Under section 6102 of the Affordable Care Act, on March 23, 2013, skilled nursing facilities (SNFs) and nursing facilities (NFs) are required to have “in operation” compliance and ethics programs that are effective in preventing and detecting criminal, civil and administrative violations.
The ACA identifies eight required elements for compliance and ethics programs. (more…)
On March 26, the long-awaited Omnibus Health Insurance Portability and Accountability Act final rule becomes effective. Covered entities, including healthcare providers and health plans, and their business associates have until September 23, 2013, to comply with the final rules or, in the case of existing business associate agreements, until September 22, 2014 to make changes.
The final rule strengthens the privacy and security protections established under the Health Insurance Portability and Accountability Act of 1996 (HIPAA). It also includes the final modifications to the Breach Notification Rule, which replace the interim final rule that was published in 2009 as required by the HITECH Act. In addition, the final rule improves enforcement as provided for in the Health Information Technology for Economic and Clinical Health (HITECH) Act.
For publicly-traded pharmaceutical and medical device companies, the risk of conducting business outside the U.S. is increasingly evident. In the last year, the Department of Justice (DOJ) and the Securities and Exchange Commission (SEC) have announced high-profile, high-dollar settlements of Foreign Corrupt Practices Act (FCPA) allegations against pharmaceutical and medical device companies:
In March 2012, Biomet Inc., a Warsaw, Indiana-based medical device company, entered into a deferred prosecution agreement with the DOJ to resolve alleged violations of the FCPA. The DOJ alleged Biomet, its subsidiaries, employees and agents made various improper payments from approximately 2000 to 2008 to publicly-employed health care providers in Argentina, Brazil and China to secure lucrative business with hospitals.
Biomet agreed to pay a $17.28 million criminal penalty. Biomet also agreed to disgorge $5.4 million in profits, including interest, to resolve SEC allegations.
Earlier this month at the U.N.’s conference on climate change, U.N. Secretary General Ban Ki-moon said the abnormal is the new normal with Arctic sea ice at record lows, superstorms and rising sea levels.
Secretary General Ban is in good company in his assessment that no one is immune to climate change – rich or poor.
Recently the World Bank released a report, Turn Down the Heat, finding that at the current rate of global warming, “[v]arious climatic extremes can be expected to change in intensity or frequency, including heat waves, intense rainfall events and related floods, and tropical cyclone intensity.”
State insurance exchanges form a central part of healthcare reform under the Affordable Care Act (ACA). Beginning in 2014, nearly every individual who is not covered under through an employer or government plan much purchase insurance or be subject to a penalty. State insurance exchanges will provide competitive marketplaces for individuals and small employers to directly compare and purchase private health insurance options based on price, quality and other factors.
In order to allow time for individuals to shop for and purchase insurance by the January 1, 2014 deadline, state insurance exchanges must be operational by October 1, 2013.
Although a few states moved quickly to establish an exchange, many states waited until after the Supreme Court ruling upholding the individual mandate and even after November election to decide on whether to establish an exchange. Further, the Department of Health and Human Services (HHS) has been slow to release the necessary regulations.
However, with the deadline for decisions looming this week, momentum is building.
This summer, the Supreme Court upheld the individual mandate provision of the Affordable Care Act (ACA), ensuring that millions of individuals in the U.S. now will have health insurance. And, although the Court rejected the penalty under the Medicaid expansion provision, it appears that millions more will gain insurance through this state-based program.
The simple reality is that without insurance, few people can afford healthcare. According to an October 2011 report from the Kaiser Family Foundation, uninsured adults are “more than twice as likely to delay or forgo needed care as the insured” because of worries about high medical bills. Indeed, medical debt accounts for 60 percent of personal bankruptcies in the U.S.