ASPMN responds to Urban Outfitters' sale of products resembling medication containers
ASPMN's Government Affairs Director Wade Delk and the ASPMN Communications Committee have responded on behalf of the Board of Directors for ASPMN.
to read the response letter.
Please be sure to contact Wade if you have any questions or concerns.
ASPMN's response to the FDA's Drug Safety and Risk Management Advisory Committee.
ASPMN Legislative Toolkit now available! If you have suggestions to include in the toolkit, please contact Wade Delk.
Since August we have been urging CMS to modify and finalize the CY 2013 Physician Fee Schedule proposed rule to restore direct Medicare reimbursement for chronic pain management services provided by Certified Registered Nurse Anesthetists (CRNAs). We have and continue to support RNs and APRNs in their efforts to practice to the full extent of their education and training, which was also the recommendation of the Institute of Medicine (IOM) in their “Future of Nursing” report. For well over a decade, Medicare has reimbursed CRNAs directly for pain management services.
I am pleased to report that on November 1, 2012, Medicare published the 2013 physician fee schedule final rule, authorizing Medicare direct reimbursement of CRNA chronic pain management services, and of all services within CRNA scope of practice in a state where the services are permitted to be furnished. The agency’s action takes effect Jan. 1, 2013. The pain portions of the final rule are here.
- The final rule states, “Anesthesia and related care means those services that a certified registered nurse anesthetist is legally authorized to perform in the state in which the services are furnished.”
- The preamble states, “In addition, we agree with commenters that the primary responsibility for establishing the scope of services CRNAs are sufficiently trained and, thus, should be authorized to furnish, resides with the states.”
- The preamble further states, “By this action, we are defining the Medicare benefit category for CRNAs as including any services the CRNA is permitted to furnish under their state scope of practice. In addition, this action results in CRNAs being treated similarly to other advanced practice nurses for Medicare purposes. This policy is consistent with the Institute of Medicine’s recommendation that Medicare cover services provided by advanced practice nurses to the full extent of their state scope of practice.”
- The agency’s fact sheet states, “Among other changes, the final rule also expands access to services that can be provided by non-physicians practitioners. The rule allows Certified Registered Nurse Anesthetists (CRNAs) to be paid by Medicare for providing all services that they are permitted to furnish under state law. This change will allow Medicare to pay CRNAs for services to the full extent of their state scope of practice.”
ASPMN is among several nursing organizations who signed on to a letter giving comments to: CMS–1590–P – Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule.
ASPMN State Advocacy Update:
A bill has been introduced (SB 159 - http://www.nmlegis.gov/lcs/_session.aspx?chamber=S&legtype=B&legno=%20159&year=12 ) that mandates procedures relating to prescribing and dispensing of certain prescriptions for opioid medications.
Anti pill mill legislation. A bill has been introduced (SB 437 - http://www.legis.state.wv.us/Bill_Status/bills_text.cfm?billdoc=sb437%20intr.htm&yr=2012&sesstype=RS&i=437 ) for the purpose of addressing the growing substance abuse issues in the state. The bill addresses the regulation of opioid treatment programs, updates rules for opioid treatment program facilities to require clinical guidelines, recovery models, education and training requirements for treatment facility staff, and treatment limitations and requirements; requires clinical monitoring of opioid treatment programs; creates an advisory council for opioid treatment programs.
New legislation has come into effect in the state over the last eight months that have caused confusion and fear among prescribers and patients. A bill has been introduced (HB 2599 - http://apps.leg.wa.gov/documents/billdocs/2011-12/Pdf/Bills/House%20Bills/2599.pdf ) That requires the following agencies to suspend, for a period of three years following the effective date of the act, the pain management rules adopted under chapter 209, Laws of 2010: (1) The podiatric medical board; (2) The dental quality assurance commission; (3) The board of osteopathic medicine and surgery; (4) The medical quality assurance commission; and (5) The nursing care quality assurance commission.
This, if passed will allow time to for stakeholders to develop rules that will accomplish the intent of previous legislation (reducing misuse and abuse) while making sure that those in need of the medications continue to have access to them.
