drug classes.

"As a result of the (proposed) rule, patients doing well with a particular treatment may be forced to newly justify their treatment regimen or could be placed on a different treatment regimen that may be less effective," said the letter. Taking patients off treatments that are working and starting them on different medications "can undermine adherence -- resulting in hospital visits and other interventions that could have been avoided," said the organizations.

The letter also called out CMS for its shortsightedness with respect to the effect its proposals would have on drugs costs.

"CMS' analysis overlooks the importance of the costs that could be incurred from disrupting treatment for stabilized patients and restricting access for those patients starting treatment," said the organizations.

They pointed out that delayed treatment and improper treatment both lead to undesirable patient outcomes and thereby increase costs to the system.

"We urge CMS to maintain beneficiaries' access to protected class drugs to ensure timely, quality care and to prevent the total cost of care in Medicare from rising due to avoidable complications," said the letter.