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The CAP advocated for the Centers for Medicare and Medicaid Services (CMS) to revise its proposed inpatient payment system regulation that, if finalized, would make hospital standard charges public, increase emphasis on interoperability of health information technology, ensure consistent payment rates for CAR-T cell therapy settings, and further extend its “14-day rule” policy to allow laboratories to directly bill for molecular pathology tests and advanced diagnostic laboratory tests (ADLTs) regardless of the place of service. In a June 25 letter to the CMS, the CAP asks the agency to consider the “pathologist’s diagnosis and value is recognized throughout the [patient] care continuum” when considering changes to the proposed regulation.

Require Hospitals to Publish Standard Care Charges

Within the proposed regulation, the CMS mentioned its concern over challenges for patients due to insufficient price transparency. These challenges include patients being surprised by out-of-network bills for physicians who provide services at in-network hospitals. In general, out-of-network billing occurs in situations wherein patients cannot access in-network physicians in the private insurance market.

The CAP urged the CMS to assess whether health plan networks with in-network hospitals have actually contracted with facility and hospital-based physician specialties at that hospital. The CAP recommended that the CMS not require health care providers to inform patients of expected out-of-pocket costs for a service before patients receive that service since a delay may impact the patient’s care.

Promoting Interoperability

In the proposed rule, the CMS acknowledged the importance of interoperability and health information exchange by changing the name of the Advancing Care Information performance category of the Merit-Based Incentive Payment System (MIPS) to the Promoting Interoperability (PI), which now aligns with a similar program under the Medicare and Medicaid program.

For MIPS, most pathologists as non-patient-facing clinicians are not required to participate in the PI category. This reflects pathologists’ inability to attest to or report on many of the PI measures as these require face-to-face interaction with patients. While the CAP appreciated the recognition of the non-applicability of the PI category to pathologists by the CMS, the CAP is exploring alternatives for pathologists to engage. In its comment letter, the CAP supported a possible solution to allow hospital-based eligible clinicians such as pathologists to earn points in the PI category of MIPS through their hospital’s participation in the PI program. Laboratory testing and pathology diagnostic information are without question a key influence on health care decision making. Thus, allowing a pathway for hospital-based pathologists to earn points for supporting hospitals that meet PI program requirements would recognize the important role pathologists play in diagnosis and management of patient health care. The CAP also encouraged the CMS to consider alternate and more appropriate measures for non-hospital based pathologists.

Ensure Appropriate Care Setting Payment for Chimeric Antigen Receptor (CAR) T-Cell Therapy

Chimeric Antigen Receptor (CAR) T-Cell therapy is an evolving service that is high in cost, and has the potential for volume increases over time that present unique challenges for providers, patients, and the CMS. CAR T-Cell therapy is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells.

The CAP encourages that the CMS achieve a payment structure that allows physicians to utilize what they feel is the best product for each patient, in the most appropriate care setting. The CAP seeks solutions that:

  • Create a site-neutral, product-agnostic payment structure
  • Remove provider responsibility for managing product costs
  • Minimize/remove financial losses for providing CAR-T
  • Create flexibility for future products and combination therapies
  • Minimize reimbursement disruption for other cellular therapies/HCT

The CAP recommended that CMS revise MS-DRG 016 to include CAR-T therapy and pay the average sales price for the drugs in the inpatient setting. Moreover, the CMS should leave payment methodologies for these services open for further comment and revision as they, technologically and procedurally, will likely evolve from their current form. This recommendation ensures the application of a consistent payment rate across CAR-T centers.

Expand Medicare 14-day rule

The CAP asked the CMS to expand its current Medicare Part B Laboratory Date of Service (DOS) Policy, known as the 14-day rule, to include services provided in the inpatient setting to allow laboratories to bill Medicare directly for molecular pathology tests and ADLTs.

Despite 2018 revisions to improve the 14-day rule laboratory DOS billing policy in the hospital outpatient setting starting this year, these changes did not address tests performed on hospital inpatients and obtaining payment for some laboratory tests remains problematic. The CAP also urged the CMS in a MARCH 21 LETTER to expand the exclusions from the HOPPS packaging policy to include fluorescence in situ hybridization (FISH) technical component services in outpatient and inpatient hospital settings. Excluding FISH from packaging policy would allow for the direct billing of these tests provided at hospitals.

