Dr. Steven Goldstein, founder of the Houston Healthcare Initiative, is a catalyst for change for health & medical legislative issues. Here, you will find curated articles on issues of interest to everyone with an interest in getting the best care possible at a competitive price. The role of government, the pharmaceutical companies, hospital owners, and physician employment placement are here for you to read, learn and share.
Current Healthcare Legislation October 6, 2020
IN THE SENATE OF THE UNITED STATES
September 22, 2020
To amend the 21st Century Cures Act to provide for designation of institutions of higher education that provide research, data, and leadership on continuous manufacturing as National Centers of Excellence in Continuous Pharmaceutical Manufacturing, and for other purposes.
Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled:
SECTION 1. SHORT TITLE.
This Act may be cited as the “National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act of 2020”.
SEC. 2. NATIONAL CENTERS OF EXCELLENCE IN CONTINUOUS PHARMACEUTICAL MANUFACTURING.
(a) In General.—Section 3016 of the 21st Century Cures Act (21 U.S.C. 399h) is amended to read as follows:
“SEC. 3016. NATIONAL CENTERS OF EXCELLENCE IN CONTINUOUS PHARMACEUTICAL MANUFACTURING.
“(a) In General.—The Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs—
“(1) shall solicit and, beginning not later than one year after the date of enactment of the National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act of 2020, receive requests from institutions of higher education to be designated as a National Center of Excellence in Continuous Pharmaceutical Manufacturing (in this section referred to as a ‘National Center of Excellence’) to support the advancement and development of continuous manufacturing;
Passed House (01/08/2019)
Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019
This bill (1) reauthorizes, revises, and establishes several programs and entities relating to public-health emergency preparedness and response; and (2) addresses the approval process for over-the counter (OTC) drugs.
Among other programs, the bill reauthorizes through FY2023 and revises
- the Public Health Emergency Preparedness cooperative-agreement program administered by the Centers for Disease Control and Prevention (CDC),
- the Hospital Preparedness Program,
- the CDC situational-awareness and biosurveillance program,
- the Emergency System for Advance Registration of Volunteer Health Professionals,
- the National Disaster Medical System,
- the Volunteer Medical Reserve Corps,
- the National Advisory Committee on Children and Disasters,
- the Strategic National Stockpile, and
- the Biomedical Advanced Research and Development Authority.
In addition, the bill provides statutory authority for existing programs, including the CDC’s Children’s Preparedness Unit and the Public Health Emergency Medical Countermeasures Enterprise. The bill also establishes new programs and entities, including a trauma-center grant program to support military trauma teams.
The bill further modifies the approval process for OTC drugs by providing statutory authority for the Food and Drug Administration (FDA) to (1) regulate certain OTC drugs that are marketed without an approved new-drug application, and (2) issue administrative orders specifying the conditions under which an OTC drug may be deemed safe and effective and not subject to approval as a new drug. The FDA must assess and collect user fees for OTC drugs, including OTC-drug facility and OTC-drug order-request fees.
Introduced in Senate (02/13/2019)
Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2019
This bill requires manufacturers of drugs with specified percentage increases in their wholesale costs to submit to the Centers for Medicare & Medicaid Services (CMS) written justification for certain increases in drug prices. The CMS shall publish each submission, together with an easily understandable summary, on its website. Certain proprietary information may be excluded from publication, as specified by the bill.
A manufacturer that does not comply with the bill’s requirements shall be subject to civil monetary penalties. Health & Medical Legislative Issues.
As the nation works to defeat the coronavirus pandemic and re-open America’s economy, U.S. Sen. Ted Cruz (R-Texas) today announced his intention to introduce two pieces of legislation when Congress returns to expand healthcare access and make testing more accessible and widely available.
The next round of coronavirus relief legislation will likely focus on providing healthcare for millions of Americans who have found themselves suddenly jobless and uninsured due to the pandemic.
U.S. Sen. Mark Warner, from Virginia, U.S. Senator Jeanne Shaheen, from New Hampshire, and U.S. Senator Doug Jones, from Alabama, hosted a press call on Friday to discuss what that legislation could look like, if passed.
Big problems demand big solutions: Congress Must Expand Medicare Coverage to Everyone in America for the Duration of the Crisis. Health & Medical Legislative Issues
With “non-essential” businesses being forced to temporarily close their doors during the COVID-19 pandemic, Unemployment Insurance claims are surging at an unprecedented rate. Applied General Agency, Inc. (AGA) responds by hosting informative demos online for those wanting to secure work-from-home jobs.
Rep. Lloyd Doggett, D-Texas, has introduced legislation (H.R. 6532) to amend the Patient Protection and Affordable Care Act “to require the Secretary of Health and Human Services to establish a special enrollment period during the COVID-19 emergency period and to carry out outreach and educational activities.”
Health & Medical Legislative Issues