ACR Leads Coalition Response to HHS Proposed Drug Pricing Threats

Potential federal drug pricing proposals could shuffle Part B drug coverage into the Part D program and restructure reimbursements for new drugs, moves that would jeopardize patient access to care, explains Kent “Kwas” Huston, MD, a rheumatologist in Kansas City, Mo., and a member of the ACR’s Government Affairs Committee (GAC).

“We believe Part D benefits should not limit patients’ access to the medical therapy judged by the treating physician to be the most effective choice,” Dr. Huston says.

“We also reiterate that allowing the most appropriate and efficacious therapy as judged by the treating physician can result in long-term cost savings.”

The 4 Primary Concerns
The ACR is leading a coalition response to these potential policy proposals that were included in the 2019 President’s Budget and the Council of Economic Advisors (CEA) report. In a March 14 coalition letter drafted by the ACR and sent to Health and Human Services (HHS) Secretary Alex Azar, concerns shared by multiple physician societies were outlined.

Here’s a snapshot of the coalition’s four primary concerns with the proposed changes:

1. Coverage would be limited or reduced as a result of reducing formulary coverage requirements of Medicare Part D plans.

A proposed change to Part D plan formulary standards would require a minimum of just one drug per category or class, rather than two, which could restrict patient access to high-cost biologic medications.

2. Access to medications could be limited if Part B drug coverage is shuffled under the Part D program.

A proposed change would give the HHS Secretary authority to consolidate certain drugs currently covered under the Medicare Part B program into the Part D program, a drastic change that could delay and restrict patient access to certain medications through prior authorization and step therapy measures, and force patients to access these high-cost medications at higher cost care sites, which would lead to high out-of-pocket costs for patients, especially for biologics.

3. Medicare Part B physician reimbursement could be drastically limited from 6% to 3% over the wholesale acquisition costs (WAC) for new drugs, and 3% over the average sales price (ASP) for established drugs, affecting physician ability to provide necessary therapies to patients.

With the existing Part B payment structure and sequestration in place, the costs of obtaining and providing the complex therapies in the Part B program in the outpatient setting are inadequately covered. This proposed change to restructure Medicare Part B physician reimbursement to pay physicians 3% over the ASP for Part B drugs would exacerbate this less-than-adequate reimbursement, particularly for many small and rural practices that can’t negotiate bulk discounts in their drug purchases and may have already been forced to stop administering biologic therapies to Medicare patients.

“We support adherence to the statutory ASP + 6% reimbursement rate for in-office treatments and continue to urge the repeal of sequester cuts to Part B drug reimbursements,” Dr. Huston notes.

4. Introducing physician reimbursement not tied to drugs’ prices could result in further negative effects and limit patient access.

In specialties such as rheumatology that use biologic and other complex therapies, less expensive, yet equally effective, therapies typically don’t exist. Additionally, complex biologics create associated inventory and management costs for the physician. Considering that physicians have no control over the cost of drugs, ancillary services, severity of illnesses and co-morbidities of their patients, physicians should not be penalized for rampant inflation in these sectors.

Taking Action
The ACR and others will be meeting with the HHS to discuss concerns and gather more information about possible plans.

Meanwhile, GAC encourages every ACR member to learn more about how these potential policy changes will negatively impact their patients’ access to rheumatology care, says ACR Government Affairs Committee Chair Angus Worthing, MD.

“We know that our patients’ outcomes depend on early and appropriate treatment by a specialist to control disease activity and prevent or slow disease progression, in addition to preventing costly downstream procedures,” Dr. Worthing stresses. “Drug pricing policy is key to access and outcomes for our patients, and our voice is critically important right now to educate policymakers about this before our patients end up paying the price with their health.”

Carina Stanton is a freelance science journalist in Denver.