Porter Storey, MD

I work in clinic-based palliative care for Kaiser in the Denver-Boulder area when not busy with my duties as Executuve Vice-President of the AAHPM.


Posts by Porter Storey, MD

REMS ARE COMING! – Comment before Dec 7!

It was a privilege to represent AAHPM at the fall meeting of the Council of Medical Specialty Societies in Washington D.C. on November 18 & 19, 2011. This was my first CMSS meeting and I was struck by the energy, collegiality, and nimble structure of this “society of medical societies.” There is no House of Delegates to debate everything like in the AMA – just a Board of Directors, Component Groups (CEO’s, Membership directors, clinical practice guideline developers, etc.) and occasional task forces. They have done a lot, but only taken a stand on 5 public topics – the most recent being support of comparative effectiveness research (in a letter the AAHPM signed).

I spent my time in a day-long seminar on the upcoming REMS – Risk Evaluation and Mitigation Strategy for long acting opioids. Regina Labelle, from the White House Office of National Drug Control Policy certainly got my attention when she explained that in 17 states, deaths from unintended drug overdoses now outnumber deaths from traffic accidents! Understandably Congress and the Administration want something done about this. Theresa Toigo, R.Ph., M.B.A., from the FDA explained that the Food and Drug Administration Amendments Act of 2007 (FDAAA) gave FDA the authority to require manufacturers to develop and implement a REMS when necessary to ensure the benefits of a drug or biological product outweigh its risks.

On April 19, 2011, in conjunction with the Office of National Drug Control Policy (ONDCP) release of the Obama Administration’s Epidemic: Responding to America’s Prescription Drug Abuse Crisis—a comprehensive action plan to address the national prescription drug abuse epidemic, FDA issued letters to application holders (makers and seller of opioids) directing them to submit a REMS within 120 days and describing the elements that needed to be included in the REMS (REMS notification letters).

So what is REMS and why should we care?

After notifying the makers and marketers of long-acting and extended-release (LA/ER) opioid drugs that they were required to submit a risk evaluation and mitigation strategy (REMS), FDA has been working with the sponsors that market these products on the required REMS. The central component of the Opioid REMS is an education program for prescribers (e.g., us) so that LA/ER opioid drugs can be prescribed and used safely. FDA expects the prescriber training to be conducted by accredited, independent continuing education (CE) providers (like AAHPM), without cost to the healthcare professionals, under unrestricted grants to accredited CE providers funded by the sponsors. Kate Regnier, M.A., M.B.A., from ACCME assured us that industry would not be dictating the curriculum so the CME can comply with ACCME standards.

What are they going to be teaching us?

On November 4, 2011, FDA announced the availability for public comment of a draft “Blueprint.” The Blueprint, developed by FDA with advice from other Federal agencies, is a basic outline and the core messages that FDA believes should be conveyed to prescribers in a basic two to three hour educational module. After it is completed and approved as part of the REMS, the Blueprint is posted on the FDA web site for use by CE providers in developing CE courses. The Blueprint for provider education can be found at

http://www.fda.gov/downloads/Drugs/DrugSafety/InformationbyDrugClass/UCM277916.pdf

While, in general, I found these tenets reasonable, there isn’t a lot here about effective pain management for seriously ill patients. A few quotes will give you the flavor:

Health care professionals who prescribe extended-release (ER) and long-acting (LA) opioids are in a key position to balance the benefits of prescribing ER/LA opioids to treat pain against the risks of serious adverse outcomes including addiction, unintentional overdose, and death.

Prescribers should caution patients that ER/LA opioids can cause serious side effects that can lead to death.

Prescribers should explain that sharing ER/LA opioids with others may cause serious side effects including death, and that selling or giving away ER/LA opioids is against the law.