Anti pill mill legislation. A bill has been introduced (HB 4 - http://www.lrc.ky.gov/record/12RS/HB4.htm ) that creates a new section of KRS Chapter 218A to require licensing boards, the Attorney General, and the Department of Kentucky State Police to share information regarding drug diversion and improper prescribing, and specify action to be taken upon receipt of a report; create a new section of KRS Chapter 218A to describe required actions prior to and after a person with prescribing authority prescribes or dispenses a controlled substance to a patient and for other purposes.
DEA continues to crackdown on facilities that distribute controlled substances. Last week the DEA suspended the registration of a facility preventing them from distributing controlled medicines - medications used to treat conditions like epilepsy, severe pain and sleep disorders. This facility serves pharmacy customers in Florida, Georgia and South Carolina. The DEA issued an immediate suspension order for this facility. It took this extreme action based on the agency's allegations that some of the prescriptions filled at 4 of the 2,500 pharmacies served by the facility were not written for legitimate medical reasons.
For more information please contact ASPMN Director of Governmental Affairs, Wade Delk at email@example.com or 202-253-7862
Nurses Treating Pain - <--- Click here to listen to podcast
Nurses play an important role in pain management. Two nurses -- Ann Schreier of the American Society for Pain Management Nursing and Pamela Bennett of Purdue Pharma -- talk about it in this edition of The Bioethics Channel.
“RELIEVING PAIN IN AMERICA” -- Institute of Medicine Report Highlights
For the full report, contact Wade Delk, ASPMN Government Affairs Director.
ASPMN Goverment Affairs Director, Wade Delk, on the ASPMN Response to Proposed Legislation and Recently Released Federal Actions via You Tube. For a written transcript, click here.
On June 30, 2011, the Institute of Medicine’s blue ribbon Committee on Advancing Pain Research, Care and Education issued what is unquestionably the most comprehensive report on pain in America ever produced. Its findings and recommendations are summarized for viewing. Click here.
On Wednesday, April 19th 2011, the FDA unveiled their long awaited Risk Evaluation and Mitigation Strategy (REMS) for long acting , extended release opioids. The FDA REMS is focused on educating prescribers about proper pain management, and improving patient awareness about how to use opioids safely. ASPMN has been actively involved in this process for over 2 years and will continue to be as the REMS becomes operational. For more information about the FDA REMS go to:
ASPMN Goverment Affairs Director, Wade Delk, on the FDA's
Acetaminophen recommendations via You Tube. For a written transcript, click here.
ASPMN was approached by a group asking us to sign-on to a proposal regarding FDA’s REMS. We want to make you, our members, aware of why we chose not to sign on.
While it was clear that we shared some of the same values outlined in their educational proposal to ensure safe and effective use of opioids to manage pain, there are significant issues with the proposal that resulted in ASPMN’s decision not to sign on. ASPMN’s mission is to advance and promote optimal nursing care for people affected by pain by promoting best nursing practices.
A primary issue was information that could lead one to believe that “The misuse and abuse of long-acting and extended-release opioid drug products have resulted in a widespread and serious public health crisis of addiction, overdose and death.” This statement is clearly erroneous and reinforces the belief that opioids cause addiction. As experts in pain management nursing, ASPMN knows that this statement is unsupported by scientific evidence. In addition, these tragic deaths are the result of multiple factors including use of other medications and alcohol among other factors. We were concerned that media may later use this erroneous statement as a sound bite. For example, a headline could read ASPMN states that ‘opioids cause addiction’.
As nurses, ASPMN members advocate for patients, families, employers and the public at large through education and cannot support any statement that risks advocacy for effective pain management. It is our belief that this quote would have a serious negative impact upon the ability of ASPMN to continue to effectively advocate for persons experiencing pain.
ASPMN's REMS Task Force which represents multiple organizations provided comments that were submitted to the FDA. Those comments clearly state ASPMN’s position that REMS for opioids should be class-wide and not just ER/LA. In addition, this task force continues to develop a white paper supporting class-wide education for all opioids. Since the document conflicts with ASPMN’s position and comments to the FDA, this provided another reason why we were unable to sign on as a partner.