The CMS recognized that molecular pathology tests and ADLTs have unique clinical utilization distinct from conventional laboratory tests. As molecular technologies continue to advance, the CAP believes their utility will continue to differ significantly. The CAP supports the direct billing of molecular pathology tests, ADLTs and FISH on tissue samples acquired from patients during inpatient and outpatient visits as they are critically important for determining follow-up treatment plans and responsible patient care.

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CAP members and leaders continue to urge their elected officials to support legislation to increase transparency and accountability in the Medicare Local Coverage Determination (LCD) process. The LCD bill gained more sponsors in the House and Senate with a total of 64 members of the House and 18 senators, including Sen. John Kennedy (R-LA) who recently signed on as a co-sponsor.

CAP President R. Bruce Williams, MD, FCAP worked to secure both Sen. John Kennedy and Sen. Bill Cassidy, MD (R-LA) as co-sponsors to the LCD bill during the 2018 Policy Meeting’s Hill Day.

Other CAP members also helped secure support from Reps. Kathleen Rice (D-NY), Kevin Cramer (R-ND), Joseph Kennedy (D-MA), and Brad Wenstrup (R-OH), as four additional co-sponsors of the LCD from the House. They join 60 of their colleagues in support of more transparency in the LCD process.

If enacted the legislation would pave the way for much-needed LCD reform. For example, the legislation includes improvements to the LCD process that ensure that medical evidence is not used selectively to deny appropriate coverage to Medicare beneficiaries.

More updates on this issue will be published in future issues of STATLINE.

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The CMS recently issued a request for information on how the physician self-referral law, or Stark law, hinders care coordination and participation in alternative payment (APM) and care delivery models. The CAP is reviewing the request and will submit comments to the CMS before an August 24 deadline.

The Stark law prohibits Medicare providers from making referrals for designated health services payable by Medicare to an entity with which they, or immediate family members, have a financial relationship. Previously, the CAP has urged caution in changing or reforming the Stark law in such a way that would result in unintended consequences on physician self-referrals and increased utilization. The CAP has long advocated for closing the self-referral loophole and passing other laws or regulations that protect your ability to provide high-quality services in a fair competitive environment, by requiring direct billing of pathology services or prohibiting markups of services.

While the CAP supports efforts to move providers into coordinated care models, pathologists are concerned that some changes to the current Stark law could further incentivize providers to over-utilize services in self-referring arrangements; or create new opportunities for abusive self-referral arrangements to develop that over-utilize services as provider’s transition into new payment models.

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The CAP learned that the CMS will no longer send letters out to physicians regarding their eligibility status. Therefore checking the QPP Participation Lookup Tool (or logging in using an EIDM account for group practices) is the only way to confirm eligibility status for participation in the CMS Quality Payment Program.

The CMS updated its online lookup tool that enables clinicians to check their eligibility to participate in MIPS or if they are a Qualifying APM participant for 2018. Previously, clinicians had to check their MIPS eligibility and APM status separately keeping in mind that the APM status took precedence over their MIPS eligibility. With the new Quality Payment Program (QPP) look-up tool, clinicians can enter their National Provider Identifier (NPI) to find out both at the same time if they need to participate in MIPS in 2018 and if they are reporting as an APM or an eligible MIPS participant clinician.

Moreover, physicians can also check 2018 MIPS clinician eligibility at the group level and APM Predictive qualifying physician status at the APM entity level. In order to determine group eligibility, clinicians need their Enterprise Identity Data Management (EIDM) and Taxpayer Identification Number (TIN) credentials. Here are the steps to use the tool:

  • Log into the QPP website with your EIDM credentials
  • Browse to the TIN affiliated with your group
  • Access the details screen to view the eligibility status of every clinician based on their NPI
  • Download the list of all NPIs associated with your TIN, including eligibility information for each NPI

Please keep in mind that even if you might not be eligible for QPP as an individual, you may be a part of an eligible group that can report as a group, and thus participating in QPP.