Prescribers should ensure that patients adhere to a treatment plan and monitor patients for misuse and abuse by

  • Recognizing aberrant behavior
  • Utilizing Prescription Drug Monitoring Programs to identify potential abuse where available
  • Understanding the role of drug testing and performing drug screens as indicated
  • Screening and referring for substance abuse treatment when indicated
  • Performing medication reconciliation at each visit

Whether this program will be required to maintain your DEA registration is being discussed. The REMS notification letters stated that although there is no mandatory requirement that prescribers take the course as a precondition to dispensing the medication to patients, application holders will be required to establish goals for the number of prescribers trained, collect the information about the number of prescribers who took the courses, and report the information to FDA as part of periodic required assessments. Although FDA recognizes that additional training modules could be helpful, FDA’s goal is to require basic education for all prescribers of long-acting and extended-release opioids, and at this time, FDA does not intend to develop or approve messages as part of the REMS beyond those approved in the basic core module.

Can we have any input into this?

We have until December 7 to submit comments on the draft Blueprint http://www.regulations.gov.

The AAHPM has been working with a group called CORE to develop a program that meets these criteria. Stay tuned for more about this.

Palliative Care for Cancer Patients in Treatment

by Porter Storey, MD, AAHPM Executive Vice President

Palliative care teams should be consulted more often for cancer patients in active treatment.

I know, I am “preaching to the choir” on this blog, but it may be important how we explain this to our various “stakeholders.”

The Public – Palliative care can help align patient wishes with their treatments and make sure patients and families are comfortable and supported.

Patients – Palliative care can help with symptom management, care coordination, psychosocial support so that you can continue your treatment and continue to do so after it is completed.

Hospice Programs – Palliative care can provide support before they qualify for hospice and refer patients to hospices sooner, for longer lengths of stay.

Payors and Program Administrators – Palliative care consultations can reduce costs and improve quality for the sickest (and most expensive) patients we care for. It can reduce hospital readmissions and save thousands of dollars per hospitalized patients (for the latest of many articles see Nelson C, et al. Inpatient Palliative Care Consults and the Probability of Hospital Readmission. Permanente J. 2011, 15(2):48-51.)

Referring Oncologists – Palliative care can act as an extension of the oncology care team so oncologists can focus on giving treatment. And as Tom Smith and Bruce Hilner argue in the May 26 NEJM, “bend the cost curve” so that we can afford to offer expensive new treatments to patients who can benefit from them (N Engl J Med 2011; 364:2060-2065).

Let’s not apply the wrong argument to the wrong class of stakeholders.

What do we say to the politicians?

Join the discussion when AAHPM offers the webinar “Changing the Mindset: Integrating Palliative Care into Cancer Treatment” lead by Tom Smith on Tuesday July 14 at 3pm ET.

MedPAC meeting in Washington on Palliative Care

I have always yearned for a Medicare Benefit for palliative care services, so it was with some excitement that I read an e-mail from MedPAC inviting me to a meeting in Washington March 23, to discuss palliative care.

The Medicare Payment Advisory Commission (MedPAC) is an independent Congressional agency established by the Balanced Budget Act of 1997 to advise the U.S. Congress on issues affecting the Medicare program. The Commission’s statutory mandate is quite broad: In addition to advising the Congress on payments to private health plans participating in Medicare and providers in Medicare’s traditional fee-for-service program, MedPAC is also tasked with analyzing access to care, quality of care, and other issues affecting Medicare.

The Commission staff invited a diverse group of palliative care specialists to come to Washington to discuss general issues such as the definitions and scope of non-hospice palliative care, the strength of the evidence that palliative care improves quality, outcomes, and service use, and factors that enable or hinder the delivery of palliative care.

The conference was attended by MedPAC staff, a moderator from the Lewin Group, and Janet Bull (Four Seasons, NC), Lyn Ceronsky(Fairview Services, Minneapolis), Timothy Keay (U Md Ca Center, Baltimore), Randall Krakauer (Aetna, NJ), James Lee (Everett Clinic, Washington), Diane Meier (CAPC , NY), Susan Mitchell (Harvard Aging Research, Boston), Michael Nisco (UC & Hospice, Fresno), Russell Portenoy (Beth Israel, NY), Greg Sachs (U of Indiana Aging Research, Indianapolis), Linda Todd (Hospice and PACE of Siouxland, Indiana), and myself.

