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Stark Law Changes Ramp Up in 2023

Patsy Newitt, for Becker’s ASC Review:

The Consolidated Appropriations Act of 2023 updated exceptions to Stark law and anti-kickback law that will allow hospitals and healthcare providers to improve mental health services for physicians. The law issues a new exception for physician wellness programs offered by healthcare entities, including ASCs, hospitals and physician practices.

To satisfy the exception, the program must also include a written policy, which must include a description of the content and duration of the program, a description of the evidence-based support, and the estimated costs, among other stipulations.

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Collin County Man Sentenced for Federal Violations Related to Health Care Fraud Scheme

Press Release for the Eastern District of Texas:

Oscar Simon Ndereva, 45, pleaded guilty to wire fraud and was sentenced to 54 months in federal prison by U.S. District Judge Sean D. Jordan.

According to information presented in court, Ndereva was involved in an intricate scheme to defraud private pay health insurance payors.  Specifically, he used a fraudulent healthcare pharmacy called “Healogix” to submit fraudulent claims.  Ndereva caused the fraudulently obtained funds to be paid directly to bank accounts he opened in the name of another individual.

Over the course of the scheme, Ndereva moved money through various accounts in order to conceal the nature and source of those funds, and also structured check cashing transactions to avoid financial reporting requirements and to evade law enforcement detection.

In all, Ndereva’s company Healogix submitted over 780 fraudulent claims totaling over $5 million.

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Period of Enhanced Oversight for New Hospices in Arizona, California, Nevada, & Texas

CMS is placing newly enrolling hospices located in Arizona, California, Nevada, and Texas in a provisional period of enhanced oversight. Over the last 12 months, we’ve received numerous reports of hospice fraud, waste, and abuse. The number of enrolled hospices has also increased significantly in these states, raising serious concerns about market oversaturation.

“New hospices” include those 1) newly enrolling in the Medicare Program (starting July 13, 2023); 2) submitting a change of ownership (CHOW) that meets all the regulatory requirements under 42 CFR 489.18; and 3) undergoing a 100% ownership change that doesn’t fall under 42 CFR 489.18.

This enhanced oversight can be from 30 days to 1 year.

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Just More Than a Third of Hospitals Are Complying with Price Transparency Rules

Joseph Choi, for The Hill:

More than two years after federal hospital price transparency rules went into effect, only about a third of hospitals are currently in compliance, according to a report released this week.
The nonprofit Patient Rights Advocate (PRA) released its fifth semi-annual report, which found that only 36 percent of 2,000 surveyed hospitals were in complete compliance with the rule.

Since Jan. 1, 2021, hospitals have been required to give “clear, accessible pricing information” on their products and services, either through an online file or a “consumer-friendly” display of shoppable services.

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Pain Management Physician’s Assistant Charged in Amniotic Fluid Scam

Press Release for U.S. Attorney’s Office, Northern District of Texas:

Certain amniotic products have been approved by the U.S. Food and Drug Administration for wound care, but not for pain management. (In fact, the FDA has issued repeated consumer alerts warning that biologics like amniotic fluid “have not been approved for the treatment of any orthopedic condition, such as osteoarthritis, tendonitis, disc disease, tennis elbow, back pain, hip pain, knee pain, neck pain, or shoulder pain,” nor for “chronic pain or fatigue.”) Because amniotic products have not been approved to treat pain, Medicare considers amniotic injections administered to treat pain medically unnecessary and does not reimburse for them. They do reimburse for some – but not all – amniotic injections administered to reduce inflammation of damaged tissue, as in a wound.

These types of injections happen all the time under the umbrella of “Regenerative Medicine.” The idea is that the amniotic fluid contains stem cells which can help regenerate cartilage in the joints.

Clearly, the U.S. Attorney’s Office was dubious about the efficacy of the injections. But what got the PA in hot water is the submission of the charges to Medicare for reimbursement.

