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CAP Home > CAP Advocacy > STATLINE – CAP’s Biweekly Federal and State Advocacy E-Newsletter
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  STATLINE — CAP’s Biweekly Federal and
  State Advocacy E–Newsletter

July 17, 2014  •  Volume 30, Number 15
Next Issue: July 31, 2014
© 2014 College of American Pathologists

In This Issue:

Pathologists Receive Support for Relief from EHR Penalties

The CAP gained the bipartisan support of 89 House lawmakers who signed a letter calling on the Centers for Medicare & Medicaid Services (CMS) to prevent future Medicare payment cuts to pathologists from the electronic health record (EHR) meaningful use (MU) program.

The CAP has worked with the CMS to exempt pathologists from the MU penalty in 2015, but the Medicare agency has not indicated if it will extend the hardship exception to pathologists in subsequent years when the penalty stands to lower Medicare part B payments by 2% in 2016 and 3% in 2017. Further, the CMS has stated that pathologists and other physicians should not expect relief from future penalties.

Lawmakers sent the letter to the CMS on July 10.

“The EHR meaningful use program overlooks the unique circumstances of pathology practice,” said CAP President Gene N. Herbek, MD, FCAP. “Pathologists use sophisticated computerized laboratory systems (LISs) to support the work of analyzing patient specimens and generating test results. These LISs exchange laboratory and pathology data with EHRs. CMS has recognized this difference by exempting pathologists from the 2015 MU penalty. The letter urges CMS to grant all eligible pathologists the significant hardship exception from meaningful use incentives and penalties for the full five years allowed under current law.”

Rep. Tom Price (R-GA) and Rep. Ron Kind (D-WI) led the bipartisan effort to gather signatures on the letter to CMS Administrator Marilyn Tavenner. A similar letter is now circulating in the Senate, and CAP members can use the College’s PathNET grassroots tool to email their senators and encourage them to sign the letter.

The CAP also supports the Health Information Technology Reform Act (HR 1309) introduced by Reps. Price and Kind, which would remove pathologists from the class of providers eligible for incentives or penalties.

In addition, bipartisan and bicameral legislation to repeal and reform Medicare’s broken sustainable growth rate (SGR) payment formula includes language offering pathologists greater flexibility to meet current requirements in MU and other Medicare quality programs.

CAP Addresses CLFS and NGS Payment, PAMA Policy Reforms with CMS

At a July 14 meeting with Medicare officials, the CAP provided recommendations for several new CPT codes for consideration in the 2015 Medicare clinical laboratory fee schedule (CLFS).

Following the meeting, the CAP further engaged with the CMS and advocated for the careful implementation of new CLFS provisions created by recent Medicare legislation. These provisions must be applied in a way that ensures patient access to testing and minimizes administrative burdens, the CAP said.

College Calls for Crosswalk Methodology

Regarding the CLFS, the CAP has remained concerned with the transparency issues associated with the 2013 gap-fill process for the molecular pathology codes, said Michael McEachin, MD, FCAP. Dr. McEachin serves as chair of the CAP Economic Affairs Committee’s CPT-RUC Subcommittee and spoke at the CMS’ annual CLFS public meeting on behalf of the CAP. Medicare administrative contractor pricing adds unnecessary administrative complexities and unnecessary costs to providers and beneficiaries, he said.

“As a result, we believe that crosswalk methodology should be used to determine the 2015 clinical laboratory fee schedule payment for the new Category I molecular pathology Tier 1 codes and the new codes for genomic sequencing procedures and other molecular multianalyte assays,” Dr. McEachin said.

The CMS’ annual CLFS meeting allows stakeholders to request that the CMS either crosswalk payment rates of new tests to existing services, or utilize the gap-filling process which requires Medicare contractors to develop payment rates for CLFS services.

New codes for genomic sequencing and other molecular multianalyte assays were developed through the efforts of the American Medical Association Current Procedural Terminology (AMA CPT) Next Gen Sequencing Workgroup. The CAP subsequently worked in conjunction with the Association for Molecular Pathology to develop the recommended methodology for crosswalks for these new codes, Dr. McEachin said.

The CAP submitted crosswalk recommendations for new CLFS codes. The CMS will post its preliminary payment rate determinations on its website in early September.

CAP Recommendations on PAMA Provisions

The Medicare agency also held a public session to gather comments on provisions in the Protecting Access to Medicare Act (PAMA) of 2014. PAMA, signed into law on April 1, prevented drastic sustainable growth rate cuts to all Medicare payments, but also included a section titled “Improving Policies for Clinical Diagnostic Laboratory Tests” that reforms the CLFS. The meeting was the first official opportunity for stakeholders to provide input on these diagnostic laboratory provisions to the CMS.

CAP Economic Affairs Committee Chair Jonathan L. Myles, MD, FCAP, presented on the College’s behalf at the meeting. Dr. Myles’ comments highlighted recommendations in a June 2 letter the CAP sent the CMS regarding challenges in implementing the clinical diagnostic laboratory test section.

Under the new CLFS reforms, starting January 1, 2017, payment rates for clinical laboratory tests will be based on the weighted median pay for services from private payers. The CMS will collect data on private payer rates from laboratories starting January 1, 2016.

The CMS should carefully implement any exceptions to the reporting requirements, Dr. Myles said. For instance, the CMS should array the data submitted by laboratories to identify low-volume or low-expenditure threshold that will minimize the reporting burden for very small laboratories. Any potential threshold should not significantly change the weighted median payment rate that results from the mandated data collection, Dr. Myles said. New payment rates on the CLFS would be reflective to the greatest extent possible of the full range of laboratories providing the test.

