June 2008 Clinical Laboratory News: Regulatory Profiles

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June 2008: Volume 34, Number 6

President Signs GINA into Law

President Bush has signed the Genetic Information Nondiscrimination Act (GINA) into law, following its unanimous approval in the Senate, by a vote of 95-0, and near-unanimous approval in the House of Representatives, by a vote of 414-1. GINA will protect individuals by prohibiting employers from making employment-related decisions, such as hiring or firing, based on a person’s genetic information. The bill also will make it illegal for health insurers to use genetic information to raise premiums or deny coverage.

About 35 states have laws barring genetic discrimination in employment and 47 have them against health insurance discrimination, but the laws vary widely. Consumer advocates say the bill will close gaps in state laws and encourage people to take advantage of genetic testing, which they may avoid for fear of losing jobs or health benefits.

GAO Report Takes Up Hospital Acquired Infections  

A report from the Government Accountability Office (GAO) suggests that the federal government is not doing enough to prevent hospital acquired infections (HAIs)—a leading cause of death in the U.S.—and recommends that the Secretary of HHS identify priorities among the CDC’s 13 recommended guidelines and almost 1,200 practices to more effectively deal with the problem. The report suggests that failure by HHS to develop priorities among the CDC’s recommended practices has hindered their implementation. The report also recommends that HHS establish greater consistency and compatibility in its multiple databases to provide a more complete picture of these infections.

Although multiple agencies collect HAI data, each agency focuses on different types of HAIs and different types of patients. Poor integration across databases also limits the ability of analysts to interpret the data effectively. The report also calls upon HHS to take more aggressive action, including: issuing more specific guidelines of recommended practices, requiring hospitals to comply with certain standards, releasing data to expand information about the nature of the problem, and potentially adjusting hospital payment methods to encourage reducing the number of HAIs. To view the report, go online.

U.S., Japan Create Global Alliance for Pharmacogenomics

The U.S. and Japan have created the Global Alliance for Pharmacogenomics to promote collaboration among each nation’s leading scientists to identify “genetic factors that contribute to individual responses to medicines, including rare and dangerous side effects.”

Initially, the consortium will focus its attention on five items, including: understanding genetic factors that influence the effectiveness of breast cancer treatments; determining the optimal length of treatment for two drugs used to treat early stage breast cancer; discovering new genetic factors linked to serious side effects from certain pancreatic cancer drugs; exploring how genes contribute to drug-induced long QT syndrome, an irregular heart rhythm that can cause sudden cardiac arrest; and disclosing any of the information included in the bid application.

According to NIH Director Elias Zerhouni, MD, this international agreement will speed “scientific discovery and the translation of results into improved treatments for cancer, heart disease, and other serious conditions.” A copy of the letter of intent between the two countries is available on the NIH Web site.

UCLA Employee Charged With Stealing Medical Records

A former administrative assistant with the UCLA Medical Center was indicted by a federal grand jury for illegally accessing patient health records and selling celebrities’ private health information to a national media outlet. The former employee could face as many as 10 years in prison if convicted.

The Los Angeles Times linked the indictment to illegally obtained records on former news reporter and now California First Lady Maria Shriver, and actress Farah Fawcett. Private medical records are protected under the Health Insurance Portability and Accountability Act (HIPAA). Such information breaches may be subject to criminal and civil penalties that include imprisonment and potentially heavy monetary fines.

California enacted a more stringent data-breach law earlier this year to include unencrypted medical histories, information on mental or physical conditions, and medical treatments and diagnoses. Also covered are unencrypted insurance policy or subscriber numbers, any applications for insurance, claims histories, and claims appeals. The law previously applied only to financial information.

States Investigate Gene Testing Companies

New York State has sent warning letters to gene-testing companies, saying the companies need a state permit to offer such tests and services. The California Department of Public Health is investigating six companies, but has not named them.

Companies that received letters from New York State include Navigenics (Redwood Shores, Calif.), 23andMe (Mountain View, Calif.), Affymetrix (Santa Clara, Calif.), Illumina (San Diego, Calif.), HairDx (Irvine, Calif.), and DeCode Genetics (Reykjavik, Iceland). Illumina and Affymetrix supply genotyping tools to 23andMe and Navigenics, but do not market genetics services themselves. New York State health officials consider the services marketed by these companies to be medical tests, which make them subject to medical testing regulations under state law. The California agency is examining the companies’ operations based on complaints about the cost and accuracy of the tests. Another issue at stake in California is physician involvement, because state law requires that medical doctors order such tests.

Medicare Finalizes ABN Form

CMS has replaced both the General Use Advanced Beneficiary Notice (ABN) (CMS-R-131-G) and the Laboratory ABN (CMS-R-131-L) with the new Advanced Beneficiary Notice of Noncoverage (ABN) (CMS-R-131).

Providers—including independent laboratories, physicians, other practitioners, and suppliers—may use the revised ABN for all situations where Medicare payment is likely to be denied. CMS will allow a transition period from the date of implementation for use of the revised form and instructions. All providers and suppliers must begin using the revised ABN (CMS-R-131) no later than September 1, 2008.

The new ABN consolidates the ABN-G for general services and the ABN-L for lab services. It also now contains a mandatory field for cost estimates and includes an option for beneficiaries to choose a service for which they will pay out-of-pocket.

Go online to view additional information.

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