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McBrayer Blogs
The Compounding Regulations Surrounding Drug Compounding
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 >
Plan for the Worst, Hope for the Best: Why You Must Have a HIPAA Risk Assessment
“The single biggest and most common compliance weakness is the lack of a timely and thorough risk analysis.” 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 >
The False Claims Act - the Basics Every Provider Should Know, Part Two
On Tuesday, we discussed the history and basic elements of a violation of the False Claims Act. Today’s post will explore the penalties and enforcement of the Act. More >
The False Claims Act – the Basics Every Provider Should Know, Part One
The federal False Claims Act (“FCA”)[1] casts an incredibly long shadow, covering every transaction between the federal government and a private party seeking payment from it. Enacted at the height of the Civil War in 1863, the law was designed to keep military suppliers honest in their dealings with a government already strapped from fighting a war. Since then, the FCA has served as an almost nuclear deterrent to those who would attempt to defraud the government when requesting payment for services. In 2014, the Department of Justice managed to recover $5.69 billion under the law. False claims in federal healthcare programs accounted for $2.3 billion of that figure, which makes the FCA, as well as its interaction with other laws such as the Affordable Care Act, fraught with difficulty for unwary healthcare providers. More >
What changes are in store with the new CMS Proposed Rule for Medicaid managed care?
On June 1, 2015 the Centers for Medicare & Medicaid Services (“CMS”) issued a proposed rule, revising the provisions of the Medicaid managed care (“MMC”) program for the first time in over twelve years. [1] The effects of these new regulations, if adopted, will be far-reaching, because the vast majority of Medicaid beneficiaries, especially in Kentucky, receive services through managed care plans. Medicaid expansion under the Patient Protection and Affordable Care Act (“ACA”) has led to growth in the number of people eligible for Medicaid managed care. The 201-page proposed regulation attempts to modernize Medicaid managed care and Children’s Health Insurance Programs (“CHIP”) so that they align with rules for other payers, including Medicare Advantage (“MA”) and qualified health plans (“QHPs”). More >
Kentucky to Establish Hospital-to-Home Transition Care
One of the last-minute laws passed by Kentucky’s General Assembly and signed by Governor Beshear was a statute that authorizes Medicaid reimbursement for “Hospital-to-Home Transition Care,” which becomes effective on June 24, 2015. More >
Medication-Assisted Therapies, Behavioral Health Services Organizations and Issues Facing Behavioral Health Providers, Part Two
This is part two of this article of a two-part article. Part one was posted on Tuesday. More >
