Stephanie Kennan on Food and Drug Administration (FDA)

Washington Healthcare Update - May 2021 #1

This week in Washington: President Biden Announces American Families Plan Vision in Speech to Joint Session of Congress....more

5/4/2021 / Biden Administration , Centers for Disease Control and Prevention (CDC) , Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Drug Pricing , Food and Drug Administration (FDA) , GAO , Pharmaceutical Industry , Vaccinations

Washington Healthcare Update - April 2021 #3

This week in Washington: Andrea Palm’s nomination for HHS Deputy Secretary Advances out of Senate Finance Committee, Chiquita Brooks-LaSure’s nomination deadlocked....more

4/27/2021 / Affordable Care Act , Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Drug Pricing , Food and Drug Administration (FDA) , GAO , Medicare , Pharmaceutical Industry , Prescription Drugs , Proposed Rules , Skilled Nursing Facility

Washington Healthcare Update - April 2021 #2

This week in Washington: President sends budget request to Congress. ...more

4/20/2021 / Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , GAO , Medicare , Pharmaceutical Industry , Skilled Nursing Facility

Washington Healthcare Update - April 2021 #1

This week in Washington: House and Senate return from congressional work period....more

4/13/2021 / Biden Administration , Centers for Disease Control and Prevention (CDC) , Centers for Medicare & Medicaid Services (CMS) , COBRA , Coronavirus/COVID-19 , Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , Medicare , Mental Health , Popular , Skilled Nursing Facility , Vaccinations

Washington Healthcare Update - March 2021 #5

Congress - House - Representatives Propose a Permanent Extension of CHIP Funding - The House Energy and Commerce Committee is looking at ways to strengthen the Affordable Care Act (ACA) and expand Medicaid coverage. A...more

3/30/2021 / Centers for Medicare & Medicaid Services (CMS) , Children's Health Insurance Program (CHIP) , Department of Health and Human Services (HHS) , Drug Pricing , Food and Drug Administration (FDA) , GAO , Medicare , OMB , Popular , Prescription Drugs , Telehealth , Vaccinations

Washington Healthcare Update - March 2021 #4

This week in Washington: Becerra confirmed 50-49 to be Secretary of Health and Human Services...more

3/23/2021 / Centers for Medicare & Medicaid Services (CMS) , Coronavirus/COVID-19 , Department of Health and Human Services (HHS) , Drug Pricing , Emergency Use Authorization (EUA) , Food and Drug Administration (FDA) , GAO , Medicare Part D , Nursing Homes , Pharmaceutical Industry , Prescription Drugs , Vaccinations

Washington Healthcare Update - March 2021 #1

This week in Washington: The House votes on budget reconciliation while the Senate ponders the Byrd Rule; Senate committees hold hearings on HHS Secretary-designate Becerra’s confirmation....more

3/2/2021 / Centers for Medicare & Medicaid Services (CMS) , Coronavirus/COVID-19 , Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , GAO , Health Care Providers , Pharmaceutical Industry , Supply Chain , Vaccinations

Washington Healthcare Update - February 2021 #2

This week in Washington: Congress moves towards budget reconciliation....more

2/9/2021 / Centers for Medicare & Medicaid Services (CMS) , Coronavirus/COVID-19 , Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , GAO , Medicaid , Pharmaceutical Industry , Vaccinations

Washington Healthcare Update - February 2021 #1

This week in Washington: President Biden issues important executive orders on healthcare....more

2/2/2021 / Affordable Care Act , Biden Administration , Centers for Medicare & Medicaid Services (CMS) , Coronavirus/COVID-19 , Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , GAO , Prescription Drugs

The Courts and Healthcare Policy

2020 saw the courts continuing to play an important role in health policy with several notable lawsuits related to the Affordable Care Act (ACA). Several other Trump administration policies were challenged, including Medicare...more

2/2/2021 / Affordable Care Act , Association Health Plans , Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Drug Pricing , Food and Drug Administration (FDA) , Medicaid , Medicare , Section 1557 , Section 340B , Take Care Clause

Washington Healthcare Update - January 2021 #3

This week in Washington: President Joe Biden begins his term and Congress begins work to confirm cabinet secretaries....more

1/26/2021 / Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , GAO , Medicare , Pharmaceutical Industry , Pharmacy Benefit Manager (PBM) , Prescription Drugs

Washington Healthcare Update - January 2021 #2

This week in Washington: The 117th Congress will be in session on Jan. 21. Senate- Senate Finance Issues Bipartisan Report on Rising Insulin Prices...more

1/20/2021 / Centers for Medicare & Medicaid Services (CMS) , Coronavirus/COVID-19 , Food and Drug Administration (FDA) , GAO , Medicare Part D , Pharmaceutical Industry

Washington Healthcare Update - January 2021 #1

This week in Washington: The 117th Congress will be in session on Jan. 21. Administration - •CMS: 2022 Requests for Applications for the Value-Based Insurance Design (VBID) Model and its Hospice Benefit Component...more

1/12/2021 / Centers for Medicare & Medicaid Services (CMS) , Food and Drug Administration (FDA) , GAO , Medicare , MIPS

Washington Healthcare Update - December 2020 #3

This week in Washington: Washington waited for a COVID-19 stimulus and omnibus appropriations bill ahead of the holiday recess, and a deal was struck Sunday night; Attached to the COVID-19 relief provisions and omnibus...more

