Health Care

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).

On March 23, 2012, the Department of Health and Human Services (HHS) issued its statutorily required report to Congress (Report) describing the implementation of the Medicare Physician Self-Referral Disclosure Protocol (SRDP) and the status of disclosures under the SRDP to date. 

Officials from the Department of Health and Human Services Office for Civil Rights (OCR) announced March 26 that the long-awaited rule updating Health Insurance Portability and Accountability Act (HIPAA) regulations has been sent to the Office of Management and Budget (OMB).

In Advisory Opinion 12-01, the Office of Inspector General for the Department of Health and Human Services (OIG) analyzed a proposal from a nonprofit health system (the “System”) to form a group purchasing organization (the “Proposed GPO”) for the benefit of the System’s affiliates and subsidiaries. 

Mintz Levin has issued a Client Alert:  The False Claims Act: The Impact in 2012 - Part II in a Continuing Series on Health Care Enforcement. 

No one wants to be the first, especially not in this case. The Department of Health and Human Services' Office of Civil Rights (OCR) announced its first settlement with a covered entity stemming from a report submitted pursuant to the Health Information Technology for Economic and Clinical Health Act's (HITECH) Breach Notification Rule (the "Rule").

On February 22, 2012, a New York State Court held for the first time that a provider may bring a claim against a health insurer under the State’s prompt pay law (PPL). 

Starting today, March 7, 2012, clinical research consent forms for certain FDA-regulated clinical trials must contain a specific statement advising participants that clinical trial information will be entered into the ClinicalTrials.gov database. 

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.