College of American Pathologists
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March 18, 2010  •  Volume 26, Number 6
Next Issue: April 1, 2010
© 2010 College of American Pathologists

In This Issue:

Congressional Lab Tour: Dr. Maurice Fremont-Smith Hosts Senate Candidate,
Kelly Ayotte

Healthcare Reform Comes Down to the Wire
Senate Approves 7-Month Extension of SGR; House Vote Next
Physicians Urge Extension of Medicare Selection Period
NIH Announces Genetic Testing Registry
CAP to CMS: Laboratory Must Have Full Access to Electronic Health Records
PECOS Registration Requirement Delayed Until 2011

Congressional Lab Tour: Dr. Maurice Fremont-Smith Hosts Senate Candidate, Kelly Ayotte

Congressional Lab Tour: Dr. Maury Fremont-Smith Hosts Senate Candidate, Kelly Ayotte

Healthcare Reform Comes Down to the Wire

House Lawmakers will attempt to bring the healthcare reform debate to a close before their Easter recess begins on March 26th, with critical votes expected as soon as this weekend.

Early this morning the Congressional Budget Office released its determination that the revised health reform plan will cost $940 billion over 10 years, but will trim the federal deficit by $130 billion in the first ten years and $1.2 trillion in the second ten years. Release of the CBO score is a strong indication Congress is ready to act.

The process moved decidedly forward on Monday when the House Budget Committee sent to the House Rules Committee, a package of “reconciliation” legislation to amend the health care reform bill passed by the Senate on December 24, 2009.

It is anticipated that the House Rules Committee will release the revised “reconciliation” health care reform package at some point today. At the same time, the Committee will determine whether the House will vote on both the Senate Bill and the reconciliation bill separately, or whether they will “deem” that the House already voted in favor of the original Senate bill, and require the House to vote only on the reconciliation legislation.

House Speaker Nancy Pelosi showed strong interest in having the Rules Committee deem the Senate bill as passed, primarily to avoid the possibility of the bill being defeated in a vote on the House floor, or forcing House Democrats to vote in support of a bill that includes provisions they oppose.

Deeming the bill passed will allow House Democrats to take a public position only on the amendments to the bill, a far less contentious vote. Once the House votes on the Senate bill, or it is deemed as passed, it will be sent to the President to be signed into law, regardless of the outcome of the reconciliation bill.

Once the House votes on the reconciliation bill, it could go to the Senate for a vote as early as next week. The Senate would have a chance to pass it as it is currently written, or amend it and send it back to the House for a final vote.

As of press time, Congressional leaders have not released information about specific provisions in the reconciliation bill. Some of the provisions CAP staff are following include:

  • Granting authority to an Independent Payment Advisory Board that would shift responsibility for Medicare coverage and payment decisions to an unelected body in the Executive Branch.
  • A provision that would hamper innovation and competition in the growing field of personalized medicine by permitting only a select group of commercial laboratories to bill Medicare directly for particular tests.
  • Penalties associated with measuring pathologists’ value under the Physician Quality Reporting Initiative (PQRI).
  • A 10% payment bonus for primary care and some general surgery services, NOT to be offset by cuts in reimbursement rates to other physician services.
  • A one-year extension of the Technical Component (TC) Grandfather provision for anatomic pathology services.

CAP Advocacy staff is actively advocating on these issues and will provide more information about the reconciliation bill once it is released.

Senate Approves 7-Month Extension of SGR; House
Vote Next

By a vote of 62-36, the Senate last week approved a bill, H.R. 4213—The American Workers, State and Business Relief Act, that would avoid impending cuts to physician reimbursement rates through October 1, 2010. Although the legislation was originally passed in the House of Representatives, the Senate made substantial changes to H.R. 4213 which require the House to take an additional vote on the bill. After passed by the House and Senate, the bill will then need to be signed by President Obama into law. Without such a provision, physician payment would be calculated based on the flawed Sustainable Growth Rate (SGR) formula. CAP and other physician groups including the American Medical Association, have urged lawmakers to pass a permanent fix that will eliminate reliance on this flawed formula. A long-term fix seems unlikely as Congress addresses larger issues within healthcare reform. However, reliance on a series of short-term temporary fixes such as we’ve experienced this year, has dogged Congress and the physician community for several years.

