College of American Pathologists
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January 20, 2011  •  Volume 27, Number 2
Next Issue: February 3, 2011
© 2011 College of American Pathologists

In This Issue:

CAP, CLC Meet with CMS Officials on Signature Rule Concerns
CAP Leaders Discuss Meaningful Use Concerns with HHS Officials
MedPAC to Recommend 1% Physician Payment Update for 2012
CAP Comments on AHRQ Cancer Genetic Test Update
The Brookings Institution Convenes HIT Leaders for Jan. 28 Summit
New Jersey Clarifies EMR Safe Harbor Exemption Provisions
CAP, NJ State Pathology Society Push to Amend Out-Of-Network Bill
In Brief...
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CAP, CLC Meet with CMS Officials on Signature Rule Concerns

The College, together with representatives from the AMA, ACLA, and other members of the Clinical Laboratory Coalition (CLC), met with Jonathan Blum, CMS’s Deputy Administrator and Director of the Center for Medicare, on Jan. 13 to express continued concerns with the agency’s planned implementation of physician signature requirements for tests paid on the Clinical Laboratory Fee Schedule (CLFS). The meeting provided the opportunity for stakeholders to further emphasize concerns with the regulation and educate the agency on this problematic regulation.

Advocacy Efforts Result in Delay

In recent months, the College has been steadily advocating to CMS leaders how this new requirement could negatively impact labs. In mid-December, the College wrote to CMS Administrator Donald Berwick, MD, urging the delay and requesting a meeting to discuss the effect on pathologists. The letter also underscored the CAP’s concern about this requirement in comments submitted to CMS prior to the final PFS rule.

The CAP also joined with fellow members of the Clinical Laboratory Coalition (CLC) in expressing opposition to CMS Deputy Administrator Marilyn Tavenner in early December. The letter asked for a delay until at least the beginning of 2012.

Even though CMS delayed the provision through at least the first quarter of 2011, agency officials did not appear willing to back off from implementing the requirement. The rule, part of the final 2011 Physician Fee Schedule (PFS), only applies to test requisitions paid on the CLFS and not the PFS.

The provision was originally set to be implemented on Jan. 1, but was delayed after health care provider groups, including the CAP, voiced concerns about the potential confusion and negative impact of this new regulation. While officials acknowledged the confusion among providers, including pathologists, they said the provision would be implemented following education efforts by the agency throughout the first quarter of this year.

During the Jan. 13 meeting with CMS, the agency was told that three months in not a sufficient amount of time to educate physicians. CMS did not commit to any further extension, but indicated it would consider moving the effective date if confusion about the requirement remains. To assist with the education effort, agency officials are encouraging providers to submit questions and other issues needing clarification to the agency.

When pressed about the rationale for this new provision, agency officials stated that improved documentation and accountability are the motivation, adding that all other services, such as durable medical equipment (DME) providers, require such signatures.

CAP Leaders Discuss Meaningful Use Concerns with HHS Officials

As registration began early this month for providers to participate in HHS’s meaningful use electronic health record (EHR) program, CAP leaders began a dialogue with agency officials to not only clarify the impact of this final rule on pathologists, but also to ensure that members are not penalized for not meeting meaningful use requirements when the program is fully implemented in 2015.

Because meaningful use eligibility is such a concern, the CAP has formed an HIT Policy Workgroup comprised of members from the Council of Government and Professional Affairs (CGPA) and the Diagnostic Intelligence and Healthcare Information Technology (DIHIT) Committee. This Workgroup’s co-chairs—David Booker, MD, FCAP, and Richard Friedberg, MD, PhD, FCAP—met with HHS officials on Jan. 7 to launch a discussion about these concerns.

The Latest on Meaningful Use

  • Registration is now underway for eligible providers, under the direction of CMS.
  • HHS’s Health Information Technology Policy Committee (HITPC) has released proposed measures for Stage 2 Meaningful Use. HITPC is soliciting feedback on the proposal by Feb. 25. HHS is slated to issue final Stage 2 recommendations this summer.
  • The HHS Office of the National Coordinator for IT has issued a final rule establishing the permanent technology certification program. The current temporary certification program will sunset on December 31, 2011 or later.

“The meeting clarified for CMS and ONC [Office of the National Coordinator for Health Information Technology] that pathologists cannot comply with the meaningful use rules,” said Dr. Booker. “However, the meeting also underscored that pathologists are supportive of interoperable electronic health care IT systems, have long been the leaders in clinical HIT, and must be involved in ensuring that lab and pathology data are correctly incorporated into the EHR.”

Formidable Compliance Challenges

Despite being at the forefront of HIT adoption, pathologists—regardless of their practice setting—will have difficulty qualifying for incentive payments authorized through the Health Information Technology for Economic and Clinical Health Act (HITECH) portion of the American Recovery and Reinvestment Act (ARRA). According to this law, a maximum of $44,000 in incentive payments is available for Medicare physicians who demonstrate “meaningful use” by meeting the definition of an eligible provider (EP) while using “certified” electronic health record software.

