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
7/23/2018
/ Abbreviated New Drug Application (ANDA) ,
Biosimilars ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Food and Drug Administration (FDA) ,
GAO ,
Labeling ,
Medicare ,
Pharmaceutical Industry ,
SAMHSA ,
Section 340B
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
6/25/2018
/ Association Health Plans ,
Biologics ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Department of Labor (DOL) ,
Employee Benefits ,
Employee Retirement Income Security Act (ERISA) ,
Food and Drug Administration (FDA) ,
Medicaid ,
Medicare ,
Opioid ,
Pharmaceutical Industry ,
SAMHSA ,
Substance Abuse
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
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
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
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
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
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
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
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
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
I. REGULATIONS, NOTICES, & GUIDANCE -
On April 21, 2016, CMS issued a proposed rule entitled, “Medicare Program: FY 2017 Hospice Wage Index and Payment Rate Update and Hospice Quality Reporting Requirements.” This...more
4/28/2016
/ 1099s ,
Affordable Care Act ,
Biologics ,
Centers for Medicare & Medicaid Services (CMS) ,
Food and Drug Administration (FDA) ,
HCPCS ,
Health Care Providers ,
Health Savings Accounts ,
Hospice ,
HRSA ,
Inpatient Prospective Payment System (IPPS) ,
Inpatient Quality Reporting ,
Inpatient Rehab Facilities ,
IRS ,
Legislative Agendas ,
Long Term Care Facilities ,
Medicaid ,
Medicare ,
Medicare Access and CHIP Reauthorization (MACRA) ,
Medicare Part B ,
OIG ,
Opioid ,
Physician Medicare Reimbursements ,
Prescription Drugs ,
SAMHSA ,
Section 340B ,
Skilled Nursing Facility ,
Traumatic Brain Injuries ,
Veterans
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
I. REGULATIONS, NOTICES, & GUIDANCE -
On March 29, 2016, Centers for Medicare & Medicaid Services (CMS) issued a final rule entitled, “Medicaid and Children’s Health Insurance Programs: Mental Health Parity and...more
4/1/2016
/ Affordable Care Act ,
AHRQ ,
Americans with Disabilities Act (ADA) ,
Biosimilars ,
Centers for Medicare & Medicaid Services (CMS) ,
Controlled Substances ,
Controlled Substances Act ,
Cost-Sharing ,
Department of Health and Human Services (HHS) ,
Equal Employment Opportunity Commission (EEOC) ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
HRSA ,
Labeling ,
Legislative Agendas ,
Medicaid ,
Medicare ,
Medicare Access and CHIP Reauthorization (MACRA) ,
Mental Health ,
MIPS ,
OMB ,
Prescription Drugs ,
SAMHSA ,
Substance Abuse ,
Title I ,
Vaccinations ,
Wellness Programs
I. REGULATIONS, NOTICES, & GUIDANCE - On February 5, 2016, the Substance Abuse and Mental Health Administration (SAMHSA) issued a proposed rule entitled, “Confidentiality of Substance Use Disorder Patient Records.” ...more