On Tuesday, December 15, Matthias Kleinsasser presented at the Austin Bar Association’s Health Law Section meeting. His presentation, titled “The Basics of the False Claims Act, STARK, and Anti-Kickback Statute and Recent Regulatory Developments,” provided a litigator’s perspective on the basics of the False Claims Act, STARK, and the Anti-Kickback Statute, along with a
Winstead PC Shareholder Sarah Churchill Llamas recently spoke with Medpage today about the federal emergency orders in response to the Covid-19 pandemic that currently allow physicians to prescribe opioid medications to patients via telemedicine. An excerpt is below:
“In the COVID-19 era, under relaxed federal emergency orders, licensed clinicians have been able to prescribe opioid analgesics for their patients even if they’ve only ever seen the patient via telehealth, rather than in person.
For providers like Stephen Bekanich, MD, a palliative care physician for Ascension Texas in Austin, this provision allows him to help seriously ill patients without requiring in-person visits that may be difficult for them or could expose them or their caregivers to the virus.
There’s no such thing as a free lunch…. This adage is over 50 years old, and the Office of Inspector General for Health & Human Services (OIG) wants to remind doctors that it remains true.
The pharmaceutical and medical device industry continues to woo doctors with invitations to educational speaker programs in high-end restaurants, with golf excursions, or at sporting venues. On Monday, November 16, the OIG issued a new Special Fraud Alert to remind doctors that speaker programs sponsored by pharmaceutical and medical device companies must serve a legitimate educational purpose and must be appropriately tailored to meet a need in the medical community.
The Open Payments Act requires pharmaceutical and medical device companies to report their spending on entertainment. According to Open Payments data, cumulative doctor payments in the three years from 2017-2019 exceeded $2 billion, and the OIG emphasized that this high amount of spending, and its potential to influence the prescribing or ordering habits of targeted physicians, was one of the reasons for this new alert.
Today, November 12, Shareholder Sarah Churchill Llamas moderated the panel discussion “Successful Raises and Investor Considerations” at the Texas Life Science Venture Forum, hosted by Rice Alliance for Technology and Entrepreneurship and BioHouston. The panel discussed advice for entrepreneurs/inventors that impacts valuation; the specific risks that erode valuation and how companies can mitigate risks at…
On October 23, Shareholder Corinne Smith will moderate a coding webinar titled, “Changes to Outpatient Evaluation and Management (E/M) Guidelines,” which will cover the significant changes to outpatient E/M services that will go into effect on January 1, 2021. The webinar will also discuss best practices and elaborate on information that is critical for healthcare…
The U.S. Department of Health and Human Services (HHS) recently finalized transformative rules that will give patients unprecedented safe, secure access to their health data. The rules are issued by the HHS Office of the National Coordinator for Health Information Technology (ONC) and Centers for Medicare & Medicaid Services (CMS) to implement interoperability and patient access provisions of the bipartisan 21st Century Cures Act (Cures Act). These final rules mark the most extensive healthcare data sharing policies the federal government has implemented, requiring both public and private entities to share health information between patients and other parties while keeping that information private and secure. These final rules became effective as of June 30, 2020. NOTE: Due to the COVID-19 public health emergency, HHS has delayed enforcement until future dates.…
Continue Reading How HHS Information Blocking Regulations Apply to Healthcare Providers
Among the multitude of relief options under the CARES Act, the U.S. Department of Health & Human Services (HHS) allocated provider relief funds (PRF) to healthcare providers. Phase I in late April saw healthcare providers receive $50 billion in general PRF distributions, largely based on historical Medicare volume or net revenues. Phase II followed in early May with general PRF distributions of $15 billion for Medicaid, Children’s Health Insurance Program (CHIP), and dental providers. And continuing after that, HHS issued some $52 billion in targeted PRF distributions among: (1) hospitals treating large numbers of COVID-19 patients; (2) rural providers; (3) skilled nursing facilities; (4) safety net hospitals; and (5) tribal healthcare providers. All in all, HHS issued $175 billion in PRF to support healthcare providers.
Continue Reading If You Received Provider Relief Funds Under the CARES Act, Are You Preparing Adequate Support for Your Use of the Funds?
On August 4, 2020, the Office of Inspector General of Health & Human Services (OIG) used a new website resource to share informal guidance on the ability of laboratories to provide free COVID-19 antibody testing to Medicare beneficiaries. For the specific situation, the requestors indicated that the clinical lab would provide free COVID-19 antibody testing to patients—including federal healthcare program beneficiaries—in conjunction with other medically necessary blood tests performed by the lab. The lab indicated that it would not charge any patient or other payors for the COVID-19 antibody tests offered in conjunction with other paid lab tests. The requestors also indicated that the purpose of the arrangement had a public health focus as it was intended to increase patient awareness of antibodies to promote donations of COVID-19 blood plasma, which can be used for certain experimental convalescent plasma therapy treatments for COVID-19.
Continue Reading OIG Approves Free COVID-19 Antibody Testing for Medicare Beneficiaries