CLN Article

Federal Insider

Federal Panel Skeptical of Molecular Tests for Cancer

In a meeting of the influential Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) on March 24, panelists expressed doubt about molecular genetic tests that estimate the prognosis of cancer. The panelists considered tests indicated for adenocarcinoma of the colon and rectum (BRAF, KRAS, microsatellite instability, MLH1 promoter methylation, Oncotype DX Colon), breast cancer (MammaPrint, Oncotype DX Breast), and non-small cell lung cancer (ALK, EGFR, KRAS).

The Centers for Medicare and Medicaid Services (CMS) asked the panelists to weight on a scale of 1–5 their confidence that each test could affect health outcomes for Medicare patients, with 1 being highest confidence. The highest average score for any test was 3.13, microsatellite instability. CMS also asked the panel about its confidence in the tests’ clinical utility, explained as evidence for improved outcomes, and the panel only voted on the three tests that averaged above 2.5 in the previous question: microsatellite instability, MammaPrint, and Oncotype DX Breast. The average panelist scores for clinical utility were 2.13, 2.25, and 2.88, respectively.

During the meeting, CMS’s liaison to the panel James Rollins, MD, noted that Medicare coverage depends on a test’s being reasonable and necessary under the law, and said CMS’s working definition was “a sufficient level of confidence that evidence is adequate to conclude that the item or device improves clinically meaningful health outcomes in Medicare beneficiaries.”

MEDCAC’s role was to advise CMS about the use of existing evidence as the basis for future coverage determinations for these tests. MEDCAC panels do not make coverage determinations, but CMS often follows their advice.

Pompe Disease Added to the Recommended Uniform Screening Panel

Secretary of Health and Human Services Sylvia Burwell formally accepted the recommendation from the Secretary’s Advisory Committee on Heritable Diseases to add Pompe disease to the federal Recommended Uniform Screening Panel (RUSP). States will not be required to begin screening for Pompe, but some already do, and the recommendation could spur others to act.

Newborn screening was an area of focus for AACC’s advocacy efforts in 2014, including a congressional briefing, visits to congressional offices by the AACC board of directors, and strong support of the Newborn Screening Saves Lives Reauthorization Act of 2014, which President Obama signed into law in December.

In its position statement on newborn screening, AACC endorses public-private efforts to maintain, improve, and expand newborn screening programs, as well as evidence-based efforts to identify additional conditions for screening and the use of residual specimens for quality assurance and continuous improvements in pediatric healthcare.

Now, Burwell’s action adding Pompe to the RUSP will mean that, under the Affordable Care Act, most health plans will have to cover screening, as it falls under new requirements for evidence-based preventive care.

CMS Unveils New ACO Model

The Centers for Medicare and Medicaid Services (CMS) announced its Next Generation Accountable Care Organization (ACO) Model of payment and care delivery. This new model incorporates more flexible rewards for meeting quality and savings targets, as well as new tools to engage patients.

The ACOs in the new model will have to take on greater performance risk than ACOs in current models, while also potentially sharing in a greater portion of savings. To balance this risk, ACOs will have more predictable benchmarks for quality and cost savings.

The new model also offers more incentives to coordinate care, including rewards to beneficiaries for receiving their care from physicians and professionals who participate in their ACOs, coverage of skilled nursing care without prior hospitalization, and expansion of telehealth and post-discharge home services. Organizations make a 5-year commitment under the new model, with applications due June 1.