All types of healthcare providers depend on medical directors to oversee clinical operations and consult with administrative leadership on facility, unit, or clinical service line plans and performance. Medical directors function at the intersection of administration and clinical care, weighing in on matters as varied and important as accreditation, capital expenditures for equipment, staffing, standard operating procedures, and peer review. In addition to clinical skills, they ideally need excellent people skills to balance competing priorities and communicate effectively with different stakeholders. They are a valuable resource and partner for compliance professionals. With proper support, medical directors can support an organization’s compliance efforts and help mitigate risk for both employee issues and healthcare regulatory matters. This article outlines five key best practices in contracting for medical director services:Continue Reading Do Your Medical Director Arrangements Meet the Top Five Best Practices?
Dhara Waghela Sheth is an associate in the Corporate Practice Group in the firm's Century City office and is a member of the firm’s Healthcare and Life Sciences teams.
While government enforcement has traditionally been an indirect concern for private equity (“PE”) investors, such as looking at whether a target entity has been sanctioned or could be sanctioned in the future, the current trend in government enforcement has been to target PE firms directly.Continue Reading PE Firms Face Liability for the Conduct of their Portfolio Companies: Are you Paying Attention?
Assembly Bill 2080 (“AB 2080”), known as the “Health Care Consolidation and Contracting Fairness Act of 2022,” was approved by the California Assembly on May 26, 2022, and if passed by the Senate and signed into law before the August 31st recess, will significantly affect healthcare M&A activity in California for a broad spectrum of healthcare providers, payors and other stakeholders. Continue Reading Putting the Brakes on Healthcare M&A and Provider/Payor Contracting: AB 2080 Poised to Dramatically Impact Healthcare Transactions in California
“The guidance reminds the public that the HIPAA Privacy Rule does not apply to employers or employment records.”
On September 30, 2021, the U.S. Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”) released guidance (the “Guidance”) entitled, “HIPAA, COVID-19 Vaccination, and the Workplace,” regarding the applicability of the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) Privacy Rule (“Privacy Rule”) to disclosures and requests for information regarding COVID-19 vaccination status. In a frequently-asked-questions format, the Guidance sets forth a series of workplace-related scenarios involving the confidentiality of an employee’s vaccination status, an employer’s ability to obtain vaccination information from its employees, and the confidentiality of such information.Continue Reading HIPAA and COVID-19 Vaccination Status: The Office of Civil Rights Issues Workplace Guidance
On August 10, 2021, the Centers for Medicare and Medicaid (“CMS”) published a proposed rule (“Proposed Rule”) to rescind the Most Favored Nation Model (“MFN Model”) interim final rule that was published on November 26, 2020 (“Interim Final Rule”). As described in our December 2020 blog post, the Interim Final Rule established a seven-year nationwide, mandatory MFN Model that would test an alternative way for Medicare to pay for certain Medicare Part B single source drugs and biologicals. The MFN Model, originally set to begin January 1, 2021, would have tied the prices for certain Part B single-source drugs and biologics to the average price paid by several overseas countries and remove incentives to use higher cost drugs, in order to determine whether this could “control unsustainable growth in Medicare Part B spending without adversely affecting quality of care for beneficiaries.” Had the Interim Final Rule been implemented, Medicare Part B reimbursement would have been significantly reduced starting January 1, 2021.
Continue Reading Executive Order on Promoting Competition in the American Economy: The Biden Administration Considers Drug Pricing Strategies While Keeping the “Most Favored Nations” Drug Reimbursement Program on the Sidelines
On March 10, 2021, President Biden signed into law the American Rescue Plan Act of 2021 (the “Act”). This $1.9 trillion COVID-19 relief package not only includes a whole host…
Continue Reading The American Rescue Plan Act of 2021: A New Lease on Life for the Affordable Care Act?
On September 13, 2020, President Trump issued an Executive Order (the “Executive Order”) directing the Department of Health and Human Services (“HHS”) to issue regulations instituting two most-favored-nations (“MFN”) payment…
Continue Reading Medicare Part B Most Favored Nation Drug Pricing Model: New Rules, New Lawsuits, New Tweets
On October 6, 2020, the US Supreme Court (the “Court”) heard arguments on an Employee Retirement Income Security Act (“ERISA”) case that has the potential to curtail the rights of states to regulate their individual healthcare markets, in Rutledge v. Pharmaceutical Care Management Association (the “Case”).
Continue Reading ERISA: The Erosion of State Health Regulation Rights
The death of Supreme Court Justice Ruth Bader Ginsburg, and alongside it the high probability of a conservative successor to the open seat she left behind, is likely to shift the Court substantially to the right. Among the most notable cases that will likely be presented before the newly constituted Court is the pending challenge to the Affordable Care Act (the “ACA”).
Continue Reading The Death of RBG…and the ACA?
On Sunday, September 13, 2020, President Trump signed an Executive Order, the next in a series of Executive Orders targeting the pharmaceutical industry, which aims to lower prescription drug prices in the United States (the “Order”). The order repealed and replaced a similar Executive Order, which was previously signed on July 24, 2020 but was held back from release by the Trump administration, and follows the signing of the Buy American Executive Order mandating the purchase of U.S.-manufactured drugs that we analyzed here.
Continue Reading The Next in the Series of Executive Orders Affecting the Pharmaceutical Industry
On Thursday, August 6, 2020 President Trump signed an Executive Order, mandating that certain drugs and medical supplies purchased by federal agencies, including the Department of Health and Human Services, Department of Defense, and Department of Veteran’s Affairs must be US-manufactured (the “Buy American Order” or the “Order”). The list of “essential medicines, medical countermeasures and critical input” that fall under this Order will be determined by the Food and Drug Administration (“FDA”). The Order also calls on the FDA to conduct a greater amount of unannounced inspections of overseas drug plants to ensure that production of drugs is compliant with safety standards and to encourage more advanced drug manufacturing techniques.
Continue Reading President Trump’s Executive Order Mandating the Purchase of U.S. Drugs Evokes Criticism