Illinois To Strengthen ACOs With Laboratory Boards

In a win for Illinois patients and pathologists practicing in the state, CAP-model legislation that boosts the role pathologists have in accountable care organizations (ACOs) is now law.

Illinois Gov. Pat Quinn signed the ACO bill on July 16. The state becomes the second in the nation to enact the CAP’s model bill that provides pathologists with a greater role in improving patient care, improving quality, and lowering overall costs in ACOs. Similar legislation is currently pending in New Jersey and California. The CAP has strongly advocated for this legislation, while working with state pathology societies to gain the support of other physician and patient advocacy organizations.

The new law will help ensure that patients enrolled in ACOs receive all medically necessary testing and that physician directors of clinical laboratories have a requisite organizational means for providing input into pathology and laboratory service utilization.

The ACO legislation (HB 2544) effectively promotes the pathologist role in ACOs by requiring these entities to establish clinical laboratory advisory boards. For instance, these boards, with pathologist input, can advise ACOs on protocols or algorithms for clinical laboratory and pathology testing. The new Illinois law exempts hospital affiliated ACOs from the requirement.

The legislation, which passed the legislature unanimously, is endorsed by several prominent national patient advocacy groups: The Leukemia and Lymphoma Society, the Lung Cancer Alliance, the American Society for Breast Disease, and the National Brain Tumor Society.

The legislation also was supported by physician-led organizations: the Association of Pathology Chairs, the Association for Molecular Pathology, and the Illinois State Medical Society. The law takes effect January 1, 2015.

In 2012, Massachusetts enacted an abridged version of the model that ensured ACOs are evaluated by the state for clinical integration of the CLIA medical director.

UnitedHealthcare To Launch Decision Support Pilot Program in FL

The CAP is engaging with UnitedHealthcare regarding the College’s concerns with implementation of the insurer’s Florida pilot program that requires ordering and rendering physicians to use decision support designated for certain laboratory services.

The Laboratory Benefits Management Program pilot applies to laboratory services ordered by a Florida participating provider for UnitedHealthcare’s fully insured commercial enrollees who live in the state. As part of the program, ordering and rendering providers will be required to use Beacon Laboratory Benefits Solutions (Beacon) Physician Decision Support. Beacon is a subsidiary of Labcorp. Those who do not use Beacon within 90 days after the effective date may be subject to a lower fee schedule or termination according to a UnitedHealthcare communication.

The program also requires prior authorization for BRCA1 and BRCA2 testing and advance notification for roughly another 80 tests including some molecular, surgical pathology, cytology and other services. Physician offices and laboratories are to distinguish which UnitedHealthcare enrollees are in the program through an identifier located on insurer’s patient identification cards.

While the intent of the program is to deploy technology to “make it easier to choose the right tests and laboratories for members using evidence-based guidelines and industry best practices,” the program includes other features such as subspecialty certification and secondary review for certain tests. In order to perform and bill for any laboratory services, CLIA certification is required as is CAP certification for certain complex pathology tests. Advance notification also is required for tests covered under the program with place of service (POS) 11 for office-based services or POS 81 for services provided in the clinical laboratory.

The CAP will provide more information on this issue as it becomes available in future editions of STATLINE.

Sunshine Act Dispute Process Is Now Open

Physicians and teaching hospitals are encouraged to use the CMS’ Open Payments system to review and dispute, as applicable, data on payments and gifts from industry groups before the information is released publicly.

On June 1, manufacturers and group purchasing organizations (GPOs) began sending data on payments to physicians and teaching hospitals for the last five months of 2013 to the CMS. These industry groups are required to disclose certain payments under the Physician Sunshine Act. Physicians and teaching hospitals have until August 27 to dispute the reported data if necessary. The data will be posted online on September 30.

Payments to physicians and teaching hospitals required to be reported can be for research grants, consulting or speaking engagements, travel reimbursements, stock, and even meals or small trinkets provided during routine sales visits. The CMS is required under the Act to collect data on certain payments made to physicians and make it publicly available and searchable online annually.

The CMS also must allow key stakeholders the opportunity to review the information. Physicians and teaching hospitals can dispute data before the CMS publishes it online through Open Payments. The system requires fairly specific identity verification, which can take time. The CMS recommends completing the registration as soon as possible and not waiting until the end of the 45-day dispute period.

If data is disputed, applicable manufacturers and GPOs will work to resolve discrepancies and make necessary corrections before August 27. Any unresolved disputes will be noted as disputed payments in the public file. Physicians and teaching hospitals may dispute 2013 payments through the end of the year, but will be disputing payments already made public.

Misleading Conclusions Might Be Drawn From OIG Report, CAP States

The Health and Human Services Office of Inspector General (OIG) released its report, “Questionable Billing for Medicare Part B Clinical Laboratory Services” on July 9. The OIG analyzed 2010 Medicare data and found 1,000 laboratories exceeded a threshold for five or more measures of questionable billing of Medicare Part B claims for clinical laboratory services.

The vast majority of the 94,600 laboratories included in the report did not reach the threshold, as more than 73,000 laboratories had either no or only one measure of questionable billing used for the study. The study looked at clinical laboratory services only rather than anatomic pathology services. Almost half of the laboratories that had five or more questionable billing measures were in Florida and California.

The OIG stated that it did not independently verify the accuracy of the data used for the study. And, the OIG did not conduct a medical record review to determine whether the services for which labs billed were inappropriate or fraudulent.

As a result, the report did not take into account the real-world circumstances around tests being ordered. The OIG therefore could not determine whether the services in question were fraudulent, inappropriate, or whether the issue with the claim was a result of simple administrative or clerical error. It is possible that the services are in fact, appropriate.

Further, the OIG indicated the 13 measures included in the analysis were not intended to be a comprehensive set of characteristics for identifying labs with questionable billing.


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