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
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 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
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 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
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
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 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 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 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 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
I. REGULATIONS, NOTICES, & GUIDANCE -
On February 24, 2016, the Centers for Medicare & Medicaid Services (CMS) issued a guidance entitled, “Special Enrollment Confirmation Process” that will enhance program integrity...more
2/26/2016
/ Affordable Care Act ,
Cancer ,
Centers for Disease Control and Prevention (CDC) ,
Centers for Medicare & Medicaid Services (CMS) ,
Competitive Bidding ,
Department of Health and Human Services (HHS) ,
Drug & Alcohol Abuse ,
Enrollment ,
Federal Funding ,
Fee-for-Service ,
Food and Drug Administration (FDA) ,
FQHC ,
Health Care Providers ,
Health Information Technologies ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare Fraud ,
Legislative Agendas ,
Medicaid ,
Medical Devices ,
Medical Reimbursement ,
Medicare ,
Medicare Part B ,
OMB ,
ONC ,
PHI ,
Prescription Drugs ,
Public Health Insurance Marketplace ,
Right of Access ,
Rural Areas