Regulatory Profiles

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March 2014 Clinical Laboratory News: Volume 40, Number 3


In This Issue...


HHS Finalizes Rule on Patient Access to Lab Reports

The Department of Health and Human Services (HHS) published a final rule that will give patients or a person designated by the patient direct access to completed laboratory test reports, preempting a patchwork of state laws that sometimes prohibit direct patient access to lab reports.

The final rule amends the Clinical Laboratory Improvement Amendments of 1988 (CLIA’88) regulations and eliminates the exception under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule to an individual’s right to access his or her protected health information when it is held by a CLIA-certified or CLIA-exempt laboratory. While patients can continue to access their laboratory test reports through their doctors, these changes give patients a new option to obtain their test reports directly from laboratories while maintaining strong protections for patients’ privacy, according to HHS.

Under the HIPAA Privacy Rule, patients, patients’ designees, and patients’ personal representatives can see or be given a copy of patients’ protected health information, including an electronic copy, with limited exceptions. In most cases, copies must be given to the patient within 30 days of request to the lab.

The Final Rule is effective April 5, and covered entities must comply by October 2. The final rule is available for review at www.federalregister.gov.

Payment Reform Showing Progress, Savings

According to the Centers for Medicare and Medicaid Services (CMS), key healthcare delivery reforms under the Affordable Care Act are demonstrating significant savings based on new CMS financial reports. The programs include the Medicare Accountable Care Organization (ACO) initiatives, Pioneer ACOs, the Physician Group Practice demonstration, and expanded participation in the Bundled Payments for Care Improvement Initiative. Savings from both the Medicare ACOs and Pioneer ACOs have now exceeded $380 million.

ACOs are supposed to achieve savings by improving coordination of care and by incentivizing providers to aim for value over volume. The interim financial results released for the Medicare Shared Savings Program ACOs show that, in their first 12 months, nearly half—54 out of 114—of the ACOs that started in 2012 already had lower expenditures than projected.
The Pioneer ACO Model also demonstrated significant savings. This ACO model is designed for more advanced organizations willing to take on even more financial risk. Pioneer ACOs generated gross savings of $147 million in their first year. Results showed that of the 23 Pioneer ACOs, nine had significantly lower spending growth compared to Medicare fee for service while exceeding quality reporting requirements.

CMS also found that the Physician Group Practice Demonstration initiatives have produced savings for 7 out of every 10 physician group practices that participate, totaling $108 million.
Finally, CMS announced that 232 acute care hospitals, skilled nursing homes, physician group practices, long-term care hospitals, and home health agencies have entered into agreements to participate in the Bundled Payments for Care Improvement initiative that bundles payments for episodes of care.

More information about these programs is available from http://innovation.cms.gov.

Joint Commission Proposes Revised Laboratory Accreditation Standards

A revised version of the Joint Commission’s clinical laboratory accreditation requirements is open for public comment through March 20. The Joint Commission reviewed the current standards to identify disparities against the Clinical Laboratory Improvement Amendments of 1988 (CLIA ‘88) and contemporary clinical best practice guidelines. Among the numerous requirements that the Joint Commission has clarified and revised in the proposed standards, the organization also created new requirements to deal with existing and emerging issues. Some redundant requirements were also deleted. The majority of these changes occurred in cytology, human resources, quality control, and transfusion medicine.

Comments can be submitted online at www.jointcommission.org.

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