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With reforms under the 2015 Medicare Access and CHIP Reauthorization Act (MACRA) currently pending, the CAP joined the American Medical Association (AMA) and dozens of physician organizations to urge the Centers for Medicare & Medicaid Services (CMS) in an April 18 letter to adopt several recommendations that coordinate new payment initiatives with existing private payer programs.

The CAP expects the proposed MACRA regulation from the CMS to be published soon. To address concerns pertaining to the pathology specialty with the CMS, the CAP has formed a special MACRA workgroup to advise on implementation of the new Merit-Based Incentive Payment System (MIPS) and alternative payment model (APM) pathways under MACRA.

The MIPS program, for example, is expected to have a $1.5 billion impact on the pathology specialty beginning in 2019. MIPS will combine the current Medicare quality programs—the Physician Quality Reporting System (PQRS), Electronic Health Record Meaningful Use (EHR MU), the Value-Based Modifier (VBM)—as well as a new performance category termed "Clinical Practice Improvement Activities." The CAP is working to ensure pathologists can comply with MIPS which is the default pathway under MACRA and is assessing the implications of the APM program.

In the April 18 AMA letter to the CMS, the organized medicine groups wrote that they seek "to ensure the implementation of MACRA does not create an overly prescriptive, time-consuming, and complex federal approval process for clinical quality improvement and APMs as this could undermine existing programs that are already extraordinarily effective in improving care and containing costs." The letter urged the CMS to adopt several recommendations when developing policies for the MIPS and APM payment pathways.

As the varied approaches by physicians, private payers and the Centers for Medicare and Medicaid Innovation have demonstrated, no one solution achieves improving health and efficacy in the delivery system. "The CMS should allow for maximum flexibility on the public and private sector sides and not inadvertently create rules around participation that have a chilling effect on the ability to innovate—for both physicians and payers," the letter said.

There also should be clear rules for private sector payment models to meet thresholds for qualifying APMs.

Under MIPS, clinical improvement activities that physicians have worked on in the private sector also should earn them credit in the Medicare program. "These successful collaborations between physicians and health plans can serve as a first step for physicians that are not able to be part of a larger APM, but do want to be part of a value-based care model," the letter said.

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To achieve more accurate and representative fees under the next Medicare clinical laboratory payment system, the CAP advocated for a broader, more representative definition of "applicable laboratories" subject to reporting requirements.

The CAP joined with 17 pathology and laboratory groups to sign an April 13 letter to the CMS not only calling for a broader definition of "applicable laboratory", but also requesting a discussion with the agency as it implements the Protecting Access to Medicare Act (PAMA). The proposed PAMA regulation, released in October 2015, is expected to be finalized in the near future as the Office of Management and Budget posted its receipt of the final rule on April 21. PAMA reforms the Medicare clinical laboratory fee schedule (CLFS) with a new system based on private payer fee data collected from applicable laboratories.

"We are deeply troubled that, as proposed, the majority of the laboratory market would be prohibited from supplying private payer data to the CMS to calculate new CLFS reimbursement rate," the letter said. "Since all components of the laboratory market will be reimbursed using the newly created reimbursement rates, all components of the laboratory market should be part of data reporting."

According to a September 2015 report by the Department of Health and Human Services (HHS) Office of Inspector General (OIG), 57% of CLFS payments are made to independent laboratories, 24% of payments are made to hospital laboratories, and 19% are made to physician office laboratories. Although hospital laboratories represent a significant share of the market, the CMS’ proposed definition of an applicable laboratory excludes virtually all hospital laboratories.

"PAMA dramatically changes how clinical laboratory testing services are reimbursed by the Medicare program," the letter said. "The success of CLFS payment reform hinges on accurate, market based payment rates calculated in a manner consistent with the statute. We urge CMS to define applicable laboratory as a facility identified by a CLIA number that derives the majority of its Medicare revenue from the CLFS and [Medicare physician fee schedule], with appropriate low Medicare revenue thresholds to reduce the reporting burden for small laboratories."

In addition to the more granular applicable laboratory definition, the letter conveyed "While exclusions are calculated and 'applicable laboratory' is defined at the CLIA level, data certification and submission will occur at either the individual CLIA level or, in aggregate at the tax identification number (TIN) level, with a listing of all CLIA numbers under the TIN to afford flexibility and reduce administrative burden for reporting laboratories."

Read the full letter to the CMS.

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Physicians and teaching hospitals can currently review and dispute data on 2015 payments and other transfers of value reported by pharmaceutical and medical device manufacturers to the CMS' Open Payments public reporting program. The data may be disputed by May 15 before it is released online on June 30.

The CMS publishes data from applicable manufacturers and group purchasing organizations about payments or other transfers of value sent to physicians and teaching hospitals. The reporting entities are advised by the CMS to ensure the information is accurate and physicians and teaching hospitals can review and dispute the information reported about them before the CMS posts the new data online on June 30.

The CMS provides instructions and tips for reviewing and disputing the data. Questions about the program and accessing the data can be sent to openpayments@cms.hhs.gov.

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