STATLINE

Read the Latest Issue of STATLINE

In This Issue:

• Pathologists Lobby for Medicare LCD Reform at 2016 CAP Policy Meeting
• From Seattle to DC: Advocating for Pathology, Patients
• Lawmakers Reintroduce Bill to Close Self-Referral Loophole
• FDA Finalizes Technical Performance Guidance for WSI
• Pathologists Have Until June 30 to Select PQRS Reporting Mechanism

During the final day of the 2016 CAP Policy Meeting, pathologists met with the offices of their elected officials and urged members of Congress to support legislation to increase transparency and accountability in the Medicare local coverage determination (LCD) process.

The CAP's Annual Hill Day included 77 pathologists attending at least 126 meetings with House and Senate offices. CAP members also dropped off information packets about LCD process reforms at several other congressional offices.

Since 2012, CAP members have participated in 708 meetings with congressional offices and achieved several victories. For example, physicians successfully advocated for the repeal of the sustainable growth rate (SGR) Medicare payment formula. CAP members also have successfully avoided Medicare payment penalties from the Electronic Health Record (EHR) Meaningful Use program after engaging with members of Congress at previous Policy Meetings and through the CAP's grassroots network PathNET.

At the 2016 Policy Meeting, CAP members cited problems in the current LCD development process and asked for Congress to institute several changes. Those changes are:

• Require open meetings: Make Medicare Administrative Contractor (MAC) carrier advisory committee meetings open, public, and on the record with published meeting minutes.
• Establish upfront disclosure: Require a MAC—at the outset of the process—to include a description of the evidence the MAC considered when drafting an LCD and rationale it is relying on to deny coverage.
• Create meaningful reconsideration and options for appeal: Codify a meaningful LCD reconsideration process that gives providers and suppliers the opportunity to have a qualified disinterested secondary review of a reconsideration denial.
• Stop the abuse of LCDs as a backdoor to national coverage determinations (NCDs): Prohibit the Centers for Medicare & Medicaid Services from appointing a single MAC that can make local determinations used on a nationwide basis.

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STATLINE regularly features the many CAP members who have been champions for pathology in Washington and at the state level through our grassroots and PAC programs. If you would like to get involved, you can join PathNET, contribute to PathPAC, or join your state pathology society.

Name: Eric Konnick, MD, MS, FCAP
Position: Associate Director – Genetics and Solid Tumor Laboratory
Department of Laboratory Medicine, University of Washington, Seattle, WA

What advice would you give to someone who wants to be involved in advocacy?

I advise our residents to start small, and I think that a similar approach works for most people. Donate to PathPAC and pay attention to the great resources that the College provides us, such as STATLINE. Many of the issues that are at the forefront are complicated and nuanced, and it will take time to feel comfortable with the topic, but by contributing even a small amount to PathPAC, you are more likely to be engaged in the proceedings. Although trying to support a family on a resident's salary in Seattle was tough, I was able to set aside a small amount each year to contribute to PathPAC, because I recognize that we need to support the legislators who support pathologists.

When action alerts come out via email, take a few minutes and respond! As your interest grows, attending the CAP Policy Meeting will take you to the next level. Spending a few days with your colleagues and national experts in subject areas will expand your understanding and your ability to communicate with your colleagues. For residents and juniors attending, carpooling to DC and/or sharing hotel rooms makes it an easier financial proposition and allows you get involved earlier in your career than might otherwise be possible.

Do you have a favorite memory or experience that stands out in your advocacy work?

My first visit to Capitol Hill with the CAP was a great experience. The last meeting of the day was with a staff member from the House Ways and Means Committee in a hallway that had been converted into an office. The other staffers I met with that day did not have a good grasp of pathology and laboratory medicine, but this staffer was much more informed and immediately started talking about nuanced aspects of laboratory-developed tests (LDTs) and FDA-approved methods. For the next 30 minutes, we had an interesting discussion, and I was able to correct some of the misconceptions this staff person had regarding LDTs and pathology. The staff person also commented that they appreciated my perspective as a physician caring for patients, which was different from the information presented by industry lobbyists.

What do you find most rewarding and/or most challenging about being an advocate for pathology?

The most challenging thing is that at times it can be discouraging when policy or legislative efforts don't move as fast or in the vector I would like. At those times, I try to remember that advocacy is a long-term process that needs an investment of time, effort, and money in order to influence the outcome.

I also try to keep my patients at the center of my efforts. The reason I decided to become a physician was to care for patients and improve their health through the best and most appropriate diagnostic and therapeutic interventions, and advocacy is an extension of those ideals. There are many competing voices trying to influence government and regulatory agencies that hold views that are contrary to good patient care and the practice of pathology. I believe that we need to participate in the process to help obtain outcomes that enable pathologists to continue to practice medicine and protect patient access to pathology and laboratory services.

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Legislation to eliminate loopholes in the in-office ancillary services exception (IOASE) to the Stark Law was reintroduced on April 28 in the House of Representatives. The legislation would prevent physicians from referring patients for anatomic pathology (AP) and other services when they have an ownership interest in those services.

The Promoting Integrity in Medicare Act (PIMA) was introduced by Rep. Jackie Speier (D-CA) along with Reps. Jim McDermott (D-WA), ranking member of the House Ways & Means Subcommittee on Health, and Dina Titus (D-NV). The Congressional Budget Office estimated that closing the loophole would save Medicare $3.3 billion over 10 years.

