STATLINE

Read the Latest Issue of STATLINE

In This Issue:

• CAP Members Urge Senate to Pass SGR Repeal Bill
• Dispute Process for Open Payments Data Underway
• CAP Opposes UnitedHealthcare's FL Program Set to Go Live April 15
• AZ Governor Signs Bill Allowing Patients to Order Any Laboratory Test
• Legislation Fixes New Mexico Law on Genetic Testing
• CAP Urges Patent Office to Protect Scientific, Medical Advancement
• Lab Week 2015: CAP Reinforces Connection to Patients, Each Other

The CAP continues to call on members of the Senate to pass legislation that repeals the Medicare sustainable growth rate (SGR) payment formula and ensures pathologists can fully and fairly participate in a new pay system.

The Senate returned to Washington on April 13. Over a two week recess, the CAP engaged with Senate lawmakers to pass the Medicare Access and CHIP Reauthorization Act (HR 2). Pathologists responded to a CAP Action Alert and asked their Senators to support HR 2. The Senate is expected to take up the legislation over the next couple days.

The Centers for Medicare & Medicaid Services (CMS) has taken steps to limit the impact of the 21% SGR cut to Medicare payments. Since April 1, the Medicare agency has held claims for physician services to avoid paying fees with the 21% reduction. The CMS stated it would continue to hold claims until April 15, when the agency then would begin "paying at the reduced rate, based on the negative update, on a first-in, first-out basis, while continuing to hold new claims as they are received."

The CAP secured language in the bill that would give pathologists flexibility to achieve requirements in Medicare quality initiatives. HR 2 provides flexibility and alternative mechanisms to physicians for meeting quality requirements in the Medicare program. The legislation would tie future payment updates to a physician's performance on a combination of current quality programs, as well as a new performance category.

These performance programs are typically geared to office-based physicians, making it difficult for pathologists to comply. The CAP-supported provision allows the Secretary of Health and Human Services (HHS) to use alternative measures and activities under the new program for physicians that don’t have direct interaction with patients.

HR 2 does not include closing the In-Office Ancillary Services (IOAS) exemption as a "pay for" in the SGR package. However, the CAP continues to seek opportunities to engage Congress to close the IOAS exception.

CAP members can continue to visit the CAP Action Center and ask your Senators to support HR 2.

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Physicians and teaching hospitals can now review and dispute inaccurate data on 2014 payments or other transfers of value from drug and device manufacturers that will be available to the public later this year.

The CMS' Open Payments program requires manufacturers and group purchasing organizations to report certain payments and transfers of value to physicians, teaching hospitals, and any ownership or investment interest physicians, or their immediate family members, have in a company. These transfers of value include travel expenses, meals, entertainment, gifts, text books, journal reprints, and participation on a paid advisory board.

The data review and dispute process began on April 6. A CMS reference guide provides an overview on how physicians can participate in the process that lasts only 45 days. The information will be published on June 30.

"After the review and dispute period officially ends, physicians and teaching hospitals can continue to register and initiate disputes, but resolutions will not be publicly displayed until the next reporting cycle," the CMS states.

The CMS also notes that physicians and teaching hospitals who registered last year to review reported data do not need to register again in the CMS Enterprise Portal or the Open Payments system. However, the CMS Enterprise Portal locks accounts when there is no activity for 60 days or more and deactivates accounts if there is no activity for 180 days or more. To unlock an account, go to the Enterprise Portal, enter your user ID, correctly answer all challenge questions, and reset your password.

To reinstate an account, contact the Open Payments Help Desk at OpenPayments@cms.hhs.gov. Live Help Desk support also is available by calling 1-855-326-8366.

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Despite repeated calls to delay UnitedHealthcare's laboratory benefit management system in Florida, the insurer appears to be moving forward with full implementation of the pilot program on April 15.

The CAP engaged with UnitedHealthcare and continues to oppose the pilot program in Florida because it will negatively affect patient access to services, delay results, and create inconsistencies with current clinical practice, professional judgment, and laboratory operations. UnitedHealthcare had planned to launch the pilot in October 2014, but it delayed enforcement of the program's requirements following requests by the CAP, the Florida Society of pathologists (FSP), and other medical associations representing ordering physicians.

Once fully implemented on April 15, UnitedHealthcare will deny laboratories payment for services when ordering physicians do not comply with the pilot's requirements.

The CAP engaged with UnitedHealthcare and expressed pathologists' deep concerns with the pilot, which requires use of Beacon Laboratory Benefit Solutions (BeaconLBS). The pilot program will affect 79 laboratory services ordered by Florida network providers for patients covered by most fully insured UnitedHealthcare commercial members in the state.

In addition to claims denials to laboratories scheduled to begin April 15, fundamental flaws in the pilot's second review requirements are extremely concerning to CAP members. Under standard practice, pathologists make decisions on a daily basis based on their professional judgment and training when to seek secondary reviews and who should provide them, based upon the patient's actual specimen, rather than as dictated by the insurance company.

The CAP strongly objects to the pilot's interference with medical judgment and new administrative burdens created by UnitedHealthcare. Despite full implementation, the CAP will continue to advocate with UnitedHealthcare on behalf of pathologists and keep members advised of news developments on this issue through STATLINE.

