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
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
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
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
On November 15, 2017, the Food and Drug Administration (FDA) issued a draft guidance entitled, Assessing User Fees Under the Biosimilar User Fee Amendments of 2017.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
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 March 15, 2016, the Centers for Disease Control and Prevention (CDC) issued voluntary guidelines entitled, “CDC Guidelines for Prescribing Opioids for Chronic Pain — United...more
3/18/2016
/ Affordable Care Act ,
Biosimilars ,
Cancer ,
Centers for Disease Control and Prevention (CDC) ,
Centers for Medicare & Medicaid Services (CMS) ,
Chiropractors ,
Cost-Sharing ,
Department of Defense (DOD) ,
Department of Health and Human Services (HHS) ,
Department of Veterans Affairs ,
Drug & Alcohol Abuse ,
Enrollment ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Insurance ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HRSA ,
Information Requests ,
Insurance Industry ,
Legislative Agendas ,
MACPAC ,
Medicaid ,
Medical Devices ,
Medicare ,
MedPAC ,
National Institute of Health (NIH) ,
Native American Issues ,
Outpatient Services ,
Patent Applications ,
Physicians ,
Prescription Drugs ,
Reinsurance ,
Vaccinations ,
Veterans
I. REGULATIONS, NOTICES, & GUIDANCE -
On November 21, 2015, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule entitled “Patient Protection and Affordable Care Act; HHS Notice of Benefit and...more
11/25/2015
/ Affordable Care Act ,
Biosimilars ,
CCIIO ,
Centers for Medicare & Medicaid Services (CMS) ,
Congressional Budget Office ,
Food and Drug Administration (FDA) ,
GAO ,
Healthcare ,
HELP ,
HRSA ,
Legislative Agendas ,
Medicaid ,
Physician-Owned Distributors ,
Prescription Drugs ,
Provider Payments ,
Veterans
On September 25, 2015, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule entitled “Medicare Program: Medicare Clinical Diagnostic Laboratory Tests Payment System”. This proposed rule would...more
10/1/2015
/ Affordable Care Act ,
Biosimilars ,
CBO Report ,
CCIIO ,
Centers for Disease Control and Prevention (CDC) ,
Centers for Medicare & Medicaid Services (CMS) ,
Children's Health Insurance Program (CHIP) ,
CLFS ,
Clinical Trials ,
FDASIA ,
Food and Drug Administration (FDA) ,
Healthcare ,
Legislative Agendas ,
Medicaid ,
Medical Loss Ratio ,
Medicare ,
OIG ,
OMB ,
Outpatient Quality Reporting ,
PAMA ,
Prescription Drug Coverage ,
SHOP Program ,
Tax Credits