In our opinion, the above issues are significant barriers to ASPMN’s involvement and sign-on. If these issues were resolved, ASPMN would consider signing on.
REMS Q & A - see this document for Questions and Answers about REMS from our recent conference.
In July, 2010, we wrote a letter to Senator Herb Kohl (D-WI) regarding the urgent need to change DEA rules to avoid unnecessary suffering by the patients in long-term care facilities, and for the understanding and acknowledgement of the role nurses play in those facilities. We respectfully requested that he continue to seek DEA rule changes in regards to prescription authority within long–term care facilities to alleviate unnecessary patient suffering by granting nurses within those rules the same authority in long-term care facilities that they currently have in hospitals.
In the October 6, 2010, Federal Register notice the DEA addressed some of our issues. See the link below.
ASPMN along with 47 other nursing organizations signed onto a letter supporting increased funding for Title VIII Nursing Education and Training Programs at HRSA. The House Labor, Health and Human Services (LHHS) Education, and Related Agencies Appropriations Subcommittee proposed $292 million for nursing education and training in their draft Fiscal Year FY 2011 bill. Our letter is asking for the related Senate Subcommittee do the same thing. Through the “Nursing Community” (a coalition of nursing organizations that works together to advance all nursing issues) we were successful in getting an increase for these programs from $170 million in FY2009 to $242 million for FY 2010. We are now seeking another increase in these programs to $292 million for FY 2011. These programs are currently very underfunded so we have been seeking incremental increases to get them closer to the levels where they should be but they are still woefully behind. We will continue to seek increases year after year until the programs are properly funded.
Click here for letter.
ASPMN sent a letter to Senator Herbert Kohl, Chair of the Senate Special Committee on Aging regarding the U.S. Drug Enforcement Administration’s heightened regulation for dispensing prescriptions in long-term care facilities resulting in increased risk for harm to patients in pain. ASPMN believes that there is an urgent need to change DEA rules to avoid unnecessary pain and suffering by the patients in these facilities, and for the understanding and acknowledgement of the role nurses play in those facilities.
ASPMN attended The Pain Care Forum meeting in July, 2010 where the guest speaker was Dr. Tom McLellan, Deputy Director, White House Office of National Drug Control Policy. Dr. McLellan talked about the 2010 National Drug Control Strategy and other items of interest to the group during his interactive presentation. He requested that the organizations write him to comment on our mutual interests. The letter serves both as an introduction to the issues of the members of the Pain Care Forum but mainly seeks ways we can work collaboratively with the White House Office of National Drug Control Policy.
The attached letter was sent to Dr. McLellan. It includes the organizations that signed onto it. Additionally, not only did ASPMN sign onto the letter but you will notice that we were also included in the text of it.
The FDA has posted their REMS for long acting and extended release opioids that will be reviewed by a Joint Meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committees on July 22nd and 23rd, 2010.
For more information on how to provide written and/or oral testimony for REMS, please see this link: http://www.fda.gov/AdvisoryCommittees/Calendar/ucm214816.htm
Comments are being taken through October 8, 2010
GO TO: http://www.regulations.gov
ENTER keyword: FDA-2009-N-0143-1061
Comment directly on Notices: Risk Evaluation and Mitigations strategies for certain opioid, drugs; notice of public meeting; reopening of comment period (Document ID FDA-2009-N-0143-1061 (type in WORD) and then cut/paste into comment CLICK SUBMIT COMMENT
On July 22-23, 2010 the Food and Drug Administration (FDA) will be holding meetings to discuss the Risk Evaluation and Mitigation Strategy (REMS). The public has 1 hour to comment during this meeting. ASPMN has requested time to provide oral comments during the meeting and hopefully we will be able to do so as we did in May of 2009. Even if we are not one of the few able to speak (and even if we are) we will be submitting written testimony as we also did back in June 2010 that will be included in the public record. Interested stakeholders can submit written comments/testimony. We encourage our members to do this. If you do (and we hope you will) submit comments/testimony please send a copy of them to Wade Delk at firstname.lastname@example.org . If you have additional questions please contact Wade as well. Below is the link to the Federal Register notice for the July two day meeting followed by a summary of the issue.
