J. Mark Ray

J. Mark Ray

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Alston & Bird Health Care Week in Review - January 2022 #1

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and...more

1/12/2022  /  Centers for Medicare & Medicaid Services (CMS) , Coronavirus/COVID-19 , Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , Health Care Providers , Medicare , Medicare Part D

Alston & Bird Health Care Week in Review - February 2021 #1

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and...more

2/8/2021  /  Biden Administration , Centers for Medicare & Medicaid Services (CMS) , Coronavirus/COVID-19 , Department of Health and Human Services (HHS) , HRSA , Medicare , Medicare Part D , National Institute of Health (NIH) , Pharmacies , Relief Measures , Vaccinations

Alston & Bird Health Care Week in Review - January 2021 #2

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and...more

1/18/2021  /  Centers for Medicare & Medicaid Services (CMS) , Coronavirus/COVID-19 , Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , Health Care Providers , Medicaid , Medicare , Medicare Part D , Provider Relief Fund

Alston & Bird Healthcare Week in Review - February 2020 #1

Below is Alston & Bird’s Healthcare Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and...more

2/10/2020  /  Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , HRSA , Medicare , Medicare Part D , Prescription Drugs

Alston & Bird Healthcare Week in Review

Below is Alston & Bird’s Healthcare Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and...more

8/19/2019  /  Centers for Disease Control and Prevention (CDC) , Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , GAO , HRSA , Medicare Part D , Pharmaceutical Industry , Pharmacy Benefit Manager (PBM) , SAMHSA

Alston & Bird Healthcare Week in Review

Below is Alston & Bird’s Healthcare Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and...more

6/24/2019  /  Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , Medicare , Medicare Part D , Opioid , Prescription Drugs

Alston & Bird Healthcare Week in Review

Alston & Bird’s Week in Review provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and Congressional committee action; reports, studies, and analyses; and other health...more

5/20/2019  /  Abbreviated New Drug Application (ANDA) , Centers for Disease Control and Prevention (CDC) , Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , Medicare Part D , Prescription Drugs

Alston & Bird Healthcare Week in Review

Alston & Bird’s Week in Review provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and Congressional committee action; reports, studies, and analyses; and other health...more

5/13/2019  /  Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , Health Care Providers , Medicare Part D , Pharmaceutical Industry , Prescription Drugs

Alston & Bird Healthcare Week in Review

Alston & Bird’s Week in Review provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and Congressional committee action; reports, studies, and analyses; and other health...more

4/8/2019  /  Centers for Medicare & Medicaid Services (CMS) , CLIA , Clinical Laboratories , Food and Drug Administration (FDA) , GAO , Medicare Part D

Alston & Bird Healthcare Week in Review

Alston & Bird’s Week in Review provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and Congressional committee action; reports, studies, and analyses; and other health...more

3/25/2019  /  Children's Health Insurance Program (CHIP) , Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , GAO , Medicaid , Medicare , Medicare Part D , OIG

Alston & Bird Healthcare Week in Review

Alston & Bird’s Week in Review provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and Congressional committee action; reports, studies, and analyses; and other health...more

2/4/2019  /  Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , GAO , Health Care Providers , Medicare Part D , Pharmacy Benefit Manager (PBM) , SAMHSA

Alston & Bird Healthcare Week in Review

Alston & Bird’s Week in Review provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and Congressional committee action; reports, studies, and analyses; and other health...more

12/3/2018  /  Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , HRSA , Medicare , Medicare Part D , PDUFA

Alston & Bird Healthcare Week in Review

Alston & Bird’s Week in Review provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and Congressional committee action; reports, studies, and analyses; and other health...more

10/29/2018  /  Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Employee Retirement Income Security Act (ERISA) , Food and Drug Administration (FDA) , MACPAC , Medicare Part D

Alston & Bird Healthcare Week in Review

Alston & Bird’s Week in Review provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and Congressional committee action; reports, studies, and analyses; and other health...more

10/15/2018  /  Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , Health Care Providers , Medicare Part D , Prescription Drugs