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FTC Follows DOJ and Withdraws Antitrust Policy Statements

Charles Honart, for Stevens & Lee:

On July 14, the Federal Trade Commission (“FTC”), as anticipated, announced that it was withdrawing two antitrust policy statements related to enforcement in health care markets:

Statements of Antitrust Enforcement Policy in Health Care (August 1996)
Statement of Antitrust Enforcement Policy Regarding Accountable Care Organizations Participating in the Medicare Shared Savings Program (October 2011)
The FTC’s withdrawal follows the Department of Justice’s (“DOJ”) decision to rescind the same statements in February 2023. (See our previous blog post.)

In withdrawing the policy statements, the FTC stated that it had determined that the withdrawal of the statements is the best course of action for promoting fair competition in health care markets. According to the FTC, much of the statements are outdated and no longer reflect health care market realities, and, given what it describes as the “profound changes” in the market over the last 30 years, the statements no longer serve their intended purpose of providing accurate guidance to market participants

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EHR Clinical Note Length Continues to Grow Despite Coding Changes

Here’s one for the med mal attorneys. Epic Research issued a report on clinical notes documented in their system.

Researchers evaluated 1.7 billion clinical notes written by 166,318 outpatient providers from May 2020 to April 2023.

They found that the average length across all clinical notes increased 8.1 percent from May 2020 to April 2023. However, even though the average note length increased, the average time spent writing notes decreased by 11.1 percent over this same period.

The researchers also compared each provider’s average note length in 2020 to that same provider’s average note length in 2023. About 40 percent of providers decreased their average note length over the three years.

The research also revealed that almost 90 percent of providers reduced the average time they spent writing each clinical note.

Additionally, 10 percent of providers who decreased their average note lengths the most came from various specialties, including primary care, internal medicine, surgical specialties, dermatology, cardiology, and psychiatry. The researchers noted that this suggests a reduction in note length is achievable in almost any specialty.

Full article by Hannah Nelson, for EHR Intelligence.

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Artificial Intelligence, Cybersecurity and the Health Sector

HHS Health Sector Cybersecurity Coordination Center (HC3) has published a report (PDF) detailing cybersecurity concerns for healthcare providers. In particular, what can be done to remain secure, given AI-enhanced cyberthreats. The report provides an educational overview of regenerative IA, particularly ChatGPT and the difference between machine learning and neural networks.

More importantly, the report discusses how IA can threaten healthcare and ways the healthcare sector can defend against AI-enabled threats.

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CMS Proposes to Expand 36-Month Rule to Hospice Agencies

Ragini A. Acharya, for HuschBlackwell:

The 36-Month Rule, found at 42 C.F.R. § 424.550(b), provides that where there is a change in majority ownership (“CIMO”) of an HHA by sale (including asset sales, stock transfers, mergers and consolidations) within 36 months after the effective date of the HHA’s initial enrollment in Medicare or within 36 months after the HHA’s most recent CIMO, the provider agreement and Medicare billing privileges do not convey to the new owner. Rather, the prospective owner of the HHA must enroll in the Medicare program as a new HHA and obtain a state survey or accreditation from an approved accreditation organization. Notably, an indirect change of ownership does not trigger the 36-Month Rule.

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Texas Lawyer Convicted of Conspiracy and Perjury for Laundering Kickbacks

This was intentional criminal conduct of conspiracy and perjury related to Anti-Kickback Statute violations. From a U.S. Attorney’s Office for the Eastern District of Texas Press Release:

“By facilitating kickbacks, this defendant knowingly enabled theft from Medicare and Medicaid, putting personal profit before legitimate patient needs and ultimately costing taxpayers millions of dollars,” said Jason E. Meadows, Special Agent in Charge at the U.S. Department of Health and Human Services, Office of Inspector General (HHS-OIG). …

According to information presented in court, [Peter J. Bennett] created sham trusts and shell corporations through which he laundered at least $2,724,080.41 in healthcare kickback proceeds. Bennett used his law firm’s Interest on Lawyers Trust Account (IOLTA), operating account, and a personal bank account to launder and transmit the kickback proceeds. The perjury charges arose out of false statements Bennett made in response to interrogatories propounded in Civil Investigative Demands issued by the Department of Justice as part of a False Claims Act (FCA) investigation. Bennett was indicted by a federal grand jury in February 2022.