Richard K. Rifenbark

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The Federal Office for Management and Budget has withdrawn the proposed omnibus guidance for the 340B Drug Pricing Program (previously referred to as the “Mega-Regs”), creating further uncertainty in the 340B Program. The guidance was proposed in the Fall of 2015, and would have updated all areas of 340B Program guidance. The guidance would have included significant changes to the definition of an eligible patient, and to 340B Program integrity provisions. By withdrawing the…
Just in time for the New Year, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services issued final regulations (Final Regulations) that revised two existing Anti-Kickback Statute safe harbors, added two regulatory safe harbors to complement existing statutory safe harbors, and created an entirely new safe harbor regarding local transportation services.  These regulations, which became effective on January 6, 2017, finalized the proposed regulations that OIG released on October…
On June 9, 2016, California’s End of Life Option Act (the “Act”) will go into effect.  The Act authorizes an adult who is suffering from a terminal disease and meets other qualifications to request an aid-in-dying drug that may be prescribed for the purpose of ending his or her life.  California is the fifth state to enact a form of an aid-in-dying law.  Similar laws are in place in Oregon, Washington, Montana, and Vermont.…
As we enter the sixth year of the Medicare and Medicaid Electronic Health Records Incentive Programs (commonly referred to as the “Meaningful Use Programs”), the Centers for Medicare & Medicaid Services (CMS) continues to make adjustments to the Meaningful Use Programs to better accommodate providers and suppliers. Two recent updates are described below.…
The American Health Lawyers Association last week published an analysis of the changes to the Medicare penalties and bonus payments for Eligible Professionals under the electronic health records meaningful use program under the Doc-Fix bill.  The changes restructure the penalties and bonus payments under the quality framework established by the Merit-based Incentive Payment System.  The e-alert is republished below.  Please note that any further reproduction of this work requires the advance written permission of the…
The Office of Inspector General (“OIG”) of the U.S. Department of Health and Human Services (“DHHS”) released new compliance guidance for health care governing boards, attorneys, compliance officers and internal auditors on April 20, 2015. The guidance was developed in collaboration with the Association of Healthcare Internal Auditors, the American Health Lawyers Association, the Health Care Compliance Association, and OIG.…
The Centers for Medicare & Medicaid Services (“CMS”) released the Stage 3 proposed rule to the Medicare and Medicaid Electronic Health Records Incentive Programs (“Proposed Rule”) on March 20, 2015. To provide context, eligible professionals (“EPs”) and hospitals must attest to demonstrating meaningful use of certified electronic health record (“EHR”) technology to qualify for incentive payments through the Medicare and Medicaid EHR Incentive Programs. Failure to demonstrate meaningful use generally results in negative payment adjustments under the…
For the past several years, the Centers for Medicare and Medicaid Services (“CMS”) has incentivized hospitals and eligible professionals to adopt and make “meaningful use” of certified electronic health records (“EHR”) technology through the Medicare and Medicaid Meaningful Use programs. Since the inception of these programs, over $16.6 billion in Medicare incentive payments and $8.6 billion in Medicaid incentive payments have been made to hospitals and eligible professionals. Approximately 90% of hospitals and 75% of eligible…
The U.S. Government Accountability Office (GAO) recently issued a report entitled “Medicare Program Integrity: Increased Oversight and Guidance Could Improve Effectiveness and Efficiency of Post-Payment Claims Reviews,” which analyzes the processes used by the Centers for Medicare & Medicaid Services (CMS) to avoid the duplication of post-payment claims reviews by its contractors. GAO’s report focused on the extent to which: CMS has data to assess whether the CMS contractors conduct duplicative post-payment claims…
The Centers for Medicare & Medicaid Services (CMS) and the Department of Health and Human Services’ Office of Inspector General (OIG) finalized amendments to the Physician Self-Referral Law (Stark) and Anti-Kickback Statute regulations (the Regulations) on December 27, 2013, regarding the donation of electronic health records (EHR) systems. Among other important changes, CMS and the OIG extended the Regulations, which were originally scheduled to “sunset” on December 31, 2013, to December 31, 2021. The extension…