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 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 January 8, 2018, the Department of Veterans Affairs (VA) issued a rule entitled, Reimbursement for Emergency Treatment. The VA revised its regulations concerning payment or reimbursement for emergency treatment for...more
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