Bridge Oncology

We are pleased to announce Dr. Vivek S. Kavadi as the new CEO of ASTRO. Dr. Kavadi, a radiation oncologist and ASTRO member, will assume the role Nov. 1. Read today's special ASTROgram to learn more: https://ow.ly/HVEi50SmLmQ

Some key points to consider about The Tenth Amendment - Jordan Johnson, MSHA, iMPaCT Hillary Cavanagh Blake Madden Bridge Oncology Seema Verma American Hospital Association National Rural Health Association American Medical Association Nixon Gwilt Law Brennan Manna Diamond Christopher Luckett Jonathan Levitt Humana Optum Cencora McKesson Cardinal Health Guidehouse Chartis Huron ECG Management Consultants #Cancer #FDA #HealthCarePolicies #Telehealth #OncoDaily #Oncology

****Newsletter Subscription Open***** https://lnkd.in/edmv5_jT I posted the other day that the Bridge Oncology newsletter would be available for those that want to subscribe. It is almost as good as the updates from my good friend Blake Madden. You will probably see some of his great work in it too. We are on the 67th Newsletter and the reach so far is about 4500 people. It is geared towards Oncology but covers many other relational healthcare topics: --health law --health policy --billing/coding/compliance --data and statistics --emerging technologies --health strategies --mergers and acquisitions --Private equity --Bridge Oncology updates --payers and payer initiatives ---opinion pieces --etc ----------- https://lnkd.in/edmv5_jT ------ Ochsner Health HCA Healthcare AdventHealth Atrium Health Health Care Compliance Association (HCCA) Providence Health & Services American Oncology Network McKesson The US Oncology Network Daiichi Sankyo US Cardinal Health Flatiron Health OneOncology Northwestern Medicine UF Health Medical University of South Carolina Wellstar Health System CARTI Highlands Oncology Group Florida Cancer Specialists & Research Institute City of Hope VieCure Nixon Gwilt Law Oncology Nursing Society CancerX Moonshot Avera Health Veradigm®Caris Life Sciences Carrum Health OncoHealth

Informed Consent, what about "informed refusal?" Yes, it is a thing? Case Context - Truman v. Thomas 1980 Truman v. Thomas** is a landmark case in medical law that deals with the doctrine of informed refusal. ---- The 1980 case, Truman v. Thomas, centered on a patient's right to informed refusal of medical treatment. Mary Truman declined a Pap smear recommended by Dr. Thomas. Later, she developed cervical cancer and sued, alleging she wasn't adequately informed of the risks of refusing the test. The California Supreme Court ruled in favor of Truman, emphasizing that physicians must fully inform patients of the potential consequences of refusing recommended treatments. This case established that informed consent includes the duty to inform patients about the risks of not undergoing a procedure or treatment. ------- Dr. Thomas testified he never specifically informed her of the purpose of a pap smear test. There was no evidence introduced that Mrs. Truman was aware of the serious danger entailed in not undergoing the test. ----------- Legal Principles Established: 🖊 Informed Refusal ✏ Standard of Care 🖍 Duty to Inform ------- https://lnkd.in/ehQkiTGf ------- Blake MaddenHealth Care Compliance Association (HCCA) Society of Corporate Compliance and Ethics (SCCE) American Medical Association American Hospital Association HHS Office of Inspector General Centers for Medicare & Medicaid Services Sean Weiss Brennan Manna Diamond Mysty Blagg

***Private Equity in Healthcare*** Case to pay close attention to: 📢 US Anesthesia Partners Inc., a private equity-owned entity, did not succeed in obtaining a dismissal of the monopolization lawsuit filed by the US Federal Trade Commission (FTC). This lawsuit focuses on the company's strategy of acquiring smaller anesthesiology practices that serve local markets—a tactic known as "roll-up." A federal judge in Texas denied the motion to dismiss filed by USAP in the US District Court for the Southern District of Texas on Monday, but the court allowed the dismissal of the claims against the private equity owner of the practice. This decision represents the first judicial evaluation of the FTC's effort to address roll-up strategies within the healthcare sector. In September, the FTC initiated a lawsuit against USAP and its private equity partner, Welsh Carson Anderson & Stowe LP, alleging that they had monopolized the anesthesiology market in Texas. This legal action marks the first FTC challenge against the roll-up strategy employed by private equity. According to the FTC, Welsh Carson systematically acquired a significant number of anesthesiology practices, thereby establishing dominance in the Texas market and increasing patient costs. Judge Kenneth Hoyt, appointed by President Ronald Reagan, stated in his order that the FTC has reasonably alleged that these acquisitions led to increased consumer prices and involved a scheme of market allocation and price setting. Judge Hoyt emphasized that dismissing these claims at this stage would be premature. According to a source with knowledge of the matter, Judge Hoyt's ruling is seen as a pivotal development in federal efforts to regulate private equity acquisitions, which typically fall below the threshold for antitrust scrutiny. The FTC and the Department of Justice have updated merger guidelines that reflect a strategic focus on scrutinizing serial acquisitions, a stance reinforced by this decision. USAP disputes the merits of the FTC’s claims, asserting their lack of foundation. USAP physician and board member Scott Holliday emphasized that the organization will continue prioritizing patient care as the lawsuit progresses. The role of private equity in healthcare, involving transactions often below the federal antitrust review threshold of $119.5 million, continues to attract significant attention from federal regulators. In March, the FTC, DOJ, and the Department of Health and Human Services initiated an inquiry into smaller acquisitions by private equity firms within the U.S. healthcare sector. -- @blake madden

