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A Guide to the FDA's Proposed Social Media Guidance

February 23, 2014 | Blog | By Kimberly Gold

The FDA recently proposed guidance for the submission of materials disseminated through real-time social media promotions ("Interactive Promotional Media") for postmarketing reporting purposes.
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Notice to Plans and PBMs: Pay for Contraceptive Services and Maybe We Will Pay You Back

February 18, 2014 | Blog | By Theresa Carnegie

As has been widely covered in the news, regulations and guidance developed under the Affordable Care Act (“ACA”) require that non-grandfathered health plans make preventive care and screenings available to their members at no cost (i.e. no deductibles, coinsurance, or co-payments). 
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CMS Expands Payment Reform to Outpatient Care in New RFI

February 12, 2014 | Blog

Citing the need to complement a portfolio of pilot projects that focus mostly on primary care and the inpatient setting, CMS released a Request for Information (RFI) on February 11th, seeking input on potential payment and care delivery models that focus on outpatient specialty care and complex/chronic disease management care.
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OIG Plans to Fight Fraud, Waste, and Abuse While Promoting Quality, Safety, and Value in 2014

February 12, 2014 | Blog | By Theresa Carnegie

The U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) released its Work Plan for Fiscal Year 2014 on January 31, 2014. The Work Plan provides insight into the OIG’s priorities by providing a brief description of the activities it will initiate and continue during fiscal year 2014. 
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HHS-OIG Criticizes 340B Drug Discount Program

February 11, 2014 | Blog | By Theresa Carnegie

I recently posted that 2014 is expected to be a year of major developments in the 340B Drug Discount Program, with HRSA receiving enhanced funding, stepping up audit activity, and drafting regulations in response to criticism from multiple industry stakeholders.
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More Open Questions About Open Payments Under the Sunshine Act

February 10, 2014 | Blog | By Brian Dunphy

Last week, the Centers for Medicare & Medicaid Services (“CMS”) clouded the process for pharmaceutical and medical device manufacturers, and group purchasing organizations (“GPOs”), to register and submit reports under the Physician Payments Sunshine Act (the “Act”).
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ML Strategies Posts Weekly Health Care Reform Update on February 3, 2014

February 6, 2014 | Blog | By Theresa Carnegie

ML Strategies has posted its weekly Health Care Reform Update.  This publication provides timely 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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CMS Finalizes HIPAA and CLIA Amendments Intended to Increase Patient Access to Test Results

February 4, 2014 | Blog | By Karen Lovitch

Yesterday the Centers for Medicare & Medicaid Services (CMS) finally published the long-awaited final rule amending the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and the Health Insurance Portability and Accountability Act of 1996 (HIPAA) to permit CLIA-certified laboratories to provide copies of completed test reports to patients upon request.
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ACOs Show Some Savings Potential: Legislative and Regulatory Initiatives Ramping Up

February 4, 2014 | Blog

The evolution of Accountable Care Organizations (ACOs) will be a big factor this year as the Obama Administration continues to focus on curbing health care spending and Congress ramps up its efforts to address physician payment and delivery system reform.  
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OIG Issues Favorable Opinion of Arrangement Containing Percentage-Based Compensation Structure

February 3, 2014 | Blog | By Roy Albert

Last week, the OIG issued an advisory opinion indicating that it would not impose sanctions on an arrangement pursuant to which a placement agency receives a percentage-based fee for referring new residents to senior communities.
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Health Care Reform Goals Fail to Persuade Court in Antitrust Challenge to Acquisition

February 3, 2014 | Blog

On January 24, 2014,  a federal district court judge validated the trend of recent increased Federal Trade Commission (FTC) scrutiny of physician practice consolidations and acquisitions by upholding the agency’s antitrust challenge to the St. Luke’s Health System (St. Luke’s) 2012 acquisition of Saltzer Medical Group (Saltzer). 
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2014 May Be a Game-Changer for the 340B Drug Discount Program

January 29, 2014 | Blog | By Theresa Carnegie

The year 2014 looks to be a year of major developments for the 340B Drug Discount Program.
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Record Numbers for Medicare Fraud Task Force Prosecutions in 2013

January 29, 2014 | Blog | By Theresa Carnegie

On January 27, 2014, the U.S. Department of Justice issued a press release announcing that its Medicare Fraud Task Force had “set record numbers for health care prosecutions in Fiscal Year 2013.”
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ML Strategies Posts Weekly Health Care Reform Update on January 27, 2014

January 28, 2014 | Blog | By Theresa Carnegie

ML Strategies has posted its weekly Health Care Reform Update.  This publication provides timely 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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Government Imposes Moratorium on Medicare Hearings and Appeals

January 27, 2014 | Blog | By Theresa Carnegie

The Federal Office of Medicare Hearings and Appeals (OMHA) was established in July 2005 to administer the Medicare appeals program. OMHA adjudicates appeals regarding Medicare entitlement and Medicare provider reimbursement.
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CMS Issues New Policy on Disclosure of Physician Payment Information

January 24, 2014 | Blog | By Theresa Carnegie

On January 17, 2014, the Centers for Medicare & Medicaid Services (CMS) announced that it will release Medicare expenditure data on specific physicians under the Freedom of Information Act (FOIA). 
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Data Breach Wall of Shame: 2013's Highlights and Lessons

January 23, 2014 | Blog | By Kimberly Gold

Since 2009, the HHS Office for Civil Rights (“OCR”) has posted all large data breaches – those that involve 500 or more individuals – online on its so-called “Wall of Shame.”  In 2013, 160 large data breaches were reported to OCR and posted on the Wall of Shame.
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What Do the Proposed Changes to Medicare Parts C and D Mean For Your Business?

January 22, 2014 | Blog | By Theresa Carnegie

On January 10, the Centers for Medicare & Medicaid Services published proposed rules labeled as “policy and technical” changes to the Medicare Advantage (Part C) and Medicare Prescription Drug Benefit (Part D) Programs.
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ML Strategies Posts Weekly Health Care Reform Update on January 21, 2014

January 21, 2014 | Blog | By Theresa Carnegie

ML Strategies has posted its weekly Health Care Reform Update.  This publication provides timely 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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2013 Health Care Enforcement Defense Trends

January 17, 2014 | Blog

In 2013, federal and state enforcement agencies again took aim at the health care industry. Enforcement efforts targeted the domestic and international activities of health care providers, facilities, manufacturers, and other entities' from all angles through civil actions, False Claims Act cases, securities fraud investigations, and criminal prosecutions.
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