Numerous states—including Alaska, Wisconsin, Ohio and Oregon—have been busy finalizing rulemaking and legislation advancing hybrid healthcare models, modernizing licensure infrastructures and incentivizing telehealth. What have these states been up to over the last month?
Numerous states—including Louisiana, Ohio, California, Tennessee and New Jersey—have been finalizing rulemaking and legislation that create or amend professional practice standards to incorporate telehealth. Several of these states have also proposed regulations or laws related to the provision of care to youths.
Numerous states—including Wisconsin, Illinois, Kentucky and Oklahoma—have been busy finalizing rulemaking and legislation that create or amend professional practice standards to incorporate telehealth. What have these states been up to over the last month?
Numerous states—including Alaska, Maryland, California and Colorado—have been busy finalizing rulemaking and legislation impacting Medicaid coverage and maternal health. What have these states been up to over the last month?
The US Drug Enforcement Administration (DEA) and the Substance Abuse and Mental Health Services Administration (SAMHSA) are extending telehealth flexibilities that allow providers to prescribe controlled substances. While the extension is in place, the DEA indicated that it will be further evaluating its recently proposed rules for post-COVID-19 public health emergency telemedicine prescription of controlled substances.
The US Department of Health and Human Services Office of the Inspector General (HHS OIG) recently unveiled a new toolkit that seeks to help analyze telehealth claims for federal healthcare program integrity risks. It is based on methodologies highlighted in OIG’s September 2022 data brief; the data brief identified billing practices by Medicare providers that OIG was concerned posed a high risk to program integrity. OIG intends for the toolkit to be used by public and private parties—including Medicare Advantage plan sponsors, private health plans, State Medicaid Fraud Control Units and other federal healthcare agencies—to assess program integrity risks and identify providers whose billing may warrant further scrutiny.
Numerous states—including Illinois, Hawaii, Tennessee, Montana, New Hampshire and Indiana—have been busy finalizing rulemaking and legislation impacting interstate compacts, professional practice standards and COVID-19 licensure flexibilities. What have these states been up to over the last month?
Numerous states—including North Dakota, Hawaii, Indiana, Texas and New Hampshire—have been busy finalizing rulemaking and legislation impacting healthcare providers, telehealth and digital health companies, pharmacists and technology companies that deliver and facilitate virtual care. What have these states been up to over the last month?
On April 20, 2023, McDermott’s Alden Bianchi was a speaker at the ERISA Industry Committee’s 2023 Annual Spring Policy Conference, which was held at the National Press Club in Washington, D.C. The panel in which he participated was entitled “From Clinic to Courtroom – Legislation and Litigation Limiting Prescription Practices,” and it covered three main topics: state regulation of telehealth; the regulation of specialty pharmacy supply chains and delivery measures (“brown bagging,” “white bagging” and “clear bagging”); and state-level efforts to regulate pharmacy benefit managers (PBMs) following the US Supreme Court’s 2020 Rutledge decision, which held that an Arkansas law regulating the costs of prescription drugs was not preempted by the Employee Retirement Income Security Act of 1974 (ERISA).
Here are some of the program’s key takeaways and predictions:
While telehealth is here to stay, the high cost of Medicare reimbursements presents an immediate barrier to widespread adoption, and the particulars of how telehealth will be regulated will be left largely to the states.
The battle over the delivery of specialty prescription drugs is heating up as PBMs seek to capture some of the margins previously available only to providers. State laws regulating pharmacies and pharmacists will be at the center of the battle, and future legislative efforts will likely be subject to challenge.
State legislatures have read the Rutledge decision broadly in ways that virtually guarantee a good deal of future litigation. It might take as long as a decade, and it may well take more than one trip to the Supreme Court before plans, issuers, providers, state legislators and regulators, and other stakeholders have a reliable understanding of the contours of ERISA preemption in the pharmacy context.
Accompanying this post are copies of Mr. Bianchi’s panel materials, including:
We expect to see continued focus on privacy and security at the federal and state level. For example, California, Virginia, Colorado, Utah and Connecticut have new privacy laws coming into effect in 2023. As part of our State Law Privacy Video Series, McDermott described how these laws will affect health data and healthcare entities—in particular, those entities that are regulated by HIPAA.
In addition, at the end of 2022, the US Department of Health and Human Services (HHS) proposed long-awaited changes to the regulations protecting the confidentiality of substance-use disorder patient records under Part 2 of Title 42 of the Code of Federal Regulations (42 CFR Part 2, or Part 2). Specifically, the proposed rule would implement provisions of Section 3221 of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), which required HHS to align Part 2 with certain provisions of HIPAA and to make certain changes to the HIPAA Notice of Privacy Practices, the form given to patients and plan members that describes patient privacy rights, covered entity duties, and the covered entity’s uses and disclosures of protected health information.