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
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Draft Guidance ,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 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
On November 15, 2017, the Food and Drug Administration (FDA) issued a draft guidance entitled, Assessing User Fees Under the Biosimilar User Fee Amendments of 2017.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On January 9, 2017, the Food and Drug Administration (FDA) issued a draft guidance entitled, Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers: Questions and Answers; Draft...more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 May 6, 2016, the Centers for Medicare & Medicaid Services (CMS) issued an interim final rule entitled, “Patient Protection and Affordable Care Act; Amendments to Special...more
5/18/2016
/ Affordable Care Act ,
Centers for Disease Control and Prevention (CDC) ,
Centers for Medicare & Medicaid Services (CMS) ,
Food and Drug Administration (FDA) ,
GAO ,
Managed Care Contracts ,
Medicare ,
Medicare Advantage ,
Medicare Part D ,
Pharmaceutical Industry ,
Prescription Drugs ,
PTAC
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
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
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
On January 5, 2016, the Office of Management and Budget (OMB) received for review a final rule from the Centers for Medicare & Medicaid Services (CMS) entitled Covered Outpatient Drugs (CMS-2345-F). The rule had previously...more
1/15/2016
/ Affordable Care Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Department of Veterans Affairs ,
Food and Drug Administration (FDA) ,
Gun Laws ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Hospitals ,
Legislative Agendas ,
Mental Health ,
OMB ,
Prescription Drug Coverage ,
Tax Credits
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