Health Care

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.  

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). 

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.

In a significant groundbreaking victory, on January 24, 2014 after a bench trial, an Idaho federal district court judge upheld the FTC’s antitrust challenge to a hospital system’s (St. Luke’s) acquisition of a multispecialty physician group (Saltzer Medical Group) and ordered divestiture as a remedy.

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.

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.

On January 10, the Centers for Medicare & Medicaid Services (CMS) published proposed rules labeled as “policy and technical” changes to the Medicare Advantage (Part C) and Medicare Prescription Drug Benefit (Part D) Programs. Comments to the proposed rules must be submitted by March 7, 2014.

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.

As we previously reported, President Obama has made it a priority to improve the National Instant Criminal Background Check System (“NICS”). 

New legislation enacted last month will change the way many laboratories do business in Pennsylvania. Senate Bill 1042 (SB 1042), which amends Pennsylvania’s Clinical Laboratory Act (the Act), now prohibits several practices that are common across the clinical laboratory industry, including placement of laboratory employees in physician offices. 

The Office for Civil Rights (OCR) is closing out 2013 with a reminder of the importance of an effective HIPAA compliance program. 

Accountable Care Organizations (ACOs) continue to figure big in CMS’s health care reform agenda. On December 20th, the agency’s Innovation Center published a Request for Information (Pioneer RFI) seeking input on how to create the next generation of the Pioneer ACO program that began two years ago.

At long last, the Office of Inspector General for the Department of Health and Human Services (OIG) and the Centers for Medicare & Medicaid Services (CMS) have finalized regulations amending the Anti-Kickback Statute safe harbor and the Stark Law exception, respectively, for donation of electronic health records (EHR) items and services.