(In a cautionary move, the House this week passed H.R. 4851, the Continuing Extension Act of 2010, which will extend the SGR fix for another 30 days until April 30th, 2010. The bill goes next to the Senate for consideration.)

The bill H.R. 4231 also includes an extension of the technical component “grandfather” (TC “grandfather”) that will take effect retroactively from January 1, 2010 until December 31, 2010. This provision is also included in the comprehensive healthcare reform overhaul bill currently being negotiated in Congress.

For now, the current temporary SGR “fix” expires on March 31, 2010.

Physicians Urge Extension of Medicare Selection Period

Citing the pending 21.5% Medicare physician pay cut scheduled to go into effect if Congress does not act to prevent it, CAP joined the American Medical Association and other physician groups in urging CMS to extend the deadline for physicians to change their Medicare participation or non-participation status from March 17, 2010 to April 16, 2010. The extension would allow Congress time to act on H.R. 4213, the bill currently awaiting House approval which would avert the scheduled physician pay cut until October 31, 2010.

If H.R. 4213 does not pass, physicians could face a 21.5% pay cut on April 1, 2010, or it may possibly be extended to April 30th if the Senate passes the latest extension bill, H.R. 4851.

See Guidance Document S&C-10-12-CLIA in its entirety.

NIH Announces Genetic Testing Registry

The National Institutes of Health announced today that it is creating a public database that researchers, consumers, health care providers, and others can search for information submitted voluntarily by genetic test providers.

The Genetic Testing Registry (GTR) aims to enhance access to information about the availability, validity, and usefulness of genetic tests.

Currently, more than 1,600 genetic tests are available to patients and consumers, but there is no single public resource that provides detailed information about them. GTR is intended to fill that gap

Its overarching goal is to advance the public health and research into the genetic basis of health and disease. As such, the registry will have several key functions:

  • Encourage providers of genetic tests to enhance transparency by publicly sharing information about the availability and utility of their tests
  • Provide an information resource for the public, including researchers, health care providers and patients, to locate laboratories that offer particular tests
  • Facilitate genomic data-sharing for research and new scientific discoveries

The GTR project will be overseen by the NIH Office of the Director. The National Center for Biotechnology Information (NCBI), part of the National Library of Medicine at NIH, will be responsible for developing the registry, which is expected to be available in 2011.

GTR genetic test data will be integrated with information in other NIH/NCBI genetic, scientific, and medical databases to facilitate the research process.

During the development process, NIH will engage with stakeholders-such as genetic test developers, test kit manufacturers, health care providers, patients, and researchers-for their insights on the best way to collect and display test information. In addition, other federal agencies, including the Food and Drug Administration and the Centers for Medicare and Medicaid Services, will be consulted.

Find more information about the Genetic Testing Registry and NCBI.

CAP to CMS: Laboratory Must Have Full Access to Electronic Health Records

In a comment letter sent earlier this week regarding CMS’s proposed rulemaking on the meaningful use of Electronic Health Records (EHR), the College urged CMS to address the central role pathologists and laboratories have in diagnosing disease and ensuring quality patient care, and laid out pathologists’ specific concerns regarding the impact of these provisions on laboratories.

The comments were issued in response to a recently published notice of proposed rulemaking (NPRM), CMS-0033-P, “Medicare and Medicaid Programs; Electronic Record Incentive Program.”

“The College is concerned that the regulation, as drafted, does not adequately address the need for pathologist and laboratory support of Meaningful Use (MU) efforts,” the letter said. “Without this support, pathologists and laboratories, who play a central role in the diagnosis of patients and ensuring quality patient care, will be unable to facilitate Eligible Providers’ (EP’s, e.g. ordering physicians’) ability to comply with the many MU requirements that rely directly or indirectly on laboratory data.”

Read the CAP comment letter in its entirety.

CAP’s concerns focused on the definition of hospital-based providers, eligible providers, the exception process, lab-related MU measures, funding for laboratory-EHR interfaces and pathologists’ access to the full EHR.