On Wednesday, June 16th in the Russell Senate Office building in Washington, DC, ASPMN participated in a Congressional Briefing being held by the Americans for Nursing Shortage Relief (ANSR) of which we are a member. ASPMN Immediate Past President, Nancy Eksterowicz, made a presentation to Congressional staff members, and others in attendance about the important work of nurses in our healthcare system that not only makes it better but also saves it money. During this briefing she highlighted nurses in general but will also focus on the vital role that pain management nurses in particular play in our healthcare system. This briefing was an excellent opportunity for ASPMN to highlight the work our members do, and to show Congress that we are the lead organization for pain management nursing issues. Additionally, Senator Debbie Stabenow (D-MI) was in attendance and was honored for her work in helping us to advance nursing issues. Click here for Nancy's transcript of her presentation.
Ortho-McNeil-Janssen and FDA notified healthcare professionals of changes to the Warnings section of the prescribing information for tramadol, a centrally acting synthetic opioid analgesic indicated for the management of moderate to moderately severe chronic pain. The strengthened Warnings information emphasizes the risk of suicide for patients who are addiction-prone, taking tranquilizers or antidepressant drugs and also warns of the risk of overdosage. Tramadol-related deaths have occurred in patients with previous histories of emotional disturbances or suicidal ideation or attempts, as well as histories of misuse of tranquilizers, alcohol, and other CNS-active drugs. Tramadol may be expected to have additive effects when used in conjunction with alcohol, other opioids or illicit drugs that cause central nervous system depression. Serious potential consequences of overdosage with tramadol are central nervous system depression, respiratory depression and death. Tramadol has mu-opioid agonist activity, can be abused and may be subject to criminal diversion.
Read the complete MedWatch 2010 safety summary, including links to the "Dear Healthcare Professional" letters here
ASPMN joins with other nursing organization to support nursing issues in healthcare reform
In early January, ASPMN along with 44 other nursing organizations sent a letter to Speaker of the House Nancy Pelosi, and Senate Majority Leader Harry Reid highlighting important provisions that needed to remain, be included, or modified in the healthcare reform legislation.
Healthcare reform has been in limbo since, and the White House is now trying to reinvigorate it. They will hold a Summit on Thursday, February 25 to drive it forward. We have with other nursing organizations repurposed the original letter by adding a cover page to it, and then sending it to the invites of the White House Summit, including President Obama, to make sure that our issues stay in front of lawmakers.
We will continue to follow healthcare reform to ensure that no matter what happens our issues are heard.
Haitian Relief Operation
In a press release the ARC issued, The Red Cross is contributing an initial $1 million from the International Response Fund to support the relief operation, and has opened its warehouse in Panama to provide tarps, mosquito nets and cooking sets for approximately 5,000 families.
In addition to Red Cross staff already in Haiti, six disaster management specialists are being deployed to the disaster zone to help coordinate relief efforts. At this time, the American Red Cross is only deploying volunteers specially trained to manage international emergency operations.
There has been an outpouring of support from the public. To help, people can make an unrestricted donation to the International Response Fund at www.redcross.org or by calling 1-800-REDCROSS (1-800-733-2767). The public can also help by texting "Haiti" to 90999 to send a $10 donation to the Red Cross, through an effort backed by the U.S. State Department. Funds will go to support American Red Cross relief efforts in Haiti.
Groundbreaking New Survey Finds that Diverse Opinion Leaders Say Nurses Should Have More Influence on Health Systems and Services
Over the coming months we will continue to talk with the FDA and Congress about the REMS process to ensure that it is transparent and decided after all materials and input are heard and reviewed.
We will work with Congress to advance the National Pain Care Policy Act making sure the original intent of the legislation is left intact.
Additionally, using our key messages, we will continue to advocate and educate legislators and the administration on pain management and the important role that nurses play in it.
