Health Care

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.

Last week, the U.S. Department of Health and Human Services Office for Civil Rights (OCR) and Office for the National Coordinator for Health Information Technology (ONC) issued model Notices of Privacy Practices (NPPs) in Spanish.

The FDA recently proposed guidance for the submission of materials disseminated through real-time social media promotions ("Interactive Promotional Media") for postmarketing reporting purposes.

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). 

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.

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. 

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.

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”).

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.

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.

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.  

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.

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). 

The year 2014 looks to be a year of major developments for the 340B Drug Discount Program.

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.”

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. 

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.

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). 

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.

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.