It soon became clear that a new benefit for palliative care services is not on anyone’s drawing board, but the inclusion of palliative care services in new initiatives like Accountable Care Organizations, Community Health Teams to Support the Patient-Centered Medical Home, Hospital Value Based Purchasing, or Center for Medicare and Medicaid Innovation at the Center for Medicare Services is a possibility.

It was an energized discussion of wide-ranging aspects of our field, and we all hope the MedPAC staff can use what they learned from us to help Medicare beneficiaries with serious illnesses get the best possible care.

Porter Storey MD

Executive VP, AAHPM

Colorado Permanente Medical Group

Boulder, CO

Palliative Care Represented at Critical Care Conference

On September 27 and 28 the Society of Critical Care Medicine (SCCM) held a conference of stakeholders at their headquarters in Chicago, to discuss the problems patients face after a stay in intensive care. In addition to ICU physicians and nurses, physiatrists, psychiatrists, counselors, and representatives of patients and other groups (including palliative care) were invited. I was honored to represent AAHPM.

After a presentation of the evidence to date and some discussion, it became clear that many of us are concerned about the common, often severe, new and worsening impairments of physical, cognitive, and mental health that affect patients and their families following intensive care. Even though it is abundantly clear that their are many likely etiologies and sub-classes, we felt it would be helpful to name this group of disorders Post Intensive Care Syndrome (PICS).

We identified a number of promising approaches, but there are obvious and extensive gaps in our knowledge that require well-designed research studies. Included in these gaps are the needs and outcomes of palliative care patients in the ICU.

We all returned to our home institutions with a deeper knowledge and renewed commitment to raise awareness and do research on the needs and potential treatments for our most vulnerable patients. I am very pleased that hospice and palliative medicine is seen as an important partner in this effort.

Porter Storey

Pandemic Palliative Care

At the Annual Assembly in the session on Pandemic Palliative Care we discussed the increasing recognition of the role that HPM physicians will be expected to play in a disaster or pandemic. We also discussed the inability of the US to effectively protect the public health with quarantine measures. The AMA News today emphasizes this point.

Obama Administration scraps plans to implement quarantine regulations.

USA Today (4/2, Young) reports, “The Obama Administration has quietly scrapped plans to enact sweeping new federal quarantine regulations that the” CDC “touted four years ago as critical to protecting Americans from dangerous diseases spread by travelers.” Under the proposed regulations, the federal government would have the authority “to detain sick airline passengers and those exposed to certain diseases” for “three business days.” In 2007, CDC Director Julie Gerberding “testified before Congress that the proposed regulations would improve the agency’s ability to identify exposed passengers quickly.” But, the regulations were withdrawn by HHS “after discussion across the government made it clear” that additional “revision and reconsideration is necessary,” according to CDC spokeswoman Christine Pearson.

With no quarantine planning and no defined “duty to serve” as our Canadian colleagues have, how will we:

1) Effectively protect patients and healthcare workers from a deadly contagious disease,

2) Continue to care for the vulnerable HPM patients in our charge and still help palliate the symptoms of a large numbers of new dying patients, and

3) Ensure the availability of a healthcare workforce during and after such a disaster?

What this means is that we will each need to address these issues on a local level and push through the “deer-in-the-headlights” mind-numbing “lets think about something else” attitudes that are not serving us well, either locally or nationally.

Other thoughts?

Porter Storey MD

Triaged to “comfort care only” in a pandemic means…?

How would you triage patients to get life-saving care or not in a lethal epidemic?

What kind of care would your hospice patients continue to get?

What is the role of the HPM specialist in a mass casualty event?

Come to Room 309 at 12:15 today for Pandemic Palliative Care: Time to Plan.

See you there!