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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

October 9, 2014  •  Volume 30, Number 21
Next Issue: October 23, 2014
© 2014 College of American Pathologists

In This Issue:

UnitedHealthcare Moves Ahead, But Delays Pilot Enforcement Date

Following several discussions and exchanges with UnitedHealthcare over recent months, the insurer notified the CAP that it will not deny claims under a pilot laboratory benefit management program that debuted in Florida on October 1. However, UnitedHealthcare plans to enforce the pilot’s requirements starting January 1, 2015.

The CAP had formally requested UnitedHealthcare suspend its planned implementation of the pilot program. The College has concerns over fundamental flaws with the program that will negatively affect patient access to services, delay results, and create inconsistencies with current clinical practice, professional judgment and laboratory operations. The College expressed particular concern about the pilot’s secondary review and subspecialty certification requirements that UnitedHealthcare has committed to review and seriously consider over upcoming weeks.

In the meantime, UnitedHealthcare has stated the pilot will not affect payment for claims until January 1, 2015. The pilot program affects over 80 laboratory services ordered by a Florida network provider for a patient insured by most fully insured UnitedHealthcare commercial members in the state.

UnitedHealthcare provided the CAP with a Provider Alert for use with CAP members.

“To give providers additional time to acclimate to the program, claim impacts related to the Laboratory Benefit Management Program will not go into effect until January 1, 2015,” the insurer stated. “UnitedHealthcare will closely monitor progress of this pilot program and make refinements based on data, experience, and input. Please contact your UnitedHealthcare Provider Advocate if you have questions or feedback as you begin implementing the program in your practice.”

The program requires use of the Beacon Laboratory Benefits Solutions to provide notification for the frequently performed tests. Beacon is a wholly owned subsidiary of Labcorp. The program also requires laboratories to meet extensive secondary review and subspecialty certification requirements. After January 1, 2015, those who do not adhere with the program’s requirements still may be subject to lower fees or termination, according to UnitedHealthcare. The insurer has published more information on its website regarding the benefit management program and Beacon.

The sheer volume of routine tests covered by the program will disrupt workflow for ordering physicians and laboratories especially as the Beacon system currently does not electronically interface with many electronic medical records and laboratory information systems, the CAP said. Other providers and organizations, including ordering physicians and their representatives, have shared this sentiment with UnitedHealthcare.

The College will continue to engage with UnitedHealthcare on the pilot in total, including its secondary review and subspecialty certification requirements that present access to care concerns and other clinical and operational implications. The CAP will provide more information on this issue as it becomes available in future editions of STATLINE.

Register for CAP Webinar on 2015 Medicare Fee Schedule

In anticipation of the 2015 Medicare Physician Fee Schedule expected release later this month, the CAP is preparing to provide members with information through STATLINE about the rule the day it is finalized and then offer more in-depth analysis during a webinar presentation on November 5.

Registration is now open for members to reserve a spot for the webinar. The 90-minute CAP presentation begins at 1 pm EST on November 5.

Throughout the year, the CAP has advocated for favorable payment policies and mitigation of potential Medicare payment cuts in 2015. Most recently, the CAP opposed Medicare payment policy changes for prostate biopsy reimbursement. The CAP also has worked to address Medicare’s payment policy for immunohistochemistry services and encourage the adoption of three new Medicare Physician Quality Reporting System (PQRS) measures for pathologists.

On July 3, the CMS proposed the Medicare fee schedule for 2015. The CMS is expected to finalize the 2015 regulation by October 31, 2014, or soon after. The CMS will publish their response to the CAP’s advocacy efforts to impact their proposed policies in this final rule.

The CAP has called on the CMS to abandon changes for reporting prostate biopsy services next year. For 2015, the Medicare agency proposed that pathologists use only one code (G0416) to report prostate biopsy services, regardless of the number of specimens. The CAP has urged the CMS to withdraw the proposal and use existing reporting mechanisms to accurately pay for the service.

The CMS may also alter other payment policies that affect pathologists. For 2014, the CMS changed how pathologists report immunohistochemistry services. The CAP advocated for an alternative to the CMS’ proposal and now awaits an agency decision.

Medicare payment changes are expected to in situ hybridization services after action was deferred on revaluation for 2014. The CMS identified these services as overvalued as part of its misvalued code initiative.

The CMS also proposed adding three new pathology measures created by the CAP to the 2015 PQRS program. Two of the pathology measures are related to lung cancer and the other is for melanoma. With the anticipated addition of the three measures, pathologists would have a total of eight PQRS measures in 2015. The CAP appreciates the CMS’ proposal and encourages the agency to finalize the new measures.

FDA Drafts Oversight Guidance for LDTs

Following the Food and Drug Administration (FDA) release of its proposed oversight guidance for laboratory-developed tests (LDTs), the CAP will provide comments and continue to be engaged with stakeholders throughout a four-month public hearing process.

The proposal describes the FDA’s plans to enforce premarket and postmarket requirements for LDTs as well as a process to phase in agency oversight. In recent years, the CAP has outlined principles for oversight of these tests. The principles include analytic and clinical validation of tests, a stratified oversight approach based on risk, and targeted FDA review of only high-risk LDTs.

“The CAP will work to ensure LDT oversight assures quality laboratory testing for patients in a manner that is consistent with principles outlined by the CAP,” said CAP President Gene N. Herbek, MD, FCAP. “The proposed FDA guidance embodies a number of those key principles. Where there are differences, the CAP will work with stakeholders so requirements do not impede innovation or increase administrative burden on laboratories. The CAP will provide its recommendations and propose changes to improve the guidance during the public hearing and comment period.”