However, the CAP is concerned some details of the “meaningful use” regulation prevent pathologists from becoming fully compliant. Therefore, questions surround whether or not CAP members will be subjected to penalties starting in 2015. Beginning in 2015, CMS will reduce Medicare payments to EPs who do not meet the rule’s requirements. Penalties range from 1% of Medicare fees in 2015 and would grow to 5% beginning in 2017.

One example of the confusion: the meaningful use rule requires pathologists to maintain 80% of patient records in certified EHRs; however, pathologists typically use LIS or APIS systems rather than the full EHR. A whole host of additional “meaningful use” requirements are outside of pathologists scope of practice and usual interaction with patients.

In addition, CAP members are confused about how—and if—they fit into this rule’s definitions of eligible providers (EPs). Since the HITECH Act provides federal funding to both physicians and hospitals to help offset the cost of purchasing health information technology, the regulations are specifically written to prevent hospital-based physicians from “double dipping.” While a substantial portion of pathologists practice in hospital-based settings, the passage of the Continuing Education Act of 2010 designated most pathologists as non-hospital based EPs. Therefore, many CAP members who practice in hospital-based are uncertain about whether they need to comply with meaningful use rules.

CAP is closely monitoring this issue and remains committed to working with key Congressional stakeholders and federal agencies to address our concerns. Keep watching to Statline for continuing coverage of this issue.

MedPAC to Recommend 1% Physician Payment Update for 2012

The Medicare Payment Advisory Commission (MedPAC) revealed last week that it will recommend a 1% payment update in the physician fee schedule for 2012 in its annual report to Congress. During its January meeting, members of the independent Congressional agency also pledged to focus on enhancing access to primary care services, as well as examining modified physician payment policies under the sustainable growth rate (SGR) formula.

With a one-year SGR extension in place, MedPAC members acknowledged the mounting frustration from providers and patients stemming from temporary “patches” and a looming cut of at least 25% when the current fix expires on Dec. 31. Not only did the members say they would examine this discontent, but also would explore current expenditure target approaches.

CAP, AMA Look for SGR Fix

The flawed SGR formula also remains a focus of both the CAP and the American Medical Association (AMA). According to AMA’s president Cecil B. Wilson, MD, a permanent fix is vital because stabilizing the Medicare payment system is essential to implementing true health care reform, he said at a Jan. 12 webcast, “What to Expect from Washington: The Prognosis for Reform and Changes Likely Under a Divided Congress,” sponsored by Modern Healthcare magazine.

In addition to SGR, AMA is also concerned about the Independent Payment Advisory Board (IPAB). Created by the health care reform law, this 15-member board will make proposals to Congress beginning in 2014 on how to achieve Medicare savings targets. These savings proposals can include cuts to provider reimbursement. IPAB is to release its recommendations by Jan. 15 every year beginning in 2014 and Congress has very little authority to make alterations to these spending cuts. If Congress fails to pass alternative legislation that meets the same savings targets, IPAB’s recommendations automatically take effect.

Prior to the passage of the health reform law, the CAP in a letter to Congress expressed concern about the IPAB, specifically that it effectively shifts responsibility for Medicare coverage and payment decisions to an unelected body in the Executive Branch. Furthermore, the fast track legislative approval process for consideration of the board’s recommendations limits the ability of Congress to revise or reverse IPAB’s policy decisions.

At the Jan. 12 webcast, Dr. Wilson said that the AMA views IPAB as “another arbitrary system in the mold of the Medicare physician payment formula.” “The AMA believes significant changes to IPAB are needed so physicians are not subject to a double jeopardy situation where they face two sets of cuts,” he added.

More information on IPAB can be found on AMA’s website.

CAP Comments on AHRQ Cancer Genetic Test Update

The College has commented on the Agency for Healthcare Research Quality’s (AHRQ) proposed updated horizon scan of genetic tests for cancer, noting concern that the report does not appropriately distinguish between genetic and somatic mutations when characterizing these tests. The College is also concerned that the report fails to include sufficient input from relevant stakeholders, including pathologists.

In its comments, the College complimented the Tufts Medical Center Evidence-based Practice Center on the development of a web-based resource for cancer tests. Specific to the report, however, the CAP noted the inappropriate use of the term “genetic test.” Throughout the publication, entitled Update on Horizons Scan of Genetic tests currently available for Clinical Use in Cancer, this type of test often refers to acquired somatic mutations in cancer or pre-cancer cells and to differentiation markers that are not mutations at all.

In addition, the College noted that the report—a horizon scan that includes a literature review—failed to engage stakeholders from the laboratory community. “The authorship of any report involving lab tests should include pathologists who are providers of the spectrum of lab tests covered in the report,” stated the comments. “As we have noted before, the College is concerned about the performance of horizon scans and other literature reviews divorced from an understanding of the clinical use of the tests which can result in incorrect categorization of tests.”

