The American Academy of Pain Medicine

Breaking News & Updates

• FDA Reopened Comment Period for REMS until
  October 19, 2010 - 12/18/09
• HR 3961 Passes House, Now in Senate - 12/03/09
• AAPM Supports HR 3961, Medicare Physician Payment Reform Act - 11/13/09
• Department of Defense Required to Develop Pain Care Policy - 10/28/09
• Pain Care Bill Back on Track - 6/25/09
• Dr. Perry Fine Op Ed Piece on Balanced Prescribing - 6/11/09
• AAPM Comments to FDA on REMS - 5/26/09
• FDA REMS on Opioids - 5/22/09
• Health Reform Policy Papers Released - 5/01/09
• House Passed National Pain Care Act - 4/02/09
• Arthritis Bill Introduced - 3/05/09
• Stimulus bill includes increased NIH funding - 2/20/09
• PCC's 2009 Legislative Priorities - 2/5/09
• AMA Wins Court Ruling Denying Public Access to Medicare Records - 2/3/09
• Pain Care Policy Act Reintroduced in 2009 - 2/1/09
• AAPM signs on to MedPAC letter - 1/9/09
• 2008 Advocacy News Archive
  

FDA Reopened Comment Period for REMS until
October 19, 2010

December 18, 2009 -- The Food and Drug Administration (FDA) reopened the comment period for REMS until October 19, 2010. If you have not submitted a comment yet, visit www.regulations.gov and search for Document ID FDA-2009-N-0143-1061 or go to http://www.regulations.gov/search/Regs/home.html#documentDetail?R=0900006480a44cce

Back to Top

HR 3961 Passes House, Now in Senate

December 3, 2009 -- The House of Representatives passed HR 3961 on November 19, which amends title XVIII of the Social Security Act to reform the Medicare SGR payment system for physicians. The bill was received in the Senate on November 20, 2009. Read more...

Back to Top

AAPM Supports HR 3961, Medicare Physician Payment Reform Act

November 13, 2009 -- AAPM was one of over 125 organizations that were included in the signatory of a letter sent to Speaker of the House, the Honorable Nancy Pelosi, urging the House of Representatives to pass HR 3961, the "Medicare Physician Payment Reform Act". Read more...

Back to Top

Department of Defense Required to Develop Pain Care Policy

October 28, 2009 -- Important military pain care provisions requiring the Department of Defense (DoD) to develop and implement a comprehensive pain control policy throughout its health care system were signed into law by President Obama on October 28. The provisions were attached as part of the defense authorization bill for 2010 (HR 2647).

The requirements imposed on the DoD are identical to those imposed on the Department of Veterans Affairs by the Veterans Pain Care Policy Act, which was enacted into law last fall. As a result, a consistent, comprehensive pain care plan should extend throughout both the VA and the DoD.

"These two bills result from a growing awareness of how early and continuously effective pain management will positively effect the longitudinal, quality-of-life outcomes of our warriors' battlefield and deployment-related injuries, such as physical trauma, traumatic brain injury, and PTSD. I am particularly pleased for the health care workers throughout the military and VA health systems who now dedicate themselves day and night to pain management, and also for the families and community organizations that join these health teams in ensuring effective pain care for these men and women who have sacrificed so much for our country," says AAPM President Rollin Gallagher, MD, MPH.

The military pain care provisions require that the DoD's comprehensive strategy include development of educational and training programs for health care personnel, as well as research programs related to acute and chronic pain.

Back to Top

Pain Care Bill Back on Track

June 25, 2009 -- In an excellent development for pain care practitioners, the Senate Health, Education, Labor and Pensions (HELP) Committee accepted an amendment to their comprehensive health reform bill that embodies the full version of S. 660, the National Pain Care Policy Act.

Acceptance of the amendment increases the likelihood that S. 660 will pass the Senate and accelerates its timetable for passage. Earlier reports indicated that the Senate would not address S. 660 until the larger health reform debate had been concluded. By including S. 660 as an amendment, however, this important pain care bill appears to be back on the fast track. HR 756, the House version of the National Pain Care Policy Act, which is identical to S. 660, has already been approved by the full House.

