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Patient Inducements: Law and Limits

From Holland & Hart, by Kim Stanger:

Although often well-intentioned, offering free or discounted items or services to patients (e.g., gifts, rewards, writing off copays, free screening exams, free supplies, etc.) may violate federal and state laws governing improper inducements, especially if the patient is a federal program beneficiary. The government is concerned that offering or rewarding such inducements to patients may result in overutilization, biased decisions concerning care, and increased costs to the Medicare, Medicaid, or other government programs. Penalties for illegal inducements may include administrative, civil, and criminal penalties; repayment to government programs; and exclusion from federal programs. Increasingly, private payors are also challenging such inducements. It is imperative that healthcare providers and their staff understand the applicable laws and limits.

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Surprise… No Surprises Act Arbitration Is Too Expensive

Kirk Davis, Danielle Gordet, writing for Akerman:

In December of 2022, the Departments had increased the fee from $50 to $350, effective January 1, 2023, to address “the rising volume of disputes and additional expenditures associated with the Departments’ enhanced role in 2023 in conducting pre-eligibility reviews to address the backlog of disputes.” Thereafter, the Texas Medical Association (TMA) brought suit against the Departments arguing that the $350 administrative fee was prohibitive for providers with small-value claims. On August 3, 2023, the U.S. District Court for the Eastern District of Texas found in favor of TMA (See Opinion and Order).

In response to the court’s decision, the Departments announced on August 11, 2023, that the administrative fee amount for any disputes initiated on or after August 3, 2023, will be $50 per party per dispute. However, for disputes initiated on or after January 1, 2023 through August 2, 2023, where a party had “paid” the administrative fee to a certified IDR entity, the administrative fee remains $350 and refunds will not be issued.

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Texas Amends Data Breach Notification Law

Julia K. Kadish, writing for SheppardMullin:

Texas recently enacted an amendment to its data breach notification law. As of September 1, 2023, there are two changes to the requirements when notifying the Texas Attorney General. In Texas, breaches of 250 residents or more must be reported to the Attorney General. Now, as amended, this will need to be done so as soon as practicable, and not later than 30 days from determination of the breach (previously, it was 60 days). Texas joins Colorado, Florida, and Washington in requiring notice within a 30-day time frame. Notification in Texas must also be submitted electronically using a form on the AG’s website.

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The Evolution of Telehealth and What’s Next

James Tekippe, CFA, writing for VMG Health:

For those in the healthcare industry, telemedicine has been viewed as a way to increase access to healthcare, while mitigating the challenges of limited resources of physicians and healthcare providers. Although the use of telehealth has steadily grown over the past two decades, the challenges presented by the COVID-19 pandemic supercharged this growth. As the United States and the world move beyond the worst months and years of the pandemic, telemedicine usage will continue to change within the industry. This article will explore the state of telehealth immediately prior to and during the early years of the pandemic to provide context for the question, “What will be the next stage of telemedicine in the U.S. healthcare system?”

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New Texas Medical Billing Requirements Can Leave Hospitals and Other Health Care Facilities Unable to Collect for Services Provided

Joe Lecroy, Tracie Bedeauxm, writing for Katton:

Starting September 1, 2023, health care facilities in Texas will have to make changes to their billing practices to comply with a newly passed law requiring greater transparency in medical billing …

A health care provider that requests payment from a patient after providing a health care service or related supply shall provide a written, itemized bill sufficiently describing the cost of each service and supply provided to the patient. This itemized bill must be submitted within 30 days after the provider receives a final payment on the provided service or supply from a third party, including payors. The itemized bill may be submitted to the patient in writing, or electronically through a patient portal on the provider’s website. Further, the provider must provide this bill on request at any time following the issuance of the original itemized bill.

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It’s a Long Way From Here to There: Advanced Healthcare Practitioners, EMTALA’s Call Coverage Requirements, and Rural Hospitals

Nick Healey, writing for HuschBlackwell | Healthcare Law Insights:

In an attempt to fill out the call schedule, however, some rural hospitals list advanced healthcare practitioners (AHP’s) with specialized training (such as psychiatric nurse practitioners, or certified nurse midwives) on the physician call schedule for those specialties. This practice, although well-intentioned, could lead a hospital to unintentionally violate EMTALA, since EMTALA specifically requires the hospital to maintain a list of physicians who are on-call.

In addition, CMS’ guidance specifically states that only physicians, and not AHP’s, can be listed as the “first call” for the ED; if a physician is listed as “on-call”, the ED must first contact that physician, not an AHP designated by that physician. CMS does allow, on a case-by-case basis, the on-call physician to send an AHP to respond to the ED in the physician’s place, but only after consultation between the ED and the on-call physician, and only if the ED agrees. Listing an AHP on the physician call schedule for a specialty, or allowing an AHP to take the “first call” when the physician is listed as on-call, could potentially violate EMTALA.

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Unfavorable OIG Advisory Opinion Issued for a Proposed Venture with Surgeon Owners but Managed by Others

Tom Greeson, writing for ReedSmith:

Although it is possible to enter into business ventures with referral sources, care needs to be taken to ensure that the arrangement does not run afoul of the Medicare fraud and abuse laws. This month, the U.S. Health and Human Services Office of the Inspector General (OIG) refused to give its blessing to such a venture. In Advisory Opinion 23-05, the OIG reviewed the structure of a venture between surgeons who would become investors and an entity that would supply these same surgeons with intraoperative neuromonitoring (IONM) services.

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Our Health Care System May Soon Receive a Much-Needed Cybersecurity Boost

Lily Hay Newman, writing for Wired.com and Ars Technica:

The Advanced Research Projects Agency for Health (Arpa-H), a research support agency within the United States Department of Health and Human Services, said today that it is launching an initiative to find and help fund the development of cybersecurity technologies that can specifically improve defenses for digital infrastructure in US health care. Dubbed the Digital Health Security project, also known as Digiheals, the effort will allow researchers and technologists to submit proposals beginning today through September 7 for cybersecurity tools geared specifically to health care systems, hospitals and clinics, and health-related devices.

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OIG Again Concludes That Online Health Care Provider Marketplace Does Not Violate Fraud and Abuse Laws

Douglas A. Grimm, Gayland O. Hethcoat II, writing for ArentFox Schiff:

In Advisory Opinion No. 23-04, the US Department of Health and Human Services (HHS) Office of Inspector General (OIG) analyzed certain proposed changes to the functionality of a health care technology company’s online provider marketplace. As in an earlier 2019 opinion, OIG concluded that the company’s business model would not result in unlawful kickbacks and patient inducements.

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Antitrust & Competition Healthcare Quarterly Update Q2 2023

Andrew Lacy, Arman Oruc, John Goheen Kevin Walsh, and Andrew Jensen, writing for Goodwin Procter:

In the second quarter, the US antitrust agencies continued efforts to bolster their aggressive enforcement agenda by rewriting long-standing policies and procedures, including sweeping revisions to Merger Guidelines, significant changes to the HSR filing process, and withdrawing long-established antitrust healthcare guidance.

Pressure on PBMs continued to mount as the FTC expanded its study of the industry and withdrew previous advocacy statements and market studies related to PBMs.

The FTC continued to challenge major healthcare mergers, including the ongoing challenge to Illumina/Grail and a new challenge to IQVIA/Propel.

Beyond merger review, the FTC has not relented in its focus on state COPA laws, which may intensify enforcement actions in this space. Further, two states enacted notification laws for healthcare transactions that will require additional information and extend the timeline for regulatory approval.