On November 24, 2023, the U.S. Department of Health and Human Services’ Centers for Medicare and Medicaid Services (“CMS”) published a proposed rule to modify certain Patient Protection and Affordable Care Act (“ACA”)...more
On April 26, 2023, the Centers for Medicare and Medicaid Services (“CMS”) released a fact sheet on Hospital Price Transparency Enforcement Updates (the “Fact Sheet”) under the Hospital Price Transparency Rule (the “Rule”)....more
6/8/2023
/ Biden Administration ,
Centers for Medicare & Medicaid Services (CMS) ,
Compliance ,
Corrective Action Plans (CAPs) ,
Department of Health and Human Services (HHS) ,
Enforcement ,
Executive Orders ,
Health Care Providers ,
Healthcare Reform ,
Hospitals ,
Payment Systems ,
Price Transparency ,
Reporting Requirements
As reintroduced in the U.S. House of Representatives by Rep. Frank Pallone, Jr. (D-NJ-6) on April 22, 2021 after originally being introduced on September 19, 2019, H.R. 3, also known as known as the Elijah E. Cummings Lower...more
9/24/2021
/ Department of Health and Human Services (HHS) ,
Drug Pricing ,
Health Insurance ,
Healthcare Reform ,
Legislative Agendas ,
Medicare ,
Medicare Part B ,
Medicare Part D ,
Pharmaceutical Industry ,
Prescription Drugs ,
Price Transparency ,
Proposed Legislation ,
Regulatory Agenda
On August 10, 2021, the Senate passed H.R. 3684, a roughly $1 trillion infrastructure bill (the “Infrastructure Bill”) that authorizes funds for federal-aid highways, transit, broadband access and other infrastructure...more
The Biden Administration’s American Rescue Plan Act of 2021 (H.R. 1319) (the “Act”) could present an opportunity for the growth of utilization of ambulatory surgery centers (“ASCs”), continuing the trend of migration of...more
On April 1, 2021, the California Department of Health Care Services (“DHCS”) will be transitioning all Medi-Cal pharmacy benefits from managed care to fee-for-service (“FFS”). This new system to administer FFS pharmacy...more
1/12/2021
/ Drug Pricing ,
Executive Orders ,
Fee-for-Service ,
Governor Newsom ,
Long Term Care Facilities ,
Medi-Cal ,
Medicaid ,
PACE ,
Prescription Drugs ,
Reimbursements ,
Section 340B ,
Skilled Nursing Facility
On December 3, 2020, Centers for Medicare & Medicaid Services (“CMS”) announced key details concerning a new value-based reimbursement and patient care model – the Geographic Direct Contracting Model (the “Model” or “Geo”)....more
On November 30, 2020, the United States Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) issued a final rule (“Final Rule”) that makes significant changes to the federal Antikickback Statute...more
12/3/2020
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Discounts ,
Drug Pricing ,
Final Rules ,
Fixed-Fee ,
Medicaid ,
Medicare ,
OIG ,
Pharmaceutical Industry ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Rebates ,
Safe Harbors
On November 10, 2020, the U.S. Supreme Court heard oral arguments for California v. Texas, a case that will potentially decide the fate of the Patient Protection and Affordable Care Act (“ACA”).
