College of American Pathologists
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  STATLINE — CAP’s Bi–Weekly Federal and
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July 19, 2012  •  Volume 28, Number 15
Next Issue: August 2, 2012
© 2012 College of American Pathologists

In This Issue:

CAP Continues to Advocate for Molecular Pathology Code Placement on PFS

The College continues to recommend that newly developed molecular pathology codes be placed on the CMS Physician Fee Schedule (PFS), as detailed in CAP’s presentation before CMS at the agency’s annual meeting seeking recommendations for the Clinical Laboratory Fee Schedule (CLFS) on July 16.

“At the meeting, the College once again advocated that CLFS crosswalks to these new molecular pathology codes would not be appropriate, as professional work is involved in generating results that are meaningful for clinicians,” explained CAP Economic Affairs Committee Chair Jonathan L. Myles, MD, FCAP, who testified at the meeting.

Support for placement of the molecular pathology codes on the PFS was strong among other stakeholders. Representatives from the Association for Molecular Pathology (AMP), the American Society for Histocompatibility and Immunogenetics (ASHI), and the National Association of Medical Examiners (NAME) testified at the meeting that they did not have crosswalk recommendations for molecular pathology for the CLFS, as they believe the molecular codes should appropriately be placed on the PFS. Other specialty society stakeholders present at the meeting, including the American College of Medical Genetics and Genomics (ACMG) and the American Society for Clinical Pathology (ASCP), also did not offer CLFS crosswalk recommendations for the molecular pathology codes.

Placement of the molecular codes was also featured in the 2013 proposed PFS released earlier this month. CMS indicated preference for placement of all molecular pathology codes on one fee schedule. The agency is also seeking input on specific questions related to PFS placement as part of comments on the 2013 proposed rule, to which the College is preparing responses supporting placement on the PFS.

At the July 16 meeting, the CAP also provided CLFS recommendations for several non-molecular pathology codes, either through crosswalks or gapfill methodology. Any additional CLFS recommendations from the public can be provided to CMS through July 23, 2012.

2013 Proposed PFS Features Quality Reporting Changes

CMS is proposing to include the current five pathology measures in next year’s Physician Quality Reporting System (PQRS), as well as expand the group reporting option to groups from 2-25 members. This could allow pathologists without applicable measures to be covered by their group’s reporting, according to preliminary analysis by the College of the 2013 Proposed Physician Fee Schedule (PFS) released earlier this month. Providers who successfully participate in the 2013 and 2014 PQRS will be eligible for a 0.5% bonus.

The proposal also recommends basing 2015 penalties on participation in the 2013 PQRS. Physicians who do not successfully report on measures in 2013 will face penalties in fee-for-service Medicare beginning in 2015 at -1.5% of Medicare Part B revenues, and increasing to 2% in 2016 and beyond.

In addition, CMS proposes to automatically set the value-based modifier at -1% for physicians who do not successfully report at least one measure through the PQRS, which will be in addition to the PQRS penalties.

Watch for further analysis of the 2013 proposed PFS in future issues of Statline.

Senate, House Introduce PT Referral Legislation

Lawmakers in both chambers of Congress recently introduced legislation granting CMS discretion in determining sanctions for laboratories inadvertently violating the agency’s CLIA statute. Under the current statute, CMS is required to revoke the CLIA certificate for any laboratory referring its proficiency testing (PT) samples to another laboratory for analysis.

The College supports both the House bill (H.R. 6118), the Taking Essential Steps for Testing (TEST) Act, introduced on July 12, as well as the companion Senate bill introduced on July 17. Introduced by Rep. Michael Grimm (R-NY), the House bill currently has four co-sponsors: Reps. Peter Roskam (R-IL), Mike Ross (D-AR), Steve Womack (R-AR), and Steve Austria (R-OH). The companion bill (S. 3391) was introduced by Sen. Amy Klobuchar (D-MN); cosponsors were Sen. Jeanne Shaheen (D-NH) and Sen. John Boozman (R-AR). The bills’ sponsors are working to move the legislation through Congress quickly, ideally before Congress adjourns for the August recess.

Discretionary Authority

The College has long been concerned about imposing severe sanctions—which can include instituting a two-year operating or owning ban for laboratory directors or owners—for inadvertent violations. However, CMS maintains it has little enforcement discretion under the CLIA statute. As a result, a growing number of laboratories across the country have been sanctioned for inadvertent PT referrals, facing potential shut down, disruption in patient care, and substantial settlement costs.

