Patient Centeredness: Definitions Fuzzy,
Testing, Lawsuits Ahead #ECRI_FDA

Panel #2 –

Lawyers are going to have a field day with what is patient centeredness.

Jane Hyatt Thorpe, JD, Assoc. Research Prof.

ACA – Medicare – care individual/population, average.

IOM – patient centeredness refers to care – needs, desires of patient

another notion: patient experience.

right care, right patient every time — is this something that we can really provide?

Informed consent – case law — what do providers need to give pts. TeachBack type concept. What we are seeing – risks/benefits procedure. Drug use, volume – part. if influence outcomes. Financial disclosures – increasing requirements.

Advanced Directives – convey what their wishes are.

Provider liability – joint role. translate. liability, according to

Rights and responsibilities.

New delivery models – teams of care, focusing on empowering patients. HC law – a lot of policy variation.

Many openings for better definitions.

Michael Park, JD, Counsel, Alston and Bird

“the average patient”

20 quality measures in ACA – overlap with shared savings programs.

evidence towards individual.

Can we define better?

“Consent the patient” — grammar is important, words are important.

too much focus on getting the consent —

FDA only agency in country, no requirement that minorities. Diversity in clinical trials.

Hornbaugh? – Disability – we can’t have patients who can’t travel. should be accommodated. clinical trials


averages used in payment systems reconciling with indvidual in patient centeredness


Patient Centeredness in Policy & Practice:
Live from ECRI_FDA Meeting

Numerous challenges various entities are facing and building patient-centeredness.

Panel #1: Susan Dentzer, Health Affairs, Margaret Hamburg, FDA Commissioner, MD, Carolyn Clancy, MD, Director, AHRQ, Joe V. Selby, MD, MPH, Executive Director, PCORI

Hamburg: onslaught of HIV/AIDS epidemic in NYC brought patients full square at table, extend that model in cancer, but needs to be more broadly disseminated to rest of medicine. those instances worked.

We are here today bec. not working res, policy, etc.

Increase pt. empowerment- have ability to bolster research environment.

Clancy: HIV Practice Network – how effective txs are and get to people who  need them. National Minority – NIH – health literacy tools, education.

Disparities worsening. How to change on the care side in heart failure.

Clancy: Disparities report very informative. Need to customize for different ethnic groups, SES.

Selby: If not careful, can have systemwide intervention that can widen disparities. Race/ethnicity crude.

Hamburg: behind in science and math education. makes it tough for patients to grasp risk.

New Zealand/Australian woman, Harkness Fellow for Commonwealth Fund: commends mtg. first time in US where patients in title of conference. how will you engage with patients?

Patient Advisory Councils/ patient safety –  in healthcare and research. Clancy: how do we find common ground. Pts. see evidence differently.

Hamburg: FDA: Engage pts. on advisory committees, product review. reaching out to critical. Pt. centered drug stuff likely to expand.

Belzer: elevating minority health issues to institute status at NIH. Stop excluding patients from team. still don’t sufficiently. Mission enlarged and deepened by ACA. Bring patients in, not just consumers.

HHS has strategic plan re disparities.

Flexible trial design, out of academic medical center into community.



On Don Berwick and the Future of Healthcare Reform

Don Berwick, Administrator, Centers for Medicare and Medicaid

I am supposed to be in a thankful mood, but I can’t help feeling that the bah-humbug mood has come early, with the forced departure of Don Berwick, head of the Centers for Medicare and Medicaid Services (CMS). Berwick was Obama’s pick for the head of CMS and for shepherding healthcare reform. Obama appointed him during the summer recess, aware that Republicans promised to veto the appointment. The GOP relentlessly attacked Berwick.

If anyone is emblematic of healthcare reform in this country, I’d say it is Berwick. To the point of this blog, I doubt that we would be talking much about the patient point of view, trying to elicit it, and together build a sane and responsive healthcare system without him. He was not the first to say this, but he definitely believed that “the patient belongs at the table” on all matters pertaining to health.

Berwick acknowledged that the barriers to reform were political, not technical. In his landmark “Triple Aim” paper in the May/June 2008 Health Affairs, he defined the Triple Aim this way, as: “improving the experience of care, improving the health of populations, and reducing per capita costs of healthcare.” Those very ambitions got a rise out of special interest groups and groups wanting healthcare to stay the same. As his ideas galvanized more people, he became a maverick at innovating quality initiatives, suggesting new infrastructures for building a continuously improving, learning healthcare system, and putting value incentives into healthcare. Berwick pushed for science, not opinion, in healthcare, and he wanted a system that rewarded value, not volume of services.

The Urgency of Healthcare Reform

President Obama signs in healthcare reform, March 2010.

