Health Law Advisor

by Katherine R. Lofft

There are myriad opportunities right now for new businesses and talented entrepreneurs targeting healthcare, particularly in the IT sector.  It’s an exciting time for people and companies looking to harness the promise of innovation and the power of technology to improve health care delivery, empower patients and lower costs.

However, even the best ideas usually require money to get off the ground.  Sometimes they require more capital than the founders or management, or their family and friends, have available. While there are many individuals and ...

The Physician Payment Sunshine Act, which was incorporated into Section 6002 of the Affordable Care Act, requires pharmaceutical, medical device, biological and medical supply manufacturers to file annual reports on payments to physicians and teaching hospitals. Despite the requirement in the law that manufacturers submit their first report in March 2013 disclosing payments made during 2012, two events have pushed back that obligation or taken the sting out of noncompliance.

First, although Centers for Medicare & Medicaid Services (CMS) was required to publish standards for ...

Hospital M&A activity has been increasing recently, and when these transactions are public knowledge, opposition from the physician community (as well as the hospital staff) to such types of transactions may also be a side effect.  Physicians are vital to the operation of a hospital, and any resistance from the physician community, could be a tremendous obstacle, either slowing down the transaction or causing the potential buyer to pull out of the deal.  Hospital administrators, along with their advisors, should do their best to foresee any opposition and manage physicians ...

Mobile application (“app”) development is the new boon for technology companies of all sizes, and the phrase “There’s an app for that” tells the story of just how much this market has grown and matured.  Most of the early app development focused on low risk opportunities—those involving free or low-cost social media or gaming apps.  While protecting privacy and security of personally-identifiable information is generally important, privacy and security concerns typically do not rank as high priorities in decision-making when developing these types of apps.

By ...

by Lynn Shapiro Snyder and Shawn M. Gilman

Speculation abounds with respect to the decision that states will make on the issue of whether to expand Medicaid coverage under the Affordable Care Act, now that the Supreme Court of the United States has made the option to abstain a meaningful one. This health reform alert highlights some key factors that may influence a state's decision on whether to implement such an expansion.

Read the full alert here

Danielle Steele, a Summer Associate (not admitted to the practice of law) in Epstein Becker Green's Washington, DC, office, contributed ...

Imagine there are two hospitals (or two physician groups). One is highly specialized and has developed a telemedicine program for treating stroke patients; the other is a community hospital or physician practice that would like to take part in this telemedicine program but does not want to pay for the technology needed to virtually connect with the program’s specialists.  Can the telemedicine provider buy this technology for the receiving hospital or physician group, or rent it out at a deep discount, without violating the law?

This turns out to be a hard question.  Under federal law ...

Imagine there are two hospitals (or two physician groups). One is highly specialized and has developed a telemedicine program for treating stroke patients; the other is a community hospital or physician practice that would like to take part in this telemedicine program but does not want to pay for the technology needed to virtually connect with the program’s specialists. Can the telemedicine provider buy this technology for the receiving hospital or physician group, or rent it out at a deep discount, without violating the law?

This turns out to be a hard question. Under federal law ...

The following may surprise some: FDA approval or clearance is never enough. Not if manufacturers want a commercially successful product. There is no doubt that addressing FDA issues is critical. But without data to show effectiveness, payers will not reimburse a particular product or technology—and even the most promising product will languish in the market without the appropriate coverage and reimbursement.

The use of remote monitoring devices has increased significantly over the last few years. I think it is fair to say that many manufacturers of these devices worry ...