CMS halts PSA quality measure-for now

Bob GattyWashington-As a result of strong opposition from organized medicine, including the AUA and patients, the Centers for Medicare & Medicaid Services (CMS) has put on hold its development of a draft plan to penalize physicians for ordering “non-recommended” PSA tests to screen for prostate cancer.

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During a month-long comment period on its draft clinical quality measure, “Non-Recommended Prostate-Specific Antigen (PSA)-Based Screening,” CMS received 358 comments, of which:

• 58% contained statements opposing limitations on PSA screening for the general male adult population

• 40% contained comments that disagreed with the U.S. Preventive Services Task Force guidelines on which the draft measure is based, or with other evidence cited in the draft measure specifications

• 34% included personal stories about patients’ experiences with prostate cancer or cancer screening.

CMS vows to work with AUA

In its statement announcing the suspension of the project, CMS noted that unnecessary testing can lead to overtreatment or over-diagnosis of prostate cancer, which it said may outweigh the possible benefits. However, CMS said that based on the responses it received, the agency “will continue to work with the American Urological Association as well as engage additional members of the community such as providers and patients. By taking the time to engage stakeholders in reviewing the electronic specifications, we can then determine the path forward. We seek to develop quality measures that facilitate effective, safe, efficient, patient-centered, equitable, and timely care.”

Next: CMS “will continue to evaluate appropriate use measure concepts to address overuse and patient safety on prostate cancer screening, as well as additional measure gap areas.”

CMS said it would continue to solicit input from multiple stakeholders, including specialty societies, to determine whether a restructured appropriate use PSA measure should be developed. The agency said it “will continue to evaluate appropriate use measure concepts to address overuse and patient safety on prostate cancer screening, as well as additional measure gap areas.”

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The AUA said it had been notified of the project’s suspension by Rep. Michael Burgess, MD (R-TX), who along with Rep. Phil Roe (R-TN) was instrumental in generating a letter from the GOP Doctors Caucus to CMS conveying concerns about the proposal. Burgess hand-delivered the caucus’ letter to CMS Acting Administrator Andy Slavitt after his testimony during a Dec. 8 hearing last year.

In the AUA’s comments to CMS, J. Stuart Wolf, Jr., MD, chair of the association’s Science & Quality Council, declared that the AUA and its members “strongly believe that blanket statements regarding PSA testing directed at the entire male population disregard the published benefits associated with such testing in men who may be at higher risk than the average male.”

AUA lobbies CMS on Medicare pay model

So having scored at least a temporary victory on the PSA issue, the AUA and other specialty medical groups have turned to Congress once again, this time asking lawmakers to push CMS to withdraw a new Medicare Part B Drug Payment Model proposed March 8.

The AUA signed a letter submitted to CMS by the Alliance of Specialty Medicine. The letter, which also was signed by 11 other specialty groups, argued that the rule would make sweeping changes to Medicare Part B drug reimbursement without sufficient stakeholder input and could affect the care and treatment of Medicare patients with complex conditions.

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In a recent Policy & Advocacy blog post, the AUA explained that the proposed Medicare Part B Model is designed “to test different physician and patient incentives… to drive the prescribing of the most effective drugs, and test new payment approaches to reward positive patient outcomes.”

Next: Two phases

The first phase would test whether reducing the 6% add-on to 2.5% plus a flat fee payment of $16.80 per drug per day would lead to improved quality and value. CMS would update the flat fee annually by the percentage increase in the consumer price index for medical care for the most recent 12-month period. That test is scheduled to begin no sooner than 60 days after the rule is finalized.

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The second phase would produce a menu of value-based purchasing options. CMS would consider the following no sooner than Jan. 1, 2017:

• discounting or eliminating patient cost-sharing

• feedback on prescribing patterns and online decision support tools as a resource for providers and suppliers focused on safe and effective use for selected drugs and indications

• indications-based pricing, which would vary the payment for a drug based on the clinical effectiveness for different indications.

• reference pricing, which would test the practice of setting a standard payment rate for a group of therapeutically similar drug products

• risk-sharing agreements based on outcomes, which would allow CMS to enter into voluntary agreements with drug manufacturers to link  patient outcomes with price adjustments.

CMS would evaluate the proposed model over 5 years, with the goal of having both phases in full operation during the last 3 years so the changes could be evaluated.

In its letter, the Alliance of Specialty Medicine expressed fear that the initiative would “adversely affect the care and treatment of patients.” The Alliance said that under the proposed payment method, “patients would be forced to navigate a CMS initiative that could potentially lead to a halt in their ongoing treatment. This is not the right way to manage the Medicare program for any beneficiary-let alone patients with serious conditions.”

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