The Brookings Institution Convenes HIT Leaders for Jan. 28 Summit

In late January, The Brookings Institution will host leaders from various areas of health information technology (HIT) and release an anticipated white paper, Enabling Personal Medicine through HIT, by Darrell West, PhD, director of the organization’s Center for Technology Innovation. The Jan. 28 event will be held at The Brookings Institution’s Washington, DC, headquarters.

Brookings Institution to Release Enabling Personal Medicine through HIT at Jan. 28 Event

Hosted by Darrell West, PhD, director of the organization’s Center for Technology Innovation and David Brailer, MD, PhD, the former National Health Information Technology Coordinator. This event will be held at The Brookings Institution headquarters in Washington, DC.

Panel discussion speakers:
  • Personalized Medicine Coalition’s HIT task force chairman Donald Rucker, MD, Vice President and Chief Medical Officer for Siemens Medical Solutions USA
  • Mark Boguski, MD, PhD, Associate Professor, Center for Biomedical Informatics, Harvard Medical School
  • Emad Rizk, MD, President, McKesson Health Solutions, Inc.
  • Paul Billings, MD, PhD, Chief Medical Officer for Life Technologies Corp.
Event registration is free and available on a first-come-first-served basis. Online registration is available now.

This publication was developed with input from the CAP. Brookings—as well as the CAP—believes that personalized medicine will only advance if researchers can aggregate data to not only analyze trends, but also to give health care providers the appropriate tools to target treatments to the right patients.

This event will be led by Dr. West, as well as David Brailer, MD, PhD, the former National Health Information Technology Coordinator. A panel discussion will follow; speakers include the Personalized Medicine Coalition’s HIT Task Force Chair Donald Rucker, MD, who is also chief medical officer for Siemens Medical Solutions USA, and Mark Boguski MD, PhD, Associate Professor at the Center for Biomendical Informatics at Harvard Medical School (see box).

The Feb. 3 issue of Statline will feature comprehensive reporting from the event. Follow CAPDC Advocacy on Twitter for live “Tweeting” from the event.

New Jersey Clarifies EMR Safe Harbor Exemption Provisions

Clinical laboratory owners and directors in New Jersey are allowed to donate electronic medical record (EMR) systems to physician offices if they do not—and do not intend to—operate a collection station in the office, affirmed the state Department of Health’s director of Clinical Laboratory Improvement Service (CLIS), Dennis P. McDonough, in a Jan. 7 letter. However, the letter emphasized that the donation should not be an inducement for establishing a collection station in the office, or contingent on upon the referral of increased volume to the laboratory.

McDonough’s letter served to clarify and provide additional guidance on regulations governing EMR donations that state legislators passed over the summer. He noted that these EMR donations are permissible according to applicable provisions of the Federal Safe Harbor exemptions. It is important to note while Federal Safe Harbor provisions do not preempt state anti-kickback laws, New Jersey regulators opted to stay in line with exemption provisions within the federal law.

The letter goes on to emphasize that EMR donations/contributions “cannot be contingent upon the referral to, or volume or value of specimens, to the laboratory or have other restrictions limiting the ability of the physician office to refer to patient specimens to other laboratories.”

The CAP is disappointed with New Jersey’s decision to allow these EMR donations, as it has long been critical of the potential for abusive business practices, such as those outlined in McDonough’s letter. The College believes that these arrangements tie the physician group’s referrals to the donor of the technology by incorporating software and interfaces that can only be used for specimens sent to a specific laboratory or pathology provider.

CAP, NJ State Pathology Society Push to Amend Out-Of-Network Bill

The College and the New Jersey Society of Pathologists (NJSP) are seeking to amend an out-of-network bill so that pathologists would be exempt from providing written cost estimates for services to patients. This would be an amendment to legislation passed by the state Assembly on January 10, and now under consideration by the state Senate Commerce Committee. The bill, A3378, passed the Assembly by a vote of 41-28, with seven abstentions.

In a letter to New Jersey legislators in early January, NJSP’s President Louis J. Zinterhofer, MD, FCAP, wrote that the inherent nature of pathology work makes it impossible to provide patients with a meaningful estimate of charges in advance of the service. “In the case of anatomic pathology, involving the diagnosis of tissue specimens (i.e. biopsies), a pathologist cannot predict the type or number of specimens or anticipate what separate studies may be necessary,” he added.

In Brief...

CMS Hesitant on 2011 PECOS Deadline

CMS appears to be backing away from announcing a summer deadline for enrolling in the Provider Enrollment, Chain, and Ownership System (PECOS). The agency had reportedly set July 5, 2011 as the date after which it would begin rejecting claims for providers not enrolled in the system. However, CMS stated in a recent issue of MLN Matters that it “has not yet decided when it will begin to reject claims if an ordering referring provider does not have a PECOS record.”

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Follow CAP Advocacy on Twitter to keep pace with regulatory and legislative news affecting the pathology industry. For the latest health care news, be sure to check out the what we are following on Twitter.


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