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August 2012 Clinical Laboratory News: Regulatory Profiles

Regulatory Profiles

CDC Effort Expands HIV Testing into Pharmacies

The Centers for Disease Control and Prevention (CDC) announced a pilot project to train pharmacists and retail store clinic staff at 24 rural and urban sites to deliver rapid HIV screening. The goal of the program is to explore extending HIV testing and counseling into the “standard everyday services” offered by pharmacies and retail clinics.

CDC plans to use results of the pilot effort to develop a model for implementation of HIV testing in such settings across the U.S. Community pharmacies and retail clinics will play a critical role in ensuring more people have access to HIV testing, according to CDC. An estimated 30% of the U.S. population lives within a 10-minute drive of a retail clinic. Compared to healthcare settings and conventional HIV testing sites, these locations may provide an environment that is more accessible to people who may be anxious about seeking an HIV test.

“Our goal is to make HIV testing as routine as a blood pressure check,” said Jonathan Mermin, MD, director of CDC’s Division of HIV/AIDS Prevention. “This initiative is one example of how we can make testing routine and help identify the hundreds of thousands of Americans who are unaware that they are infected.”

Based on lessons learned during the 2-year pilot project, CDC plans to develop a comprehensive toolkit that pharmacists and retail clinic staff from across the country can use to implement HIV testing.

More information is available from CDC’s HIV website.

OIG Issues Report on Genetic Tests

The Department of Health and Human Services Office of the Inspector General (OIG) released a report, Coverage and Payment for Genetic Laboratory Tests, evaluating how Medicare pays for 20 high-volume and high-cost tests. The report was prepared at the request of the Centers for Medicare and Medicaid Services (CMS), which is now in the process of establishing payment rates for 101 new genetic codes created by the American Medical Association (AMA).

The OIG reported wide variation in payment amounts among state Medicaid programs for some genetic tests. For example, Pennsylvania paid $1,000 for a BRCA1 analysis, whereas Iowa reimbursed nearly $4,000. OIG did not make any formal recommendations to CMS.

The report comes as CMS mulls over whether it will pay for the new molecular codes on the clinical lab fee schedule or on the physician fee schedule. The new codes are slated to go into full effect in 2013. Because molecular tests do not have single, analyte-specific codes, labs must bill a list, or ‘stack,’ of codes that describes each separate step or methodology performed. Under the new AMA coding scheme released last year, tests that make up the majority of the volume of molecular diagnostics are covered by single analyte-specific codes.

The report is available from the OIG website.

Research Panel Created by Affordable Care Act Tackles Diagnostics

Created by the Affordable Care Act, the Patient-Centered Outcomes Research Institute (PCORI) is charged with promoting research on the benefits and harms of drugs, diagnostics, and other elements of healthcare. This public-private institute replaces the Federal Coordinating Council for Comparative Effectiveness Research that was founded under the 2009 American Recovery and Reinvestment Act, known as the stimulus bill, which allocated more than $1 billion for comparative effectiveness research. Now, PCORI has released a preliminary draft methodology report, identifying 60 standards to guide patient-centered outcomes research.

The report includes five standards for possible studies of diagnostic tests: specify the clinical context and key elements of diagnostic test study design; study design is informed by investigations of the clinical context of testing; assess the effect of factors known to affect diagnostic performance and outcomes; structure reporting of diagnostic comparative effectiveness results; and give preference to randomized designs of studies of test outcomes. PCORI is expected to fund $120 million in comparative effectiveness research in 2012.

More information is available from the PCORI website.

CMS Paid More than 100,000 Providers for Using EHRs

Surpassing the government’s 2012 goal for adoption of EHRs, more than 100,000 healthcare providers now report using electronic health records that meet federal standards. These organizations received payments from the Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs.

According to the Centers for Medicare and Medicaid Services (CMS), providers are now moving more quickly to take advantage of incentives. Early this year, CMS acting administrator Marilyn Tavenner set the goal of getting 100,000 health care providers to adopt or meaningfully use EHRs by the end of 2012. Providers surpassed that goal in June.

