Jennifer Butler

Jennifer Butler

Alston & Bird

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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

6/18/2018  /  Biologics , Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Drug Pricing , Food and Drug Administration (FDA) , Medical Devices , Pharmaceutical Industry , Prescription Drugs , 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

6/11/2018  /  Biosimilars , Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , Health Care Providers , 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

6/4/2018  /  Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , Health Care Providers , HRSA , Prescription Drugs , Section 340B

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

5/21/2018  /  Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , GAO , Generic Drugs , HRSA , Institutional Review Board (IRB) , Pharmaceutical Industry , Section 340B

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

5/14/2018  /  Centers for Medicare & Medicaid Services (CMS) , Durable Medical Equipment , Food and Drug Administration (FDA) , HCPCS , Health Care Providers , Opioid

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

5/7/2018  /  Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , HCPCS , Health Care Providers , Medicare , Prescription Drugs , Section 340B

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

4/30/2018  /  Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , EHR , Food and Drug Administration (FDA) , Health Care Providers , Inpatient Prospective Payment System (IPPS) , Medicare , Pharmaceutical Industry , Skilled Nursing Facility

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

4/23/2018  /  Biologics , Centers for Medicare & Medicaid Services (CMS) , Controlled Substances , DEA , Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , HCPCS , Opioid

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

4/16/2018  /  Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Essential Health Benefits , Food and Drug Administration (FDA) , HRSA , Qualified Health Plans

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

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

4/2/2018  /  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 , Pharmaceutical Industry , 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

3/26/2018  /  Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , NIOSH , OMB

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

3/19/2018  /  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) , HCPCS , Health Care Providers , HRSA , Medical Devices

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

3/12/2018  /  Centers for Disease Control and Prevention (CDC) , Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , HCPCS , Health Care Providers , HRSA , SAMHSA

Alston & Bird Healthcare Week In Review

I. Regulations, Notices, & Guidance - On February 26, 2018, the Food and Drug Administration (FDA) issued a final order entitled, Medical Devices; Hematology and Pathology Devices; Classification of Lynch Syndrome Test....more

3/5/2018  /  Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , HRSA , Medical Devices , Medicare , Prescription Drugs

Alston & Bird Healthcare Week In Review

I. Regulations, Notices, & Guidance - On February 20, 2018, the Department of Health and Human Services (HHS) issued a proposed rule entitled, Short-Term, Limited-Duration Insurance. The rule contains proposals amending the...more

2/26/2018  /  Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , Medical Devices , Pharmaceutical Industry , Prescription Drugs

Alston & Bird Healthcare Week In Review

I. Regulations, Notices, & Guidance - On February 12, 2018, the Food and Drug Administration (FDA) issued a guidance entitled, Bacillus Calmette-Guérin-Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drugs and...more

2/20/2018  /  Centers for Disease Control and Prevention (CDC) , Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , GAO , Health Care Providers , HRSA , Inpatient Prospective Payment System (IPPS) , OIG , SAMHSA

Alston & Bird Healthcare Week In Review

I. Regulations, Notices, & Guidance - On February 5, 2018, the Drug Enforcement Agency (DEA) issued a temporary scheduling order entitled, Schedules of Controlled Substances: Temporary Placement of Fentanyl-Related...more

2/12/2018  /  Abbreviated New Drug Application (ANDA) , Controlled Substances Act , Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , HRSA , Inpatient Prospective Payment System (IPPS) , OMB , SAMHSA

Alston & Bird Healthcare Week In Review

On January 29, 2018, the Centers for Medicare and Medicaid Services (CMS) issued a notice entitled, Medicare, Medicaid, and Children's Health Insurance Programs: Announcement of the Extension of Temporary Moratoria on...more

2/5/2018  /  21st Century Cures Act , Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Department of Veterans Affairs , FDASIA , Food and Drug Administration (FDA) , Health Care Providers , Inpatient Prospective Payment System (IPPS) , Medical Devices , Medicare , Opioid , SAMHSA , Substance Abuse

Alston & Bird Healthcare Week In Review

On January 22, 2018, the Drug Enforcement Administration (DEA) issued a final rule entitled, Implementation of the Provision of the Comprehensive Addiction and Recovery Act of 2016 Relating to the Dispensing of Narcotic Drugs...more

1/29/2018  /  Centers for Medicare & Medicaid Services (CMS) , CLIA , Clinical Laboratories , Comprehensive Addiction and Recovery Act of 2016 (CARA) , Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , HELP , HRSA , Inpatient Prospective Payment System (IPPS) , Opioid , REMS , SAMHSA

Alston & Bird Healthcare Week In Review

On January 16, 2018, the Food and Drug Administration (FDA) issued a proposed rule entitled, Internal Agency Review of Decisions; Requests for Supervisory Review of Certain Decisions Made by the Center for Devices and...more

1/23/2018  /  Centers for Disease Control and Prevention (CDC) , Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , GAO , HRSA , Inpatient Prospective Payment System (IPPS) , Medicare , OCR , REMS , SAMHSA

Alston & Bird Healthcare Week in Review

On January 8, 2018, the Department of Veterans Affairs (VA) issued a rule entitled, Reimbursement for Emergency Treatment. The VA revised its regulations concerning payment or reimbursement for emergency treatment for...more

1/15/2018  /  Children's Health Insurance Program (CHIP) , Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , Health Care Providers , Medicaid , Medicare Access and CHIP Reauthorization (MACRA)

Alston & Bird Healthcare Week in Review

On January 2, 2018, the Substance Abuse and Mental Health Services Administration (SAMHSA) issued a final rule entitled, Confidentiality of Substance Use Disorder Patient Records. The final rule makes changes to the SAMHSA...more

1/9/2018  /  Abbreviated New Drug Application (ANDA) , Centers for Medicare & Medicaid Services (CMS) , CLIA , Department of Health and Human Services (HHS) , Department of Labor (DOL) , Employee Retirement Income Security Act (ERISA) , Food and Drug Administration (FDA) , Health Care Providers , Inpatient Prospective Payment System (IPPS) , Mental Health , SAMHSA , Substance Abuse

Alston & Bird Healthcare Week in Review

On December 18, 2017, the Food and Drug Administration (FDA) issued a notice entitled, Ophthalmic Devices; Classification of the Tear Electrostimulation Device. The FDA is classifying tear electrostimulation device into class...more

12/27/2017  /  Centers for Medicare & Medicaid Services (CMS) , Food and Drug Administration (FDA) , Medical Devices , Medicare , Medicare Shared Savings Program

Alston & Bird Healthcare Week in Review

On December 11, 2017, the Food and Drug Administration (FDA) issued a guidance entitled, Product Name Placement, Size, and Prominence in Promotional Labeling and Advertisements. The guidance clarifies the requirements for...more

12/19/2017  /  Ambulatory Surgery Centers , Centers for Disease Control and Prevention (CDC) , Centers for Medicare & Medicaid Services (CMS) , Children's Health Insurance Program (CHIP) , Department of Health and Human Services (HHS) , Draft Guidance , Food and Drug Administration (FDA) , GAO , Health Care Providers , Inpatient Prospective Payment System (IPPS) , Medical Devices , OPDP , OPPS , Physicians , REMS
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