A survey conducted by Harvard Medical School, published in JAMA Network Open, reveals that oncologists agree AI tools must be explainable, patients must consent to AI use, and oncologists must protect patients from AI biases. Despite this, many oncologists lack confidence in recognizing AI biases, highlighting a need for structured AI education and ethical guidelines. The survey found that 37% of oncologists would let patients decide between their own and AI treatment recommendations, and 77% believe they should protect patients from biased AI, though only 28% feel capable of identifying such biases.
Category: Alert
Press Release from United States Department of Justice, Southern District of Texas:
On June 27, 2024, the U.S. Attorney’s Office for the Southern District of Texas announced charges against eight individuals as part of the Justice Department’s 2024 National Health Care Fraud Enforcement Action. These charges involve various schemes, including fraudulent Medicare billing, kickbacks, and money laundering, amounting to over $2.75 billion in false billings nationwide. The accused include residents from Texas and Florida, with allegations ranging from operating fake businesses to billing for unprovided medical services. The enforcement action resulted in the seizure of over $231 million in assets. The FBI, Health and Human Services OIG, and other federal and state agencies conducted the investigations, while Assistant U.S. Attorneys and Department of Justice Trial Attorneys are prosecuting the cases.
Summary of press release from United States Department of Justice:
A Texas pharmacy owner was sentenced today to four years and four months in prison and ordered to pay over $59 million in restitution for paying illegal kickbacks and engaging in a money laundering conspiracy. According to court documents and evidence presented at trial, Richard Hall, 53, of Fort Worth, worked with others to create and market expensive compounded medications, which are intended to be custom-tailored to individual patient needs. Hall paid marketers to recruit area doctors to write prescriptions for these expensive compounded medications, including by creating so-called “investment opportunities” so that doctors who wrote prescriptions to the pharmacy could profit from the pharmacy operations. Hall paid illegal kickbacks to these marketers and engaged in a conspiracy to launder the unlawful proceeds. A federal jury in the Northern District of Texas convicted Hall in July 2023 of four counts of paying and receiving unlawful kickbacks and one count of conspiring to launder money.
The Texas Department of Licensing and Regulation adopted a rule for speech-language pathologists and audiologists confirming that direct and indirect supervision may be performed through tele-supervision and that in-person supervision is not required. This rule also allows a licensee providing telehealth services to provide proof of licensure to a requestor through the department’s online license search.
Summary of article from MassDevice, by Sean Whooley:
Profound Medical has received FDA 510(k) clearance for its second AI model, the Contouring Assistant, designed to treat prostate cancer. The Contouring Assistant is part of the company’s TULSA-Pro system, which uses transurethral ultrasound ablation (TULSA) to ablate diseased tissue in patients with various stages of prostate cancer, benign prostatic hyperplasia (BPH), or those requiring salvage therapy. The TULSA procedure uses real-time magnetic resonance guidance to preserve urinary continence and sexual function while targeting cancerous tissue. The newly cleared AI module uses machine learning to segment the prostate, aiding in the delineation of the target ablation volume. Profound Medical is also developing another TULSA-AI module, TULSA BPH, with more details expected later in 2024.
Press Release from U.S. Attorney’s Office, Eastern District of Michigan:
I don’t normally report on False Claims Act (FCA) matters from other states, but this one serves as a cautionary tale on “incident to” billing.
Under Medicare rules, covered services provided by non-physician practitioners (NPPs), like physician assistants, nurse practitioners, clinical nurse specialists, etc., are reimbursed at a reduced rate of 85 percent of the fee schedule amount.
The “incident-to” billing rules provide an exception, allowing 100 percent reimbursement for NPP services that meet the requirements detailed in the Medicare Benefit Policy Manual, Chapter 15, Section 60 (Services and Supplies Furnished Incident To a Physician’s/NPP’s Professional Service).
Among other requirements, to bill a NPPs services as “incident to” the physician’s initial evaluation, the physician must provide direct supervision. Without direct supervision, the NPPs services must be billed under the NPPs provider number at the reduced rate.
Direct supervision in the office setting does not mean that the physician must be present in the same room, but the physician must be present in the office suite and immediately available to provide assistance and direction throughout the time the aide is performing services.
Direct supervision in the home health setting, requires the physician to be physically present in the home to oversee the care.
In this reported FCA settlement, the NPP’s home health services were being billed “incident to” the physician’s services, but the physician was not physicially present in the home. Thus, the physican and his practice falsely claimed an extra 15% reimbursement on all those services.
The physician and his practice paid $2,003,800.91 to resolve the FCA allegations.
The moral of the story … know the rules about billing, and if you don’t, hire someone who does.
Fitch Ratings reports that the Federal Trade Commission’s (FTC) new rule banning non-compete clauses could cause staffing issues for not-for-profit (NFP) hospitals already grappling with wage increases. The rule, which is set to take effect 120 days after its April 30, 2024, publication in the Federal Register, has already faced legal challenges. It could potentially increase wage pressure and introduce operational instability due to higher staff turnover, especially in smaller or rural NFP hospitals. The impact of the rule, if it survives court challenges, is expected to be felt in 2025. This development, along with other factors like minimum wage laws and increased scrutiny of hospital mergers and acquisitions, could sustain pressure on the sector.
On April 18, 2024, the Federal Trade Commission (FTC), U.S. Department of Justice (DOJ), and U.S. Department of Health and Human Services (HHS) launched a public web portal for reporting anticompetitive practices in the health care sector. The portal, www.healthycompetition.gov, allows anyone to submit complaints about potential anticompetitive conduct in the healthcare industry. The portal provides information about federal laws ensuring healthy competition and examples of conduct that can harm competition in healthcare. The agencies have not limited the sources of reports, implying a wide scope for potential informants, from the general public to industry insiders. The launch of this portal necessitates increased vigilance from healthcare entities, as any information could potentially trigger an investigation by the FTC or DOJ.
The Biden-Harris Administration has announced a Final Rule through the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) to enhance the HIPAA Privacy Rule and protect reproductive health care privacy. This rule prohibits the disclosure of protected health information (PHI) related to lawful reproductive health care under certain conditions. The rule was issued in response to community feedback for better patient confidentiality and to prevent misuse of medical records related to reproductive health care. The rule mandates regulated health care providers and organizations to modify their Notice of Privacy Practices and obtain a signed attestation for certain requests for PHI related to reproductive health care. The current HIPAA Privacy Rule remains in effect until the new rule is implemented.
Cerebral, Inc., a telehealth company, has agreed to settle Federal Trade Commission (FTC) charges over its failure to secure and protect sensitive consumer health data. The settlement includes a $7 million fine for disclosing consumers’ personal health information to third parties for advertising purposes and failing to uphold its cancellation policies. The FTC claimed that Cerebral violated privacy rights by revealing sensitive mental health conditions across the internet and in the mail. The proposed order will restrict Cerebral’s use and disclosure of sensitive consumer data and require the company to implement a comprehensive privacy and data security program. The order, which must be approved by a court, also mandates that Cerebral provide an easy way for consumers to cancel services.