12/22/2020 / Centers for Medicare & Medicaid Services (CMS) , Coronavirus/COVID-19 , Food and Drug Administration (FDA) , Health Care Providers , Medicaid , Pharmaceutical Industry , Vaccinations

Washington Healthcare Update - December 2020 #2

This week in Washington: Congress passes funding bill for an additional week to come up with full-year spending legislation to avoid a government shutdown....more

12/15/2020 / Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Drug Pricing , Food and Drug Administration (FDA) , GAO , Health Care Providers , Medicaid , Pharmaceutical Industry , Prescription Drugs , Section 340B

Washington Healthcare Update - December 2020 #1

This week in Washington: COVID-19 relief bill negotiations begin in earnest; Congress works on Appropriations bills hoping to have them passed before government funding ends on Dec. 11....more

12/8/2020 / Ambulatory Surgery Centers , Centers for Medicare & Medicaid Services (CMS) , Comment Period , Coronavirus/COVID-19 , Final Rules , Food and Drug Administration (FDA) , GAO , Infectious Diseases , Vaccinations

Washington Healthcare Update - November 2020 #3

This week in Washington: Congress gets organized for next Congress; House passes health care bills; COVID-19 vaccine is the talk of the town....more

11/24/2020 / Anti-Kickback Statute , Centers for Medicare & Medicaid Services (CMS) , Coronavirus/COVID-19 , Department of Health and Human Services (HHS) , Emergency Use Authorization (EUA) , Food and Drug Administration (FDA) , GAO , Infectious Diseases , Medicare Part B , OIG , Vaccinations

Washington Healthcare Update - November 2020 #2

This week in Washington: House Minority Leader Kevin McCarthy announced he is waiting to see who will become the next House speaker before working on another COVID-19 stimulus package; Senate Appropriations Committee releases...more

11/17/2020 / Centers for Medicare & Medicaid Services (CMS) , Comment Period , Coronavirus/COVID-19 , Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , GAO , Health Care Providers , Health Insurance , Hospitals , Interim Final Rules (IFR) , Medicaid , Physicians , Trump Administration

Washington Healthcare Update - October 2020 #5

This week in Washington: Washington is relatively quiet because of Election Day on Tuesday, Nov. 3rd. Grassley, Hassan Introduce Bipartisan Legislation to Increase Transparency and Accountability within the Federal Government...more

11/3/2020 / Centers for Medicare & Medicaid Services (CMS) , Coronavirus/COVID-19 , Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , Health Care Providers , Interim Final Rules (IFR) , Medicare , Proposed Rules , Vaccinations

Washington Healthcare Update - October 2020 #4

This week in Washington: Mnuchin and Pelosi continue discussions for COVID-19 stimulus package....more

10/27/2020 / Centers for Medicare & Medicaid Services (CMS) , Coronavirus/COVID-19 , Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , GAO , Health Care Providers , HRSA , Pharmaceutical Industry , Section 340B , Vaccinations

Washington Healthcare Update - October 2020 #3

House - Democrats Ask GAO to Investigate Legality of President Trump’s Medicare Drug Gift Cards - On Oct. 13, House Energy & Commerce Chair Frank Pallone (D-NJ), House Ways & Means Chair Richard Neal (D-MA) and Senate...more

10/20/2020 / Centers for Medicare & Medicaid Services (CMS) , Coronavirus/COVID-19 , Department of Health and Human Services (HHS) , Drug Pricing , Food and Drug Administration (FDA) , Medicare , Pharmaceutical Industry , Prescription Drugs , Section 340B , Trump Administration , Vaccinations

Washington Healthcare Update - October 2020 #2

This week in Washington: Negotiations for COVID-19 stimulus package are ongoing; House and Senate are in recess....more

10/13/2020 / Centers for Medicare & Medicaid Services (CMS) , Coronavirus/COVID-19 , Department of Health and Human Services (HHS) , Drug Pricing , Food and Drug Administration (FDA) , GAO , Health Care Providers , Medicare , Medicare Part D , OIG , Pharmaceutical Industry , Pharmacy Benefit Manager (PBM) , Prescription Drugs , Section 340B

Washington Healthcare Update - October 2020 #1

This week in Washington: The Continuing Resolution (CR) to fund the government until Dec. 11 was signed by President Trump; House passes COVID-19 stimulus bill....more

10/6/2020 / Centers for Medicare & Medicaid Services (CMS) , Coronavirus/COVID-19 , Cost-Sharing , Department of Health and Human Services (HHS) , Department of Justice (DOJ) , Drug Pricing , Food and Drug Administration (FDA) , Healthcare Fraud , Medicaid , OMB , Pharmaceutical Industry , Telehealth , Trump Administration

Washington Healthcare Update - September 2020 #1

This week in Washington: The Republican COVID-19 legislative package fails to pass in the Senate; Congress is in negotiations for a continuing resolution to fund the government until 2021....more

9/15/2020 / Centers for Disease Control and Prevention (CDC) , Centers for Medicare & Medicaid Services (CMS) , Coronavirus/COVID-19 , Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , GAO , Medicaid , Medicare , Prescription Drugs

Washington Healthcare Update - August 2020 #4

This week in Washington: Congress remains in a district work period, while COVID-19 legislative talks continue....more

9/1/2020 / Centers for Medicare & Medicaid Services (CMS) , Coronavirus/COVID-19 , Department of Justice (DOJ) , Food and Drug Administration (FDA) , Health Care Providers , Medicaid , Medicare , Right to Try , Telehealth

Stephanie Kennan

McGuireWoods LLP

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