On March 31, 2020, the Centers for Medicare & Medicaid Services (CMS) issued an interim final rule with comment period (IFC). This alert is part of a series of alerts discussing the IFC provisions and comprehensive actions...more
On March 28, 2020, the Centers for Medicare & Medicaid Services (CMS) released guidance expanding its Accelerated and Advanced Payment Program, which now allows most Medicare Part A and Part B providers and suppliers to...more
This week in Washington: Hearings scheduled on the U.S. response to the Coronavirus. ...more
Upcoming Hearings/Markups -
Wednesday, February 26, 2020 -
House Committee on Appropriations, Subcommittee on Labor, Health and Human Services, Education, and Related Agencies: “Department of Health and Human Services...more
This week in Washington: The House and Senate will be in recess the week of Feb. 17 in observation of Presidents Day....more
2/18/2020
/ Biosimilars ,
Centers for Medicare & Medicaid Services (CMS) ,
Controlled Substances ,
Department of Health and Human Services (HHS) ,
Food and Drug Administration (FDA) ,
GAO ,
HRSA ,
Medicaid ,
Medicare ,
Medicare Advantage ,
Medicare Part D ,
Trump Administration
This week in Washington: The House is not in session. The Senate will resume the impeachment trial on Tuesday....more
1/22/2020
/ Centers for Medicare & Medicaid Services (CMS) ,
Children's Health Insurance Program (CHIP) ,
Drug Pricing ,
Food and Drug Administration (FDA) ,
HRSA ,
MACPAC ,
Medicare ,
Medicare Advantage ,
Pharmaceutical Industry ,
Trump Administration ,
United States-Mexico-Canada Agreement (USMCA)
On Dec. 12, 2019, the U.S. House of Representatives passed HR 3, the Elijah Cummings Lower Drug Costs Now Act, which would allow the government to negotiate drug prices, among other reforms. Prior to HR 3 being considered on...more
This week in Washington: House returns from recess and has scheduled hearing on caring for aging Americans; Senate to hold hearing on rising electronic cigarette use among youth and will hold a confirmation hearing for Dr....more
11/12/2019
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Drug Pricing ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Medicare ,
Medicare Part B ,
OIG ,
Pharmaceutical Industry ,
Prescription Drugs ,
Safe Harbors ,
Self-Referral ,
Stark Law
On Oct. 28, 2019, the U.S. House of Representatives unanimously passed two bills that, if enacted, require public disclosure of the discounts drug companies provide to pharmacy benefit managers (PBMs)....more
In keeping with U.S. House Speaker Nancy Pelosi’s schedule for pushing H.R. 3, the Lower Drug Costs Now Act, through the House of Representatives, the three committees of jurisdiction held mark-ups and passed the proposal, as...more
This week in Washington: Senate to hold a hearing on eligibility requirements under the Medicaid program, as well as a hearing to review a number of healthcare bills, including OTC drug safety, innovation and reform....more
10/29/2019
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Drug Pricing ,
Food and Drug Administration (FDA) ,
GAO ,
Health Care Providers ,
MACPAC ,
Medicare ,
OIG ,
Opioid ,
Pharmaceutical Industry ,
Physicians ,
Prescription Drugs ,
Self-Referral ,
Stark Law ,
Trump Administration
This week in Washington: House to hold a markup of five healthcare bills, as well as a hearing to seek clarity on the Trump administration's health care policy choices; Senate to discuss solutions to the substance misuse...more
10/22/2019
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Congressional Budget Office ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
GAO ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
MACPAC ,
Medicare ,
OIG ,
Open Enrollment ,
Pharmaceutical Industry ,
Physicians ,
Prescription Drugs ,
SAMHSA ,
Self-Referral ,
Stark Law ,
Trump Administration
This week in Washington: The House and Senate are in recess. Congress House Senate Administration Proposed Regulations/Guidance Final Rules/Guidance Reports House Bipartisan Legislation Introduced on Accurate Provider...more
10/8/2019
/ Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Food and Drug Administration (FDA) ,
GAO ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Medical Devices ,
Medicare ,
OMB ,
Prescription Drugs ,
SAMHSA ,
Trump Administration
This week in Washington: Hearings on the public health impact of e-cigarettes, making prescription drugs more affordable and promoting healthy aging. ...more
