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Dhara Waghela is an associate in the Corporate Practice Group in the firm's Century City office and is a member of the firm’s Healthcare team.

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  The order repealed and replaced a similar Executive Order, which was previously signed on July 24, 2020 but was held back from release by the Trump administration, and follows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

On Thursday, April 16, 2020, the California Department of Managed Health Care (the “Department”) released an all plan letter (the “Letter”) regarding changes to the Department’s General Licensure Regulation (the “Regulation”) in light of the coronavirus (COVID-19) pandemic.  The Letter updated the Department’s previous guidance concerning the Regulation that was issued on June 13, 2019.  For further information, see our previous post regarding the Regulation here.  
Continue Reading The California Department of Managed Health Care Extends the Phase-In Period for the General Licensure Regulation

The Supreme Court issued a long-awaited ruling on April 27, 2020, directed at a more than $12 billion challenge related to the temporary risk corridors program established by the Affordable Care Act (the “ACA”).  Challenges were brought under multiple consolidated cases, Maine Community Health Options v. United States, Moda Health Plan v. United States, Land of Lincoln Mutual Health v. United States, and Blue Cross Blue Shield of North Carolina v. United States (the “Consolidated Cases”).  In its decision, the Court reversed the decision of the United States Court of Appeals for the Federal Circuit and remanded the case for further proceedings.
Continue Reading Supreme Court Issues Long Awaited Ruling on Affordable Care Act Risk Corridors Program

When Alex Azar, the Secretary of the Department of Health and Human Services (“DHHS”), declared a national emergency on January 31, 2020 in response to the COVID-19 pandemic, he triggered an exception to the “in-person medical evaluation” requirement for online prescribing as set forth in the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (the “Haight Act”).  In short, the Haight Act prohibits physicians and other prescribers from issuing a valid prescription for a controlled substance by means of the internet (which includes telehealth technologies) without having first conducted at least one in-person medical evaluation, except in certain specified circumstances.  A public health emergency is one such exception to the in-person medical examination requirement.
Continue Reading Telehealth and Online Prescribing: COVID-19 Triggers Changes to the Prescriber/Patient/Pharmacist Relationship

On Tuesday, April 7, 2020, the California Department of Managed Health Care (the “DMHC”) released a guidance letter (the “Letter”) to all health care service plans regarding billing for and delivering telehealth services during the COVID-19 state of emergency.  The Letter provides  follow-up guidance to previous guidance the DMHC released on Wednesday, March 18, 2020 (the “Initial Guidance”).  The DMHC has also provided additional information regarding the most frequently asked telehealth questions it has received (the “FAQs”).
Continue Reading California Department of Managed Health Care Releases Additional Guidance on Telehealth Services