The College is pleased that the bills give CMS greater flexibility to match sanctions to the level of noncompliance, wrote CAP President Stanley J. Robboy, MD, FCAP, in a letter to one of the bill’s cosponsors, Sen. Shaheen (D-NH). “The TEST Act would still forbid the practice of PT referral,” he wrote. “CMS would still be able to hold ‘bad actors’ accountable to the fullest extent of the law. However, the agency could impose lesser sanctions, if at all, for inadvertent PT referrals.” The letter also notes that additional modifications may be needed to make sure that PT keeps pace with evolving laboratory practice.

The CAP looks forward to further dialogue with Congress and CMS about details of the legislation, including how best to apply discretion.

CAP, NYSSPATH Urge Gov. Cuomo (D-NY) to Veto Self-Referral Changes

The CAP and the New York State Society of Pathologists (NYSSPATH) are pressing Gov. Andrew Cuomo (D-NY) to veto legislation repealing provisions of the state’s anti-self-referral law. If the legislation becomes law, New York will be the first state to dismantle state-based protections and limitations on physician self-referral.

“In our meeting with officials from Gov. Cuomo’s office, we are stressing that if this law goes into effect, it will be a great disservice to patients, who have no way of knowing about these financial arrangements, but could undergo unnecessary biopsies or treatments that put them at risk,” NYSSPATH President Rana Samuel, MD, FCAP, told Statline. “Our advocacy efforts are progressing, but grassroots support is especially important right now.” New York pathologists are encouraged to relay their concerns to Gov. Cuomo using the CAP Action Alert on this issue.

CAP and NYSSPATH members’ advocacy efforts have also emphasized that if enacted, this legislation could fuel already-escalating health care costs. Furthermore, the financial abuses that prompted New York lawmakers over 20 years ago to enact the current restrictions continue to burgeon. Indeed, this law was passed under the current governor’s father, former Gov. Mario Cuomo’s leadership.

“As such, enacting AB 3551/SB 4660 into law will significantly alter health care policy in New York by reversing longstanding protections that are needed to continue safeguarding patients from improper medical decision-making,” stated CAP President Stanley J. Robboy and Dr. Samuel in a letter to the current governor requesting a veto. Without these state restrictions, federal (Stark) law over self-referral of physician services would apply, the letter goes on to note.

In addition to the CAP, the NYSSPATH, and other laboratory groups, the New York Blue Cross Blue Shield plans are also supporting the veto, citing concerns about continuing financial abuses. The New York State Bar Association supports the legislation.

West Va. Board of Medicine Clarifies EHR Donation Restrictions

EHR donation state guidance and opinion letters for Missouri, New Jersey, New York, and Pennsylvania are available on the CAP website.

The West Virginia Board of Medicine recently affirmed that state law forbids physicians from accepting electronic health record (EHR) donations from laboratories to which they refer, even if the arrangement meets the requirement of the federal safe harbor that the physician cover 15% of the cost of the donation. West Virginia is now the fifth state to clarify EHR donation provisions following interpretation requests from the CAP and state pathology societies (see box).

This clarification was outlined in a letter from Robert C. Knittle, the Board of Medicine’s Executive Director, to Kymberly A. Gyure, MD, FCAP, President, West Virginia Association of Pathologists (WVAP). The state pathology society, along with the CAP, requested an interpretation of the West Virginia Medical Practice Act as it relates to the donation of EHRs by clinical laboratories to referring physicians.

The Board’s interpretation goes on to clarify details of the interpretation. “If a complaint were to be filed at this office against a medical doctor for receiving a monetary donation to cover 85% of the cost of the physician’s electronic health record when the recipient physician either continues a referral arrangement with the laboratory, or subsequently initiates an arrangement for the referral of specimens to the donating laboratory for analysis, then it would be evident that West Virginia Code § 30-3-14(c)(6) had been violated,” stated the letter.

UnitedHealthcare Reverses TC Payment Policy

Following exchanges with the College, one of the country’s largest insurers is reversing a policy that would have impacted payment for the technical component (TC) of pathology services provided at ambulatory surgical centers (ASCs).

UnitedHealthcare announced earlier this year that beginning July 15, ASCs would be treated as a facility place of service (POS 24) when reported on the CMS 1500 claim form, and that claims submitted by physicians or other health care professionals would not be reimbursed for the TC for services provided at ASCs.

The motive for this policy change was to prevent duplicative reimbursements of the TC to physicians and ASCs by aligning their policy with CMS guidelines, which United asserted did not support payment for the TC. However, the insurer reversed the policy based on additional information provided by the CAP. Specifically, the College detailed how this policy misinterprets Medicare rules outlined in the Medical Learning Network Ambulatory Surgical Center Fee Schedule Payment System Fact Sheet, Medicare Claims Processing Manual, and applicable federal regulations stating that services furnished by an independent laboratory are not included within the ASC payment.

