Over the last several weeks, the Biden administration has released numerous final regulations in order to “beat the clock” before it ticks down to the Congressional Review Act (CRA) deadline. The CRA authorizes Congress to...more
5/9/2024
/ Affordable Care Act ,
American Health Care Act (AHCA) ,
Centers for Medicare & Medicaid Services (CMS) ,
Clinical Laboratory Testing ,
DACA ,
Federal Trade Commission (FTC) ,
Final Rules ,
Food and Drug Administration (FDA) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Laboratory Developed Tests ,
Life Sciences ,
Managed Care Contracts ,
Medicaid ,
Non-Compete Agreements ,
Non-Discrimination Rules ,
Nursing Homes ,
Pharmaceutical Industry ,
Proposed Rules ,
Regulatory Agenda ,
Regulatory Oversight ,
Regulatory Requirements ,
Senate Committees ,
U.S. House
On April 29, 2024, the US Food and Drug Administration (FDA) issued the long-awaited final rule around the regulation of laboratory developed tests (LDTs), which are in vitro diagnostic products (IVDs) that FDA describes as...more
During this election year, McDermottPlus is actively monitoring annual regulations that federal agencies are expected to release, as well as “ad hoc” regulations that will be released at the discretion of federal agencies. ...more
4/26/2024
/ Centers for Medicare & Medicaid Services (CMS) ,
DEA ,
Department of Health and Human Services (HHS) ,
Department of Labor (DOL) ,
Department of Veterans Affairs ,
Employee Benefits ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Health and Welfare Plans ,
Healthcare ,
Healthcare Reform ,
New Regulations ,
OCR ,
OIG ,
OSHA ,
Proposed Regulation ,
Regulatory Agenda ,
Regulatory Reform
On March 15, 2024, four of the US Food and Drug Administration’s (FDA) medical products centers released a joint paper, titled “Artificial Intelligence & Medical Products: How CBER, CDER, CDRH, and OCP are Working Together,”...more
The Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1) final rule, issued by the US Department of Health and Human Services (HHS) Office of...more
4/10/2024
/ Algorithms ,
Artificial Intelligence ,
Certification Requirements ,
Data Protection ,
Department of Health and Human Services (HHS) ,
Final Rules ,
Health Information Technologies ,
Healthcare ,
Information Technology ,
ONC ,
Risk Management ,
Technology
A few weeks ago, Regs & Eggs highlighted the major issues that McDermott+Consulting is monitoring this year – and the implementation of the president’s executive order (EO) on artificial intelligence (AI) was definitely part...more
2/1/2024
/ Artificial Intelligence ,
Biden Administration ,
Deadlines ,
Department of Health and Human Services (HHS) ,
Executive Orders ,
Health Care Providers ,
Health Information Technologies ,
Healthcare ,
Healthcare Reform ,
Legislative Agendas ,
Machine Learning ,
New Legislation ,
ONC ,
State and Local Government ,
State Legislatures ,
Technology
What does December 31, 2024, mean to you? New Year’s Eve? Post-2024 election? Too far away to know?
Our answer: December 31, 2024, is when we will go over a “telehealth cliff” if Congress fails to act before that date,...more
On December 13, 2023, the US Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology (ONC) issued the Health Data, Technology, and Interoperability: Certification...more
Happy New Year! As we enter 2024, we want to lay out some of the main regulatory issues (both new and old) that McDermott+Consulting will be tracking over the next year. While these may evolve, we think they are still...more
1/4/2024
/ Artificial Intelligence ,
CARES Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
Healthcare Reform ,
Laboratory Developed Tests ,
Managed Care Contracts ,
Medicaid ,
Medicare ,
MIPS ,
No Surprises Act (NSA) ,
Physician Fee Schedule ,
Proposed Regulation ,
Regulatory Agenda ,
Regulatory Reform ,
Telehealth ,
Telemedicine
On October 30, 2023, the US Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology (ONC) and the Centers for Medicare & Medicaid Services (CMS) released a...more
A few weeks ago, Regs & Eggs discussed the constant give and take between federal agencies and Congress as they both work on overlapping policies and objectives. The major regs released last week provide an excellent example...more
11/9/2023
/ Centers for Medicare & Medicaid Services (CMS) ,
Congressional Committees ,
Healthcare ,
Healthcare Reform ,
Legislative Agendas ,
New Legislation ,
Outpatient Prospective Payment System (OPPS) ,
Physician Fee Schedule ,
Price Transparency ,
Proposed Legislation ,
Senate Committees ,
Telehealth ,
U.S. House
On November 2, 2023, the Centers for Medicare & Medicaid Services (CMS) released the calendar year (CY) 2024 Revisions to Payment Policies Under the Physician Fee Schedule (PFS) and Other Revisions to Medicare Part B...more
On October 30, 2023, the White House released a long-awaited Executive Order (EO) on the “Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence.” The EO acknowledges the transformative potential of AI...more
