On June 28, in Loper Bright Enterprises v. Raimondo, the Supreme Court overturned the longstanding Chevron doctrine, under which courts generally granted deference to a federal agency’s reasonable interpretation of ambiguous...more
7/9/2024
/ Administrative Procedure Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Chevron Deference ,
Chevron v NRDC ,
Corner Post Inc v Board of Governors of the Federal Reserve System ,
Department of Health and Human Services (HHS) ,
Food and Drug Administration (FDA) ,
Government Agencies ,
Healthcare ,
Judicial Authority ,
Life Sciences ,
Loper Bright Enterprises v Raimondo ,
Regulatory Authority ,
SCOTUS ,
Statutory Interpretation
On May 16th, the U.S. Drug Enforcement Administration (DEA) issued a Notice of Proposed Rulemaking (NPRM) to initiate the rescheduling of marijuana from a Schedule I to a Schedule III drug. The NPRM, which was published in...more
5/31/2024
/ Classification ,
Controlled Substances Act ,
DEA ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Farm Bill ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Final Rules ,
Food and Drug Administration (FDA) ,
Internal Revenue Code (IRC) ,
Marijuana ,
Notice of Proposed Rulemaking (NOPR) ,
Regulatory Reform ,
Schedule I Drugs
On April 29, 2024, the Office of the Federal Register placed on display the Food and Drug Administration’s (FDA) final rule on the regulation of laboratory developed tests (LDTs). Set to be officially published on May 6, this...more
Key Points - The scientific review supporting HHS’s recommendation to DEA that cannabis be reclassified from a Schedule I to a Schedule III drug was published on January 12, 2024. Classifying cannabis as a Schedule III...more
2/26/2024
/ Banking Acts ,
Biden Administration ,
Cannabis Products ,
Controlled Substances Act ,
DEA ,
Department of Health and Human Services (HHS) ,
Executive Orders ,
Legislative Agendas ,
Popular ,
Public Comment ,
Schedule I Drugs
In January, the U.S. Food and Drug Administration (FDA) kicked off the year by announcing a much-anticipated proposal to restructure their human foods program (HFP), and the agency has continued to work on the details of...more
On October 3rd, the Food and Drug Administration (FDA) published its widely anticipated proposed rule on the regulation of laboratory developed tests (LDTs). Last year, Congress failed to pass the Verifying Accurate,...more
On February 1, 2023, the Federal Trade Commission (FTC) announced that it had taken enforcement action against prescription drug discount company GoodRx, which agreed to injunctive relief and to pay a $1.5 million civil...more
On January 31, 2023, the U.S. Food and Drug Administration (FDA) announced a proposal to restructure the agency’s human foods program. FDA regulates almost 80 percent of the nation’s food supply and this work is a cornerstone...more
The U.S. Food and Drug Administration (FDA) announced the conclusion of an internal working group that cannabidiol (CBD) will require a new regulatory pathway. The FDA explicitly denied three citizen petitions urging the...more
On May 17 the Senate Health, Education, Labor and Pensions (HELP) Committee released a bipartisan legislative discussion draft of the Food and Drug Administration (FDA) Safety and Landmark Advancements Act (FDASLA), which...more
Last month, the Senate Health, Education, Labor and Pensions (HELP) Committee voted 20 to 2 to advance S. 3799, the Prepare for and Respond to Existing Viruses, Emerging New Threats and Pandemics Act (the “PREVENT Pandemics...more
[co-author: Christina Barone]
The Infrastructure Investment and Jobs Act (the “bill”) is historic bipartisan legislation that will make available $1.2 trillion in funding for infrastructure programs across the...more
In vitro diagnostics (IVD) reform re-entered the legislative fray this week. The Verifying Accurate Leading-edge IVCT Development Act of 2021 (the “VALID Act of 2021,” the “VALID Act” or the “Act”) was introduced in both the...more
On March 9, 2021, the U.S. Department of Health and Human Services Office for Civil Rights announced that the public comment period for the HIPAA proposed privacy rule would be extended until May 6, 2021. The rulemaking was...more
On January 21, 2020, the far-reaching HIPAA Privacy Proposed Rule, initially released on December 10, 2020, was published in the Federal Register. Despite speculation that the publication timeline would be altered when the...more
3/3/2021
/ Business Associates ,
Covered Entities ,
Cybersecurity ,
Data Protection ,
Data Security ,
Department of Health and Human Services (HHS) ,
Electronic Protected Health Information (ePHI) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
OCR ,
PHI ,
Proposed Rules
Today, the far-reaching HIPAA Privacy Proposed Rule, initially released on December 10, 2020, was posted for public inspection on the Federal Register website. The rule is scheduled to be published in the Federal Register on...more
- As the COVID-19 pandemic continues, the clamor for liability protections for the nation’s health care providers continues.
- Although there are serious political divisions, the COVID Phase 4 relief legislation may...more
8/7/2020
/ Coronavirus/COVID-19 ,
Health Care Providers ,
Healthcare Facilities ,
Healthcare Workers ,
Immunity ,
Legislative Agendas ,
Liability ,
Long Term Care Facilities ,
Nursing Homes ,
Physicians ,
Proposed Legislation
- Tucked into a massive Medicare payment rule is a proposal to fundamentally change how CMS sets hospital payment rates.
- Recognizing that a hospital’s chargemaster rarely reflects true market costs, CMS seeks to use...more
5/15/2020
/ Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Fee-for-Service ,
Health Care Providers ,
Hospitals ,
Inpatient Prospective Payment System (IPPS) ,
Market Pricing ,
Medicare ,
Payment Rates ,
Physician Medicare Reimbursements ,
Physicians ,
Proposed Rules ,
Public Comment ,
Reporting Requirements
On April 2, 2020, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) announced that the agency will exercise enforcement discretion with respect to certain uses and disclosures of protected...more
4/13/2020
/ Business Associates ,
Covered Entities ,
Data-Sharing ,
Department of Health and Human Services (HHS) ,
Enforcement Actions ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HIPAA Privacy Rule ,
OCR ,
PHI ,
Public Health
While the United States now leads the world with the number of reported cases of COVID-19, the Coronavirus Aid, Relief, and Economic Security (CARES) Act (or “the Act”) takes major, though perhaps still incomplete, steps...more
4/1/2020
/ CARES Act ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Financial Stimulus ,
Health Care Providers ,
Hospitals ,
Medical Devices ,
Medical Supplies ,
Medical Testing ,
Over The Counter Drugs (OTC) ,
Personal Protective Equipment ,
Pharmaceutical Industry ,
Relief Measures
As COVID-19 continues to spread, health care providers, health plans and employers are facing difficult privacy questions as they attempt to balance privacy concerns against the need to protect patients, employees and...more
3/27/2020
/ Coronavirus/COVID-19 ,
Data Privacy ,
Employee Privacy Rights ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Infectious Diseases ,
Patient Privacy Rights ,
PHI ,
Privacy Laws ,
Privacy Policy ,
Public Health