HELP has been working for several weeks on its reform bill, called the Affordable Health Choices Act. The amendment that includes S. 660, called Hatch amendment #10, is one of a series of amendments agreed to by Republican and Democratic senators. Sen. Christopher Dodd (D CT), one of the original co-sponsors of S. 660, is chairing the HELP Committee meetings as Sen. Edward Kennedy (D MA) recovers from medical treatments.

Back to Top

Forty lives saved from ODs: Cheap at twice the price
By Perry G. Fine

June 11, 2009 -- What's the value of a human life? No one can answer this age-old question, but thanks to the efforts of the Utah Department of Health, many volunteer health professionals and the state Legislature, we have learned how much it costs to save a life. Full story...

Back to Top

FDA REMS on Opioids

May 22, 2009 -- The Food and Drug Administration initiated a process last fall largely outside the notice of most physicians that could have a profound affect on how extended-release medications, including morphine, oxycodone, and methadone, are prescribed for pain relief. The medical community, including AAPM, has now taken a more active role in that process in an effort to ensure that any decision reached by the FDA considers the needs of legitimate pain medicine prescribers and their patients.

S 660 authorizes an Institute of Medicine Conference on Pain Care, promotes pain research at NIH, provides comprehensive pain care education and training for health care professionals, and institutes a public awareness campaign on pain management. Introduced by Sens. Orrin Hatch (R-UT) and Christopher Dodd (D-CT), S 660 has been referred to the Senate Committee on Health, Education, Labor, and Pensions.

Under a mandate from Congress to reduce the morbidity and mortality associated with the abuse, misuse, and diversion of prescription drugs, the FDA decided in November that the manufacturers of all extended-release opioids would be required to submit what is referred to as a Risk Evaluation and Mitigation Strategy (REMS) when seeking FDA approval to sell a drug in that class. Under federal law, a REMS is required where the FDA is concerned that a drug’s risks might outweigh its benefits and would typically include a medication guide, a patient package insert, a communication plan, elements to assure safe use, and an implementation system.

To begin the process of determining what would be required in the REMS for opioids, the FDA in February invited 16 drug manufacturers to a March 3 meeting. The medical community, upon learning of the meeting, asked the FDA for a second meeting so that it could provide input. The FDA agreed to a meeting on May 4 in Washington, D.C.

On April 29, medical community representatives, including Scott Fishman, MD, an AAPM director at large, and Phil Saigh, AAPM’s executive director, met at the American Medical Association headquarters in Washington, D.C., to prepare for the May 4 meeting, to discuss their response to the FDA, and to set priorities for what they thought should be in the REMS. The representatives agreed to three priorities:

(1)  A prescription monitoring program (PMP) should be developed that would provide physicians with accurate, real-time data on opioid prescriptions so that a physician would have access to a patient's prescription drug history before prescribing the opioid. Approximately 38 states have a PMP, with varying degrees of success. The goal would be to use the elements of existing PMPs that have proven most successful to create PMP standards that the states could use to draft PMP-enabling legislation or to modify the existing PMP. Ideally, the various state databases would be linked to prevent abusers and misusers from jumping across state lines to get new prescriptions. New patient registries, on the other hand, should not be a part of the REMS because they are generally ineffective in stopping drug misuse and abuse, and they raise privacy concerns.

(2)  The FDA should use the REMS to target all opioids rather than limit the REMS to slow-release opioids. The danger in limiting the REMS to slow-release opioids is that if the process of prescribing slow-release opioids were to become more cumbersome than other types of medication, physicians will migrate to short-acting opioids, options will be limited, and healthcare quality will suffer.

(3)  Education programs should be developed to help everyone involved understand the issues when prescribing opioids, including physicians, pharmacists, and patients. The education should include all related matters, including how to properly use the PMP. And, most importantly, the education program should be developed with significant input from experts in the field.

"We think the best approach," Dr. Fishman says, "is to work to prevent the problem from occurring rather than waiting until after it has occurred." PMPs are a key part of that approach, and AAPM hopes that the FDA will support PMPs, perhaps by using some of the fees they collect from drug manufacturers to help fund PMPs, and that they will urge drug manufacturers to support PMPs directly. National All Schedules Prescription Electronic Reporting (NASPER) is a currently underfunded federal law designed to provide financial assistance to state PMPs, so the mechanism for channeling money to states for PMPs is already in place.