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Legislation to give Arizona patients the right to order any laboratory test of their choosing without a physician's request or written authorization has been signed into law. In February, the original bill was amended by the CAP and the Arizona Society of Pathologists (ASP) to make clear that the laboratory ultimately decides which tests, if any, patients may order.

The new law, signed by Gov. Doug Ducey on April 6, takes effect on July 3.

On February 19, with the support of the CAP and ASP, the bill was amended on the state House floor to provide certain protections for pathologists. On February 16, ASP President Richard Trepeta, MD, FCAP, had requested several amendments to the original bill. Specifically, the House floor amendments addressed potential pathologist liability concerns.

A health care provider would not be subject to liability or disciplinary actions for the failure to review or act on results of a laboratory test when the provider did not request or authorize the test. Test reports must state in bold type that the patient who was tested should arrange for a consultation and interpretation of the test results.

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New Mexico Gov. Susana Martinez has signed legislation to correct defects in state law limiting access to genetic testing.

The "Informed Consent for Genetic Testing" bill (HB 369) will remedy state statute by specifically allowing laboratories to conduct genetic testing and retain DNA samples upon the orders of a health care practitioner. Prior law disallowed such actions without the patient's specific informed consent. The change would be consistent with CAP policy and has the support of the New Mexico Society of Pathologists (NMSP).

"Genetic testing has become an integral part of patient care, particularly in the diagnosis and treatment of cancer," wrote NMSP President Michael J. Crossey, MD, PhD, FCAP in a March 30 letter to Gov. Martinez. "The requirement that laboratories obtain a separate informed consent for medically necessary genetic testing is often burdensome to the laboratory and confusing to the patient given there is written order from their healthcare provider. The requirement can result in delays in diagnosis and treatment."

Gov. Martinez signed the bill into law on April 10 after passing 60-0 in the state House on March 7 and 40-0 in the Senate on March 20.

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The United States Patent & Trademark Office (USPTO) must ensure patents do not interfere with medical advancement and innovation as the agency moves to implement new guidance following the recent landmark Supreme Court case that invalidated gene patents.

The USPTO recently enlisted feedback on its 2014 Interim Guidance on Subject Matter Eligibility. The CAP, along with the Association of Molecular Pathology (AMP) and other organizations, made several written recommendations to the USPTO on March 16. The USPTO must ensure it not issue patents on products of nature, laws of nature, or abstract ideas, because such patents interfere with scientific and medical advancement, the groups stated.

The CAP was a co-plaintiff in the 2013 case Association of Molecular Pathology (AMP) et al, vs Myriad Genetics, Inc., in which the court reached a unanimous decision to invalidate the patents at issue held by Myriad Genetics on BRCA1 and BRCA2 genes. By invalidating Myriad's claims to human genes, as well as all naturally occurring mutations of the genes, the court opened the door for other companies and researchers to create their own tests and conduct their own research on the genes. Patient groups and medical groups had voiced concern that the patents stifled innovation, while the high cost of the tests made it difficult for many women to benefit from the tests that already exist.

Limiting gene-sequence based test services to a single provider is not in the public interest. That's a primary reason why the CAP joined the suit as a plaintiff in the Myriad case. Gene patents prevent physicians and clinical laboratories from providing gene-based diagnostic services, limit access to medical care, jeopardize its quality, and raise its cost, according to CAP policy.

In the letter, the groups underscored the need for effective guidance.

"Since the Myriad decision, we have seen how the lifting of patents on products of nature benefits the public," the letter said. "Many more laboratories now offer genetic testing of the BRCA1 and BRCA2 genes, often in combination with testing other genes connected to cancer risk and at lower cost. This has provided more options to patients and clinicians. In addition, with the diversity of laboratories now offering testing, Myriad can no longer control all data regarding the BRCA1 and BRCA2 genes."

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The CAP will celebrate Medical Laboratory Professionals Week, April 19-25, offering tools and ideas to help you recognize and thank your team, and each other, for contributions to the patient care team while rigorously safeguarding the quality of laboratory medicine.

In a video address, CAP President Gene N. Herbek, MD, FCAP thanks pathologists and medical laboratory professionals for the invaluable work that ensures improved patient care.

The CAP's Tools and Suggestions for Promoting Lab Week offer simple steps to celebrate and share our important work with laboratory and hospital colleagues as well as the community.

New to this year's Lab Week celebration, the CAP would like pathologists and laboratory professionals to share their connections to patients with a video. Video submission details are outlined on cap.org.

As with previous Lab Week celebrations, the CAP is providing an easy way to express gratitude and show appreciation to all laboratory team members via the CAP's eCard Center. It provides the cards and delivery/email service.

As part of Lab Week, the CAP and the American Hospital Association's (AHA) Health Forum are hosting a webinar "Pathologists and the Laboratory: Reaping the Value of Team-based Care" on Tuesday, April 21 at 2:00 PM ET.

Discussion will focus on diagnostic protocols and guidelines that pathologists and oncologists developed collaboratively to improve the effectiveness of laboratory, diagnostic, and treatment decisions. Also highlighted will be the Cleveland Clinic's $2 million in cost avoidance, the result of a pathologist led multidisciplinary test utilization task force.

The featured speakers are Elizabeth Hammond, MD, FCAP, Intermountain Healthcare, and Gary Procop, MD, FCAP, The Cleveland Clinic. AHA's Bob Kehoe, assisting managing editor, Hospitals and Health Networks, will moderate. The event is free and open to all, but registration is required.

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