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Countdown Begins for HIPAA Omnibus Rule Compliance

March 26, 2013 | Blog | By Dianne Bourque

The HIPAA Omnibus Rule goes into effect today, which officially starts the clock for covered entities, business associates, and their subcontractors to begin updating their agreements, forms, policies, procedures, and practices to meet approaching compliance deadlines.
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CMS Focuses on Fraud Associated with Increased Use of Electronic Health Records

March 22, 2013 | Blog | By Theresa Carnegie

Acting CMS Administrator, Marilyn Tavenner, recently reaffirmed the agency’s concern that the increased use of electronic health records (“EHRs”) has contributed to increases in fraudulent billing practices by providers.
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CMS Hospital Inspection Report Database Creates More Transparency

March 21, 2013 | Blog

Transparency in healthcare reached a new level over the weekend when the Association of Healthcare Journalists (AHCJ) unveiled a searchable database of past Centers for Medicare & Medicaid Services (CMS) hospital deficiency reports, formally known as “Form 2567s.” 
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A Look at ACGME’s Next Accreditation System

March 13, 2013 | Blog | By Karen Lovitch

To ease the administrative burden on hospitals and academic medical centers, the Accreditation Council for Graduate Medical Education (ACGME) is introducing a new accreditation model. Dubbed the Next Accreditation System (NAS), the new process will be rolled out starting in July 2013.
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OIG Report Critical of P&T Committee Oversight

March 11, 2013 | Blog | By Theresa Carnegie

In a newly issued Report, the OIG has expressed concern regarding CMS’s lack of oversight of P&T Committee conflicts of interest. As the entities responsible for making Medicare Part D formulary decisions, P&T Committees must ensure that their decisions are made based on scientific evidence and not based on the personal financial interests of committee members.
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Detailed Analysis of the Final Rule Implementing the Physician Payments Sunshine Act

March 8, 2013 | Blog | By Karen Lovitch

When the Centers for Medicare & Medicaid Services published the final rule (Final Rule) implementing the Physician Payments Sunshine Act (Sunshine Act) last month, it ushered in a new regulatory landscape.
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Mintz’s Health Care Enforcement Defense Group Releases 2012 Year in Review

February 26, 2013 | Blog

In its most recent advisory, Mintz Levin’s Health Care Enforcement Defense Group reviews the key health care fraud enforcement trends from 2012 in its Year in Review report, as it did for 2011.
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Report Highlights Record-Breaking Year of Enforcement for HHS and DOJ

February 12, 2013 | Blog | By Theresa Carnegie

Yesterday, the Department of Health and Human Services (“HHS”) and the Department of Justice (“DOJ”) released their Annual Report for the Health Care Fraud and Abuse Control Program (the “Program”).
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Obama Administration Outlines Religious Accommodations for Contraception Coverage Mandate

February 7, 2013 | Blog | By Karen Lovitch

Last week, federal regulators released a Proposed Rule outlining accommodations for religious employers that object to the Affordable Care Act’s contraception coverage mandate. The Proposed Rule expands the range of employers that qualify for the existing religious exemption and outlines promised accommodations for other religious employers.
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CMS Publishes Proposed Changes to CLIA’s Proficiency Testing Regulations

February 5, 2013 | Blog | By Karen Lovitch

Yesterday the Centers for Medicare & Medicaid Services (CMS) filed a proposed rule (the Proposed Rule) that would make significant changes to existing regulations governing the proficiency testing (PT) process mandated by the Clinical Laboratory Improvement Amendments of 1988 (CLIA). 
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ML Strategies Publishes Weekly Health Care Reform Update on February 4, 2013

February 5, 2013 | Blog | By Daria Niewenhous

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.
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Mintz Publishes Comparison of Proposed and Final Sunshine Act Regulations

February 4, 2013 | Blog | By Karen Lovitch

As described in a blog post earlier today, the Centers for Medicare & Medicaid Services (CMS) has released the Final Rule (the Final Rule) implementing the Physician Payments Sunshine Act (Sunshine Act).
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Let the Collection and Reporting Begin: CMS Publishes Final Sunshine Act Regulations

February 4, 2013 | Blog | By Karen Lovitch , Brian Dunphy

The long-awaited final rule (the Final Rule) implementing the Physician Payments Sunshine Act (Sunshine Act) has arrived at the Federal Register.  It amends key definitions and adds new terms; retains broad reporting provisions but includes new limitations; exempts certain continuing medical education (CME) payments from disclosure; and includes additional reporting guidance.
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FDA Will Not Appeal Second Circuit Decision in U.S. v. Caronia

January 29, 2013 | Blog | By Karen Lovitch

After the Second Circuit’s split decision in U.S. v. Caronia, holding that truthful off-label marketing is protected under the First Amendment and thus cannot be prosecuted under the misbranding provisions of the Food Drug and Cosmetic Act (FDCA), I predicted in a previous post that the government would file a motion for rehearing and would eventually take the case to the U.S. Supreme Court.
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Stakeholders Call for Final Sunshine Act Rule

January 17, 2013 | Blog | By Brian Dunphy

On January 14, 2013, a group of stakeholders, including the AARP and the AFL-CIO, urged the Obama Administration to issue the long-awaited final rule (the "Final Rule") implementing the Physician Payments Sunshine Act (the "Sunshine Act").
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Medicare Shared Savings Program Grows by 106 ACOs in 2013

January 11, 2013 | Blog

Yesterday the Centers for Medicare & Medicaid Services formally announced the 106 new Accountable Care Organizations (ACOs) participating in the 2013 Medicare Shared Savings Program (MSSP) cycle. CMS also announced that 15 of the new ACOs qualified to participate in the Advance Payment ACO Model. 
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OIG Approves Gift Cards to Encourage Clinical Visits to Health Center

January 9, 2013 | Blog | By Daria Niewenhous, Theresa Carnegie

In Advisory Opinion 12-21, the OIG concluded that a Federally qualified health center’s offer of grocery store gift cards to capitated managed care patients would not constitute grounds for the imposition of sanctions under the civil monetary penalty law’s beneficiary inducement prohibition or the Anti-Kickback Statute.
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ML Strategies Publishes Weekly Health Care Reform Update on January 7, 2013

January 8, 2013 | Blog | By Daria Niewenhous

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.
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First OCR Resolution for Data Breach Involving Less than 500 Patients: No Breach is “Too Small”

January 3, 2013 | Blog

The Department of Health and Human Services, Office for Civil Rights (OCR) reached its first settlement for a breach involving data regarding less than 500 individuals. Under the December 2012 settlement, the Hospice of North Idaho (HONI) will pay OCR a $50,000 penalty to resolve allegations that it violated the HIPAA Security Rule.
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OIG Approves Hospital’s Electronic Interface Arrangement

December 21, 2012 | Blog | By Daria Niewenhous, Theresa Carnegie

In OIG Advisory Opinion 12-20, the OIG determined that a proposed arrangement (the “Proposed Arrangement”) by a hospital (the “Requestor”) would not constitute grounds for the imposition of sanctions under the Anti-Kickback Statute (“AKS”).
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