J. Mark Ray

J. Mark Ray

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Alston & Bird Healthcare Week in Review

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

9/24/2018  /  Centers for Medicare & Medicaid Services (CMS) , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Health Care Providers , Pharmaceutical Industry

Alston & Bird Healthcare Week in Review

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

8/27/2018  /  Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , GAO , Health Care Providers , Healthcare Fraud , HRSA , Inpatient Prospective Payment System (IPPS) , Medicare , OIG

Alston & Bird Healthcare Week in Review

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

8/20/2018  /  Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , FDARA , Food and Drug Administration (FDA) , Health Care Providers

Alston & Bird Healthcare Week in Review

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

8/13/2018  /  ACOs , Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Fee-for-Service , Food and Drug Administration (FDA) , Health Care Providers

Alston & Bird Healthcare Week in Review

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

8/7/2018  /  Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Health Care Providers , Inpatient Prospective Payment System (IPPS) , Medicaid , Medicare , Prospective Payment System (PPS) , Skilled Nursing Facility

Alston & Bird Healthcare Week in Review

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

7/30/2018  /  Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , Generic Drugs , Health Care Providers , Medical Device User Fee Program (MDUFA IV) , Outpatient Prospective Payment System (OPPS) , Pharmaceutical Industry , SAMHSA

Alston & Bird Healthcare Week in Review

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

7/16/2018  /  Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Durable Medical Equipment , Food and Drug Administration (FDA) , Health Care Providers , Medicaid , Medicare , Physician Fee Schedule , Physicians

Alston & Bird Healthcare Week in Review

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

6/11/2018  /  Biosimilars , Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , Health Care Providers , Pharmaceutical Industry , Prescription Drugs

Alston & Bird Healthcare Week in Review

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

6/4/2018  /  Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , Health Care Providers , HRSA , Prescription Drugs , Section 340B

Alston & Bird Healthcare Week in Review

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

5/14/2018  /  Centers for Medicare & Medicaid Services (CMS) , Durable Medical Equipment , Food and Drug Administration (FDA) , HCPCS , Health Care Providers , Opioid

Alston & Bird Healthcare Week in Review

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

5/7/2018  /  Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , HCPCS , Health Care Providers , Medicare , Prescription Drugs , Section 340B

Alston & Bird Healthcare Week in Review

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

4/30/2018  /  Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , EHR , Food and Drug Administration (FDA) , Health Care Providers , Inpatient Prospective Payment System (IPPS) , Medicare , Pharmaceutical Industry , Skilled Nursing Facility

Alston & Bird Healthcare Week In Review

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

3/19/2018  /  Centers for Disease Control and Prevention (CDC) , Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , HCPCS , Health Care Providers , HRSA , Medical Devices

Alston & Bird Healthcare Week In Review

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

3/12/2018  /  Centers for Disease Control and Prevention (CDC) , Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , HCPCS , Health Care Providers , HRSA , SAMHSA

Alston & Bird Healthcare Week In Review

I. Regulations, Notices, & Guidance - On February 12, 2018, the Food and Drug Administration (FDA) issued a guidance entitled, Bacillus Calmette-Guérin-Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drugs and...more

2/20/2018  /  Centers for Disease Control and Prevention (CDC) , Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , GAO , Health Care Providers , HRSA , Inpatient Prospective Payment System (IPPS) , OIG , SAMHSA

Alston & Bird Healthcare Week In Review

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

Alston & Bird Healthcare Week in Review

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

1/15/2018  /  Children's Health Insurance Program (CHIP) , Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , Health Care Providers , Medicaid , Medicare Access and CHIP Reauthorization (MACRA)

Alston & Bird Healthcare Week in Review

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

Alston & Bird Healthcare Week in Review

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

Alston & Bird Healthcare Week in Review

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

12/6/2017  /  21st Century Cures Act , Centers for Medicare & Medicaid Services (CMS) , CLIA , Department of Health and Human Services (HHS) , Episode Payment Models (EPM) , Food and Drug Administration (FDA) , Health Care Providers , HELP , HRSA , Inpatient Prospective Payment System (IPPS)

A&B Healthcare Week in Review

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

A&B Healthcare Week in Review

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

A&B Healthcare Week in Review

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

A&B Healthcare Week in Review

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

A&B Healthcare Week in Review

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
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