Don’t have an EIDM account? Refer to the EIDM User Guide for instructions.

You can also use the QPP Participation Lookup Tool to find out whether individual clinicians are eligible for the 2018 performance year without needing to login to the feature.

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The CMS updated the Explore Measures section, including MIPS quality measures and improvement activities (IAs), of the QPP website for the 2018 MIPS performance period.

The CAP has customized a list of pathology-specific measures from the CMS Quality measures. These pathology-specific measures allow pathologists to earn reimbursement incentives from Medicare payers. The CMS website only includes the CAP’s QPP measures but the CAP has developed additional quality measures that are only available in the Pathologists Quality Registry.

Through the development of quality measures by the CAP for the CMS, pathologists avoid Medicare payment penalties and earn bonuses when reported correctly. In 2016, for example, pathologists faced a combined $30.9 million in penalties from Medicare's quality programs if measures were not successfully reported.

The Explore Measures tool is for informational purposes only; it cannot be used to submit or attest to measures and activities. For more information on MIPS measures and activities, visit the 2018 Resources webpage.

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The Massachusetts House of Representatives accepted several amendments to the recently passed out-of-network services legislation that establishes a payment formula for the services. The amendments help to enhance payment and transparency for these services and were crafted by the Massachusetts Medical Society with the full support of the Massachusetts Society of Pathologists (MSP) and CAP.

The bill will now go to a conference committee for the next several weeks to address this and other issues, including the CAP and MSP’s concern that any proposed legislation must include a provision to require payers to identify federally regulated ERISA plans since such plans cannot be subject to the requirements of the proposed legislation.

To support the amendments, the CAP activated its grassroots network PathNET and worked with MSP to encourage pathologists to contact their legislators. Through PathNET, pathologists can build relationships with their legislators and assist the CAP in achieving our legislative goals. A total of 23 individuals contacted legislators about the bill.

The initial bill would have required out-of-network payment to be set at 115% of the average in-network rate or 125% of Medicare, whichever is greater. Under the adopted amendments, the Commissioner of Insurance is given direction and authority to exclude certain data sets from the “average rate” calculation, “including the exclusion of public payer claims, and by excluding other claims which do not accurately reflect the valuation of provider services for commercial carrier plans.”

Furthermore, rather than being plan specific, the average rate calculation now keys to services “performed by a health care provider in the same or similar specialty and provided in Massachusetts.” Such language promotes the use of an independent, aggregated, and transparent database for determining the payment calculation as the physician community had urged. In addition, prior written estimates required to be furnished to patients have been clarified to be only upon “initial encounter with the patient” and “when care is scheduled.” The final bill also deleted draconian penalty provisions that were based on consumer protection provisions against improper business practices and could also have resulted in the loss of a physician’s license.

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July 11, 2018
1 pm ET/ 12 pm CT

Register today.

In the coming weeks, the CMS will issue its proposed updates to the 2019 Medicare Physician Fee Schedule and the Quality Payment Program regulations, including the Merit-based Incentive Payment System (MIPS).

Regulation changes will impact payment for services and pathologists’ participation in MIPS. Throughout this 60-minute panel discussion, CAP experts will review the proposed changes to the fee schedule and MIPS. The webinar will begin at 1 PM ET on July 11. The CMS will finalize the 2019 Physician Fee Schedule and Quality Payment Program regulations during the fall of 2018.

Presenters are:

Donald Karcher, MD, FCAP

Donald S. Karcher, MD, FCAP
Chair of the Council on Government and Professional Affairs

Emily E. Volk, MD, FCAP

Emily E. Volk, MD, FCAP
Vice-Chair of the Council on Government and Professional Affairs
Chair of the CAP Clinical Data Registry Ad-Hoc Committee

W. Stephen Black-Schaffer MD, FCAP

W. Stephen Black-Schaffer MD, FCAP
Chair of the CAP Economic Affairs Committee

Learn and understand the practice and financial implications that these Medicare program changes will have on pathologists in 2019. Register Today.

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