Definition of a Hospital-Based EP:

  • CAP recommended CMS take into consideration whether a pathologist has or will be required to contribute funding towards an EHR in setting criteria for defining hospital-based EPs. The College argued that EPs who are required to contribute funding should not be considered hospital-based, as they are not provided full access to the facilities and equipment of the hospital, including the hospital’s qualified EHR.
  • The proposed rule defined a hospital-based EP as one who furnishes 90% or more of covered professional services in the year preceding the payment year in a hospital setting. CAP requested CMS explicitly address the treatment of providers whose status may change from year to year.
  • The proposed rule requires all EPs to report on all Core Measures (i.e., preventive care, screening regarding tobacco use; blood pressure measurement, and drugs to be avoided by the elderly, and a subset of clinical measures that are most appropriate to a physician’s specialty.) The CAP argued that given the nature of pathology’s scope of practice, none of the Core Measures could be met by pathologists in their day-to-day practice. The CAP urged CMS to ensure that pathologists who are currently defined as EPs are not penalized for the failure to meet measures they have no way to meeting in their normal scope of practice, and recommended that CMS consider pathologists as “non-qualifying” eligible providers, exempt from future MU penalties. Beginning in 2016, the Proposed Rule would impose financial penalties on EPs who fail to participate in the MU program.

Definition and Criteria for Eligible Providers

  • CAP recommended that CMS formally define a Non-Qualifying Eligible Provider as any EP who cannot report any specialty group and core measures, as written in the preamble of the regulation.

Exception Process

  • CAP recommended that CMS create a structured regulatory-defined process for the “Non-Qualifying Eligible Provider” to “attest” as to the inapplicability of selecting and/or reporting any specialty group or core measures, and that pathologists be presumed to be Non-Qualifying EPs , and as long as a specialist’s specialty could be identified as pathology, they would be presumed to be exempt by virtue of being a pathologist. Those providers would thereby be exempt from penalties.

Lab-Related MU Measures

  • CAP questioned the impact of requiring that at least 50% of all clinical lab results be incorporated in certified EHRs as “structured data”, and called on CMS and the Small Business Administration to determine the effects of such a requirement on laboratory competition, particularly given the importance of small laboratories to many rural and underserved communities. CAP further argued that without standards necessary to support the electronic transfer of lab data and accommodate this MU measure, the requirement to mandate the integration of lab data into the EHR in a standardized and structured format may need to be modified to support inter-provider transfer of laboratory data in a standardized fashion. (The Office of Advocacy at the Small Business Administration amplified CAP’s position in its comments to CMS issued earlier this week.

Funding for Laboratory EHR

  • CAP noted that although the proposed MU rule focuses on ordering physicians, laboratory data is essential to the achievement of the meaningful use measures by eligible providers, and the costs to labs in developing interfaces to each qualified EP&38217;s system can be significant. CAP requested CMS identify a funding stream to help laboratories underwrite the cost of creating interfaces between their HIT systems and qualified EP EHR systems.

Pathologists Access to the Full EHR

  • The College noted that pathologists will be required play an important role in coordinating care with primary care and other clinicians inside and outside the hospital setting, but in order to do so, laboratories will need access to the complete EHRs including necessary software integration with electronic LIS infrastructures and anatomic pathology information systems (APIS).

The CAP is committed to working with policymakers on a spectrum of issues related to Health Information Technology, and will report regularly on these efforts in Statline.

PECOS Registration Requirement Delayed Until 2011

The Centers for Medicare & Medicaid Services (CMS) has delayed until January 3, 2011, enforcement of the requirement for physicians and non-physician practitioners who order items or services for Medicare beneficiaries, or refer Medicare beneficiaries to other Medicare providers or suppliers, to be enrolled with a current enrollment record in Medicare’s Provider Enrollment, Chain and Ownership System (PECOS).

Although enrolled in Medicare, many physicians and non-physician practitioners who are eligible to order items or services or refer Medicare beneficiaries to other Medicare providers or suppliers for services, do not have current enrollment records in Medicare. A current enrollment record is one that is in the PECOS system and contains a unique National Provider Identifier (NPI).

After January 3, 2011, a physician or non-physician practitioner who orders or refers and who does not have a current enrollment record that contains the NPI will cause the claim submitted by the Part B provider/supplier who furnished the ordered or referred item or service to be rejected.

CAP members can access directions on meeting this requirement and other assistance from the February 2010 issue of CAP@Your Service.


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