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Wachler & Associates Health Law Blog

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Proposed Stage 3 Meaningful Use Rules

On Friday March 20, 2015, the Centers for Medicare & Medicaid Services (“CMS“) announced the release of the new Stage 3 meaningful use proposed rules. Concurrently, the Office of the National Coordinator for Health Information Technology (“ONC”) released its new EHR certification requirements, which are linked to its previously released…

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OIG Advisory Opinion Clarifies that Excluded Providers May Receive Payments for Services Performed and Billed by Practice Prior to Exclusion

On February 9, 2015, the U.S. Department of Health and Human Services Office of Inspector General (OIG) delivered an advisory opinion finding that a physician or provider previously excluded from participating in Medicare, Medicaid, and all other federal health care programs was permitted to share in federal payments with his…

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FDA Gives Finalized Guidance on Medical Device Data Systems, Mobile Apps, and Medical Image Storage and Communications Devices

The Food and Drug Administration (FDA) issued non-binding guidance on February 9, 2015 finalizing its position on regulatory compliance of medical device data systems (MDDS), medical image storage and communications devices and mobile medical applications. In its recently issued guidance, the FDA explained that it will not enforce compliance with…

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CMS Offers Clarification to HHA Contradictory Guidance

On March 18, 2015, Wachler & Associates attorneys, Andrew Wachler and Jessica Forster, highlighted contradictory guidance released by the Centers for Medicare and Medicaid Services (“CMS”) relating to home health agencies (“HHAs”) face-to-face encounter documentation. When the calendar year (“CY”) 2015 Home Health Final Rule (“Final Rule”) went into effect…

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CMS to Audit All Home Health Agencies

In response to a report issued by the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) titled Limited Compliance with Medicare’s Home Health Face-to-Face Documentation Requirements, the Centers for Medicare and Medicaid Services (“CMS”) has decided to audit all home health agencies (“HHAs”) in the country.…

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President’s 2016 Budget Proposes Changes to Recovery Audit Procedures

On February 2, 2015, the White House released President Obama’s budget report for fiscal year 2016. A significant portion of the report is dedicated to healthcare issues. The report proposes several reforms to the Medicare program and purports a projected savings of $407.2 billion in the next 10 years. Additionally,…

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CMS Considers Shortening the Meaningful Use Reporting Period

On January 29, 2015, the Centers for Medicare and Medicaid Services (“CMS”) announced that it will consider shortening the meaningful use reporting period for electronic health record (“EHR”) systems. Specifically, CMS stated that it intends to reduce the 2015 reporting period from 12 months to 90 days. Under the meaningful…

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CMS Modifies Manual Medical Review Process for Outpatient Therapy Claims Above Cap

The Protecting Access to Medicare Act of 2014 extended the process for exceptions to Medicare’s outpatient therapy caps through March 2015. Exceptions to Medicare’s outpatient therapy caps are allowed for medically necessary and reasonably therapy services. However, claims above $3,700 for physical therapy and speech language pathology services combined, and…

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Pharmaceutical Company Pays $39 million to Settle Anti-Kickback and False Claims Allegations

On January 9, 2015, the Federal Bureau of Investigations and Department of Justice, along with several state Medicaid programs, announced that Daiichi Sankyo Inc. (“Daiichi”), a U.S. subsidiary of a Japanese pharmaceutical company, agreed to pay $39 million to settle alleged violations of the Anti-Kickback Statute and False Claims Act…

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HHS Sets Timelines for Focus of Reimbursement to Shift from Quantity to Quality

On January 26, 2015, the U.S. Department of Health and Human Services (“HHS”), for the first time ever, announced a timeline and corresponding goals to shift the basis of Medicare reimbursement away from the quantity of care provided towards the quality furnished to beneficiaries. With the passage of the Patient…

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