The PIMA bill continues to face strong opposition from many members in Congress, including the GOP Doctors Caucus consisting of Republican physician and health professional members of Congress. Legislation also has been vigorously opposed by physician and medical specialty groups.

Several studies in recent years have shown that the IOAS exception increases utilization of AP that costs Medicare millions of dollars each year. A 2014 report by the Government Accountability Office (GAO) found that in 2010 self-referring providers likely referred nearly one million more unnecessary anatomic pathology (AP) services than non-self-referring providers, costing Medicare approximately $69 million. An April 2012 study published in Health Affairs had similar findings.

For several years, the Obama Administration has recommended closing the loophole as part of its annual budget submitted to Congress. The administration projects an estimated savings of nearly $5 billion over ten years. At a time when Medicare costs and premiums continue to rise, this kind of cost savings is substantial, Rep. Speier said.

The CAP has long advocated for closing the self-referral loophole and in January sent a letter to congressional leaders urging them to eliminate the exception to the Stark Law. The IOAS exception is intended to allow simple ancillary services, such as blood tests or urinalyses, deemed necessary by a clinician to help inform the diagnosis and treatment of a patient during an office visit. However, the CAP is concerned with potential abuses by physicians, who self-refer AP services when they have a financial incentive to do so.

The Alliance of Integrity in Medicare (AIM), of which the CAP is a member, applauded Rep. Speier and her colleagues for introduction of PIMA, which is designed to address ongoing self-referrals practices in advanced diagnostic imaging, anatomic pathology, physical therapy and radiation therapy. "By removing these four services from the in-office ancillary services exception under the Medicare self-referral law, your legislation will realign provider incentives, which is in the best interest of Medicare beneficiaries, taxpayers, and the American health care system overall," AIM wrote in an April 27 letter.

The AIM coalition also consists of American Clinical Laboratory Association, American Physical Therapy Association, American Society for Clinical Pathology, American Society for Radiation Oncology, Association for Quality Imaging, and Radiology Business Management Association. The American College of Radiology recently withdrew from the coalition.

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The Food and Drug Administration (FDA) finalized guidance providing direction to manufacturers on how manufacturers should characterize their whole slide imaging (WSI) systems for clinical use on April 20.

Currently, no devices have been approved by the FDA for primary diagnosis. The CAP has engaged with the FDA on WSI to provide testimony and official comments for several years. The CAP continues to monitor and engage the FDA on WSI technology and will keep CAP members informed on new developments.

As a Class 3 device under current FDA rules, scanners cannot be marketed as devices for making primary diagnoses. The final guidance made a few changes from the initial proposed guidance released in February 2015. In May 2015, the CAP submitted written comments to the FDA and commended the agency's approach that focused on the technical performance aspects of WSI. A WSI system should not, and cannot be expected to, be validated separately for every diagnostic entity as a test measure, the CAP said.

The final guidance made changes to the light source and the response times needed to be recorded. The full guidance document can be viewed on the FDA's website.

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Pathologists and other eligible professionals (EPs) may now log on to Medicare's Physician Value-Physician Quality Reporting System (PV-PQRS) Registration System to select a Group Reporting Option (GPRO). Groups of two or more EPs can avoid the -2% 2018 PQRS payment adjustment by meeting satisfactory reporting criteria under GPRO.

The PV-PQRS Registration System will be open through June 30 for groups to select a GRPO reporting mechanism. Among the options the reporting mechanisms that EPs can select:

• Qualified PQRS Registry
• Electronic Health Record (EHR) via Direct EHR using certified EHR technology (CEHRT) or CEHRT via Data Submission Vendor
• Web Interface (for groups with 25 or more EPs only)
• Qualified Clinical Data Registry (QCDR)
• Consumer Assessment of Health Providers and Systems (CAHPS) for PQRS Survey via a survey vendor certified by the Centers for Medicare and Medicaid Services (as a supplement to another GPRO reporting mechanism)

EPs can register at the CMS' website. For additional assistance, providers may wish to access the CMS' registration guide. Providers may also access the PQRS Payment Adjustment Information webpage and CAHPS for PQRS Made Simple.

Avoiding the 2018 PQRS payment adjustment by satisfactorily reporting via a PQRS GPRO is one of the ways groups can avoid the automatic downward payment adjustment under the Value-Base Modifier (-2% or -4% depending on the size and composition of the group) and qualify for adjustments based on performance in 2018.

Alternatively, groups that choose not to report via the PQRS GPRO in 2016 must ensure that eligible professionals in the group participate in the PQRS as individuals in 2016 and that at least 50% of the EPs meet the criteria to avoid the CY 2018 PQRS payment adjustment.

Avoid PQRS Payment Penalties

Pathologists may access the CAP's online tool to determine how your practice can participate in the 2016 PQRS and learn about Medicare reimbursement penalties under the VBM program. While the CMS has stated that the penalties will not apply for pathologists who have no applicable PQRS measures, the agency plans to review claims to check that none of the measures applied.

To use the CAP PQRS/VBM tool, you select choices on how to participate in the PQRS. Answer selections will depend on the size and type of your practice. The tool will help guide your decisions to determine eligibility and includes a frequently asked questions section at the end.

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