Health Care

Massachusetts voters passed a referendum question eliminating state criminal and civil penalties for the medical use of marijuana by patients with certain “debilitating medical conditions,” including cancer, glaucoma, HIV, AIDS, hepatitis C, Crohn’s disease, Parkinson’s disease, ALS, or multiple sclerosis.

Yesterday the Centers for Medicare & Medicaid Services (CMS) published a final rule with comment period implementing the Medicare Physician Fee Schedule for 2013, and it covers a number of  issues of interest to independent laboratories.

As discussed in our recent post on the new Medicare Advantage (MA) star ratings, there is ongoing controversy regarding HHS’s Medicare Advantage Quality Bonus Payment Demonstration Project.

New England Compounding Center (NECC) distributed contaminated syringes that caused a meningitis outbreak – killing fifteen people in fifteen states. Officials estimate that as many as 14,000 patients may have received injections of steroids compounded by NECC from contaminated syringes.

Earlier today, CMS made available its 2013 Medicare Health Plan Quality and Performance Ratings, also called “Star Ratings.” The Star Ratings will assist enrollees during the annual enrollment period that extends from October 15, 2012 to December 7, 2012 and will also play a significant role in determining reimbursement rates for Medicare Advantage Plans.

Yesterday the U.S. Department of Health and Human Services Office of Inspector General (OIG) released the results of a study entitled CMS Response to Breaches and Medical Identity Theft. 

The OIG held a roundtable meeting with representatives from 32 companies that have entered into Corporate Integrity Agreements (CIAs) since 2009. Following from the August 7, 2012, roundtable meeting, this week the OIG published a roundtable paper Focus on Compliance: The Next Generation of Corporate Integrity Agreements. 

Last week, the OIG published its FY 2013 Work Plan. The Work Plan summarizes new and ongoing reviews and activities that the OIG plans to pursue with respect to HHS programs and operations during FY 2013 and beyond.

I recently co-chaired an American Conference Institute (ACI) forum on Pharmaceutical Pricing Litigation, which featured a number of key players who provided their unique perspectives on state and federal litigation involving pharmaceutical manufacturers and their products.

Earlier this week, New York State Governor Andrew Cuomo vetoed legislation that would have brought the State’s restrictions on physician self-referrals (the State Law) in line with the federal ban on self-referrals, which is commonly known as the Stark Law.  

As reported in an earlier post, the U.S. Department of Health and Human Services Office of Inspector General (OIG) has released its Work Plan for Fiscal Year 2013 (Work Plan). 

HHS OIG posted its Work Plan for FY 2013 earlier today. The Work Plan is always of interest to the health care industry because it provides a roadmap of the HHS OIG's priorities for the coming fiscal year. 

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.

The use of employee-owned devices in the business setting - often referred to as "bring-your-own-device" or "BYOD" - presents data security challenges for all businesses. 

Secretary Sebelius and Attorney General Holder issued a joint letter to the American Hospital Association and four other associations representing hospitals and medical centers, warning of indications that some providers are using electronic health records (EHRs) to upcode the intensity of patient care.

On September 19th, the Massachusetts Department of Public Health (“DPH”) published emergency amendments to its regulations, 105 CMR 970.000 et seq. (“Proposed Regulations”), designed to implement recent changes to the Massachusetts Pharmaceutical and Medical Device Manufacturer Code of Conduct, M.G.L. c. 111N (the “Gift Ban Law”). 

The most recent, published Office for Civil Rights (OCR) HIPAA enforcement action serves as an important reminder that self-reported breaches can and do lead to investigations and enforcement.

On September 10, 2012, the Department of Justice (DOJ) and the Federal Trade Commission (FTC) hosted a public workshop exploring the uses of most-favored-nation (MFN) clauses and their implications for antitrust enforcement policy. 

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.

On August 16, 2012, the California Assembly passed a bill (AB 2492) amending California’s False Claims Act, Cal. Gov’t Code §§ 12650-12656 (“CA FCA”), which must be signed into law by Governor Jerry Brown.