At the May 4 meeting, attended by Perry Fine, MD, AAPM treasurer, and Phil Saigh, the medical community shared its priorities with the FDA, whom Dr. Fine described as being "incredibly responsive" and "genuinely trying to figure out how to get the job done." The FDA, Dr. Fine said, has been put in an especially difficult position because it has been ordered to reduce mortality from opioid misuse, yet it has no leverage other than forcing drug manufacturers to submit a REMS.

A genuine solution, he says, would not be achieved until the full range of agencies with jurisdiction in this matter-the Centers for Disease Control and Prevention, the National Institutes of Health, the Institute of Medicine, the National Institute on Drug Abuse, etc.-are brought into the discussion. In addition, the problem cannot be solved, he says, until we are able to understand the root causes of why people abuse and misuse the prescription drugs, an analysis that would have to take place in a different forum.

In the meantime, the most important step that can be taken is to make sure that the requirements for the FDA's REMS are appropriately crafted. From AAPM's perspective, that would be "ensuring that the REMS is created with the best interests of the patient in mind," Phil Saigh says. "We must find a proper balance between the war on drugs and the war on pain." Dr. Fine warns that "the REMS must not impose rules so complex and onerous on that they have a chilling effect on prescriptions."

AAPM representatives will continue to work to ensure that the REMS considers the needs of the medical community. They will continue to meet with the FDA and with other stakeholders, to testify in Congressional hearings if called upon, and to do whatever else is necessary to ensure that legitimate prescription practices are protected.

Back to Top

Health Reform Policy Papers Released

May 1, 2009 -- On Tuesday, April 28, Senators Max Baucus (D-MT) and Charles Grassley (R-IA) released the first of three policy option papers on health system reform. The deadline for submitting public comments on the options set forth in the paper is May 15. The Committee intends to mark up comprehensive health system reform legislation in June. Full story...

Back to Top

House Passed National Pain Care Act, Contact Your Senator to Seek Their Support of S 660

April 2, 2009 -- The National Pain Care Policy Act of 2009 passed this week in the House. Now, as AAPM's top legislative priority, members are encouraged to contact their senators to pass S 660.

S 660 authorizes an Institute of Medicine Conference on Pain Care, promotes pain research at NIH, provides comprehensive pain care education and training for health care professionals, and institutes a public awareness campaign on pain management. Introduced by Sens. Orrin Hatch (R-UT) and Christopher Dodd (D-CT), S 660 has been referred to the Senate Committee on Health, Education, Labor, and Pensions.

"This bill," says Scott Fishman, MD, AAPM board member and past president who has been active in legislative matters, "represents an enormous step in promoting quality pain management. Once passed," he said, "it will be a major achievement in advancing health care reform."

Last year, the National Pain Care Policy Act passed the House, before failing to get through the Senate prior to the end of year recess. The bill's supporters believe that it has a good chance to pass this year.

The fact that such an important bill is now pending in both houses presents AAPM members with a unique opportunity to play a key role in making the final push needed to get this bill enacted. The American Pain Foundation has created a form letter that can be sent to your senator in support of S. 660. To send the letter, go to http://action.painfoundation.org/site/R?i=63_dyYc-0jIUJvHw7LStxw. Please help AAPM in its efforts to get this measure through Congress by asking your senator to co-sponsor S 660.

Back to Top

Arthritis Bill Introduced

March 5, 2009 -- The Arthritis Prevention, Control, and Cure Act of 2009 (HR 1210), which would provide funds for combating what has been described as this country’s most common cause of disability, was introduced in the House of Representatives on February 26. An estimated 46 million adults and 300,000 children suffer from arthritis.

Introduced by Reps. Anna Eshoo (D-CA) and Fred Upton (R-MI), HR 1210 would provide funds to the Centers for Disease Control and Prevention to develop and implement a National Arthritis Action Program, to the National Institutes of Health for juvenile arthritis programs and a national juvenile arthritis population database, and to the Department of Health and Human Services to establish a loan repayment program to address the shortage of pediatric rheumatologists. The legislation is supported by the American College of Rheumatology and the Arthritis Foundation.

