Health Care

The Office of Management and Budget (OMB) announced on Friday, June 22, 2012, that it has extended the review period for the highly-anticipated omnibus rule intended to update key definitions and enforcement provisions relating to the implementation of  the Health Insurance Portability and Accountability Act (HIPAA).

On Monday, June 18th, the Office of Inspector General (OIG) published a notice that it intends to update its Provider Self-Disclosure Protocol (Protocol), through which health care providers can disclose potential fraud and resolve liability under the OIG’s civil monetary penalty authority. 

ML Strategies has posted its weekly Health Care Reform Update. This publication provides timely and concise information on  implementation of the Affordable Care Act, and other state and federal administrative and legislative activities related to health care reform.

Last week at the OCR/NIST conference, Building Assurance through HIPAA Security, Linda Sanches of the Office for Civil Rights provided an extensive update on the pilot HITECH audit program, including preliminary findings,  what regulated entities can expect next and suggestions for covered entities concerned about being audited. 

In OIG Advisory Opinion 12-06, the OIG determined that two proposed arrangements between an anesthesia services provider (the "Requestor") and professional corporations ("PCs") or limited liability companies ("LLCs") that own ambulatory surgical centers ("ASCs") would potentially violate the federal Anti-Kickback Statute ("AKS") and thus would be subject to enforcement and administrative sanctions.

One month from today, the law that permits independent laboratories to bill and receive payment from Medicare Part B for the technical component of certain anatomic pathology, cytopathology, and surgical pathology services ("TC Services") provided to patients of "covered hospitals" will expire.

The G2 Compliance Report recently published a very informative article written by Hope Foster, Leader of Mintz Levin's Health Care Enforcement Defense Practice, on the whistleblower's role in health care fraud enforcement and strategies for avoiding qui tam suits. 

Health care transactions present unique due diligence challenges. The buyer must evaluate the seller's compliance policies and procedures, arrangements with referral sources, patient and payor data, clinical data and compliance with federal and state licensure, certification and reimbursement regulations. 

Individuals who access protected health information without authorization may be found guilty of a misdemeanor even if they lack knowledge that their actions are illegal. 

Abbott Laboratories (Abbott), an Illinois company, will pay over $1.6 billion in penalties to the federal government and several states related to its alleged illegal promotion of the prescription drug Depakote for off-label uses, as announced by the settling parties on May 7, 2012. 

The Centers for Medicare & Medicaid Services Center for Consumer Information and Insurance Oversight (CCIIO) and the Internal Revenue Service (IRS) recently released four important documents related to the implementation of the Affordable Care Act (ACA) that address employer-provided health insurance plan reporting requirements and the availability of premium tax credits to individuals and families.The Centers for Medicare & Medicaid Services Center for Consumer Information and Insurance Oversight (CCIIO) and the Internal Revenue Service (IRS) recently released four important documents related to the implementation of the Affordable Care Act (ACA) that address employer-provided health insurance plan reporting requirements and the availability of premium tax credits to individuals and families.

Most state and federal health care investigations are prompted by audits or claims brought by whistleblowers. But a recent newspaper article about a debt collection company’s tactics has prompted Congressional ire and potentially a federal investigation. 

With little fanfare, the Centers for Medicare & Medicaid Services (CMS) announced today on the CMS Blog that it is delaying data collection under the Sunshine Act until 2013. 

In OIG Advisory Opinion 12-05, the OIG found that a consumer rewards program (the “Program”) offered by a supermarket chain with in-store and independent pharmacies (the “Requestor”) would not be subject to enforcement under the Anti-Kickback Statute (the “Kickback Statute”) or the beneficiary inducement prohibition found in the civil monetary penalties law (the “CMP Law”).

Christi Braun and Farrah Short have submitted a paper for the 2012 ABA/AHLA Antitrust in Healthcare Conference in which they discuss the proper role of antitrust enforcement in achieving today’s health care reform goals in the context of hospital-health insurer vertical mergers. 

Hospital chains Hospital Corporation of America (HCA) and Tenet Healthcare Corporation (Tenet) announced on April 12th that the Centers for Medicare & Medicaid Services (CMS) has admitted that it erroneously calculated the rural floor provision established by the Balanced Budget Act of 1997.

In another step toward implementation of Accountable Care Organizations (ACOs), on April 10, 2012, the Centers for Medicare & Medicaid Services (CMS) selected 27 ACOs in 18 states to participate in the Medicare Shared Savings Program (Shared Savings Program).

The Centers for Medicare & Medicaid Services (“CMS”) recently published final regulations implementing program and technical changes to the Medicare Advantage (“MA”) and Medicare Prescription Drug (“Part D”) benefit programs.

ML Strategies has posted its weekly Health Care Reform Update.  This publication provides timely and concise information on  implementation of the Affordable Care Act, and other state and federal administrative and legislative activities related to health care reform. 

For insights into how Foreign Corrupt Practices Act (FCPA) enforcement is creeping into the pharmaceutical and medical device manufacturer arena, see this article, which I co-authored with Paul Pelletier, former principal deputy chief of the Criminal Division's Fraud Section at the Department of Justice (DOJ).