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
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
11/5/2018
/ ACOs ,
Ambulatory Surgery Centers ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Food and Drug Administration (FDA) ,
HRSA ,
Medicare Part B ,
Outpatient Prospective Payment System (OPPS) ,
Pharmaceutical Industry ,
Prescription Drugs ,
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
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
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
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’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 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
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 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 November 27, 2017, the Food and Drug Administration (FDA) issued a guidance entitled, Pediatric Information for X-ray imaging Device Premarket Notifications. The guidance outlines FDA’s rationale regarding information that...more
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 15, 2016, the Food and Drug Administration (FDA) issued a proposed rule entitled, “Applications for Approval and Combinations of Active Ingredients Under Consideration for...more
4/21/2016
/ Abbreviated New Drug Application (ANDA) ,
Affordable Care Act ,
AHRQ ,
Centers for Disease Control and Prevention (CDC) ,
Centers for Medicare & Medicaid Services (CMS) ,
CGMP ,
Department of Health and Human Services (HHS) ,
DSCSA ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Insurance ,
HRSA ,
IRS ,
Legislative Agendas ,
Medicaid ,
Medical Devices ,
Medicare ,
OIG ,
Overpayment ,
Pharmaceutical Industry ,
Prescription Drugs ,
Public Health Insurance Marketplace ,
Tax Liability
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