We need to amplify the absolute urgency there is for healthcare reform and make sure it is not thwarted. Without reform, universal coverage vanishes, pre-existing conditions are back, and caps on paying out of pocket are kaput. That is just the tip of the iceberg. Without healthcare reform, it is the same old business, lack of access, and questionable value in healthcare.

Healthcare reform stands at a crossroads, with 3 cases now reaching the Supreme Court.  The Reporters Committee for Freedom of the Press, representing several news organizations, submitted a letter Nov. 18 to the Supreme Court, requesting real time audio and video coverage of arguments on healthcare reform. In it, Reporters Committee Executive Director Lucy A. Daiglish writes:

“Federal health-care reform affects everyone’s well-being, and everyone has the right to see and hear the arguments over this important issue made before the highest court in the country. And they have the right to see it and hear it as it happens.”

Further, the Reporters Committee adds: “To be sure, the American public’s access to affordable health care is among the most significant issues to inform public debate in this country and to come before its highest Court in many years…The time has come” for public access to include visual recordings.

It’s time to level with the American people. Let’s make sure that the SCOTUS briefs on healthcare reform are not presented behind closed doors and not manipulated by special interests. Americans ought to see this.

Who Knew?: HHS’ Less-than-Transparent
“Listening Sessions” on Essential Health Benefits

If you are listening, Health and Human Services (HHS), how about informing the public about the “Listening Sessions” on an Essential Health Benefits package on your website?

Americans care about essential health benefits and HHS should be openly soliciting your feedback.

Some HHS listening sessions have already occurred, more are happening shortly. You’d think with all the health information technology people power in the federal government and HHS, this would have surfaced somewhere on the web, but no, Google comes up empty. Outreach to the public has been pitiful.

Here at the locations and dates of the upcoming HHS Essential Health Benefits “Listening Sessions,” as well as information on how to register:

  • ·    New York: Nov. 14, from 10 to noon at 25 Federal Plaza, Suite 3835, Manhattan.  RSVP to by Nov. 9 (try anyway)
  • ·     Kansas City, MO: Nov. 15, from 10 a.m. to noon at Bolling Federal Office Building, 8th Floor SSA Conference room, 601 E. 12th Street.  RSVP to by Nov. 10 (try anyway)
  • ·    Atlanta, GA: Nov. 16, from 10 a.m. to noon at 61 Forsyth St., SW, Suite 5B95.  RSVP to by Nov. 14.
  • ·    Denver, CO: Nov. 18, from 9 a.m. to noon at 999 18th St. , South Terrace, Suite 400. RSVP to
  • ·    San Francisco, CA: Nov. 21, from 3 to 5 p.m. at 90 Seventh Street, Suite 5-100.  RSVP to  No cut-off date for RSVPs has yet been announced.
  • ·    Seattle, WA: Nov. 17, from 2 to 5 p.m. at the Jackson Federal Building, 915 2nd Ave, South Auditorium, Seattle, WA.  No RSVP information has been released yet.

If you missed the RSVP deadline, I urge you to RSVP anyway and see whether you can come.

What are Essential Health Benefits?

The yet-to-be-defined “Essential Health Benefits Package” is part of healthcare reform. What may sound dry and dull, is not. In fact, one colleague of mine called the behind-the-scenes battles over these benefits as “nothing short of Armaggedon.”

People want to be sure that their health care needs are included in the essential health package. You can imagine that people concerned about all sorts of important areas to their healthcare will want a say.

Ten basic areas must be addressed in the Essential Health Benefits Package:
·    Ambulatory patient services
·    Emergency services
·    Hospitalization
·    Maternity and newborn care
·    Mental health and substance use disorder services, including behavioral health treatment
·    Prescription drugs
·    Rehabilitative and habilitative services and devices
·    Laboratory services
·    Preventive and wellness services and chronic disease management
·    Pediatric services, including oral and vision care

An Institute of Medicine Panel report on Esssential Health Benefits  defined essential health benefits this way:

“[Essential health benefits] must be affordable, maximize the number of people with insurance, protect the most vulnerable individuals, promote better care ensure stewardship of limited financial resources by focusing on high value services of proven effectiveness, promote shared responsibility for improving our health, and address the medical concerns of greatest importance to us all.” – Institute of Medicine Report on Essential Health Benefits, Oct. 2011.

The IOM Report is not the easiest reading because it steers clear of anything concrete, instead defining the overall goal of the benefits package as one that “balances comprehensiveness with affordability.” Evidence-based medicine is being promoted as what should be embraced in establishing the floor; affordability and cost also factor in.The Essential Health Benefits package will  set the floor for a set of preventive, diagnostic, and treatment service and products that must be incorporated into health plans participating in the health insurance exchanges.

I hope that many readers have a chance to go and report back. These issues are much too important to be decided behind closed doors.

The Essential Health Benefits package is slated to be determined by the end of 2011.