CMS Guidance

The Centers for Medicare & Medicaid Services ("CMS") have released several helpful transmittals and publications on various topics that may be of interest to providers:

Additional resources, tools, and publications may be accessed here.

CMS Enrollment

CMS recently announced a moratoria on the enrollment of home health agencies in certain high-risk areas located in Florida, Texas, Illinois, and Michigan. The moratoria will be reviewed in six months, at which time they may be lifted or extended.

OIG Update

The Office of Inspector General ("OIG") recently released its Fiscal Year 2014 Work Plan, providing insight into the areas that the OIG will be focused on over the coming months. It is recommended that all providers review the Work Plan and their compliance with regard to the specific areas mentioned. A copy of the Work Plan is available here.

The OIG recently issued the final rule extending the Stark Law exception and Anti-Kickback safe-harbor for donated electronic health records ("EHR") and items until December 31, 2021. The exception and safe-harbor were set to expire at the end of 2013. In conjunction, the final rule contains certain revisions to the exception and safe-harbor. For example, laboratories are now excluded from the types of entities that can donate EHR items and services and donated EHR systems no longer must have electronic prescribing capabilities. Additional information is available here.

As a reminder, the OIG maintains a provider compliance page designed to help health care providers understand various compliance issues. The OIG compliance page may be accessed here.

HIPAA Update

The Office of Civil Rights ("OCR") is preparing for a second round of HIPAA compliance audits which will review compliance with the HIPAA privacy and security requirements. OCR has stated that this next round of audits will include business associates as well as covered entities. Additional information is available here.

OCR recently released guidance on the interaction between HIPAA and mental health information, addressing when providers may share information related to mental health patients under HIPAA. Specifically, the guidance addresses communications with family and friends, protection of psychotherapy notes, accessing the mental health records of minors, and the interaction of HIPAA with more stringent state and federal laws. Additional information is available here.

OCR recently expanded a patient's ability to directly access laboratory test results. Under the new rule, a laboratory may provide test results directly to a patient or his/her designee or personal representative. Prior to the rule change, laboratories could only disclose test results to the person authorized under state law to receive the results, the person responsible for using the results for treatment purposes, or the referring laboratory. Additional information is available here.

RAC Update

CMS recently ordered Recovery Audit Contractors ("RAC") and Medicare Administrative Contractors ("MACs") to cease issuing additional documentation requests by February 28, 2014. However, RACs can continue to conduct automated reviews that do not require the solicitation of medical records through June 1, 2014. RACs may also continue to complete reviews implemented prior to February 28, 2014. CMS has stated that the audits and documentation requests will be reinstated once the new RAC contracts are issued.

FDA Update

The Food and Drug Administration ("FDA") recently issued a final rule requiring mandatory electronic reporting for individual medical device adverse events. This rule does not change the underlying reporting requirements, but rather changes the manner in which they are submitted to the FDA by requiring electronic reporting. Additional information regarding medical device reporting is available here.

OSHA Update

In 2011, hospitals recorded 253,700 work-related injuries and illnesses. In attempts to reduce this number, the Occupational Safety and Health Administration ("OSHA") recently unveiled a new online resource for hospitals and employers designed to help prevent and adequately address workplace injuries. Additional information is available here.