Alston & Bird Healthcare Week in Review

Alston & Bird’s Week in Review provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and Congressional committee action; reports, studies, and analyses; and other health...more

10/1/2018  /  Centers for Disease Control and Prevention (CDC) , Centers for Medicare & Medicaid Services (CMS) , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Medicare , Medicare Part D , Pharmaceutical Industry , Prescription Drug Coverage , Prescription Drugs , Section 503

Alston & Bird Healthcare Week in Review

Alston & Bird’s Week in Review provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and Congressional committee action; reports, studies, and analyses; and other health...more

4/9/2018  /  Abbreviated New Drug Application (ANDA) , Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , Generic Drugs , HCPCS , HRSA , Medicare Advantage , Medicare Part A , Medicare Part D , Pharmaceutical Industry

Alston & Bird Healthcare Week in Review

On November 15, 2017, the Food and Drug Administration (FDA) issued a draft guidance entitled, Assessing User Fees Under the Biosimilar User Fee Amendments of 2017. The Biosimilar User Fee Amendments of 2017 (BsUFA II)...more

11/24/2017  /  21st Century Cures Act , Biologics , Biosimilars , BsUFA , Comprehensive Addiction and Recovery Act of 2016 (CARA) , Food and Drug Administration (FDA) , Healthcare , Medical Devices , Medicare , Medicare Advantage , Medicare Part C , Medicare Part D , New Guidance , PACE , Pharmaceutical Industry

A&B Healthcare Week in Review

I. REGULATIONS, NOTICES, & GUIDANCE - On May 6, 2016, the Centers for Medicare & Medicaid Services (CMS) issued an interim final rule entitled, “Patient Protection and Affordable Care Act; Amendments to Special...more

5/18/2016  /  Affordable Care Act , Centers for Disease Control and Prevention (CDC) , Centers for Medicare & Medicaid Services (CMS) , Food and Drug Administration (FDA) , GAO , Managed Care Contracts , Medicare , Medicare Advantage , Medicare Part D , Pharmaceutical Industry , Prescription Drugs , PTAC

A&B Healthcare Week in Review

I. REGULATIONS, NOTICES, & GUIDANCE - On April 4, 2016, the Centers for Medicare & Medicaid Services (CMS) issued the Final Calendar Year (CY) 2017 Medicare Advantage Capitation Rates and Medicare Advantage (MA) and...more

4/8/2016  /  Affordable Care Act , Biologics , Cancer , Centers for Medicare & Medicaid Services (CMS) , Department of Veterans Affairs , Food and Drug Administration (FDA) , Health Care Providers , HRSA , Legislative Agendas , Medicaid , Medical Devices , Medicare , Medicare Access and CHIP Reauthorization (MACRA) , Medicare Advantage , Medicare Part D , OIG , OMB , Organ Donation , Over The Counter Derivatives (OTC) , Prescription Drugs , Qualified Health Plans , SAMHSA , Vaccinations , Veterans

A&B Healthcare Week in Review

I. REGULATIONS, NOTICES, & GUIDANCE - On March 24, 2016, the Food and Drug Administration (FDA) issued a guidance entitled, “Draft Guidance for Industry: General Principles for Evaluating the Abuse Deterrence of Generic...more

3/25/2016  /  Affordable Care Act , Biologics , Cancer , CCIIO , Centers for Disease Control and Prevention (CDC) , Centers for Medicare & Medicaid Services (CMS) , Controlled Substances , Controlled Substances Act , DEA , Department of Health and Human Services (HHS) , Department of Justice (DOJ) , Food and Drug Administration (FDA) , HCPCS , Legislative Agendas , Medicaid , Medical Devices , Medical Reimbursement , Medicare , Medicare Access and CHIP Reauthorization (MACRA) , Medicare Part D , Native American Issues , Opioid , Pharmaceutical Industry , Prescription Drugs , Public Health Insurance Marketplace , Stem cells , Toxic Exposure , Zika
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