11/1/2023
/ Artificial Intelligence ,
Biden Administration ,
Data Security ,
Executive Orders ,
Healthcare ,
Healthcare Reform ,
Innovative Technology ,
Legislative Agendas ,
New Legislation ,
New Regulations ,
Privacy Laws ,
Regulatory Agenda ,
Regulatory Requirements ,
Technology
The United States Drug Enforcement Administration (DEA) and the Substance Abuse and Mental Health Services Administration (SAMHSA) have further extended flexibilities that allow providers to prescribe controlled substances...more
10/9/2023
/ Controlled Substances ,
Coronavirus/COVID-19 ,
DEA ,
Extensions ,
Healthcare ,
Prescription Drugs ,
Public Health Emergency ,
SAMHSA ,
Telehealth ,
Telemedicine ,
Temporary Regulations
On September 29, 2023, the US Food and Drug Administration (FDA) published a long-awaited proposed rule on laboratory-developed tests (LDTs). If FDA finalizes this rule as proposed, FDA will regulate virtually all LDTs as...more
Congress and federal agencies often engage in a game, each trying to see what the other is willing to do to achieve a particular policy or outcome. While Congress and federal agencies have unique authorities (legislative...more
10/5/2023
/ Centers for Medicare & Medicaid Services (CMS) ,
Clinical Laboratories ,
Congressional Committees ,
Diagnostic Tests ,
Food and Drug Administration (FDA) ,
Laboratory Developed Tests ,
Legislative Agendas ,
Life Sciences ,
Medical Devices ,
Medicare Advantage ,
Proposed Rules
In the 118th Congress, the US House of Representatives is keenly interested in healthcare price transparency. Three House committees—Energy and Commerce, Ways and Means, and Education and the Workforce—each approved...more
The price of prescription drugs has brought scrutiny to the entire drug supply chain. Congress and other policymakers continue to seek opportunities to lower costs for patients and the federal government.
Pharmacy benefit...more
9/6/2023
/ Drug Pricing ,
MCOs ,
Medicare ,
Medicare Advantage ,
Medicare Part D ,
Pharmaceutical Industry ,
Pharmacies ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drug Coverage ,
Prescription Drugs ,
Supply Chain
August 31, 2023 – When it comes to prescription drug costs, policymakers have set their focus on the consumer:
“Let’s lower drug prices for the consumer.”
“Let’s give consumers more options in paying their out-of-pocket...more
8/31/2023
/ Centers for Medicare & Medicaid Services (CMS) ,
Drug Pricing ,
Healthcare Reform ,
Inflation Reduction Act (IRA) ,
Medicare ,
Medicare Part B ,
Medicare Part D ,
Negotiations ,
Pharmaceutical Industry ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Rebates ,
Transparency
In the 118th Congress, the US House of Representatives is keenly interested in price transparency in healthcare. Three House committees—Energy and Commerce, Ways and Means and Education and the Workforce—each approved...more
On July 13, 2023, the Centers for Medicare & Medicaid Services (CMS) released the Calendar Year (CY) 2024 Revisions to Payment Policies Under the Physician Fee Schedule (PFS) and Other Revisions to Medicare Part B...more
On July 7, 2023, the US Departments of Health and Human Services, Labor, and Treasury (collectively, the departments) released a Notice of Proposed Rulemaking (NPRM) and Fact Sheet that proposes to revise the definition of...more
During this session, panelists offered insights into the regulatory action, rulemaking and legislation shaping the future of digital health, with a particular focus on artificial intelligence (AI), data privacy and the end of...more
6/19/2023
/ Artificial Intelligence ,
Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Data Privacy ,
Digital Health ,
Healthcare ,
Healthcare Reform ,
Legislative Agendas ,
Proposed Legislation ,
Proposed Regulation ,
Public Health Emergency ,
Regulatory Agenda ,
Telehealth
Following the May 1 White House announcement that the federal government would wind down certain remaining COVID-19 vaccination requirements, on May 31, 2023, the Centers for Medicare & Medicaid Services (CMS) issued a final...more
6/2/2023
/ Biden Administration ,
Coronavirus/COVID-19 ,
Emergency Management Plans ,
Employer Liability Issues ,
Employer Mandates ,
Essential Workers ,
Health and Safety ,
Health Care Providers ,
Healthcare Facilities ,
Healthcare Workers ,
Infectious Diseases ,
Public Health Emergency ,
Vaccinations ,
Workplace Safety
At the onset of the COVID-19 PHE, CMS was permitted to issue several temporary emergency statutory and regulatory waivers to help providers appropriately respond to the pandemic. On May 1, 2023, the Secretary released a memo...more
5/11/2023
/ Acute Facilities ,
Ambulatory Surgery Centers ,
Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Health Care Providers ,
Home Health Care ,
Hospice ,
Hospitals ,
Long Term Care Facilities ,
Mental Health ,
Public Health Emergency ,
Skilled Nursing Facility ,
Waivers