CLN Article

Federal Insider

AACC Cautions FDA on Next-Generation Sequencing Guidance

AACC is expressing concern that the Food and Drug Administration (FDA) draft guidance, “Use of Standards in FDA Regulatory Oversight of Next Generation Sequencing (NGS)-Based In Vitro Diagnostics (IVDs) Used for Diagnosing Germline Diseases,” may hinder NGS testing, especially in light of FDA’s pending guidance on laboratory developed tests (LDTs). A number of professional organizations and state entities already offer guidance on how to ensure quality and accuracy of NGS tests, and AACC believes this public-private partnership should continue, the association said in a letter to FDA.

AACC called out elements of the draft guidance as inaccurate. For example, FDA states that it is “unaware of any existing, comprehensive standards for analytical validation applicable to NGS-based tests for germline diseases,” while in fact guidance is available from the American College of Medical Genetics and Genomics, The College of American Pathologists, and the Joint Commission. 

AACC also called FDA’s proposed accuracy requirements unrealistic, at least in the near term, due to differing NGS technology metrics and pipelines. In particular, FDA’s requirements are impossible to achieve for rare inherited diseases in which positive samples for a condition are difficult to obtain. The association is asking FDA to reconsider this recommendation or release the scientific evidence that supports it. Similarly, AACC believes that FDA's proposed precision requirements, while achievable by medical device manufacturers, would be cost-prohibitive for academic medical centers. 

The association is also recommending that ethnic variability be included as a consideration for determining the target populations and that incidental findings be discussed with a patient’s physician. The complete comment letter is available on

Medicare Finalizes New Physician Payment Program

A final rule implementing the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) will bring sweeping changes to how physicians are paid under Medicare and likely affect laboratories and medical professionals who work with physicians. With unusual bipartisan support in Congress, MACRA drops the much-maligned sustainable growth rate formula that required a congressional fix every year to avoid drastic reductions in reimbursement to physicians. But the law also supports Medicare’s vision for aggressively moving to value-oriented payment versus fee-for-service. 

For physicians who choose not to enter into a shared savings program—such as the better-known Accountable Care Organizations (ACO)—Medicare in 2019 will begin offering bonuses or penalties to reimbursement based on a Merit Based Incentive Payment System (MIPS). MIPS combines several categories of performance: quality (50%); interoperability and information exchange (25%); practice improvement (15%); and cost of care (10%). The last category will compare across practices resources used to treat similar care episodes and clinical condition groups. 

The Centers for Medicare and Medicaid Services (CMS) believes most physicians will be subject to MIPS, but wants to drive physicians as much as possible toward advanced alternative payment models (APM). Physicians in certain kinds of APMs will be exempt from MIPS reporting and will receive a payment equal to 5% of the previous year’s fee-for-service payments. The APM path requires certified electronic health record technology, reporting quality measures comparable to those under MIPS, and calls for physicians to bear some financial risk for the cost of patient care. For 2016–2018, physicians can still expect a 0.5% fee schedule increase each year, unless they opt for the APM path. In 2019, the MIPS adjustments take over, and MIPS payment adjustments based on quality and cost criteria—either positive or negative—will begin at 4%. In 2020 those adjustments go up to 5%, then 7% in 2021, and 9% onward.