Federal
ASCP Urges CMS to Strengthen Anti-Markup Rule on Pathology Services
On August 29, ASCP strongly urged the Centers for Medicare and Medicaid Services (CMS) to strengthen the anti-markup rule prohibiting physicians from marking up anatomic pathology services. In so doing, ASCP advocated that CMS exempt pathology services from the in-office ancillary services exception of the Stark Law, saying it was the best way to deter overutilization and billing abuse of pathology services. ASCP’s comments were in response to CMS’ proposed rule on the physician fee schedule for 2009.
In its letter, ASCP stated its belief that “allowing providers to profit from the referral of pathology services distorts medical decision-making, undermines patient trust in the medical profession, and can adversely affect patient care.” Moreover, ASCP wrote that “we see little difference between in-office pathology arrangements, such as the recent increase in in-office histology (technical component-only) labs, and pod labs” in terms of their ability to enable physicians to profit on the pathology services they order.
In this year’s proposed rule, CMS proposed modifying its anti-markup rule and sought comments on two possible approaches. The first, dubbed the “share a practice” model, would apply the anti-markup provisions to diagnostic testing services performed or supervised by a physician unless the performing or supervising physician shared a practice with the billing physician or physician organization.
The second approach maintains the current anti-markup rule’s “site of service” approach, albeit clarifying its application. It would continue its application to the technical and professional components (TC and PC, respectively) of non-purchased tests performed outside of the “office of the billing physician.” Last year’s final rule also expanded the anti-markup rule to the professional component of purchased tests.
ASCP also raised concern about CMS’ proposal to require laboratories to maintain ordering and referring documentation for 10 years rather than the current seven years, as well as the proposal to mandate verification of the National Provider Identifier with each order. ASCP also urged that the TC grandfather provisions be made permanent, enabling certain independent clinical laboratories to bill for the technical component of services provided to hospital inpatients and outpatients. The grandfathering provisions were extended through December 31, 2009, by Congress as part of the Medicare Improvements for Patients and Providers Act of 2008.
ASCP Urges CMS to Clarify “Intentional” PT Referral
Recently, ASCP wrote CMS regarding its proficiency testing (PT) referral enforcement policies to raise concern about recent enforcement actions. CMS has been revoking clinical laboratories’ CLIA certificates and imposing the two-year ban on owning or operating a lab in cases involving accidental or inadvertent PT referrals.
These enforcement actions relate to CMS’ interpretation of the term, “intentional referral,” which is not defined in the regulations for the Clinical Laboratory Improvement Amendments of 1988 (CLIA). According to the CLIA statute, “Any laboratory that the Secretary determines intentionally refers its proficiency testing samples to another laboratory for analysis shall have its certificate revoked for at least one year and shall be subject to appropriate fines and penalties.” In addition, CLIA states that no person who has owned or operated a laboratory that has had its CLIA certificate revoked may own or operate a laboratory for two years from the date of revocation.
In writing CMS, ASCP argued that certain PT referrals should not be considered intentional. For example, when a proficiency testing sample provides an unexpected abnormal value, reflexive testing at a second laboratory may be necessary. Such cases should not result in the revocation of the certificate and the imposition of a two-year ban on owning or operating a laboratory. In fact, such cases point to two CLIA statutory mandates that are in direct conflict: one prohibiting referrals and the other requiring treating proficiency testing samples in the same manner as patient specimens.
ASCP urged CMS to clarify the rule to allow the agency to “act swiftly against clinical laboratories intent on evading CLIA’s important patient safety requirements while at the same time allowing those laboratories that have committed minor compliance infractions to come back into compliance in a less disruptive manner.”
Election Preview
Will Results of Presidential Elections Chart a New Course for the Nation’s Health Care System?
Candidates Weigh In: How will Health Care Look Under My Administration?
With the presidential election just months away, voters are homing in on what Senators John McCain and Barack Obama are saying about the issues that impact voters’ lives. Key among their concerns is health care. In fact, the Kaiser Foundation recently reported that, “when it comes to the relative importance of different issues in deciding their vote, health care was one of the top five issues chosen by voters in three of the last four presidential elections” and is likely to be an important factor in this election as well. During the primary season, likely voters ranked health care third in order of importance behind the economy and the war in Iraq.
In the midst of clear evidence that health care matters to the electorate, how do the candidates of the two major parties propose to repair what many consider to be a “broken” health care system. Both Senators McCain and Obama propose expanding the State Children’s Health Insurance Program (SCHIP), which is designed to provide low-cost health insurance for children and families. In addition to assuring the children are covered, what else are the candidates putting on the table?
The Obama Plan
Senator Obama proposes a national health program that will allow individuals and small businesses to buy affordable health care similar to that available to federal employees. Subsidies would be available to help with the cost of premiums for those that need assistance. Moreover, there are plans to make available a National Health Insurance Exchange to reform the private insurance market. The premise is that any American could enroll in private plans that would be required to provide comprehensive benefits, to issue every applicant a policy, and to charge fair and stable premiums. In addition to SCHIP, Senator Obama proposes to expand Medicaid and require employers to make “meaningful” contributions to the health coverage of their employees. His plan also places great emphasis on reducing costs and moving toward a public health model. For details on Senator Obama’s proposed health plan, visit his website.
The McCain Plan
Senator McCain’s plan has a basic premise to provide affordable health care without a mandate, thereby reducing regulations and government intervention and increasing individual responsibility. The Senator thinks that there should be an expansion of community health centers; tax incentives for low-income Americans to be able to afford health care coverage; expansion of health care online; reform of medical malpractice; and more availability of health savings accounts. Senator McCain advocates for employers to continue to provide health care coverage to employees or increase salaries so that they might purchase individual coverage. In addition, his proposal calls for federal subsidies for high-risk health insurance pools to help those who cannot obtain private coverage because of pre-existing medical conditions or lack of any previous health coverage. For details on Senator McCain’s proposed health plan, visit his website.
Health care is indeed a high priority issue for voters and candidates alike. The issue clearly becomes how to balance costs yet at the same time provide quality, affordable health care to all. If you are interested in comparing the candidates’ proposals, take a look at the following side-by-side summary by the Kaiser Family Foundation: www.health08.org
E-Policy will report in upcoming issues on changes being made to the U.S. health care system and, most importantly, on changes that impact the field of laboratory medicine.
As a Section 501(c)(3) organization, ASCP does not endorse any candidate in any race on the national, state or local front. Although this article focuses on the health care policies of the nominees by the two major parties, it is important to note that many third-party candidates also have positions on health care issues, and their websites can be consulted for further details.