Congress -
House - In Recess -
Cummings and Sanders Seek Information About Possible Obstruction of a Congressional Investigation on Generic Drug Prices...more
Congress -
House -
House Passes Short-Term Funding Extension for Medicaid Pilot Program -
On July 30, the House passed a bill to keep a $1 billion Medicaid pilot providing mental health and addiction services running...more
8/6/2019
/ Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Food and Drug Administration (FDA) ,
GAO ,
Health Care Providers ,
Medicaid ,
Medicare ,
Opioid ,
Pharmaceutical Industry ,
Physicians ,
Prescription Drugs ,
Trump Administration
This week in Washington: Senate to hold hearing on the enforcement of antitrust laws, while the House plans to cover a number of health care bills that reauthorize a variety of health programs for Americans. The House may...more
In a 7-to-1 decision, the U.S. Supreme Court on June 3, 2019, held that “Because the Department of Health and Human Services neglected its statutory notice-and-comment obligations when it revealed a new policy that...more
6/11/2019
/ Administrative Procedure Act ,
Azar v Allina Health Services ,
Department of Health and Human Services (HHS) ,
Hospitals ,
Low-Income Issues ,
Medicare ,
Medicare Advantage ,
Medicare Part A ,
Medicare Part C ,
Notice and Comment ,
Pay Reductions ,
Provider Payments ,
Reaffirmation ,
Retroactive Application ,
SCOTUS ,
Substantive Rule ,
Vacated
This week in Washington: House to hold hearings on PFAS contamination and exposure, the maternal mortality crisis and single-payer issues....more
5/14/2019
/ Affordable Care Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Congressional Budget Office ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Food and Drug Administration (FDA) ,
GAO ,
Inpatient Prospective Payment System (IPPS) ,
Medicare ,
Medicare Access and CHIP Reauthorization (MACRA) ,
Pharmacy Benefit Manager (PBM) ,
Popular ,
Prescription Drugs ,
Trump Administration
This week in Washington: Hearings continue on the price of prescription drugs, Senate Committee on Finance to hold a hearing on Medicare physician payment reform, while the Senate HELP Committee will hold its second hearing...more
5/7/2019
/ Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Food and Drug Administration (FDA) ,
Inpatient Prospective Payment System (IPPS) ,
Medicare ,
Medicare for All ,
Medicare Part B ,
Medicare Part D ,
Pharmaceutical Industry ,
Popular ,
Prescription Drugs ,
Trump Administration
Congress -
Hearings/Markups -
Senate Finance Committee: "Drug Pricing in America: A Prescription for Change, Part III" -
Tuesday, April 9, 2019: The Senate Finance Committee continued its drug pricing series by...more
4/16/2019
/ Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Medicare ,
Medicare for All ,
OMB ,
Pharmaceutical Industry ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Trump Administration
Coming Week’s Highlights: CMS seeks recommendations that allow Americans to purchase health insurance across state lines, House to hold hearings on the 2020 HHS budget and lowering the cost of prescription drugs....more
Upcoming Hearings -
Tuesday, March 5, 2019 -
Senate Committee on Health, Education, Labor and Pensions (HELP): “Vaccines Save Lives: What is Driving Preventable Disease Outbreaks?” -
The Senate Committee on Health,...more
3/5/2019
/ Affordable Care Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Medicare ,
OMB ,
Pharmaceutical Industry ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs
Upcoming Hearings -
Tuesday, Feb. 26, 2019 -
Senate Finance Committee: “TBA Hearing on Drug Pricing” -
The second hearing in a series on drug pricing in the Senate Finance Committee will include the testimonies of...more
2/19/2019
/ Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Health Care Providers ,
Medicare ,
Medicare Part D ,
OMB ,
Opioid ,
Pharmaceutical Industry ,
Prescription Drugs ,
Trump Administration
Coming Week’s Highlights: This week’s focus by many will be whether the government shuts down once more. Legislation must be passed and signed by the President by February 15, in order to keep the departments not yet funded...more
2/12/2019
/ Affordable Care Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Medicaid ,
Medicare ,
Pharmaceutical Industry ,
Prescription Drugs ,
Trump Administration