ASPMN Statement of Support:
A Call to Revolutionize Pain
Care in America
ASPMN sends Connie Luedtke to Nurse Internship In Washington (NIWI)
Public Health Crisis Spurs American Society for Pain Management Nursing to Take Action
The National Pain Care Policy Act of 2009, H.R. 756, passes the House
The House of Representatives passed the National Pain Care Policy Act of 2009, H.R. 756. Thank to all of you who made telephone calls, and sent letters to your Congressman. The Senate introduced similar legislation last week. We posted information on our web site asking you to contact your Senators to seek their support and passage of this legislation. Please contact them to ask that they co-sponsor the National Pain Care Policy Act of 2009, S.660. With your help we will see this Act become law.
The National Pain Care Policy Act 2009, S.660, has been introduced in the Senate and your help is needed!
Please contact your two U.S. Senators requesting their co-sponsorship of the National Pain Care Policy Act of 2009, S.660
Pain is the most common reason Americans access the health care system and is a leading contributor to health care costs. Pain is also a leading cause of disability. Most painful conditions can be relieved with proper treatment, and providing adequate pain management is a crucial component of improving and maintaining quality of life for patients, survivors, and their loved ones. Yet people in pain often face significant barriers that can prevent proper assessment, diagnosis, treatment and management of their pain. The National Pain Care Policy Act of 2009 is designed to address many of these barriers by improving pain care research, education, training, access, outreach and care.
Below is a sample letter that you can send to each of your two US Senators by simply inserting their name, yours at the bottom, and your organization. Also, be sure to include your address and telephone number in case their office wishes to contact you. This letter can be sent via email by clicking the following link: http://senate.gov/general/contact_information/senators_cfm.cfm
Using the above link, search for each of your Senator’s website, and then cut and paste the below letter into their e-mail form.
With your help we will be successful in passing this important piece of legislation for the pain care community.
Re: NATIONAL PAIN CARE POLICY ACT of 2009, S.660
Dear Senator XX,
As a resident of your state, I am writing to request that you CO-SPONSOR the NATIONAL PAIN CARE POLICY ACT of 2009, S.660. It is critical to the constituents of our state that you show support for federal pain policy reform through support for S.660.
According to the National Institutes of Health, pain is the most common reason Americans access the health care system (over 76.5 million Americans suffer from pain, both chronic and acute). It also drives up health care costs, estimated at $100 billion annually in health care expenses, lost income, and lost productivity. It is critical that this issue gets the national attention it requires. The National Pain Care Policy Act addresses the tremendous barriers to proper pain care by improving coordination of pain research, supporting healthcare practitioner education & training, and creating a national public awareness campaign.
(Your Name and Organization, address and telephone number here)
The Americans for Nursing Shortage Relief (ANSR) Alliance, of which we are members, has developed a Consensus Document that we have endorsed. It seeks to have Congress enact and fund a comprehensive set of initiatives to address the nursing shortage to ensure that the nation has an adequate infrastructure of well-qualified nurses. It outlines programs and evidence-based, cost-effective best practices across the federal agencies that hold the most promise for the federal government to adequately address the issue.
Additionally, we are requesting that Congress provide $215 million in funding for Nursing Workforce Development Programs under Title VIII of the Public Health Service Act at the Health Resources and Services Administration (HRSA) in FY 2010. As part of this funding, the Advanced Education Nursing training program (Sec. 811) should be funded at an increased level on par with the other Title VIII programs.
Please read the following Consensus Document for full details
H.R.2994, the Pain Care Policy Act of 2008 passed by unanimous vote last night (9/24/08) in the House of Representatives. A Senate Companion Bill was introduced by Senators Hatch and Dodd this summer. Their offices have approved the revised H.R.2994 and will be promoting passage of the identical bill in the Senate this week. We have urged the Members of the Senate Health, Education, Labor and Pensions Committee by way of a letter to each of them to support this important healthcare legislation. The Pain Care Policy Act addresses the barriers to proper pain care by improving coordination of pain research, supporting education & training for health care providers and creating a national public awareness campaign.
ASPMN sent a letter to Washington State Governor Christine Gregoire on the issue of intrathecal drug delivery coverage. In Washington State injured workers are often denied coverage by the Department of Labor and Industries to pain therapies involving spinal cord stimulation and intrathecal drug delivery. Washington is the only state in the nation where the state run workers’ compensation program has taken a non-coverage approach. However, injured patients enrolled with the state’s Health Care Authority or Medicaid programs are granted access to this treatment and all major private insurers in the state also provide for coverage. To correct the inequities in coverage we asked that there be standardization and uniformity in these coverage policies amongst Washington State agencies to allow for intrathecal drug delivery to be covered as one of the treatment options.