The Corporate Practice of Medicine The Corporate Practice of Medicine (CPOM) doctrine prohibits corporations from engaging in the practice of medicine or from employing physicians to deliver professional medical services. This prohibition stems from state medical practice acts and is influenced by various public policy considerations. These include concerns that corporate involvement in medicine may lead to its commercialization, potential conflicts between corporate obligations to shareholders and physicians' duties to their patients, and the possibility of corporate employment compromising physicians’ independent medical judgment. Although the CPOM is prevalent across most states, there are significant exceptions in nearly every state, such as allowances for professional medical corporations and specific healthcare entities to employ physicians. This is an overview of the relevant state laws. The rise of Private equity and "business arrangements" have come under increased scrutiny as the lines of CPOM have become blurred and enforcement has been lax. Amid heightened scrutiny from advocates and regulators concerning private equity (PE) investment in healthcare, the case of American Academy of Emergency Medicine Physician Group (AAEM-PG) v. Envision Healthcare stands out as a critical potential precedent, especially with its emphasis on the Corporate Practice of Medicine (CPOM) claims. The Independent Emergency Physicians Consortium heralded the case as a “momentous event,” pointing to a possible turning point in the growing corporatization of medicine. However, the momentum was stalled in May 2023 when the defendant declared bankruptcy, leaving the future proceedings of the case uncertain. Regardless of its current status, the Envision case remains a pivotal example of how Unfair Competition Law and the Corporate Practice of Medicine doctrine can be strategically employed to mitigate the adverse effects of PE’s encroachment on the medical field. https://lnkd.in/etTmXHK7 The American Medical Association has been considering a resolution to seek a federal ban on the corporate practice of medicine. LAWS PROHIBITING THE CORPORATE PRACTICE OF MEDICINE stand strong across the majority of states, yet their enforcement is strikingly inconsistent. Historically, state medical societies implemented CPOM bans during the 1920s and 1930s, explicitly targeting the prevalent practice where railroad and mining executives hired "company doctors" to perform basic health screenings and address workplace injuries, often deducting the cost directly from employees' wages. These laws were a bold response to curb corporate overreach into personal health and worker exploitation. https://lnkd.in/efbcTNzR Blake Madden American Medical Association American Hospital Association National Rural Health Association Eric Bricker, MD HCA Healthcare Brennan Manna Diamond

More antitrust scrutiny coming: The concerns raised by Doha Mekki and Susan Athey about the under-enforcement of antitrust laws in the healthcare industry, particularly regarding consolidation among groups of doctors and nurses, highlight significant issues in the market. Here's a breakdown of the key points and implications: 1.Consolidation Trends: The US healthcare industry has seen significant consolidation over the years, with fewer hospitals existing today compared to 1998. This consolidation extends beyond hospitals to include health insurers and other healthcare service providers. 2. UnitedHealth Group Inc.: While Mekki didn't name specific companies, UnitedHealth Group Inc. has drawn scrutiny for its aggressive acquisition strategy, particularly in buying up doctor groups across the US. The company's extensive reach across various sectors of the healthcare system, including insurance coverage and healthcare services through its subsidiary Optum, has raised concerns about its market dominance. 3. Antitrust Scrutiny: The Justice Department is actively reviewing UnitedHealth's proposed acquisitions, including its takeover of Amedisys Inc. and its proposed acquisition of Steward Medical Group Inc. These reviews indicate a growing awareness of the potential anticompetitive effects of consolidation in the healthcare industry. 4. Consumer Impact: Athey emphasized the importance of ensuring consumers have sufficient choice in healthcare services. Consolidation can limit competition, potentially leading to higher prices, reduced quality of care, and limit 5. Competition and Consumer Welfare: The fundamental question raised by Athey is whether consolidation in the healthcare industry ultimately benefits consumers. If market consolidation leads to decreased competition and consumer choice, it could undermine efforts to improve healthcare affordability, accessibility, and quality. Overall, the comments from Justice Department officials underscore the need for vigilant antitrust enforcement in the healthcare industry to protect consumer welfare and ensure a competitive marketplace. ----- OneOncology HHS Office of Inspector General Centers for Medicare & Medicaid Services American Hospital Association American Oncology Network American Medical Association Humana Blue Cross Blue Shield of Massachusetts UnitedHealth Group Optum

