American Association for Clinical Chemistry
Better health through laboratory medicine
September 2011 Clinical Laboratory News: Regulatory Profiles

Regulatory Profiles


CAP Releases New Accreditation Checklists

The College of American Pathologists (CAP) Laboratory Accreditation Program has released new checklists that are used in the accreditation inspection process to help laboratories meet Centers for Medicare and Medicaid Services (CMS) requirements. The new checklists are designed to provide less redundancy and remove obsolete requirements. They also consolidate requirements that are similar or identical across most disciplines into a newly created All Common Checklist, removing requirements from discipline-specific and the Laboratory General checklists. All Common requirements include proficiency testing, test method validation, procedure manuals, and critical results.

More information is available online.

IOM Recommends Additional Preventive Services for Women

A new report from the Institute of Medicine (IOM) recommends that eight preventive health services for women be added to the list that health plans will cover at no cost to patients under the healthcare reform law, the Affordable Care Act. The act requires health plans to cover all services listed in the U.S. Department of Health and Human Services’ (HHS) comprehensive list of preventive services.

If HHS adopts IOM’s recommendations, new health insurance plans beginning on or after August 1, 2012 must cover well-woman visits, screening for gestational diabetes, human papillomavirus DNA testing for women 30 years and older, sexually-transmitted infection counseling, HIV screening and counseling, FDA-approved contraception methods and contraceptive counseling, breastfeeding support, and domestic violence screening and counseling. The recommendations are based on IOM’s evaluation of existing guidelines and the evidence on the effectiveness of different preventive services.

In 2010, HHS released new insurance market rules under the Affordable Care Act requiring all new private health plans to cover several evidence-based preventive services like mammograms, colonoscopies, blood pressure checks, and childhood immunizations without charging a copayment, deductible, or coinsurance. The Affordable Care Act also made recommended preventive services free for people on Medicare.

The new guidelines are available online.

WHO Recommends Molecular Tests for TB

Calling current antibody tests for tuberculosis (TB) substandard and unreliable, the World Health Organization (WHO) is now urging countries to ban all tests that are not microbiological or molecular.

The new recommendation comes after 12 months of analysis by WHO and global experts. WHO found very low sensitivity in commercial blood tests, leading to an unacceptably high number of patients receiving false-negative results. The research also found low specificity.

According to WHO, more than one million blood tests are carried out annually to diagnose active TB, often at cost to patients. Some patients pay $30 per test. Most of the 18 available tests are manufactured in Europe and North America, even though they are not approved by any recognized regulatory body.

This is the first time WHO has issued an explicit negative policy recommendation against a practice that is widely used in tuberculosis care.

WHO’s report and recommendations are available online.

HHS Moves Ahead with Insurance Exchanges

The Department of Health and Human Services (HHS) has proposed a framework to assist states in building Affordable Insurance Exchanges, state-based marketplaces where individuals and small businesses will be able to purchase private health insurance. Starting in 2014, these exchanges aim to help individuals and small businesses to compare health plans, get answers to questions, and find out if they are eligible for tax credits for private insurance or health programs like the Children’s Health Insurance Program.

Under the framework announced by HHS, the agency proposed new rules offering states guidance on how to structure their exchanges, including setting standards for establishing exchanges, performing the basic functions of an exchange, certifying health plans for participation in the exchange, and ways of ensuring premium stability for plans and enrollees.

Forty-nine states, the District of Columbia, and four territories have accepted grants to help plan and operate exchanges. In addition, over half of all states are taking additional action beyond receiving a planning grant, such as passing legislation or taking administrative action to begin building exchanges. States will continue to implement exchanges on different schedules through 2014.

More information is available online from HHS.

Medicare Final Payment Rule Focuses on Readmissions

The Centers for Medicare & Medicaid Services (CMS) issued a final rule that will update Medicare payment policies and rates for hospitals in fiscal year 2012. The final rule, which will affect Medicare payments to general acute care hospitals and long-term care hospitals for inpatient stays, aims to improve quality by further cutting payments for errors and readmissions.

The final rule also adopts a Medicare spending per beneficiary program required by the Affordable Care Act. The new measure will assess Part A and Part B beneficiary spending during a period of time that spans from 3 days prior to a hospital admission through 30 days after the patient is discharged. The goal is to encourage hospitals to provide quality care to Medicare beneficiaries at a lower cost and to promote greater efficiencies across care settings.

CMS projects that total Medicare operating payments to acute care hospitals for inpatient services occurring in 2012 will increase by $1.13 billion, or 1.1%, in 2012 compared with 2011, due to a 1.0% increase in payment rates together with other policies adopted in the final rule.

The Affordable Care Act requires CMS to implement a Hospital Readmissions Reduction Program that will reduce payments beginning in 2013. To comply, the CMS final rule finalizes readmissions measures for three conditions—acute myocardial infarction, heart failure, and pneumonia—as well as the methodology that will be used to calculate excess readmission rates for these conditions.

The final rule will increase payments to general acute care hospitals by 1.1 %, and will increase payments to long-term care hospitals by 2.5%.

The final rule is available from the Federal Register website.