As discussed in prior...more
As highlighted in a May 2020 Milbank Memorial Fund white paper titled, “How Payment Reform Could Enable Primary Care to Respond to COVID-19,” the COVID-19 public health emergency has driven transformation in the provision of...more
On Sunday, September 13, 2020, President Trump signed an Executive Order, the next in a series of Executive Orders targeting the pharmaceutical industry, which aims to lower prescription drug prices in the United States (the...more
9/18/2020
/ Buy America ,
Coronavirus/COVID-19 ,
Drug Pricing ,
Executive Orders ,
Medicare Part B ,
Medicare Part D ,
Most-Favored Nations ,
Patients ,
Pharmaceutical Industry ,
PHRMA ,
Prescription Drugs ,
Trump Administration
On Thursday, August 6, 2020 President Trump signed an Executive Order, mandating that certain drugs and medical supplies purchased by federal agencies, including the Department of Health and Human Services, Department of...more
On June 24, 2020, House Democrats proposed the Patient Protection and Affordable Care Enhancement Act (H.R. 1425) (the “Proposed Act”), legislation aimed at reinforcing the Affordable Care Act (the “ACA”) by: (i) lowering...more
According to a recent study (Study) published in Nature Reviews Drug Discovery on May 10, 2020 regarding the impact that the COVID-19 pandemic has had on the conduct of oncology clinical trials, the COVID-19 pandemic has...more
On May 18, 2020, California Senate Bill 977 (“SB-977”) was passed out of the California Senate Health Committee and is now scheduled for its first hearing before the Senate Appropriations Committee on June 1, 2020. SB-977...more
In 2012, the U.S. Supreme Court in NFIB v. Sebelius struck down a provision in the Patient Protection and Affordable Care Act (the “ACA”) which, for all intents and purposes, made the expansion of the Medicaid program...more
In recent years, there has been a trend towards the provision of cardiovascular procedures in the outpatient setting and particularly in ambulatory surgery centers (“ASCs”). This trend is in part motivated by the fact that...more
As discussed in a prior blog post, in order to manage the unprecedented medical need due to the COVID-19 pandemic, some states have loosened scope of practice restrictions imposed on healthcare professionals. The relaxing of...more
5/11/2020
/ CARES Act ,
Coronavirus/COVID-19 ,
Executive Orders ,
Governor Cuomo ,
Governor Lamont ,
Governor Murphy ,
Governor Pritzker ,
Health Care Providers ,
Immunity ,
Medical Malpractice ,
Public Readiness and Emergency Preparedness Act (PREP Act)
On March 17, 2020, the Centers for Medicare & Medicaid Services (“CMS”) issued a memorandum to provide information to organizations that participate in the Programs of All-Inclusive Care for the Elderly (“PACE”) program in...more
On March 10, 2020, the Centers for Medicare & Medicaid Services (“CMS”) supplemented the guidance that we previously discussed in our March 6, 2020 blog post in order to provide additional guidance to healthcare providers,...more
On March 4, 2020, the Centers for Medicare & Medicaid Services (“CMS”) announced several measures aimed at preventing the spread of the Novel Coronavirus 2019 (“COVID-19”). Described by CMS Administrator Seema Verma as...more
Information Collection Request. On November 27, 2019, 340B Health, a nonprofit membership organization comprised of hospitals and health systems that participate in the federal 340B drug pricing program (“340B Program”),...more
12/13/2019
/ Centers for Medicare & Medicaid Services (CMS) ,
Data Collection ,
Drug Pricing ,
Final Rules ,
Health Care Providers ,
Hospitals ,
Information Requests ,
Medicaid ,
Medicare ,
Pharmaceutical Industry ,
Physician Medicare Reimbursements ,
Physicians ,
Preliminary Injunctions ,
Prescription Drugs ,
Section 340B
On April 21, 2019, the Center for Medicare and Medicaid Innovation (“CMMI”) announced the CMS Primary Cares Initiative – a voluntary, risk-based initiative to transform the Medicare program’s reimbursement of primary care...more
12/2/2019
/ Alternative Payment Models (APM) ,
Applications ,
Centers for Medicare & Medicaid Services (CMS) ,
CMMI ,
Fee-for-Service ,
Health Care Providers ,
Healthcare ,
Healthcare Reform ,
Hospitals ,
Letters of Intent ,
Medicaid ,
Medicare ,
Physicians ,
Value-Based Care
As we noted in our November 1, 2019 Healthcare Law Blog post, California Attorney General Xavier Becerra rejected the proposed merger between Adventist Health System/West and St. Joseph Health System (the “Proposed Merger”)...more
On October 31, 2019, the California Department of Justice (“DOJ”) issued a denial letter rejecting a proposed merger between Adventist Health System/West and St. Joseph Health System. The parties had submitted notices to the...more