The Administrative Regulations of the People’s Republic of China on Human Genetic Resources (the “Regulations”), promulgated by China’s State Council, have been in effect for almost three years. As the administrative department under the State Council with the primary responsibility for the administration and enforcement of the Regulations, China’s Ministry…
On March 15, 2022, President Biden signed into law the $1.5 trillion Consolidated Appropriations Act of 2022 (the “Omnibus Bill”). Included in the 2,700+ page Omnibus Bill is an extension of Medicare coverage of professional consultations, office visits, and office psychiatry services conducted via telemedicine for 151 days after the…
The COVID-19 Public Health Emergency (“PHE”) fundamentally changed the healthcare industry, forcing healthcare providers and patients onto their computers and phones to enable continuation of care when patients were mandated to stay home across the country. Prior to the COVID-19 PHE, approximately 12,5000 Medicare beneficiaries received telehealth services and only…
Clinical drug candidates are often claimed in a patent as a pharmaceutical composition or formulation with a specified concentration range of the drug or an excipient; as being purified within certain temperature or pH ranges; or in a method of treating a disease by administering the drug at a certain…
In a recent publication we helped co-author, we examined ClinicalTrials.gov entries and their possible impact on informing potential subjects of their eligibility to participate in clinical trials. In particular, we analyzed certain clinical trials focused on HIV treatment or prevention that allowed entry of pregnant women to assess the use…
On July 1, 2019, the Administrative Regulations on Human Genetic Resources (人类遗传资源管理条例) (the “Regulations”) issued by the State Council of the People’s Republic of China (the “PRC”) came into effect. On October 17, 2020, the Standing Committee of the PRC National People’s Congress promulgated the Biosecurity Law (中华人民共和国生物安全法) (the “Biosecurity…
On December 20, 2021, a group of emergency medicine physicians in California filed suit against a private equity-backed health care services company, claiming that (among other things), the company has run afoul of the state’s prohibition on the corporate practice of medicine (“CPOM”) since it took over an emergency department…
On January 11, 2022, the Centers for Medicare and Medicaid Services (CMS) released a proposed National Coverage Determination (NCD) decision memo limiting Medicare coverage for Biogen’s new Alzheimer’s drug, Aduhelm. Under the terms of the NCD – despite FDA’s 2021 approval of the drug – CMS will only pay for Aduhelm for…
During the COVID-19 public health emergency, the United States Food and Drug Administration (FDA) has issued hundreds of Emergency Use Authorizations (EUAs) and numerous enforcement policies to facilitate the availability of important medical devices. On December 23, 2021, FDA published two draft guidances setting forth the Agency’s proposed process for…
The FDA’s Center for Drug Evaluation and Research (CDER) approved 50 new drugs and biological products in 2021 (not including the vaccines, cellular and gene therapy products, or other products approved in 2021 by the Center for Biologics Evaluation and Research). As in past years, small molecule drug approvals dominated…