Government Affairs

ASPAN GOVERNMENTAL AFFAIRS UPDATE MARCH 2003 

ANSR Sends Letter to Representative McCarthy 

  • On March 14, The Americans for Nursing Shortage Relief (ANSR) sent a letter to Representative Carolyn McCarthy expressing strong support for her introduction of H.R. 934, "The Teacher and Nurse Support Act of 2003"
  • ASPAN was 1 of 38 associations who signed this letter

Congressional Nursing Caucus Formed 

  • A Congressional Nursing Caucus in the US House of Representatives was formed by Representatives Lois Capps (D-CA) and Ed Whitfield (R-KY)

  • The purpose of this bipartisan caucus is to educate Congress on all aspects of the nursing profession and how nursing issues impact the delivery of safe, quality care

  • This caucus was formed after consultation between congressional leaders and ANA

  • The caucus will hold regular briefings on matters such as the nursing shortage, bioterrorism preparedness, Medicare and patient safety issues

  • The caucus will also serve as a clearinghouse for information and a sounding board for ideas brought forth by the nursing community

  • So far the caucus has 56 members

  • One subject the caucus will likely address is the smallpox vaccination program

  • www.nursingworld.org

HHS Proposes Smallpox Vaccination Compensation Plan 

  • On March 5, HHS Secretary Tommy Thompson proposed a plan to create a smallpox vaccination compensation program to provide benefits to public health and medical response team members who are injured as a result of receiving the smallpox vaccine-it is based on a similar compensation package that is currently available to police officers and firefighters

  • Dr. Julie Gerberding (Director of the CDC) stated, "We are asking these health professionals to perform a vital public duty, so we are proposing to provide them the same sort of benefits that we provide our public safety officers when they are injured on the job.  We are truly grateful for their commitment and willingness to take part in this vital program."

  • The benefits package would be administered by HHS and be retroactive to cover those who already have been vaccinated under the program

  • The 4 elements of the plan include:

    • Permanent and total disability benefit

    • Death benefit

    • Temporary or partial disability benefit

    • Health care benefit

  • Also, HHS would provide compensation to third parties who contract vaccinia from public health and medical response team workers who have been vaccinated

  • All states have submitted smallpox response plans and as of March 4, 45 jurisdictions have vaccinated nearly 12,404 individuals

  • Pre-attack vaccination of these teams will allow them to vaccinate the American public in the event of an attack-if there is a release of smallpox, vaccine will be made available to the general public

  • Thompson stated, "We do not, however, recommend that the general public get the vaccine at this time because the risk of the vaccine outweighs the risk of a potential exposure to smallpox."

  • This compensation plan does not cover the general public, as it is not recommended that they receive the vaccine

  • www.hhs.gov

  • ANA is also concerned with the following smallpox issues:

    • The potential transmission of the vaccinia virus to patients/family members

    • The right to coverage of medical costs associated with receiving the vaccine

    • The utilization of safer bifurcated needles

    • The critical need to establish an adequate prescreening and education program

    • Maintaining sufficient staffing during the voluntary, pre-event vaccination program

    • Compensation for lost time at work due to adverse effects of the vaccination program

    • Protection from job discrimination or retaliation for refusing to be vaccinated

  • www.nursingworld.org

Reducing Medication Errors 

  • On March 13, HHS Secretary Thompson announced 2 proposed rules from the FDA that will improve patient safety by reducing medication errors and by more quickly identifying potential errors that may occur

  • The new rules will require bar coding on medications and will improve reporting requirements for safety problems involving medicines

  • The proposed requirement for bar codes-adopts a technology that is widely used in other industries to reduce the number of medication errors in hospitals and other health care settings

  • The required bar code would contain the National Drug Code (NDC) number, unique identifying information about the drug that is to be dispensed to the patient, in a linear bar code as part of the drug label

  • The proposed design would allow manufacturers to include additional information, and more information could also be added to the bar code standards as information technology progresses

