LEGISLATIVE UPDATE

Wednesday, March 6

Drug Pricing: Senator Susan Collins (R-ME) and Senator Tim Kaine (D-VA) Introduce the Biologic Patent Transparency Act

  • Senator Bob Casey (D-PA) on Prescription Drug Prices Overwhelming Americans
  • Energy and Commerce Chairman Frank Pallone, Jr. (D-NJ) Remarks on Proposals to Make Health Care More Affordable

Prescription Drugs: Energy and Commerce Chairman Frank Pallone, Jr. (D-NJ) and Health Subcommittee Chairwoman Anna G. Eshoo (D-CA) AnnounceHearing to Lower Prescription Drug Costs

Opioids: House Committee on Oversight and Reform to Hold Hearing on the Trump Administration’s Response to the Opioid Crisis

Thursday, March 7

Disability Payments: Newly Introduced Haven Act will Treat VA Disability Payments the Same as Social Security Disability Payments for Bankruptcy Purposes

Drug Pricing: Senator Bob Casey (D-PA) Introduces Two Bills to Make Prescription Drugs More Affordable

Indian Health Services: Bipartisan Energy and Commerce Leaders Send Letter to Indian Health Service Acting Director Requesting a Briefing on Reported Medical Errors and Systemic Failures at IHS Hospitals

Health Care Markets: House Judiciary Committee Chairman Jerrold Nadler (D-NY) Opening Statement for Subcommittee Hearing on Diagnosing the Problem

Medicare: Doggett’s Opening Statement from Hearing on Promoting Competition to Lower Medicare Drug Prices

Friday, March 8

Medicaid: Senate Finance Committee Chairman Chuck Grassley and Finance Subcommittee on Health Care Chairman Pat Toomey Push Oversight and Integrity of Medicaid Eligibility Payments


REGULATORY UPDATE

Monday, March 4

CMS: CMS Proposes New Rule to Move Health Care in the Direction of Interoperability

FDA: FDA Announces Availability of Final Guidance for Industry Entitled “Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503b of the Federal Food, Drug, and Cosmetic Act

  • FDA Evaluates Bulk Drug Substances Under Section 503b

HHS: HHS and ONC Propose Rule that Would Implement Provisions of the 21st Century Cures Act

Tuesday, March 5

CDC: CDC Calls for Increased Prevention to Protect Patients from Deadly Staph Infections

FDA: FDA Approves New Nasal Spray Medication for Treatment-Resistant Depression

NIH: NIH-Sponsored Trial Suggests Home-Based HIV Testing and Referral to Care Works at Population Level

  • New Findings from NIH Clinical Trial Shows Benefit for Subset of Hospitalized Patients

HHS: HHS’ BARDA Funds Its First Marburg Virus Vaccine Development

  • Secretary Azar Praises Commissioner Scott Gottlieb’s Service at FDA

Wednesday, March 6

CMS: CMS and HHS Announce the Release of Data Underlying the Proposed Policies Regarding the Use of Extrapolation in MA Risk Adjustment Data Validation Audits and FFS Adjuster

NIH: NIH-Supported Analysis Shows Tuberculosis Diagnosis in People with HIV Increases Risk of Death Within 10 Years

CMS: CMS Seeks Recommendations that Allow Americans to Purchase Health Insurance Across State Lines

CMS: CMS Administrator Seema Verma’s Statement on the Resignation of FDA Commissioner Scott Gottlieb

Thursday, March 7

FDA: FDA Publishes List of Premarket Approval Applications Approved by the Center for Biologics Evaluation and Research

  • Statement from then FDA Commissioner Scott Gottlieb, M.D., on Naming Biological Medicines to Balance Competition and Safety for Patients

NIH: Researchers Report High Rate of Viral Suppression Among People New to HIV Care

HRSA: HRSA’s Federal Office of Rural Health Policy Releases Notice of Funding Opportunity for New Rural Communities Opioid Response Program

Friday, March 8

FDA: FDA Announces Opportunity for Public Comment on Information Collection Associated with the Processes Available to Outside Stakeholders to Request Additional Review of Decisions or Actions by CDRH Employees


UPCOMING EVENTS

FDA
Meeting: Enhancing the Incorporation of Patient Perspectives on Clinical Trials
March 18, 2019 9 AM – 5 PM
Tommy Douglas Conference Center, 10000 New Hampshire Ave., Silver Spring, MD 20903

FDA
Meeting: Neurological Devices Panel of the Medical Devices Advisory Committee
March 21,2019 8 AM – 5 PM
Hilton Washington, DC North/Gaithersburg, Salons A, B, C and D, 620 Perry Pkwy., Gaithersburg, MD 20877

NIH
Meeting: Office of AIDS Research Advisory Council
March 28, 2019 8:30 AM – 4:30 PM
National Institutes of Health, Conference Room 1D13, 5601 Fishers Lane, Rockville, MD 20892

CDC
Meeting: Clinical Laboratory Improvement Advisory Committee
April 11, 2019 8:30 AM – 1:00 PM
The Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, Maryland 21244

NIH
Meeting: NIH Clinical Center Research Hospital Board
April 12, 2019 9:00 AM – 3:00 PM
National Institutes of Health, Building 1, Wilson Hall, 1 Center Drive, Bethesda, MD 20892

CMS
Meeting: Healthcare Common Procedure Coding System
May 13, 2019 9 AM – 5 PM
Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244-1850

CMS
Meeting: Healthcare Common Procedure Coding System
May 14, 2019 9 AM – 5 PM
Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244-1850

CMS
Meeting: Healthcare Common Procedure Coding System
May 15, 2019 9 AM – 5 PM
Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244-1850

NIH
Meeting: National Advisory Council on Aging
May 21, 2019 3:00 PM – 5:00 PM
National Institutes of Health, Building 60, Lecture Hall, One Cloister Court, Bethesda, MD 20892

NIH
Meeting: National Advisory Mental Health Council
May 30, 2019 9:00 AM – 1:00 PM
National Institutes of Health, Neuroscience Center Building (NSC), Conference Rooms C/D/E, 6001 Executive Boulevard, Rockville, MD 20852

NIH
Meeting: National Heart, Lung, and Blood Advisory Council
June 4, 2019 8:00 AM – 12:00 PM
National Institutes of Health, Porter Neuroscience Research Center, Building 35A Convent Drive, Bethesda, MD 20892

HRSA
Meeting: Council on Graduate Medical Education
June 5, 2019  8:30 AM – 5:00 PM & June 6 8:30 AM – 2:00 PM
5600 Fishers Lane, Rockville, Maryland 20857

NIH
National Advisory Council on Aging
September 10-11, 2019 3:00 PM – 5:00 PM
National Institutes of Health, Neuroscience Center Building (NSC), North Bethesda, 6001 Executive Boulevard, Rockville, MD 28052

NIH
Meeting: Center for Scientific Review
September 23, 2019 8:30 AM – 3:00 PM
National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892

NIH
Meeting: Board of Scientific Counselors, NIDDK
October 10-11, 2019 8:00 AM – 6:00 PM
National Institutes of Health, Building 10, Solarium Conference Room 9S233, 10 Center Drive, Bethesda, MD 20892

NIH
Meeting: Board of Scientific Counselors, National Institute of Neurological Disorders and Stroke
June 23-25, 2019 6:00 PM – 12:00 PM
Residence Inn Bethesda, 7335 Wisconsin Avenue, Bethesda, MD 20814