In January of 2019, the Centers for Medicare and Medicaid Services (“CMS”) implemented a helpful change to the signature exception to the Stark Law. In particular, the exception may now be used more than once during a 3-year period for compensation arrangements with the same referring physician.

History of Signature Exception

The signature exception to the Stark Law has undergone several revisions within the past few years. The original version of the exception was implemented by CMS effective October 1, 2008 in response to concerns regarding the potential for significant Stark Law penalties for mere “technical” violations of the statute. The original language in the signature exception provided for a grace period for noncompliance with the signature requirement of many of the compensation arrangement exceptions to the Stark Law, such as the personal service arrangements exception and fair market value exception. In particular, a 90-day grace period was permitted for late signatures that were inadvertent, and a 30-day grace period was permitted for late signatures that were “not inadvertent.” In addition, the exception could only be used once for the same referring physician during a 3-year period. In other words, after the exception was used once by a DHS entity for a late signature on a compensation agreement with a referring physician, any late signatures on other agreements entered into by the DHS entity and the same referring physician during the following 3-year period would trigger a violation of the Stark Law. Continue Reading CMS Finalizes Helpful Change to Stark Law Signature Exception

On April 24-26, The National Association of Accountable Care Organizations held its semi-annual conference for members. NAACOS invites its business partner members, including Husch Blackwell, to attend their semi-annual meetings. Scott Loftin, a Healthcare Regulatory Associate in Husch Blackwell’s Denver office, and I were fortunate enough to attend the conference on behalf of the firm. This conference provided an opportunity for us to listen to the issues, challenges, concerns, and ideas ACO leadership are exploring and facing in today’s regulatory landscape. The presentations and conversations among the members provided us with a deeper understanding of our ACO clients’ business and legal needs. Continue Reading Husch Blackwell at the NAACOS Conference

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On Wednesday, April 17, a three-judge panel of the Eighth Circuit heard oral arguments in an appeal from the United States District Court for the Eastern District of Missouri in Horton v. Midwest Geriatric Management LLC. Although the forthcoming Eighth Circuit decision would add to the split among the federal circuits as to whether the prohibition against sex discrimination in Title VII applies to discrimination based on sexual orientation, today’s order list indicates that SCOTUS will settle the issue.

Learn more about the implications of this development in our legal alert.

MedicareIf you track national health care policy developments, you’ve been busy lately.

Following weeks of growing declarations from Democrats in support of Medicare for All, US House Speaker Nancy Pelosi tamped down exuberance over any plans to replace the Affordable Care Act (ACA).  Then the US Justice Department spoke up.

In a March 25 statement to the Court of Appeals for the Fifth Circuit, Justice Department lawyers said US District Court Judge Reed O’Connor’s ruling should be affirmed—that the entire ACA coverage mandate is unconstitutional, and since the provision is inseverable from the ACA, the entire Act is invalid.  The ACA remains in place as the District Court ruling is under appeal. Continue Reading Medicare for All, Part 2: Cost, Financing and Impact on Provider Payment

As provided in the Texas Register on March 22, 2019, the Texas Health and Human Services Commission (“HHSC”) has proposed several amendments to Title 1 of the Texas Administrative Code, which include amendments to the rules and procedures for preventing and investigating Medicaid fraud and abuse. Continue Reading Texas Health & Human Services Proposes Amendments to Fraud and Abuse Rules

After years of insisting that nursing colleges separately incorporate from related hospitals and hospital systems, causing some schools to relinquish Medicare “pass-through” funding,  the Higher Learning Commission (HLC) has changed course. Today, HLC issued a Separate Incorporation Policy Change.

Removing language interpreted by prior HLC leadership as requiring separate incorporation, the revised policy substitutes a requirement that HLC-accredited institutions have a “primary purpose” of providing higher education. More specifically, the revised policy (HLC’s “Jurisdiction” policy, INST.B.10.010): Continue Reading HLC Announces Separate Incorporation Policy Change

Recently enacted federal law expanding criminal liability for kickbacks related to all payors, and increased government enforcement activity in behavioral health (see press release), has heightened the importance of clinical due diligence for private equity investors targeting deals and acquisitions in the emerging behavioral health space.  PE firms continue to target behavioral health opportunities as federal and commercial insurance coverage expands for mental health, including substance abuse treatment and telehealth services.  Such commercial coverage will only become more commonplace after a federal court this month found United Behavioral Health improperly denied benefits for treatment of mental health and substance use disorders to plan participants because United’s guidelines did not comply with the terms of its own insurance plans and state law.[1]  PE firms entering the behavioral health market, though, particularly opportunities related to substance abuse treatment and laboratory services, should carefully review a company’s compliance with the Eliminating Kickbacks in Recovery Act of 2018 (“EKRA”). Continue Reading Private Equity in Behavioral Health: Clinical Due Diligence Requires Consideration of EKRA, the New Anti-Kickback Law Applicable to All Payors

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First in a series.

Like it or not, the 2020 presidential election campaign is well underway. With it comes the latest in public policy ideas, including more attempts to overhaul health care in the U.S.

The phrase “Medicare for All” has captured the minds, if not the hearts, of several candidates and an impressive portion of the voting public. It has shifted the conversation about health care in politics, at least temporarily, away from both “repeal and replace” and “protect the Affordable Care Act.” Continue Reading Medicare for All…or Is It?

Husch Blackwell's Wakaba Tessier and Renee Zerbonia and ARJ Infusion Services Edie GigotThis year’s National Home Infusion Association (NHIA) conference kicked off with the 2nd Annual Sterile Compounding Forum. The well-attended track provided an overview of the state of sterile compounding, insight into the most common citations confronting sterile compounders, considerations for compliance and risks relating to compounding, background on how states and the FDA are implementing rules and regulations, including those involved in the delivery of home infusion products.

We are pleased to sponsor the NHIA conference and participate in the following activities: Continue Reading NHIA 2019 Annual Conference

For decades, pundits, policymakers and consumer groups have called for better tools to make health care purchasing decisions easier.  Greater cost transparency and clear indicators of quality, they say, would help consumers make the right choices, which would lead to lower costs and better quality care.

If only it were as easy as using Angie’s List:  describe the need and up pops the names of local providers, along with comparative information on their performance.

Increasingly, such information and tools are available.  But their impact is unclear.

Since 2010, Medicare consumers have had an “Angie’s List” type of resource in Physician Compare, an online service produced by the Centers for Medicare and Medicaid Services (CMS).  The website was mandated by the Patient Protection and Affordable Care Act (ACA).  It serves a two-fold purpose, according to CMS: Continue Reading Physician Quality Measures—Growing Numbers of them, but are they being used?