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Compliance Update
Possible delay of MU Stage 3? Print E-mail
Written by FHI's Week in Review   
Monday, 27 July 2015 00:00

Virgil Dickson, in a 7.23.15 Modern Healthcare post, reports:

The Senate Health, Education, Labor and Pensions Committee is asking to delay Stage 3 Meaningful-Use Rules, its chairman, Lamar Alexander (R-Tenn.), said during a news conference Thursday.

This will be one of several recommendations his committee will make to the Obama administration in a push to expand the use of electronic health records, which some providers say are costly and time-consuming. Sen. Alexander expressed hope that healthcare would not "go backwards on EHRs," but discussed the possibility of delaying MU3 to ensure the process goes smoothly.

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Last Updated on Tuesday, 28 July 2015 13:03
Federal prosecutors increasingly target individual healthcare execs in anti-fraud efforts Print E-mail
Written by Health Law Offices of Anthony Vitale   
Thursday, 16 July 2015 11:07

Last month's sentencing of the former president and CEO of OtisMed Corporation to two years in prison should serve as yet another example that federal prosecutors are not holding back when it comes to holding corporate executives accountable.
Charlie Chi was sentenced for intentionally distributing a medical device used in knee replacement surgery despite the fact that the Food and Drug Administration had denied the company's application for marketing clearance. In December 2014, Chi admitted to distributing, with the intent to defraud and mislead, adulterated medical devices into interstate commerce in violation of the Federal Food, Drug, and Cosmetic Act.
In addition to the 24-month prison sentence, Chi was ordered to serve one-year of supervised release and to pay a $75,000 fine. Prior to his own sentencing, OtisMed Corp., in September 2014, was hit with a criminal fine of $34.4 million and ordered to pay $5.16 million in criminal forfeiture.

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Last Updated on Tuesday, 18 August 2015 11:22
Court Upholds CMS' Prohibition on 'Under-Arrangements' Transactions, Strikes Down CMS' Prohibition on 'Per-Click' Equipment Rental Arrangements Print E-mail
Written by   
Monday, 29 June 2015 00:00

A 2008 rule change from the Centers for Medicare and Medicaid (CMS)-which effectively prohibited referring physician-owned companies from furnishing hospital services "under arrangements"-has withstood a challenge by a urology trade association. On June 12, 2015, the U.S. Court of Appeals for the District of Columbia Circuit (D.C. Circuit) held that the 2008 rule change, which redefined an "entity furnishing designated health services" to include entities that perform the services, not just bill for them, constituted a reasonable construction of the Stark Law and was entitled to deference. The appellate court, however, held that CMS' prohibition on "per-click" equipment rental arrangements lacked a rational basis in light of the agency's "tortured reading" of a relevant conference report, which, the court noted, was "the stuff of caprice." Accordingly, the court struck down CMS' 2008 prohibition on per-click equipment rental arrangements involving referring physician-owned equipment leasing companies.

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Governing Boards in Healthcare: Making Compliance a Priority Print E-mail
Written by Jackie Bain | Florida Healthcare Law Firm Blog   
Tuesday, 16 June 2015 00:00

Does your healthcare entity have a governing Board? How involved is that Board in overseeing your business? Would your Board members be able to respond to questions about your business' compliance-related activities? 

Recently, the Office of the Inspector General ("OIG"), in conjunction with a host of non-profit healthcare associations, released guidance on achieving compliance for healthcare governing boards. The guidance is not based on abstract principals of compliance, instead it points to applicable federal law, OIG guidance, case law, and sentencing guidelines.

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The Saga Continues: CMS Further Delays Enforcement of Medicare Enrollment Requirements for Prescribers of Part D Drugs Print E-mail
Written by   
Thursday, 11 June 2015 00:00

The Centers for Medicare & Medicaid Services (CMS) on June 1, 2015, published its "Medicare Part D Prescriber Enrollment Requirement Update" (Update). The Update further delays-until June 1, 2016-enforcement of the regulatory requirement that health care professionals eligible to enroll in the Medicare Program (referred to herein as eligible to be a Medicare Prescriber) either enroll or opt out in order for drugs they prescribe to be covered under Medicare Part D. Besides providing additional time for prescribers to comply with the enrollment requirement, the Update also provides guidance for Part D Plan Sponsors (Sponsors), their pharmacy benefit managers (PBMs), and contracted pharmacies concerning how to alert prescribers to the enrollment requirement. The Update also explains Sponsors' obligations to verify that Part D claims contain an active and valid prescriber National Provider Identifier (NPI), as well as to issue notices to affected members.

Prescriber Enrollment Requirement Finalized in May 2014 Final Rule and Modified by the Interim Final Rule

In May 2014, CMS promulgated a final rule finalizing the requirement that Sponsors reject (or direct their PBMs to reject) a pharmacy claim or member reimbursement request for a Part D drug if (i) the claim does not contain the prescriber's active and valid NPI, or (ii) the physician or eligible professional, as the terms are defined in the Social Security Act, is neither enrolled in Medicare nor has a valid opt-out affidavit on file.

On May 6, 2015, CMS published an interim final rule with comment period (Interim Rule) requiring prescribers of Part D drugs to become Medicare Prescribers by January 1, 2016.

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