Ongoing investigations by both the Department of Defense (DOD) and a major U.S. media organization allege that suspicious marketing and prescribing activities have led to astronomical increases in TRICARE costs for compounded medications. According to the Military Times, TRICARE paid $769 million for compound prescriptions between January and March 2015, ... Read More »
Category Archives: Healthcare law
Feed Subscription<Concussion and traumatic brain injury: A historical perspective
April 7, 2015
Public awareness of the long-term effect of head injuries sustained in competitive sports, including but certainly not limited to collegiate and professional football, has increased significantly in the past decade. The highly publicized National Football League (NFL) federal court litigation has transitioned from the sports section to page-one treatment in ... Read More »
A little more time! CMS extends meaningful use attestation deadline
March 25, 2015
On February 25, 2015, the Centers for Medicare and Medicaid Services (“CMS”) announced that Eligible Professionals (“EPs”) participating in the Medicare Electronic Health Record Incentive Program (“Meaningful Use”) now have until 11:59 p.m. ET on March 20, 2015, to attest to Meaningful Use for the 2014 reporting year. The previous ... Read More »
Home healthcare worker violates HIPAA and steals protected health information: due diligence of employees and mandated criminal background checks
March 12, 2015
In Lee County, Florida, a home healthcare nurse stands accused of stealing from her elderly patients. Police investigators say that the nurse opened fraudulent credit card accounts under the names of at least eight of her patients. Computer and transaction records indicate that she used stolen or fraudulently obtained credit ... Read More »
DEA issues new rules on controlled substances take-back programs
September 22, 2014
This week, the Drug Enforcement Administration (DEA) greatly expanded the number of entities that may take back controlled substances from individuals lawfully in possession of such drugs. The DEA rule implements a 2010 law that aims to reduce abuse, misuse, diversion, and accidental ingestion of controlled substances stored in home ... Read More »
Meaningful use: an update on the recent health it policy committee findings
September 8, 2014
At the Health IT Policy Committee meeting in July 2014, CMS and the ONC reported on attestations for meaningful use (MU) Stage 2 as well as the progress and performance of eligible professionals (EPs) in the first three years of the EHR Incentive Program. 2014 attestations through July 1 included ... Read More »
GAO issues “health” reports
August 25, 2014
The Government Accountability Office (GAO) has recently issued two important reports discussing important aspects of the roll-out of the federal exchange and cost-effective preventive measures in U.S. healthcare. The first report, published on July 30, 2014, examines the problematic roll-out of Healthcare.gov. In this report, entitled “HEALTHCARE.GOV – Ineffective Planning ... Read More »
Hospital pays $150,000 in penalties and fees for violating HIPPA and state data breach laws
August 5, 2014
The Women & Infants Hospital of Rhode Island recently agreed to pay the Massachusetts Attorney General $150,000 in penalties, attorney’s fees, and contributions to funds for education and data security litigation. The hospital’s settlement demonstrates the risks that health care entities face from aggressive state attorneys general, even those across ... Read More »
Physicians and teaching hospitals should register and review reporting of payments made and interests held before they are released to the public
July 28, 2014
On September 30, 2014, the Centers for Medicare and Medicaid Services (“CMS”) will release information to the public relating to certain payments to physicians and teaching hospitals (collectively “Covered Providers”) from drug/device manufacturers and group purchasing organizations, as well as information on physician ownership and investment interests in certain drug/device ... Read More »
FDA issues pharmacy related compounding regulations and guidance documents
July 15, 2014
On July 1, 2014, the Food and Drug Administration (FDA) released several documents applicable to compounding pharmacies, which are in the business of preparing custom-tailored drugs intended for patients. The first document is draft interim guidance that describes the FDA’s expectations regarding compliance with current good manufacturing practice requirements. It focuses on ... Read More »
The national government unilaterally terminates the Protocol expansion guarantee structure social housing (1999)
June 19, 2014
On 4 June 2014, the government further explained its vision concerning people with care needs living independently for longer in a letter to Parliament. This letter also includes a passage concerning the status of the Protocol expansion guarantee structure social housing from 1999 (the Protocol). The passage is not very ... Read More »
New HHS risk assessment tool designed to facilitate HIPAA/HITECH compliance
May 7, 2014
The Department of Health and Human Services (HHS) has recently released a new security risk assessment tool for the purpose of aiding covered entities and business associates in their never-ending duty of ensuring HIPAA/HITECH compliance with their operations.Under HIPAA/HITECH, covered entities and business associates must conduct regular risk assessments of ... Read More »
FDA issues “deeming regulations” covering additional tobacco products including electronic cigarettes and cigars
May 6, 2014
On April 24, 2014, the Food and Drug Administration (FDA) issued its long-awaited proposed regulations (Deeming Regulations) to bring electronic cigarettes, cigars, pipe tobacco, water pipe (hookah) tobacco, dissolvables and nicotine gels (Newly Covered Products) under the agency’s tobacco regulatory authority. The Deeming Regulations would subject Newly Covered Products to ... Read More »
Insurers nationwide continue to drop medical providers from medicare advantage plans
February 14, 2014
Since last fall, tens of thousands of physicians, medical practices and pharmacies nationwide, and their patients, have received notifications from some of the country’s largest Medicare Advantage plan providers, including health insurance giants UnitedHealthcare (UHC) and Humana, that the physicians, and entire provider groups, will be terminated from the insurers’ ... Read More »