In addition to Reps. Eshoo and Upton, the bill has 59 co-sponsors, including Rep. Lois Capps (D-CA), who introduced in January the Pain Care Policy Act (HR 756), AAPM’s top legislative priority. HR 1210 has been referred to the House Committee on Energy and Commerce.

Back to Top

Stimulus Package Includes Huge NIH Funding Increase

February 20, 2009 -- The recently enacted $787 billion stimulus package included an extra $10 billion for the National Institutes of Health. Most of the money is reported to be going to funding scientific grants, many of which in past years have been left unfunded because of budgetary constraints.

NIH funding this year will jump to $39 billion from the $29 billion originally budgeted, thanks largely to the efforts of Sen. Arlen Specter (R PA), who, according to the New York Times, negotiated the extra money in return for his vote on the stimulus package. Sen. Specter's interest in NIH funding is apparently tied to his own medical struggles, which have included two cancer diagnoses and an open-heart surgery.

Whether any of NIH's funding windfall will be used for pain research or involve pain-related grants is unknown at this point. The National Pain Care Policy Act (HR 756), AAPM's top legislative priority, which was introduced in late January, includes a provision calling for pain care research at NIH. If that bill becomes law, presumably additional funding for the research would be provided.

In any event, the pain care community is mostly united behind the idea that more needs to be done at the federal level. "With pain a huge and growing public health problem in an aging population, a stepped up effort at NIH and other federal agencies is essential," said Dr. Ed Michna, chair of the Pain Care Coalition.

Back to Top

Legislative Priorities for 2009

February 5, 2009 -- The Pain Care Coalition (PCC), the organization co-founded by AAPM to influence federal healthcare legislation, is hoping to continue into 2009 the momentum created by its 2008 legislative successes, including passage of the Veterans’ Mental Health and Other Care Improvements Act of 2008 and the National Defense Authorization Act of 2009, which included provisions from the Military Pain Bill.

The PCC’s steering committee, composed of two representatives of each of the PCC’s four member organizations – AAPM, the American Pain Society, the American Headache Society, and the American Society of Anesthesiologists, as well as staff representatives of these organizations – held a strategic planning session on January 19 to discuss legislative priorities. According to Bob Saner of Powers, Pyles, Sutter & Verville, PC, in Washington, D.C., who coordinates the PCC’s lobbying efforts, the steering committee wants to focus in 2009 on the following priorities:

 1. Pain Care Policy Act
 2. Implementation of VA and military pain care initiatives
 3. National Institutes of Health (NIH) appropriations for pain research
 4. Participation in the healthcare reform debate.

The Pain Care Policy Act is a bill originally introduced in 2007 that passed the House in September 2008 but did not come for a vote in the Senate before the fall recess. As a result, it had to be reintroduced in 2009, and it was on January 28 as HR 756, by Rep. Lois Capps (D-CA) and Rep. Mike Rogers (R-MI). The bill has been referred to the Committee on Energy and Commerce, which is chaired by Rep. Henry Waxman (D-CA).

HR 756 would authorize an Institute of Medicine Conference on Pain Care, promote pain research at NIH, provide comprehensive pain care education and training for health care professionals, and institute a public awareness campaign on pain management. The Pain Care Policy Act has remained, since its original introduction, the PCC’s number one legislative priority.

“With this same bill having passed the House on a bi-partisan basis last year, we think this will get to the finish line in the 111th Congress,” said Dr. Ed Michna, Director Pain Trials Center Brigham & Women’s Hospital, Instructor of Anesthesia Harvard Medical School and PCC chairman. For more, see the PCC’s press release.

Implementation of VA and military initiatives will focus on following up to make sure that the VA and military legislative victories in 2008 are implemented. The PCC will conduct an additional legislative push, if necessary.

A recent finding that pain research funding at NIH is declining has triggered the need for focusing efforts on funding. PCC lobbying efforts, therefore, will concentrate on the appropriation committees and subcommittees rather than on the authorizing committees.

The Obama Administration has made special efforts to reach out to the public and to practitioners for suggestions on developing healthcare initiatives. For example, it convened a series of local healthcare meetings around the country in December, and it has invited the public to submit comments to a Web site it created for that purpose. Both the PCC as a coalition and AAPM individually hope to play a role in helping to shape the healthcare debate and to ensure that pain care initiatives are part of that discussion. The PCC intends to develop a core set of principles on which all PCC members can agree in order to give pain care a voice as the healthcare reform debate continues.

