Regulatory Profiles

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April 2014 Clinical Laboratory News: Volume 40, Number 4


In This Issue...

Medicare Proposes Paying for HCV Screening

The Centers for Medicare and Medicaid Services (CMS) issued a proposal that would cover hepatitis C virus (HCV) screening for those at high risk and for baby boomers. The agency’s proposed decision memo for National Coverage Analysis noted that “the evidence is adequate to conclude that screening for HCV, consistent with the grade B recommendations by the U.S. Preventive Services Task Force (USPSTF), is reasonable and necessary for the prevention or early detection of an illness or disability and is appropriate for individuals entitled to benefits under Medicare Part A or enrolled under Part B.”

Under the proposal, Medicare would cover testing under two conditions. First would be those at high risk for HCV, defined as persons with a current or past history of illicit injection drug use and persons who have a history of receiving a blood transfusion prior to 1992. Repeat screening for high risk persons would be covered annually only for those who have had continued illicit injection drug use since the prior negative screening test. The second group includes anyone born from 1945–1965 who does not meet the high risk definition, and only for a single screening test.

The proposal calls for Medicare only to cover Food and Drug Administration (FDA)-approved/cleared tests and only when ordered by the beneficiary’s primary care physician or practitioner within the context of a primary care setting.

CMS noted in the proposal that according to a 2012 systematic review from USPSTF, up to three quarters of HCV-infected persons are unaware of their status. CDC recommends that HCV testing be initiated with an FDA-approved test for antibody HCV followed by an HCV nucleic acid test for those who test positive. CMS plans to make a final coverage decision in June.

More information on the proposal is available from CMS online, www.cms.gov/medicare-coverage-database.

OIG to Investigate Questionable Lab Billing

The Department of Health and Human Services (HHS) Office of the Inspector General (OIG) plans a study for 2014 that will review billing characteristics and identify questionable billing for Medicare Part B lab tests. OIG described the study in its annual work plan that lays out investigative studies for the year. Of note, OIG does not have any published plans to continue its study on oversight of laboratory-developed tests. Last year, OIG promised a report on this issue in 2014.

In explaining its intention to study lab billing, OIG noted that Medicare payments for lab services in 2008 represented an increase of 92% over payments in 1998. In 2010, Medicare paid about $8.2 billion for lab tests, but this only accounted for 3% of all Medicare Part B payments. Much of the growth in lab spending has resulted from the increased volume of ordered services, OIG wrote.

The OIG work plan is available on the OIG website, http://oig.hhs.gov.

Report: Government’s EHR Incentive Program Lacks Strategy

Even though the electronic health records (EHR) incentive program has seen increased participation, the Department of Health and Human Services (HHS) needs to fix problem areas that are holding back some providers, and it should implement a strategy to show how EHRs make a difference in healthcare, according to a report from the Government Accountability Office (GAO).

The Health Information Technology for Economic and Clinical Health (HITECH) Act of 2009 established the EHR incentive program that offers special bonuses to hospitals and physicians who adopt and use EHRs according to tiered standards called meaningful use. So far, HHS has met its goal for 50% of physician offices and 80% of eligible hospitals to have EHRs by the end of 2013.

However, some meaningful use measures are creating problems for providers, according to GAO, especially measures involving the electronic exchange of information. For example, GAO found that fewer than 15% of professionals reported on an optional stage 1 meaningful use measure to provide a summary of care document at each care transition or referral, which is mandatory in stage 2.

HHS also needs to apply a more thoughtful approach to planning the next stages of meaningful use under the EHR incentive program, GAO commented. The lack of a comprehensive strategy limits the ability of HHS to ensure it can reliably use the clinical quality measures collected from EHRs.

GAO also chided HHS for lacking a means to track progress toward outcomes such as healthcare quality, efficiency, and patient safety. Although EHRs have potential to help achieve improved outcomes, “that result is not yet assured,” GAO noted.

GAO recommended that HHS develop a comprehensive strategy to improve the reliability of clinical quality measure data and use outcome-oriented performance measures to monitor progress toward goals.

More information is available from the GAO website, www.gao.gov/products/GAO-14-207.

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