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The CAP Files Amicus Brief in Support of ACLA Motion for Summary Judgement in PAMA Lawsuit

On February 21, the CAP filed an amicus curiae brief in support of a motion by the American Clinical Laboratory Association (ACLA) for summary judgement to set aside how the Department of Health and Human Services (HHS) implemented market-based reforms to clinical laboratory fees mandated by the Protecting Access to Medicare Act (PAMA) of 2014. The CAP has strongly supported ACLA’s lawsuit against the HHS and efforts to correct the administration’s execution of PAMA’s clinical laboratory payment reforms.

The CAP’s amicus brief states that the HHS definition of applicable laboratory contradicted the PAMA statute. For example, the HHS excluded the vast majority of hospital-based laboratories from its data collection process and calculation of supposedly market-based rates for clinical laboratory services for 2018. In 2017, hospital laboratories accounted for 48.2% of laboratory market share by test volume. However, a mere 1% of the reported test volume came from hospital laboratories when HHS set 2018 Medicare clinical laboratory fee schedule rates.

In PAMA, Congress had required HHS to collect comprehensive and accurate reimbursement data from all independent and hospital-based laboratories that receive most of their Medicare revenues from serving beneficiaries whom are not hospital inpatients or outpatients.

“The CAP submits this amicus brief to urge the court to require the secretary to consider the full range of laboratory pricing data, including from hospital laboratories, so that Medicare patients may maintain access to laboratory services that are vitally important to their diagnosis, treatment, and care,” the CAP said.

The amicus brief was filed in the U.S. District Court for the District of Columbia on February 21. Read the CAP’s full amicus brief.

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2018 QPP MIPS Reporting Provisions for Small Practices

In the 2018 Quality Payment Program (QPP) final regulation, the Centers for Medicare & Medicaid Services (CMS) outlined some provisions that accommodate small practices. These include the increased low-volume threshold, bonus points for small practices with 15 or fewer clinicians, and favorable scoring for small practices under the quality category of MIPS. Many current CAP members are in small practice settings and may be able to take advantage of these provisions for the 2018 reporting year.

Low-Volume Threshold


The CMS expanded the low-volume threshold that exempts some Medicare providers from having to report under MIPS.

Under an Arizona law enacted in 2016, pathologists are prohibited from ordering genetic tests on a patient specimen “without the specific written consent of the subject.” As reported in the January 30 edition of STATLINE, the CAP and ASP have long argued that because the definition of genetic test in the law is overly broad, pathologists were legally hindered from ordering or requiring the performance of genetic testing to diagnose a patient for optimal patient care.

In 2017, the CAP advocated for relief for small pathology practices. Therefore, the CMS increased the low-volume threshold to less than or equal to $90,000 in Medicare Part B allowed charges, or less than or equal to 200 Medicare Part B patients for 2018. According to the CMS numbers, this excludes an estimated additional 2,000 pathologists from MIPS in 2018. Subsequently, if your practice meets these requirements, you do not need to report on MIPS for 2018.

Additional Provisions for Small Practices


If your practice is eligible to report on MIPS and has 15 or fewer clinicians, the CMS will award five bonus points to a provider’s or group practice’s MIPS final scores.

Moreover, the CMS will award small practices three points for reporting on measures in the quality performance category regardless if they meet data completeness requirements. One point will be awarded to those eligible clinicians that are not in small practices.

If you have questions, please review the MIPS FAQs under CAP Resources.

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CAP Presents at FDA Self-Collection for Pap Test Workshop

On January 11, the Food and Drug Administration (FDA) held a Self-Collection Devices for Pap Test workshop where CAP Cytopathology Resource Committee Chair Christine Booth, MD, FCAP, represented the CAP as a panelist. The FDA workshop was a chance to review the feasibility, benefits, and risks of Pap testing self-collection.

The workshop was the first of many public discussions where panelists and participants evaluated the risks and benefits of self-collection of Pap testing, and its potential impact to the current standard of care. Other considerations such as proper use of the device to ensure patient safety, the collection of adequate samples for testing, and the use of these test results in patient care were discussed.

Despite the established standard of care for cervical cancer screening in the United States, gaps in cervical cancer screening exist, such as limited access to screenings in rural areas. As a result, cervical cancer incidence and death rate are still high in these communities. However, the role of self-sampling in overcoming these barriers is unclear. Dr. Booth discussed the validation of the self-collection of Pap testing and the regulatory considerations, especially on the current standard of care.

The CAP will continue to monitor the topic and will update in future issues of STATLINE.

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White House 2019 Budget Proposal Outlines Medicare Changes

President Donald Trump's 2019 budget recommendation to Congress called for several changes to the Medicare program, including achieving savings through accountable care organizations (ACOs).

The Trump administration released the 2019 fiscal year budget plan on February 12. Even though the President proposes the budget for the federal government, Congress controls spending and must pass appropriations funding legislation.

The 2019 presidential budget includes a number of proposals that eliminate excessive spending and distortionary payment incentives without harming beneficiaries' access to care or altering covered items and services. It refines reimbursement for uncompensated and post-acute care, reforms competitive bidding for durable medical equipment, and eliminates higher out-of-pocket costs and unnecessarily high payments for services delivered at off-campus, hospital-owned physician offices. In addition, the budget proposal would establish a new exception to the physician self-referral law for arrangements that arise due to participation in Advanced Alternative Payment Models. In addition, the budget proposes to establish a prior authorization program for high utilization practitioners of radiation therapy, therapy services, advanced imaging, and anatomic pathology services.

The ACO savings are to broaden the set of primary care providers to include nurse practitioners and physician assistants so that more patients could be moved to ACOs without limiting access to primary care. It also seeks to empower patients to work directly with providers in their ACO.

STATLINE will continue to report on the president's proposed budget and Congress's final appropriation legislation.

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Upcoming Webinar: Policy Meeting 101—What to Know Before You Go

Policy Meeting

Wednesday, April 4, 2018
1:00 PM ET/ Noon CT

If you are one of the many pathologists concerned about practice or patient care implications from emerging policies and regulations, join us in this 60 minute webinar to learn the most effective ways you can ensure your voice is heard in Washington on issues that matter to you.

Get the basics on how Congress works, why grassroots advocacy matters, and the unique advocacy resources and support the CAP provides for members. Gain insight on best practices and understand the difference you can make by engaging with your colleagues in protecting scope of practice and the quality of care for patients.

Already registered to attend this year’s Policy Meeting? This is a great webinar for CAP members who are attending the Policy Meeting, especially those attending for the first time, as you’ll gain a general understanding of grassroots advocacy before you arrive in Washington.

Whether you are DC bound or looking to get involved in your district, you’ll want to hear from experienced advocates Donald Karcher, MD, FCAP, Chair of the Committee of Government and Professional Affairs, Joe Saad, MD, FCAP, Federal and State Affairs Committee Chair, and moderator Michael Giuliani, CAP Advocacy Senior Director.

Register Today.

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