In June ASPMN signed-on to a letter urging Congress to ensure that the final FY 2009 302b allocations for the House and Senate Labor, Health and Human Services, Education Appropriations Subcommittees reflects at least a $15 billion increase above the FY 2008 level for critically important programs. In July we received information that the Subcommittee did increase the funding as we requested. In August we signed-on to a follow-up letter urging Congress to approve the funding levels included by the Subcommittee in hope that the funding increases continue to be included in the final FY2009 budget.
Purdue Pharma is proud to present the new, In the Face of Pain® Online Advocacy Toolkit, a free interactive resource for the pain advocacy community.
The comprehensive Toolkit provides pain-specific advocacy information and resources covering topics related to legislative, media, community and professional organizations, as well as advocacy through research and access to care. The web site also provides advocates with the ability to research hundreds of current pain-related statistics based on condition, population or issue.
A unique feature of the In the Face of Pain Online Advocacy Toolkit is that it helps advocates create individualized advocacy action plans and educational materials, such as fact sheets or presentations that are tailored to the advocate’s specific area of focus.
The development of the Toolkit is part of Purdue’s continued commitment to serving patients, caregivers, and healthcare professionals to help alleviate unnecessary suffering by advancing standards of pain care through education and advocacy. The introduction of the Toolkit follows the recent relaunch of Partners Against Pain® www.partnersagainstpain.com, a comprehensive resource that offers a wide range of information about various chronic pain conditions including arthritis, fibromyalgia and cancer; pain measurement and assessment tools; pain policy, legislation and community relations; and links to other relevant web sites.
Below you will find the In the Face of Pain Online Advocacy Toolkit direct web site link. Please feel free to share this information with others and/or include it in your communications with members of your association.
ASPMN, to ensure that our nation has a sufficient and adequately prepared nursing workforce to provide quality care to all well into the 21st century, has sent a letter to Members of Congress urging them to appropriate at least $200 million in funding for Nursing Workforce Development Programs under Title VIII of the Public Health Service Act at the Health Resources and Services Administration (HRSA) in FY 2009, and requests that they restore the Advanced Education Nursing program (Sec. 811) and fund it at a level on par with the proposed FY 2009 increase for the other Title VIII programs. See letter for further details.
ASPMN, signed on to a letter along with other stakeholders representing the full range of programs of the Departments of Education, Health and Human Services and Labor urging Congress to ensure that the final FY 2009 302b allocations for the House and Senate Labor, Health and Human Services, Education Appropriations Subcommittees reflects at least a $15 billion increase above the FY 2008 level for these critically important programs. This amount would:
(1) restore cuts of core program funding over the last four years,
(2) more appropriately account for four years of inflation and population growth to maintain service levels and purchasing power; and
(3) return these programs to the FY 2005 level. See letter for further details.
November 14, 2007 -- Veterans Pain Care Act of 2007, S 2160, was passed by the Senate Veteran's Affairs Committee
ANSR Consensus Document
Illinois Nurses Association Position Paper
IMPROVING PAIN MANAGEMENT
DEA Response Statement Docket No. DEA-286P
DEA Consensus Statement Docket No. DEA-287N
Letter to the DEA Docket DEA-261 (pdf)
(DEA’s) withdrawal of the Prescription Pain Medications: Frequently Asked Questions and Answers for Health Care Professionals and Law Enforcement Personnel (FAQ)
COALITION FOR PATIENTS' RIGHTS (CPR)
CALLS ON AMA TO CEASE DIVISIVE EFFORTS TO LIMIT PATIENTS’ CHOICE OF PROVIDERS
24 health care organizations* unite to ensure patients a full range of health care provider options and the right to choose among them
Available for Download:
Achieving Balance in State Pain Policy: A Progress Report Card (second edition)
US COURT OF APPEALS DECISION
USA v. Hurwitz