The Centers for Medicare & Medicaid Services (CMS) on Sept. 20, 2024, released the Misclassification of Drugs, Program Administration and Program Integrity Updates Under the Medicaid Drug Rebate Program (CMS-2434) Final Rule....more
For nearly 40 years and in more than 18,000 judicial opinions, federal courts have used the Chevron doctrine to defer to an agency's reasonable interpretation of an ambiguous statute. On June 28, 2024, the U.S. Supreme Court...more
9/3/2024
/ Administrative Procedure Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Chevron Deference ,
Chevron v NRDC ,
Consumer Financial Protection Bureau (CFPB) ,
Corner Post Inc v Board of Governors of the Federal Reserve System ,
Department of Justice (DOJ) ,
Department of Labor (DOL) ,
Department of Transportation (DOT) ,
Environmental Protection Agency (EPA) ,
Federal Trade Commission (FTC) ,
FERC ,
Food and Drug Administration (FDA) ,
Government Agencies ,
HUD ,
IRS ,
Judicial Authority ,
Loper Bright Enterprises v Raimondo ,
NTSB ,
OCC ,
Popular ,
Regulatory Authority ,
Relentless Inc v US Department of Commerce ,
SCOTUS ,
Stare Decisis ,
Statute of Limitations ,
Statutory Interpretation ,
U.S. Treasury
The Centers for Medicare & Medicaid Services (CMS) issued the final rule for fiscal year (FY) 2025 Inpatient Prospective Payment System (IPPS) and Long-Term Care Hospital Prospective Payment System (LTCH PPS) on Aug. 1, 2024....more
The Centers for Medicare & Medicaid Services (CMS) has released the calendar year (CY) 2025 Revisions to Payment Policies Under the Physician Fee Schedule (MPFS) and Other Revisions to Medicare Part B (CMS-1807-P) Proposed...more
The Centers for Medicare & Medicaid Services (CMS) has released the calendar year (CY) 2025 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System Proposed Rule (CMS-1809-P),...more
The U.S. Supreme Court issued a significant ruling on June 28, 2024, that changes the respective roles of administrative agencies and the courts in interpreting statutes. In Loper Bright Enterprises v. Raimondo, the court...more
7/5/2024
/ Administrative Procedure Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Chevron Deference ,
Department of Health and Human Services (HHS) ,
Food and Drug Administration (FDA) ,
Government Agencies ,
Health Care Providers ,
Loper Bright Enterprises v Raimondo ,
OCR ,
Regulatory Authority ,
SCOTUS ,
Statutory Interpretation
The Centers for Medicare & Medicaid Services (CMS) on April 10, 2024, released a proposed rule for the fiscal year (FY) 2025 Inpatient Prospective Payment System (IPPS) and Long-Term Care Hospital Prospective Payment System...more
4/17/2024
/ Centers for Medicare & Medicaid Services (CMS) ,
Coding ,
Food and Drug Administration (FDA) ,
Graduate Medical Education ,
Health Care Providers ,
Hospitals ,
Inpatient Prospective Payment System (IPPS) ,
Long-Term Care ,
Medical Coding ,
Medicare ,
Payment Rates ,
Proposed Rules ,
Public Health Emergency ,
Rural Health Care Providers
The Centers for Medicare & Medicaid Services (CMS) released its Advance Notice of Methodological Changes for Calendar Year (CY) 2025 for Medicare Advantage (MA) Capitation Rates and Part C and Part D Payment Policies on Jan....more
2/8/2024
/ 21st Century Cures Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
ESRD ,
Medicare ,
Medicare Advantage ,
Medicare Part A ,
Medicare Part B ,
Medicare Part C ,
Medicare Part D ,
Physician Medicare Reimbursements ,
Puerto Rico
The Centers for Medicare & Medicaid Services (CMS) issued the CMS Interoperability and Prior Authorization Final Rule (Final Rule) on Jan. 17, 2024. The agency proposed the rule in December 2022 (See Holland & Knight's...more
Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more
12/15/2023
/ Biden Administration ,
Centers for Medicare & Medicaid Services (CMS) ,
Congressional Committees ,
Cybersecurity ,
Drug Pricing ,
Federal Funding ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Interim Final Rules (IFR) ,
Medicaid ,
Medicare ,
Medicare Part B ,
MedPAC ,
OMB ,
Pending Legislation ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Private Equity ,
Private Equity Firms ,
Resignation ,
Transparency
Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more
11/30/2023
/ Artificial Intelligence ,
Biden Administration ,
Centers for Disease Control and Prevention (CDC) ,
Centers for Medicare & Medicaid Services (CMS) ,
Congressional Investigations & Hearings ,
Continuing Resolution ,
Defense Production Act ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Medicare ,
Medicare Advantage ,
NDAA ,
Physician Fee Schedule ,
Physicians ,
Retirement ,
Supply Chain
The Centers for Medicare & Medicaid Services (CMS) released the final calendar year (CY) 2024 Physician Fee Schedule (PFS) on Nov. 2, 2023. The rule, which finalizes policies for Medicare payments under the PFS and other...more
11/15/2023
/ Ambulance Providers ,
Centers for Medicare & Medicaid Services (CMS) ,
Community Health Systems ,
Data Collection ,
Effective Date ,
Electronic Monitoring ,
Final Rules ,
Health Care Providers ,
Medicare ,
Medicare Part B ,
Physician Fee Schedule ,
Physicians ,
Prescription Drugs ,
Rural Health Care Providers ,
Telehealth
Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more
11/13/2023
/ Artificial Intelligence ,
Biden Administration ,
Centers for Medicare & Medicaid Services (CMS) ,
Confirmation Proceedings ,
Congressional Committees ,
Continuing Resolution ,
Executive Orders ,
False Advertising ,
Federal Funding ,
Final Rules ,
Government Shutdown ,
Health Care Providers ,
Medicare Advantage ,
Medicare Part D ,
National Institute of Health (NIH) ,
Outpatient Prospective Payment System (OPPS) ,
Physician Fee Schedule ,
Prescription Drugs
The Centers for Medicare & Medicaid Services (CMS) released a final rule on Nov. 2, 2023, detailing how the agency will remedy underpayments from 2018 to 2022 for drugs acquired via the 340B Drug Pricing Program. The final...more
11/13/2023
/ Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Final Rules ,
Hospitals ,
Medicare ,
MedPAC ,
Outpatient Prospective Payment System (OPPS) ,
Prescription Drugs ,
Section 340B ,
Underpayment
Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector.
