American Association for Clinical Chemistry
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September 2012 Clinical Laboratory News: Regulatory Profiles

Regulatory Profiles

CAP Adds Next Generation Sequencing to Accreditation Checklist

The College of American Pathologists (CAP) published a revised version of its molecular pathology checklist with a dedicated section on next generation sequencing (NGS) as part of the new edition of the CAP Laboratory Accreditation Program checklists. CAP is the first accrediting organization to publish an accreditation checklist that addresses NGS.

According to CAP, the NGS Working Group aimed to balance the necessary framework for clinical testing using NGS while still accommodating different platforms and rapidly changing technology.

The new NGS section of the molecular pathology checklist has 18 requirements that deal with the analytical wet bench process, including conversion of DNA into an NGS library followed by sequencing, as well as bioinformatics analyses such as sequence alignment and mapping, variant calling, and annotation.

In its announcement, CAP also said it has plans to develop NGS proficiency testing products in the near future.

More information is available online.

Free Screening Tests for Women Go Into Effect

Beginning in August, eight preventive healthcare services and screening tests must now be made available to women without a copay, under new rules governing health insurance included in the Affordable Care Act.

According to a Department of Health and Human Services report, approximately 47 million women are in health plans that must cover these new preventive services at no charge. The services are: well-woman visits, gestational diabetes screening, domestic and interpersonal violence screening and counseling, FDA-approved contraceptive methods and counseling, breastfeeding supplies and counseling, human papilloma virus DNA testing for women older than age 30, sexually transmitted infections counseling, and HIV screening and counseling.

The services are based on recommendations from the Institute of Medicine that came out in July 2011. Already in effect under the Affordable Care Act are rules that require coverage for mammograms, cholesterol screenings, and flu shots without coinsurance or deductibles.

Group health plans and issuers that have maintained grandfathered status are not required to cover these services. In addition, certain nonprofit religious organizations, such as churches and schools, are exempt.

More information is available online.

CMS Stalling on New Molecular Test Codes

The Centers for Medicare and Medicaid Services (CMS) has yet to decide what it will do with the new analyte-specific molecular pathology billing codes being developed by the American Medical Asso-ciation (AMA). However, in its annual proposed rule for the physician fee schedule (PFS), the agency has said that it would prefer to place all of the new molecular codes on either the PFS or the clinical laboratory fee schedule (CLFS).

Currently, molecular tests do not have single, analyte-specific codes, so labs must bill a list, or stack, of codes from the CLFS that describes each separate step or methodology performed. Under the new AMA coding scheme released in 2011, tests that make up the majority of the volume of molecular diagnostics are covered by single analyte-specific codes. Some organizations, including AACC, had recommended that only those tests that require a pathologist’s interpretation should move onto the physician fee schedule, while the College of American Pathologists and the Association for Molecular Pathology recommended all the new codes be placed on the physician fee schedule.

In its comments about the codes in the proposed rule for the PFS, CMS noted concern that “establishing different prices for comparable laboratory services across two different payment systems would create a financial incentive to choose one test over another simply because of its fee schedule placement.” The American Clinical Laboratory Association reviewed the codes and found that only 32 of more than 100 codes required physician interpretation, while AMA’s review identified 79.

The final PFS rule is slated to be issued this month, and in it CMS is expected to announce its decision about where the molecular codes should be placed. However, CMS indicated that the agency does not yet feel prepared to begin pricing the codes, and will need to rely on local Medicare contractors for the job.

The CMS proposed rule is available from the Federal Register, online.

Bills Could Fix Proficiency Testing Referral Problem

Senator Amy Klobuchar (D-Minn.) and Representative Michael Grimm (R-N.Y.) recently introduced legislation, “Taking Essential Steps for Testing Act of 2012,” S.3391 and H.R.6118, that would give the Centers for Medicare and Medicaid Services (CMS) more leeway in how it deals with proficiency testing (PT) referral violations.

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA ’88), laboratories that refer PT specimens to an outside laboratory for analysis lose their CLIA certificate for at least 1 year, even if the specimen was not referred to intentionally cheat. Since many labs have policies that automatically refer certain specimens to another lab, this statute has been a cause for concern for many years. Labs consider the statute especially onerous because when CMS revokes a CLIA certificate, the lab director cannot direct a clinical laboratory for 2 years and the owner cannot own or operate a laboratory for the same period.

Both of the bills would modify the statute to give CMS the flexibility to impose lesser sanctions if the agency determines that a referral was done in error.

Both bills are available on the Library of Congress’s website.

Supreme Court Ruling Means Reform Costs Less but Covers Fewer

According to a recent analysis from the Congressional Budget Office (CBO), the Supreme Court’s June ruling on the Affordable Care Act (ACA) will translate into greater federal deficit reduction but fewer people with healthcare coverage. Under the court’s ruling, the federal government may not force states to increase the number of people covered under Medicaid. This expansion of Medicaid at the state level was one of the main ways that the law attempted to broaden coverage for low-income people.

CBO now estimates that the insurance coverage provisions of the ACA will cost about $1.168 trillion over the 2012–2022 period. This is compared to the previous estimate of $1.252 trillion, resulting in a net savings of about $84 billion. The CBO expects that lower Medicaid enrollment will more than offset costs of the potentially greater participation in the new health insurance exchanges subsidized under the law. Overall, CBO estimates that the law will cover 6 million fewer people than projected before the Supreme Court ruling.

Fewer people will be covered under the law because only a portion of the people who will not be eligible for Medicaid will now be eligible for subsidies through the exchanges. CBO estimates that as a consequence of the ruling, up to two-thirds of the people previously estimated to become eligible for Medicaid under the ACA will have income too low to qualify for exchange subsidies, while roughly one-third will have income high enough to be eligible for exchange subsidies.

CBO did not attempt to predict which states would move forward and expand their Medicaid programs, and which would not. The report makes a general assumption that about half of the population will live in states that either do not expand Medicaid, or do so only partially.

The report is available from the CBO website.