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Providers Wary after First Ruling on 60-Day Rule

The False Claims Act (“FCA”) is already a minefield for healthcare providers, especially when coupled with the Stark Law. Treble damages and fines of up to $11,000 per violation add up quickly under the FCA. The U.S. District Court for the Southern District of New York just made further FCA “reverse false claims” nightmares that much more of a reality in the case of Kane v. Healthfirst. That case is illustrative of how the government will interpret and enforce the Centers for Medicare & Medicaid Services’ (“CMS”) “60-day rule” for retention of overpayments, and the result should make all healthcare providers take notice. More >

CMS Sends a Lifeline on Stark after Tuomey Affirmed: What Health Providers Should Know

In July, the Court of Appeals for the Fourth Circuit upheld a record verdict of $237 million against Tuomey Healthcare Systems in the case of U.S. ex rel. Drakeford v. Tuomey Healthcare System, Inc. for violations of the False Claims Act and the Stark Law. Tuomey allegedly violated these laws in over 21,000 claims, submitting bills to Medicare worth $39 million. The False Claims Act allows up to triple damages per claim, as well as a penalty of up to $11,000 per violation. Perhaps in light of such a verdict, the Center for Medicare & Medicaid Services (“CMS”) issued a set of proposed changes and clarifications to the Stark Law that should help healthcare providers to breathe a sigh of relief. More >

CMS Proposes Sweeping Changes for Nursing Home Oversight

On July 16, 2015, the Center for Medicare and Medicaid Services (“CMS”) published a Proposed Rule with new standards that will have a sweeping effect on the long-term care industry. This new Rule is the first comprehensive review and update to Medicare and Medicaid nursing home standards since 1991. Since the last update, the number of Medicare beneficiaries, excluding Medicare Advantage beneficiaries, residing in nursing homes has tripled to 1.8 million residents and the Medicaid Program has become the primary payer of long term care (64% of residents are on Medicaid).[1] More >

Changes and Challenges for Mental and Behavioral Health Providers

As Kentucky’s Senate Bill 192 highlights, coverage and treatment of substance abuse problems is dramatically changing as the current penal model is slowly being replaced with a treatment model. Even terminology for what has been called "drug addiction" is now referred to as a "substance disorder" problem. Behavioral health has become the new catchall name for both mental health and substance disorders. As substance disorders become medical problems rather than drug abuse problems, the Federal Mental Health Parity Act and the Affordable Care Act now mandate that substance disorders and mental health problems, which often go hand in hand, must be covered by health insurance just as medical problems are covered. As of January 1, 2015, these illnesses must also covered by Medicare and Medicaid. Paving the road for coverage, however, has not been easy as a wealth of new federal and state government regulations are creating a complicated framework with a host of changes for behavioral health providers. While Kentucky struggles to provide and pay for services for the 150,000+ new Medicaid beneficiaries, these new laws and regulations significantly affect not just behavioral health providers, but also employers as the struggle to treat individuals who suffer from these maladies is addressed. More >

Think Twice about DEA Voluntary Surrender

It can be an intimidating experience to be sure... A DEA agent or Diversion Investigator, on an unscheduled visit to your office, confronts you with a KASPER, a KBML complaint or some other state regulatory action and alleges violations of the Controlled Substances Act. The DEA Agent then asks you to sign DEA Form 104. This form, which is titled “Voluntary Surrender of Controlled Substances Privileges,” is placed in front of you while the agent explains why you should sign it immediately, rather than face potential action to revoke your DEA and other adverse consequences. The DEA Agent tells you that you are already in deep, deep trouble (of a vague and unspecified nature), and that the simple act of signing this form can make your troubles go away and prevent federal action. Also, he tells you that all you have to do to get the number back is to reapply! Hold on...this is not the full story! This scenario is becoming a harsh reality and common situation for physicians, pharmacists, nurse practitioners, and PAs. More >

The Compounding Regulations Surrounding Drug Compounding

Posted In Pharmacists

Drug compounding as a practice has, until recently, been met with far looser regulation than the manufacture of drugs. This practice serves to meet the needs of individuals who require certain formulations not available in manufactured form, such as discontinued medications or forms of manufactured drugs that do not contain ingredients to which a patient might be sensitive. Compounding may also change the form of the drug for patients who cannot take manufactured drugs in the manner in which they exist commercially. As industrial-level compounding grows to provide larger amounts of compounded drugs, regulators are scrambling to ensure the quality and safety of these drugs. More >

ALERT - Supreme Court Upholds Affordable Care Act Insurance Subsidies

In a 6-3 decision on Thursday, June 25th, the United States Supreme Court upheld the legality of the government healthcare insurance subsidies provided under the Patient Protection and Affordable Care Act (“ACA”) in the case of King v. Burwell. At issue was language in the ACA that granted subsidies to taxpayers enrolled in an insurance plan through “an Exchange established by the State.” 26 U.S.C. §§36B(b)(2)(A). More >

Structuring Healthcare Provider Agreements for Compliance

On June 23rd, the Healthcare Law Blog discussed the Fraud Alert recently issued by the Office of Inspector General of the United States Department of Health and Human Services regarding physician compensation arrangements which telegraphed the Office of Inspector General’s intention to increase scrutiny of financial arrangements between physicians and providers to whom physicians make referrals. In today’s post, we examine the steps physicians and other healthcare providers should take to ensure that any financial relationships are in compliance with federal statutes and regulations. More >

OIG Fraud Alert Targets Physician Compensation Arrangements

It bears repeating so much that even the Office of Inspector General of the Department of Health and Human Services just issued a Fraud Alert on it – physician compensation arrangements are fraught with potential violations of the Anti-Kickback Statute (“AKS”) as well as the Stark Statute and regulations. The AKS is a large enough trap that it catches even the most above-board agreements in its net, and physicians should be wary of the implications. Likewise, the Stark Statute and regulations are broad and are strict liability laws: if you do not meet a Stark exception, the referral and the resulting claim are tainted and the money received based upon the tainted claim must be repaid to the government. More >

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