  • When used with bar code scanners and computerized patient information systems, bar code technology can prevent many medication errors including administering the wrong drug, administering a drug to a patient who is known to be allergic, administering the wrong dose, administering the drug at the wrong time, or using the wrong route of administration

  • In addition to the human suffering they cause, medication errors represent a significant economic cost to the US

  • According to the Institute of Medicine (IOM) and other experts, thousands of deaths and millions of hospitalizations result from medication errors-the expected annual benefit from preventing adverse events due to medication errors is equivalent to $3.9 billion

  • The proposed rule would apply to all prescription drug products and OTC drugs that are commonly used in hospitals

  • Standardized bar codes would also be required on prescription drug products used in other settings such as retail pharmacies

  • The second action HHS is announcing-the proposed revamping of safety reporting requirements-aims to enhance HHS's ability to effectively monitor and improve the safe use of medications including drugs and biologics

  • The proposed rule would:

    • Improve the quality and usefulness of safety reports submitted to HHS as well as facilitating the consistency of safety reporting around the world

    • Require the submission of all suspected serious reactions for blood and blood products on the market

    • Require reports on important potential medication errors

  • To expedite HHS's review of and response to medication errors, the proposed amendments would require companies to submit to FDA (within 15 calendar days) all reports they receive of actual and potential ("near miss") medication errors occurring in the US

  • The proposal would also raise the quality and consistency of safety reports by requiring the use of internationally agreed definitions reporting formats, and other safety reporting standards

  • www.hhs.gov

  • www.fda.gov

Potential Worldwide Flu Outbreak 

  • President Bush has proposed a new $100 million initiative to prepare for a possible influenza pandemic involving a worldwide outbreak of a dangerous new flu variant

  • HHS Secretary Thompson commented that the initiative would better prepare America for an outbreak such as the one that occurred in 1918 and killed 25 million people worldwide

  • The constant changes in circulating influenza strains makes it impossible to stockpile vaccine as is done with other vaccines

  • Thompson stated, "If we wait until a pandemic begins, it may be too late to act to minimize the loss of life in our country and across the world.  While vaccines cannot be prepared and stockpiled, we must plan and prepare for an outbreak now to ensure we have the ability to quickly produce fresh vaccine that is effective against a pandemic flu strain."

  • www.hhs.gov

Bioterrorism Aid for States 

  • On March 20 HHS Secretary Thompson announced $1.4 billion to be provided to states this year to help them enhance preparations against terrorism or other public health emergencies

  • Thompson also announced special provisions that would allow states to obtain up to 20% of their 2003 funding immediately in order to support current activities, including smallpox vaccination for selected health workers and emergency responders

  • www.hhs.gov

 

HHS to Test Use of Handheld Device Network for Transmitting Urgent Information About Biological Agents to Clinicians 

  • On March 21 HHS Secretary Thompson announced that HHS will begin testing a system using handheld personal digital assistants (PDAs) for transmitting urgent information about biological agents to clinicians

  • The 3 month pilot test of the PDA network is designed to gauge the best ways for federal officials to communicate effectively with front-line clinicians in the event of a bioterrorist attack

  • The project will evaluate how and when clinicians download this urgent information and whether they find it useful to receive it via their PDAs

  • The project will evaluate the use of a system created by ePocrates, the nation's largest physicians' handheld network, for sending an urgent "Doc Alert" message to more than 700,000 front-line clinicians

  • The test message will contain a special memo on the highest threat (category A) biological diseases/agents, which include anthrax, botulism, plague, smallpox, tularemia and viral hemorrhagic fevers, including Ebola

  • The message will also include Web links for clinicians to go to for additional information about diagnosing and treating the conditions caused by the biological agents

  • The pilot project will be managed by HHS' Agency for Healthcare Research and Quality (AHRQ) and is designed to complement the CDC's existing Health Alert Network

  • www.cpsi.ahrq.gov

  • www.hhs.gov

JCR Publishes Patient Safety:  Essentials for Health Care 

  • On March 19, Joint Commission Resources (JCR) announced the publication of a definitive guide to patient safety standards for JCAHO's behavioral health care, critical access hospital, acute care hospital and long term care accreditation programs-it includes detailed explanations of the standards, how they are surveyed, and how to comply with them