In the near future, United has indicated it will make changes to its claims processing system to allow for the TC payment of laboratory services when reported with an ASC POS (24), and will post an announcement to their Network Bulletin when the changes are completed. The College is requesting that this system fix be applied retroactive to the intended policy effective date of July 15. Statline will continue to provide updates on this issue.

89 New Medicare ACOs Launched on July 1

Earlier this month, CMS announced that 89 new ACOs participating in the Medicare Shared Savings Program launched on July 1, including CAP ACO Network member Advocate Health Partners, based in the Chicago region. In addition, CMS announced that 15 of these were Advance Payment ACOs.

Advocate is already involved in a commercial ACO—AdvocateCare, as part of a three-year partnership with Blue Cross Blue Shield of Illinois (BCBSIL), the system’s largest payer. This commercial coordinated care model is already reporting positive results, explained Chief Medical Officer, Lee Sacks, MD, during his June keynote address at the National ACO Summit in Washington, DC.

Through the third quarter of this year, AdvocateCare’s hospital admissions were down 11.3% and the length of stays were down 1.2%, compared to the previous year, said Dr. Sacks. On the outpatient side, surgeries were down 9.4% and advanced imaging was down 6%. In fact, by the end of 2012, the ACO’s attributable lives number is expected to climb 70,000 to 395,000, up from 325,000 at the model’s launch, Dr. Sacks revealed.

But even before the coordinated care partnership with BCBSIL, Advocate had a strong integrated foundation, noted Michael Weldon-Linne, MD, FCAP, who is Chairman, Department of Pathology at the Advocate’s Illinois Masonic Medical Center (IMMC). IMMC is one of Advocate’s 10 hospitals, eight of which are located in the metro-Chicago region.

“We have a strong background of being laser-focused on improving quality and service and cost efficiency, therefore Advocate decided that many of the key pieces were in place to operate as an ACO,” he explained. “In addition, there’s a mutual agreement in the health care industry that coordinated care is the way forward, as its vital to cutting costs and improving care. We need to be driving clinical integration, with pathology at the heart of this movement.”

Interested in joining the CAP-ACO network? CAP members who work in a facility that is currently—or will be—part of an ACO are encouraged to join the network.

For more information—or if you have a question about ACOs—please email us.

N.J. State Senate Passes NJSP, CAP-Supported Genetic Counselor Bill

New Jersey state senators recently passed legislation that removes “interpretation” of genetic tests from a genetic counselor’s scope of practice and categorically exempts physicians from the licensure law. The bill passed the full Senate unanimously (40-0) on June 28.

The bill, S. 555, amends the state’s current genetic counselor law to conform to the scope of practice agreement between the CAP and the National Society of Genetic Counselors (NSGC). In addition to support from the CAP and New Jersey Society of Pathologists, the legislation was also supported by the Oncology Society of New Jersey.

ONC Releases Result Reporting Guidance Using Direct Project Specifications

The HHS Office of the National Coordinator for Health IT (ONC) has released a guidance on lab result reporting that aligns it with the agency’s Direct Project standards and specifications. The College, along with representatives from CMS’s CLIA program, the ONC, LabCorp, and Quest Diagnostics, participated in the workgroup that developed this guidance. Thomas Williams, MD, FCAP, of the Methodist Hospital of Omaha and chief information officer of Pathology Inc. represented the CAP.

The ONC launched the Direct Project in March 2010 as a part of the Nationwide Health Information Network, with a focus on creating a secure, standards-based online method for sending authenticated, encrypted health information.

These recent guidelines indicate that any electronic lab reporting method must comply with CLIA, and provide accurate, reliable, confidential, and timely delivery of laboratory results from the performing laboratory to the final report destination. To align with the Direct Project specifications, the sending laboratory must receive positive notification of delivery success or failure in a manner consistent with other methods of electronic result delivery currently in use by accredited clinical laboratories, such as a fax transmission.

Following this guidance, CMS plans on issuing a CLIA FAQ document to clarify these guidelines for accreditation agencies, clinical laboratories and providers. CAP has been asked to remain in this workgroup, which will now focus on reviewing the current status of interface standards, clinical vocabulary, testing methodologies and certification processes for electronic health records (EHRs) and ambulatory laboratory testing to determine steps that may need to be taken to minimize the time, cost and operational impact of establishing new EHR-laboratory information system interfaces. Watch Statline for continuing coverage.

Keep Up with the Latest CAP Advocacy News on Twitter

CAP Advocacy is now on Twitter. Follow CAP Advocacy’s daily “tweets” to keep pace with regulatory and legislative news affecting pathology. For the latest health care news, be sure to check out what we are following on Twitter.


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