***Bridge Oncology Approved*** It does look like a better and smarter position has prevailed. As all other medical professions have moved forward and evolved on how and when to apply general and direct virtual supervision, there was radiation oncology. Our professional without input or discussion sent a letter to CMS to return to 2010 Direct supervision standards. To no one's surprise this would be restrictive for patients and providers. Yesterday, ACRO our other professional society, after open discussions and feedback established their position on supervision: Direct and general supervision have a role in safe, quality care delivery when used responsibly.  1. Some degree of flexibility at the discretion of the Radiation Oncologist is warranted in all sites of service.  2. Certain treatments demand direct supervision at each session, while other treatments may only require direct supervision at the initiation of therapy. 3. Supervision requirements with reasonable exceptions should be unrelated to site of service and geographic location.   4.Variations in supervision requirements based on advances in technology (e.g. “virtual direct supervision”) should be considered after further review in the future.  https://lnkd.in/eA7YX9pZ ------ Our team at Bridge Oncology supports this position and looks forward to further clarifying in the coming months as we did in our research earlier this year: https://lnkd.in/eNyV3z5A ------- American Oncology Network Florida Cancer Specialists & Research Institute PrecisCa American Hospital Association American Medical Association National Rural Health Association Sutter Health Ochsner Health

A ton of Movement on the FTC front Next week will be a big week on the Non-Compete Front. Our team at Bridge Oncology has spent a ton of time on this initiative so we will see where it lands. 1. FTC Announces Special Open Commission Meeting on Rule to Ban Non-Competes The Commission is scheduled to deliberate on a proposed final rule aimed at curbing the widespread use of noncompete agreements by employers. This proposed final rule seeks to restrict most employers from implementing noncompete clauses, as outlined in the Notice of Proposed Rulemaking. The rationale behind this initiative, as elucidated in the notice, underscores the detrimental impact of non-competes on wage suppression, hindrance of innovation, and obstruction of entrepreneurial ventures. The forthcoming decision by the Commission is a result of the FTC's January 2023 Notice of Proposed Rulemaking, which underwent a thorough 90-day public comment period. https://lnkd.in/eRZHRMq9 2. Federal Agencies Launch Portal for Public Reporting of Anticompetitive Practices in the Health Care Sector Today marks the official launch of an easily accessible online portal, HealthyCompetition.gov, by the Federal Trade Commission (FTC), the Justice Department, and the U.S. Department of Health and Human Services (HHS). This portal is designed to enable the public to report health care practices that may impede competition. HealthyCompetition.gov empowers individuals to report potentially unfair and anticompetitive health care practices directly to the FTC and the Justice Department's Antitrust Division. This collaborative effort signifies a significant step forward in the Biden-Harris Administration's commitment to reducing health care and prescription drug expenses. Moreover, it aims to foster more competitive health care markets that prioritize fairness for patients, providers, payers, and workers. FTC Chair Lina M. Khan emphasized the importance of this initiative, stating, "All too often, we hear about unfair competition methods and monopolistic practices that could limit Americans' access to affordable, high-quality healthcare. This joint endeavor between the FTC, DOJ, and HHS establishes a vital avenue for the public to voice concerns, enhancing our ability to address unlawful business practices that detrimentally affect consumers and workers." https://lnkd.in/enjssAcC Blake Madden American Medical Association American Hospital Association Sutter Health Cardinal Health Brennan Manna Diamond Ochsner Health American Oncology Network American College of Healthcare Executives Novartis Guidehouse Kaiser Permanente HCA Healthcare Atrium Health AdventHealth Providence Health & Services

The Federal Trade Commission Making Moves Proposed FTC Order will Prohibit Telehealth Firm Cerebral from Using or Disclosing Sensitive Data for Advertising Purposes, and Require it to Pay $7 Million- Complaint alleges that Cerebral and its former CEO, Kyle Robertson, deceived users about its data sharing and security practices, and misled consumers about its cancellation policies. The allegations outlined in the complaint assert that during CEO Robertson's tenure, Cerebral neglected to establish sufficient safeguards for the protection of sensitive consumer data, demonstrating lax security protocols. Key points detailed in the complaint include: 1. Careless Marketing Practices: Cerebral distributed promotional postcards to over 6,000 patients without utilizing envelopes, potentially exposing personal information, including diagnoses and treatment details, to unintended recipients. 2. Failure to Restrict Former Employee Access: Between May and December 2021, the company neglected to revoke access privileges for former employees, thereby risking unauthorized entry into confidential electronic medical records belonging to Cerebral patients. 3. Employment of Insecure Access Methods: Cerebral relied on a single sign-on mechanism for its patient portal, resulting in instances where confidential medical data and patient details, such as diagnoses, medications, email addresses, and phone numbers, were inadvertently accessible to other users sharing the portal simultaneously. 4. Insufficient Implementation of Policies and Training: The company fell short in restricting access to consumer data solely to necessary personnel, neglected to establish comprehensive procedures and training protocols regarding sensitive data handling, and failed to develop and enforce robust information security standards, policies, and procedures. These allegations underscore the importance of implementing robust security measures and adhering to best practices in data management to safeguard consumer privacy and uphold organizational integrity. https://lnkd.in/esBtW42m ---- Rebecca E. Gwilt Federal Trade Commission HHS Office of Inspector General U.S. Department of Health and Human Services (HHS) Eric Rubenstein, MSCJ, CFE Sean Weiss Hillary Cavanagh Blake Madden