...more
10/26/2023
/ Centers for Medicare & Medicaid Services (CMS) ,
Congressional Committees ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Medicare ,
Mental Health ,
Outpatient Prospective Payment System (OPPS) ,
Physician Fee Schedule ,
Physician Medicare Reimbursements ,
Telehealth
Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector.
...more
10/18/2023
/ Biden Administration ,
Centers for Medicare & Medicaid Services (CMS) ,
Congressional Investigations & Hearings ,
Deductibles ,
Department of Health and Human Services (HHS) ,
Final Rules ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Hospitals ,
Information Reports ,
Medicare ,
Medicare Part A ,
Medicare Part B ,
National Institute of Health (NIH) ,
Nonprofits ,
Outpatient Prospective Payment System (OPPS) ,
Pfizer ,
Physician Fee Schedule ,
Premiums ,
Presidential Nominations ,
Public Policy ,
Section 340B ,
Speaker of the House
Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more
9/14/2023
/ Anti-Discrimination Policies ,
Artificial Intelligence ,
Centers for Medicare & Medicaid Services (CMS) ,
CMMI ,
Congressional Investigations & Hearings ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Federal Budget ,
Health Care Providers ,
Information Reports ,
Long Term Care Facilities ,
Medicaid ,
Medicare ,
Medicare Part B ,
Nurses ,
Pharmacy Benefit Manager (PBM) ,
PHI ,
Prescription Drugs ,
Proposed Rules ,
Transparency
The Centers for Medicare & Medicaid Services (CMS) on Aug. 1, 2023, published its final rule for the federal fiscal year (FY) 2024 inpatient prospective payment system (IPPS) and long-term care hospital (LTCH) prospective...more
8/8/2023
/ Centers for Medicare & Medicaid Services (CMS) ,
EHR ,
Final Rules ,
Graduate Medical Education ,
Health Care Providers ,
Healthcare Facilities ,
Hospitals ,
Inpatient Prospective Payment System (IPPS) ,
Inpatient Quality Reporting ,
Long Term Care Facilities ,
Medicare ,
Prospective Payment System (PPS) ,
Rural Health Care Providers ,
Value-Based Care
The Centers for Medicare & Medicaid Services (CMS) has released the calendar year (CY) 2024 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System Proposed Rule (CMS-1786-P),...more
7/27/2023
/ Ambulatory Surgery Centers ,
Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Hospitals ,
Inpatient Prospective Payment System (IPPS) ,
Medicare ,
Mental Health ,
Mental Health Parity Rule ,
Outpatient Prospective Payment System (OPPS) ,
Outpatient Services ,
Payment Systems ,
Prescription Drugs ,
Proposed Rules ,
Psychiatric Hospitals ,
Section 340B
Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector.
...more
Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector.
...more
The Centers for Medicare & Medicaid Services (CMS) recently issued a long-awaited Notice with Comment Period outlining a proposed Transitional Coverage for Emerging Technologies (TCET) pathway under Medicare that would be...more
7/14/2023
/ Administrative Procedure ,
Centers for Medicare & Medicaid Services (CMS) ,
Emerging Technologies ,
Expedited Approval Process ,
Food and Drug Administration (FDA) ,
MACs ,
Medical Devices ,
Medicare ,
New Guidance ,
Notice and Comment ,
Rulemaking Process
Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector.
...more
7/12/2023
/ 21st Century Cures Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Congressional Committees ,
Consumer Financial Protection Bureau (CFPB) ,
Department of Health and Human Services (HHS) ,
Guidance Update ,
Health Care Providers ,
Home Health Care ,
Inflation Reduction Act (IRA) ,
Information Blocking Rules ,
Legislative Agendas ,
Medical Bills ,
Medicare ,
No Surprises Act (NSA) ,
OIG ,
Physician Fee Schedule ,
Request For Information ,
Surprise Medical Bills
The Centers for Medicare & Medicaid Services (CMS) released the Hospital Outpatient Prospective Payment System: Remedy for 340B-Acquired Drugs Purchased in Cost Years 2018-2022 Proposed Rule on July 7, 2023. CMS has published...more
7/12/2023
/ Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Hospitals ,
Medicare ,
MedPAC ,
Outpatient Prospective Payment System (OPPS) ,
Prescription Drugs ,
Proposed Rules ,
Public Health Service Act ,
Section 340B
Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector.
...more
6/22/2023
/ Centers for Medicare & Medicaid Services (CMS) ,
Children's Health Insurance Program (CHIP) ,
Congressional Committees ,
Congressional Investigations & Hearings ,
Federal Funding ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
MACPAC ,
Medicare ,
Medicare Part D ,
MedPAC ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs