The Food and Drug Administration has issued a proposed rule that would allow states to pursue pilot programs to import drugs from Canada and a draft guidance that would allow drugmakers to import their own products and sell them under different drug codes.

On October 9, 2019, the Centers for Medicare and Medicaid Services ("CMS") proposed sweeping changes to the federal Physician Self-Referral Law, commonly referred to as the Stark Law.

Driven by Federal Health Care Reform and a desire to remain independent of hospitals and health care systems, physician groups are actively exploring different collaborative and alignment options, including the formation of independent practice associations (IPAs), integrated care networks (ICNs), and participation in accountable care organizations (ACOs).

On May 21, 2019, the Department of Health and Human Services (HHS) issued the final regulations referred to as the Federal conscience and anti-discrimination laws.

Make no mistake, the federal government intends to hold health information technology ("HIT") companies accountable for failures to develop HIT in accordance with federal certification standards and compliance with federal fraud and abuse laws, including payments for customer referrals.

This December, the U.S. Department of Health and Human Services Healthcare & Public Health Sector Coordinating Councils issued voluntary guidelines to assist healthcare providers assess cybersecurity risks and suggestions for mitigating those risks.

Starting January 1st, Medicare will put the competitive bidding program (CBP) on durable medical equipment on hiatus. For patients and businesses alike, this opens the door to easier access and a larger market in Birmingham for the sales and rentals of anything from nebulizers to prosthetics to home hospital beds.

If you ask a healthcare provider to state the healthcare laws and regulations that give them a headache, you are likely to receive a range of responses.

We recently reported that Michael Granston, Director of the Civil Fraud Section of the Department of Justice (DOJ), made comments during a November 2017 healthcare compliance conference suggesting that in cases where the DOJ has determined allegations in a qui tam (or "whistleblower") lawsuit lack merit, the government may more aggressively exercise its statutory authority - rarely used in the past - to dismiss such cases.

The battle over 340B continues as hospitals serving some of the nation's most vulnerable patients worry what will happen if $1.6 billion in cuts go through.

Not every major action takes an act of legislation.

The Department of Justice (DOJ) recently made a surprising announcement that it may begin seeking dismissal of meritless qui tam cases brought under the False Claims Act.

Last year drew to a close with promises for the swift repeal and replacement of the Affordable Care Act after the inauguration of Donald Trump.

During last year's Alabama legislative session, Senator Trip Pittman introduced a proposal to rein in the costs of malpractice suits. Senate Bill 413 would have replaced the trial-based system with a no-blame, administrative one.

As providers who are currently undergoing a Medicare claims appeal know, there is a lengthy delay to having an appeal actually heard by an Administrative Law Judge (ALJ). Some estimates indicate that it will currently take over 10 years to have an appeal heard.

The Department of Health and Human Services Office of the Inspector (OIG ) recently issued an advisory opinion that determined that a vaccine storage and dispensing system with a per-dispense fee did not violate the Anti-Kickback Statute.

Unfortunately for most healthcare providers, the Office of Inspector General of the US Department of Health & Human Services (OIG) continues to demand and receive large settlements under the Physician Self-Referral Law found at 42 US Code Section 1395nnn (Stark Act).