The comment period began on October 3 and will last four months.

The CAP hosted a recent webinar on LDT oversight with the FDA’s Alberto Gutierrez, PhD. An archived version of the webinar is available along with the presentation slides to view or download.

The main elements of the proposed FDA oversight framework include notification to the FDA of LDTs manufactured by a laboratory; continued enforcement discretion regarding low-risk LDTs, traditional LDTs, LDTs used for rare diseases, and LDTs for unmet needs; and, a risk-based, phased-in approach to enforcing review requirements for high-risk and moderate-risk LDTs. Oversight also would involve the use of clinical literature to support clinical validity.

Over the past decade, the number, complexity, and importance of LDTs in diagnosing and treating disease have increased dramatically, creating the need for strengthened oversight that will ensure public safety. Responding to this need, the CAP had proposed a risk-based model employing a public-private partnership to address oversight of LDTs in an inclusive, systematic way. The CAP’s top priorities for LDT oversight are to assure quality laboratory testing for patients, allow for innovation, and prevent undue administrative or regulatory burdens.

New HIPAA Requirements on Patient Access Now Effective

Laboratories must now comply with HIPAA requirements regarding patient access to their laboratory test results. The CAP has the resources that members can use to understand and meet new patient access rules.

The Department of Health and Human Services (HHS) published a federal regulation on February 3, 2014 allowing patients to request and receive test results from the laboratory. The deadline to implement the new policy was October 6. All practices that are HIPAA covered entities must comply with the rule. Failure to comply with the rule’s access provisions may subject your practice to an enforcement action that may include civil monetary penalties. In addition, practices may be harmed by the potential damage to a practice’s reputation and relationships with other health care providers and patients as well.

In the February 3 HHS rule, the department accepted several recommendations made by the CAP. For instance, the CAP supported the release of laboratory results to patients upon request and advocated for the federal rule to preempt state laws that impede patients directly receiving test results from the laboratory.

To help pathologists and laboratories, the CAP Practice Management Committee has developed a compliance toolkit. Information includes how to:

  • Manage requests for laboratory test results, including suggested methods to authenticate a patient’s identify and deliver reports
  • Identify potential documentation needs
  • Understand report format requirements
  • Calculate allowable fees
  • And, assess workflow and opportunities

The specific components of the toolkit are:

  • Guide 1, Compliance Summary and Impact Analysis – What does this rule change meant to your practice?
  • Guide 2, Management the Process – Addresses operation areas and suggested approaches
  • Guide 3, Opportunity Assessment and FAQ – Explore potential opportunities for your practice and common questions
  • And, an Appendix 1 with a Resource and Reference Guide

Pathologists May Still Dispute Open Payments Data

Despite problems and delays with the implementation of the CMS Open Payments system, the public reporting website with information on payments and transfers of value to physicians from manufacturers went live on September 30.

The CAP, along with the American Medical Association (AMA) and more than 100 physician specialty and state societies, urged the CMS to delay the website’s launch. Physicians and teaching hospitals experienced significant problems accessing data reported by device and pharmaceutical companies. At various periods in August and September lasting several days in August, physicians could not access reports because of system outages.

Medical and drug industry manufacturers that participate in federal health care programs reported to the CMS 2013 payment data as required by the Physician Payments Sunshine Act, passed as part of the Affordable Care Act in 2010. The law states manufacturers must disclose payments or other transfers of value such as meals, medical journal reprints or other educational materials, and speakers’ honoraria, to physicians and teaching hospitals. Doctors had until September 10 to review and dispute the payment information before it was published.

Pathologists can still review their data by logging onto the Open Payments system. Login requires the physician to complete the CMS’ electronic verification process through its enterprise portal. Once the physician has access to the portal, he or she can register in the Open Payments system.

Physicians can then review the data for accuracy. Errors then can be reported to manufacturers through the CMS system or by contacting the company directly, according to the AMA. Open Payments contacts are listed on most pharmaceutical and device manufacturer websites. Physicians may dispute the reported data until December 31.

The AMA offers several resources, including talking points for physicians (AMA website login required) who may be asked questions about their own information published on Open Payments.

CMS Hosts October 23 Call On Medicare Quality, Resource Use

The CMS will review how to read and interpret 2013 Quality and Resource Use Reports (QRURs) for group practices and physicians during a call on October 23.

Registration details are on the CMS’ website and there is no fee to participate.

On September 30, the CMS made 2013 quality and resource use reports available to group practices and physician solo practitioners nationwide. The 2013 reports contain quality and cost performance data for 2013, which is the performance period for the value-based payment modifier that will be applied to physician payments for groups of 100 or more eligible professionals in 2015. The CMS states that the 2013 report also can be used to plan for improving the quality and efficiency of care provided to Medicare beneficiaries. Physicians can review the information to understand and improve performance on quality and cost measures for implementation of future modifier adjustments.

The CAP has opposed the modifier adjustment and future increases to the penalty. The CAP has advocated for an alternative approach that better reflects the value pathologists bring to their patients.

The 2013 reports include data assessing a group practice or solo practitioner’s performance on cost measures, information about the services and procedures contributing most to beneficiaries’ costs, as well as performance on quality measures including performance on three outcome measures.


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