  • This publication also highlights how to conduct a failure mode and effects analysis and a root cause analysis

  • www.jcaho.org

MedPAC Prepares June Report 

  • At its March 20-21 meeting, the Medicare Payment Advisory Commission (MedPAC) discussed issues to be incorporated into its June 2003 Report to Congress

  • The issues included:

    • The payment method for outpatient drugs

    • The growth in the volume of physician services

    • Using quality incentives in the Medicare Program

  • The annual rate of growth for outpatient drugs has been more than 20% for the past 3 years-there are several problems with the current system, including:

    • Payments based on the average wholesale price overstate provider acquisition costs

    • The payment system can lead to higher prices

    • High drug prices may be used to subsidize payments for drug administration

  • A presentation on the growth in the volume of physician services focused on whether "defensive medicine" in states with high professional liability insurance premiums contributed to the increased volume

  • As far as the quality incentives, commissioners discussed whether incentives should be provider based (bonuses) or beneficiary based (lower premiums)

  • An April meeting is also planned

  • www.aamc.org/advocacy/library/washhigh

Senate Passes Budget Plan 

  • On March 26 the Senate passed its FY 2004 budget resolution (S. Con. Res.23) by a 56 to 44 vote after 8 days of debate and 50 roll call votes

  • The Senate resolution must now be reconciled with the version (H. Con. Res. 95) the House passed March 21 by a vote of 215 to 212

  • Much of the attention of the House and Senate negotiators will focus on the difference between the 2 resolutions in the size of the proposed tax cut-the House's plan includes the President's proposal for $726 billion in tax cuts, while the Senate voted to limit it to $350 billion

  • Other issues to be resolved include the levels of Medicaid and discretionary spending for FY 2004

  • One factor that may delay the budget conference is consideration of the $74.7 billion FY 2003 supplemental spending request for the war in Iraq that the President submitted to Congress March 25-House and Senate leaders have indicated they will push for completion of the supplement before the start of the 2 week recess on April 11

  •  www.aamc.org/advocacy/library/washhigh

 Bills/Resolutions Updates 

H.R. 1463 "To provide benefits for certain individuals with injuries resulting from administration of a smallpox vaccine, and for other purposes"

Sponsor:  Representative Richard Burr (R-NC)

Introduced:  3-27-03

Latest Major Action:  On 3-31-03 failed of passage/not agreed to in House

Status:  On motion to suspend the rules and pass the bill failed by the Yeas and Nays:  (2/3 required):  184-206, roll call vote

 

S. 15 "A bill to amend the Public Health Service Act to provide for the payment of compensation for certain individuals with injuries resulting from the administration of smallpox countermeasures, to provide protections and countermeasures against chemical, radiological, or nuclear agents that may be used in a terrorist attack against the US, and to improve immunization rates by increasing the distribution of vaccines and improving and clarifying the vaccine injury compensation program"

Sponsor:  Senator Judd Gregg (R-NH)

Introduced:  3-11-03

Latest Major Action

  • On March 19, the Senate Health, Education, Labor, and Pension (HELP) Committee approved the portion that codifies the President's proposed "Project Bioshield," but postponed a vote on the smallpox vaccine compensation program to address concerns raised by Ranking Member Edward Kennedy (D-MA) 

  • "Project Bioshield" was approved unanimously by the committee

  • www.thomas.loc

  • www.aamc.org/advocacy/library/washhigh

S. 204 "Medicaid Safety Net Improvement Act of 2003"

Sponsor:  Senator Jeff Bingaman

Introduced:  1-22-03

Latest major action:  On 1-22-03 referred to the Finance Committee

Summary:

Amends title XIX (Medicaid) of the Social Security Act (SSA) to increase the allowed Federal Medicaid disproportionate share hospital (DSH) allotment in "extremely low-DSH" States from 1% to 3% of the State's Medicaid program costs

