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Welcome To Our New York Health Care Law Blog

Largest-ever settlement in Medicare "risk-score" manipulation case

Stories in New York and across the country seem to surface just about every day to underscore -- as we note on our health care law website at Daniels, Porco & Lusardi, LLP -- that, "Within the health care arena, every legal matter comes with layers of regulatory and compliance issues that must be addressed."

Like a care provider's need to scrupulously toe the line regarding the myriad exactions imposed by authorities administering the Medicare and Medicaid programs and state programs modeled on those initiatives, for example.

Scrutiny on FDA following new study on drug warnings

As we have duly noted in prior select posts, many individuals and enterprises operating within the health care realm in New York and nationally are routinely under intense public and regulatory scrutiny.

And among all those industry participants, there is perhaps no other entity so closely perused as the U.S. Food and Drug Administration, especially in its capacity as the nation's chief regulator of pharmaceuticals made available for public use.

Will private hospital compliance matters soon be made public?

Health care facilities should be concerned about regulatory compliance matters for the sake of their future business operations. If violations are found, a facility might lose its accreditation and/or right to lawfully operate.

Yet according to a recent article, passing an inspection from a private health care accreditor may not necessarily put a facility in the clear. According to the Centers for Medicare and Medicaid Services, hospitals that are overseen by private health care accreditors may still have serious safety deficiencies. Since private accreditors inspect nearly 90 percent of the nation’s hospitals, this could be a sizable problem.

MD's admonitory tale: What many doctors are unprepared for

A doctor who makes it a point to speak to medical student groups and at health-care forums says that she always seeks to underscore for her audience that, "Wow, this is how it happens."

It happens like this for doctors with growing medical practices. Diverse groups of people -- termed a "parade of drug, device and other representatives" in a recent report on the doctor and her story -- vie for entry inside the office door, offering services and products.

Growing regulatory concerns for a niche health care actor

Recent New York-based news relevant to the health care industry bears special significance for one emerging class of participants in that realm, on at least two material fronts.

First, a recent money settlement clearly indicates a newly heightened regulatory focus on so-called "digital health companies," which most consumers might more familiarly know as online health app developers.

FDA drug approval: too fast, too slow or just about right?

In the realm of federal oversight over marketplace drug approval, do officials from the U.S. Food and Drug Administration act so cautiously that they dangerously slow up the process and materially delay the marketplace entrance of new drugs and medications that many consumers badly need?

Or, conversely, do they signal approval in precipitous fashion, so quickly and without due regard for the facts that they imperil the public's health?

Will increasingly more medical actors become litigation targets?

One commentator in a recent national media focus on medical actors being targeted in criminal and civil investigations refers to "a new permutation" that is well worth noting in the health care industry. He calls it "the beginning of the next round" for what might be in store for legions of medical industry participants, ranging from pharmaceutical drug makers and wholesale manufacturers to pharmacies and other entities.

Here is what he's talking about: new strategies employed by various individuals and groups to legally pursue drug companies and others for alleged fraud-related acts such as price fixing and collusion.

Focus: expanded liability potential for health-care entities

If you are a covered entity in any matter involving the federal Health Insurance Portability and Accountability Act of 1996 (HIPPA), you might derive some comfort from knowing that the legislation does not provide for a private right of legal action against you for any alleged wrongdoing under that law.

In other words, HIPPA does not grant license for any private individual to bring a lawsuit against you for damages.

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