Back to Top

AMA Wins Court Ruling Denying Public Access to Medicare Records

February 3, 2009 -- The D.C. federal appeals court ruled on February 2 that records of Medicare payments to physicians are not subject to public disclosure., reversing a lower court ruling that had found that such records could be obtained through a Freedom of Information Act (FOIA) request.

The court, in a split decision, ruled that there is “no public interest” in such disclosure because the FOIA grants access to government operations, not to private businesses. Furthermore, the court said, physicians have a “substantial privacy interest” in any Medicare payments they receive, which meant that the balance between public interest and privacy weighed heavily in favor of nondisclosure.

Consumers Checkbook, a nonprofit company, had filed the FOIA request for the purposes of developing a physician rating system that would rely in part on the Medicare data. The Department of Health and Human Services and the American Medical Association (AMA) filed suit in federal district court to prevent the disclosure. They lost in the district court in 2007 and appealed the decision to the D.C. Court of Appeals. In addition to the privacy argument, the AMA was concerned that the raw data could be misinterpreted by Consumers Checkbook and could lead to a flawed rating system.

For more information, see the AMA press release.

Back to Top

Pain Care Policy Act Reintroduced in 2009

February 1, 2009 -- The National Pain Care Policy Act, AAPM's top legislative priority, was reintroduced into the House on Jan 28 as HR 756. The bill, originally introduced in 2007, passed the House in September of 2008 but failed to come for a vote in the Senate before the fall recess, thus requiring that it be reintroduced in 2009.

The new bill, introduced by Rep. Lois Capps (D-CA) and co-sponsored by Rep. Mike Rogers (R-MI), would authorize an Institute of Medicine Conference on Pain Care, promote pain research at NIH, provide comprehensive pain care education and training for health care professionals, and institute a public awareness campaign on pain management. The bill has been referred to the Committee on Energy and Commerce, which is chaired by Rep. Henry Waxman (D-CA).

"I am pleased to join my colleague Congressman Rogers and ninety-eight organizations representing the pain care community in supporting this legislation that will help millions of Americans suffering from pain," Rep. Capps said. For more information, including a full list of the 98 organizations supporting HR 756, see Rep. Capps' press release.

Back to Top

AAPM Signs On to MedPAC Letter Urging a More Realistic Physician Update

January 9, 2009 -- Sixty-eight medical organizations, including AAPM, have signed a letter to the chairman of the Medicare Payment Advisory Commission (MedPAC) urging MedPAC to recommend that the physician update for 2010 not include a productivity adjustment that would severely reduce the rate increase that physicians would otherwise receive under Medicare.

In a January 5 letter to Glenn Hackbarth, MedPAC chairman, AAPM and the other medical organizations pointed out that the Medicare Economic Index (MEI), which underpins MedPAC’s annual fee increase recommendation, is unfairly reduced by a productivity adjustment of 1.3 percent. Thus, the letter says, the current estimate of the increase in input prices of 2.4 percent would be reduced by the productivity adjustment to 1.1 percent, which isn’t likely to cover practice costs increases because the MEI “routinely understates the true cost of care.”

Reducing the MEI by a productivity adjustment is unfair, the letter says, for two reasons. First, the MEI was itself established in 1973, long before computers and other modern office necessities existed so that it fails to reflect the true costs of operating a modern medical practice. Second, the productivity adjustment assumes that physicians’ offices are becoming 1.3 percent more productive year in and year out, which is unrealistic. In any event, any productivity gains that do occur are typically lost to increased regulatory compliance requirements.

Some hope for reducing or eliminating the productivity adjustment does exist. In the past six years, only once has MedPAC ‘s recommendation included the full amount of the productivity adjustment. Even so, average physician payment rates are only slightly higher than they were in 2001, even though the MEI has risen by 22 percent during that same period. As a result, to help the physician update catch up to a rate that better reflects current costs, AAPM and the others are asking that the productivity adjustment not be applied in 2010.

To read the full letter, see MedPAC letter.

Back to Top