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
7/6/2021
/ Biden Administration ,
Biologics ,
Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Payment Systems ,
Pharmaceutical Industry ,
Prescription Drugs ,
Qualified Health Plans
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
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
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
On November 15, 2017, the Food and Drug Administration (FDA) issued a draft guidance entitled, Assessing User Fees Under the Biosimilar User Fee Amendments of 2017.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
On January 9, 2017, the Food and Drug Administration (FDA) issued a draft guidance entitled, Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers: Questions and Answers; Draft...more
1/31/2017
/ Affordable Care Act ,
Biologics ,
Centers for Medicare & Medicaid Services (CMS) ,
CGMP ,
Comment Period ,
Department of Veterans Affairs ,
DSCSA ,
Employer Payment Plans ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
GAO ,
Home Health Agencies ,
Manufacturers ,
Over-the-Counter Sales
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 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
I. REGULATIONS, NOTICES, & GUIDANCE -
On March 8, 2016, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule entitled, “Medicare Program; Part B Drug Payment Model.” The proposed rule seeks...more
3/11/2016
/ Affordable Care Act ,
Biologics ,
Cancer ,
Centers for Disease Control and Prevention (CDC) ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Veterans Affairs ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Health Care Providers ,
Hospitals ,
Legislative Agendas ,
Long Term Care Facilities ,
Medicaid ,
Medical Devices ,
Medicare ,
Medicare Part B ,
Native American Issues ,
Physician Fee Schedule ,
Physician Medicare Reimbursements ,
Prescription Drugs ,
Public Health Service Act ,
Rural Areas ,
Rural Health Care Program ,
Skilled Nursing Facility ,
Telehealth ,
Veterans