With time running out, some lab associations still hope for a delay in PAMA implementation.
Steve Halasey
Almost since the day of its passage, the Protecting Access to Medicare Act of 2014 (PAMA) has been acknowledged as the next big thing—and a great excursion into the unknown—for the clinical laboratory community.1
PAMA section 216 represents the first major adjustment to the Medicare clinical laboratory fee schedule (CLFS) since it was established more than 30 years ago. The new law creates a system for pricing clinical laboratory testing that will be based on the rates paid by private payors. It requires a defined group of ‘applicable laboratories’ to report their pricing (a step completed earlier this year), and will then apply a set of rules to calculate the new Medicare pricing schedule.
But moving PAMA along the road toward implementation has proven to be a difficult task with a number of significant obstacles. Laboratory associations and other stakeholders in the clinical laboratory community early on recognized that the statutory definition of an ‘applicable laboratory’ would result in a narrow and unrepresentative sampling of the clinical laboratory marketplace, with the potential to reduce pricing to levels that many labs will not be able to sustain. In 2016, the American Society for Clinical Laboratory Science (ASCLS) and the American Society for Clinical Pathology (ASCP) each launched grassroots advocacy campaigns, encouraging their members to submit comments about the implementing regulations proposed by CMS—but without apparent effect.
Later that year, the HHS Office of Inspector General reported that PAMA rules would capture data from just 5% of all clinical laboratories: “half of independent labs will be required to report their private payer data, whereas only a small portion of physician office labs and few hospital labs will be required to their report data [sic].”2 But the OIG report did not seem to spur any action from CMS.
Undaunted by such a lack of acknowledgment, earlier this year a group of 10 lab-related organizations wrote to HHS Secretary Tom Price, MD, formally requesting a delay in the implementation of CLFS reform so that the definition of an ‘applicable laboratory’ could be reconsidered.
The exclusion of an entire laboratory sector, particularly hospitals operating large outreach laboratories, negatively affects the integrity of rate calculations under PAMA. The implications are immense and would ultimately threaten to reduce laboratory infrastructure across the country, and therefore, limit beneficiary access to laboratory test services that support patient clinical care management. The applicable laboratory definition should be redefined to appropriately capture the true laboratory market.3
Following an April meeting with CMS Administrator Seema Verma, the American Clinical Laboratory Association (ACLA) contributed an extensive plan for getting PAMA implementation back on track, including a proposed redefinition of ‘applicable laboratory’ and a timeline for the submission of pricing information from newly eligible labs.4
Julie Khan, American Clinical Laboratory Association.
Despite such bursts of activity earlier this year, however, there was little motion to suggest that CMS intended to respond to the ongoing calls from the clinical laboratory community. In September, ACLA President Julie Khani wrote to Senators Roy Blunt and Patty Murray of the appropriations subcommittee of the Senate Committee on Labor, Health and Human Services, Education, and Related Agencies, to applaud their report language urging CMS “to address data accuracy concerns and ensure that the reported data appropriately represents the full spectrum of laboratories.”5
Also in September, the Association for Molecular Pathology (AMP)—not a signatory among the organizations that previously requested a delay—added its thoughts on the challenges of implementing PAMA:
We understand that CMS finds itself working within a tight timeline to make pricing determinations for January 1, 2018, as mandated by section 216 of PAMA for the first time. However, the combination of onerous reporting requirements and unresolved systemic problems leaves room for grave concern that final pricing will not accurately reflect payer market rates and could harm Medicare beneficiaries by reducing patient access and choices in testing, decreasing innovation, inhibiting research, and resulting in inaccurate payment rates. CMS should make every effort to address the concerns surrounding data collection and integrity as the new pricing structure is implemented.6
Federico A. Monzon, MD, Association for Molecular Pathology.
While expressing concern over possible problems associated with PAMA implementation, however, AMP still stopped short of calling for any further delay. “The AMP organization represents a variety of stakeholders and is not taking an official position on the delay in PAMA implementation to permit a redefined group of ‘applicable laboratories’ to supply data,” says Federico A. Monzon, MD, AMP president. “While AMP shares some of the same concerns about PAMA implementation as have been identified by other lab groups, our current advocacy initiatives are focused on ensuring data accuracy and improving patient care.”
It remains to be seen whether CMS will make any effort to address the concerns of many clinical laboratory organizations before January 2018, when the new PAMA pricing schedule will take effect. But it is certain that the time remaining for such action to be taken is rapidly dwindling. If the dire predictions of lab sector analysts turn out to be correct, many clinical laboratories—and the patients they serve—will be in for very difficult times in the coming year.
Steve Halasey is chief editor of CLP.
REFERENCES
1. Protecting Access to Medicare Act of 2014. PL 113-93.
2. Murrin S. Medicare Payments for Clinical Diagnostic Laboratory Tests in 2015: Year 2 of Baseline Data. HHS OIG Data Brief OEI-09-16-00040. Washington, DC: HHS OIG, 2016. Available at: https://oig.hhs.gov/oei/reports/oei-09-16-00040.pdf. Accessed September 20, 2017.
3. ACLA Letter to HHS Secretary Tom Price about Implementation of the Medicare Clinical Laboratory Fee Schedule (CLFS) Reform as Enacted by Section 216 of the Protecting Access to Medicare Act of 2014 (PAMA). Washington, DC: American Clinical Laboratory Association, 2017. Available at: www.acla.com/acla-letter-to-hhs-secretary-tom-price-about-implementation-of-the-medicare-clinical-laboratory-fee-schedule-clfs-reform-as-enacted-by-section-216-of-the-protecting-access-to-medicare-act-of-2014-p. Accessed September 20, 2017.
4. ACLA Writes CMS Administrator Verma, Urging Delay and Fix to PAMA. Washington, DC: American Clinical Laboratory Association, 2017. Available at: www.acla.com/acla-writes-cms-administrator-verma-urging-delay-and-fix-to-pama. Accessed September 20, 2017.
5. ACLA Thanks Chairman Blunt and Ranking Member Murray for Including PAMA Report Language in the FY2018 Labor-HHS Appropriations Bill. Washington, DC: American Clinical Laboratory Association, 2017. Available at: www.acla.com/acla-thanks-chairman-blunt-and-ranking-member-murray-for-including-pama-report-language-in-the-fy2018-labor-hhs-appropriations-bill. Accessed September 20, 2017.
6. Comments to CMS on the CY2018 Physician Fee Schedule Proposed Rule. Washington, DC: Association for Molecular Pathology, 2017. Available at: www.amp.org/publications_resources/position_statements_letters/documents/ampcomments-cy2018pfs-docketcms-2017-0092-final.pdf. Accessed September 21, 2107.