H.R. 663 "Patient Safety and Quality Improvement Act"

Sponsor:  Representative Michael Bilirakis

Latest Major Action:  House passed on March 12 (418-6)

  • This legislation creates a voluntary and confidential medical errors reporting system

  • The system would compile, review, and analyze the data with the intent of providing evidence-based information that would help prevent medical errors

  • The legislation amends the Public Health Service Act and is not funded by the Medicare Trust Fund

  • The bill authorizes $25 million annually in FYs 2004 and 2005 for matching grants to help hospitals and other providers purchase information technologies that would improve patient care quality and reduce medical errors

  • The legislation also addresses the implementation of "product identification technology" (e.g., barcodes for medical supplies)

  • www.thomas.loc.gov

  • www.aamc.org/advocacy/library/washhigh

 

H.R. 810 "Medicare Regulatory and Contracting Reform Act of 2003"

Sponsor:  Representative Nancy Johnson

Introduced:  2-13-03

Latest Major Action:  The House Energy and Commerce Committee passed by voice vote on 3-26-03

H. Res. 139 "Providing for consideration of the bill (H.R. 5) to improve patient access to health care services and provide improved medical care by reducing the excessive burden the liability system places on the health care delivery system"

Sponsor:  Representative Thomas Reynolds

Introduced:  3-12-03

Latest Major Action:  On 3-13-03 passed/agreed to in House 

S. 607 "A bill to improve patient access to health care services and provide improved medical care by reducing the excessive burden the liability system places on the health care delivery system"

Sponsor:  Senator John Ensign

Introduced:  3-12-03

Latest Major Action:  On 3-13-03 Senate preparation for floor 

  • On March 13 the House passed medical liability reform legislation ("HEALTH Act", H.R. 5) by a vote of 229-196

  • The base bill had been introduced in February and on 3-12, in lieu of amendments recommended by the Judiciary and Energy and Commerce Committees, the Rules Committee agreed to an amendment in the nature of a substitute, which was offered by Energy and Commerce Committee Chairman Bill Tauzin and Judiciary Chairman James Sensenbrenner

  • The Tauzin/Sensenbrenner amendment maintains the key provisions of the base bill, including a $250,000 cap on awards for non-economic damages ("pain and suffering")

  • It sets punitive awards at the greater of $250,000 or twice economic damages, and allows defendants to introduce evidence of plaintiffs receiving compensation for losses from outside sources

  • Under H.R. 5, courts may authorize the payment of certain awards over time

  • It establishes a 3-year statute of limitations and a "fair share rule that allocates damages in direct proportion to fault and limits contingency fees for lawyers

  • Products meeting FDA requirements are exempt from damages

  • The legislation allows states to set their won cap on non-economic damages, regardless of whether they exceed or fall below $250,000

  • Democrats strongly opposed passage of H.R. 5, arguing that it failed to hold medical device companies, HMOs, and drug companies accountable

  • Several Democrats also criticized it for pre-empting or threatening states' patient rights laws

  • Democratic Senators have suggested premium controls and increased insurance regulation as more effective alternatives

  • The Senate version was introduced on 3-12

  • The full 'Senate has previously opposed the reforms outlined by the HEALTH Act

  • Last year the House passed a version of liability reform (H.R. 4600), but the legislation was never raised by the Senate

  • www.thomas.loc.gov

  • www.aamc.org/advocacy/library/washhigh

 

S. 652 "Access to Hospitals Act of 2003"

Sponsor:  Senator Lincoln Chafee

Introduced:  3-18-03

Latest Major Action:  On 3-18-03 referred to Finance Committee 

H.R. 328 "Access to Hospitals Act of 2003"

Sponsor:  Representative Ed Whitfield

Introduced:  1-8-03

Latest Major Action:  On 2-3-03 referred to Health Subcommittee 

H.R. 1342 "Medicaid Safety Net Improvement Act of 2003"

Sponsor:  Representative Heather Wilson

Introduced:  3-18-03

Latest Major Action:  On 3-18-03 referred to Energy and Commerce Committee