The EHR Incentive Programs, which began in 2011, provides incentive payments to eligible professionals, hospitals, and critical access hospitals as they adopt, implement, and upgrade certified EHR technology in ways that improve care. The program was established by the Health Information for Clinical and Economic Health Act of 2009 (HITECH).

At the end of May 2012, more than 110,000 eligible professionals and over 2,400 eligible hospitals have been paid by the Medicare and Medicaid EHR Incentive Programs. Approximately 48% of all eligible hospitals and critical access hospitals in the U.S. have received an incentive payment for adopting, implementing, or upgrading an EHR. One out of every five eligible providers who serve Medicare patients in the U.S. has received an incentive payment. 

More information on the EHR Incentive Program is available from the CMS website.

CDC Study: Nearly Half of U.S. Adults Miss Key Preventive Services

Prior to 2010, only about half of U.S. adults received selected preventive services such as screenings, consultations, and prescriptions, from a health care professional, according to a study by the Centers for Disease Control and Prevention (CDC). The study, Use of Selected Clinical Preventive Services Among Adults – United States, 2007–2010, offers a comprehensive look at adult clinical preventive services in the U.S.

The report provides baseline data on the use of selected adult preventive services. It found that during visits to their doctors only 47% of patients with heart disease were prescribed the recommended daily use of aspirin, and fewer than half of those with high blood pressure had it under control.

Similarly, 33% percent of men and 25% percent of women did not receive recommended cholesterol screenings during the preceding 5 years. Of those adults identified with high levels of LDL cholesterol, only about 32% had it under control. The report also provides baseline data on diabetes management, colon and breast cancer screening, HIV testing, and influenza vaccination.

CDC emphasized that the report findings indicate that tens of millions of people in the U.S. have not been benefitting from key preventive clinical services, and that there are large disparities by demographics, geography, and healthcare coverage and access in the provision of these services.

According to CDC, certain provisions in the Affordable Care Act will address these problems. These include a requirement for new private health insurance plans to cover recommended preventive services with no cost-sharing. The healthcare law also requires coverage for a new annual wellness visit under Medicare and eliminates cost sharing for recommended preventive services provided to Medicare beneficiaries. In addition, the law gives state Medicaid programs financial incentives to cover preventive services for adults and supports initiatives to improve public understanding of the benefits of preventive services.

More about the study is available from the CDC website.

CMS Proposes Payment Changes for Hospital Outpatient Care

The Centers for Medicare and Medicaid Services (CMS) issued a proposed rule that would update payment policies and payment rates for services for Medicare beneficiaries in hospital outpatient departments (HOPDs) and ambulatory surgical centers (ASCs) beginning Jan. 1, 2013. The proposals would affect HOPDs in more than 4,000 hospitals and approximately 5,000 Medicare-participating ASCs.

CMS is proposing to increase HOPD payment rates by 2.1% and to increase ASC payment rates by 1.3%. Based on the proposed updates and other policies in the proposed rule, CMS projects that total payments to hospitals under the Outpatient Prospective Payment System (OPPS) in calendar year 2013 will be approximately $48.1 billion. CMS also projects that payments to ASCs under the ASC Payment System will be approximately $4.1 billion.

The proposed rule also would streamline the operations of Quality Improvement Organizations (QIOs) and make them more responsive to beneficiary complaints about quality of care. By law, each state must have a QIO that is in charge of reviewing the care for Medicare patients who have complaints about their care. Under the proposed rule, beneficiaries would be given more information about a QIO’s review process, and would create a new alternative dispute resolution option, called Immediate Advocacy, to resolve beneficiary complaints. The proposed rule also would give QIOs authority to send and receive secure transmissions of electronic versions of health information. Finally, the proposals would enable QIOs to release more information about the results of their reviews to affected beneficiaries.

CMS will accept comments on the proposed rule until September 4, 2012, and will respond to all comments in a final rule to be issued by Nov. 1, 2012. The proposed rule is available from the Federal Register website.