Theranos on trial

 Podcast: 'The Dropout: Elizabeth Holmes on Trial'

ABC News' #1 podcast is back with new episodes, available on Tuesdays.

Money. Romance. Tragedy. Deception. The story of Elizabeth Holmes and Theranos is an unbelievable tale of ambition and fame gone terribly wrong.

You'll find it in Spotify every week

 

CRISPR therapeutic success

 Treatment by CRISPR-Cas9 Gene Editing — A Proof of Principle

CRISPR-Cas9 Gene Editing for Sickle Cell Disease and β-Thalassemia

Transfusion-dependent β-thalassemia (TDT) and sickle cell disease (SCD) are severe monogenic diseases with severe and potentially life-threatening manifestations. BCL11A is a transcription factor that represses γ-globin expression and fetal hemoglobin in erythroid cells. We performed electroporation of CD34+ hematopoietic stem and progenitor cells obtained from healthy donors, with CRISPR-Cas9 targeting the BCL11A erythroid-specific enhancer. Approximately 80% of the alleles at this locus were modified, with no evidence of off-target editing. After undergoing myeloablation, two patients — one with TDT and the other with SCD — received autologous CD34+ cells edited with CRISPR-Cas9 targeting the same BCL11A enhancer. More than a year later, both patients had high levels of allelic editing in bone marrow and blood, increases in fetal hemoglobin that were distributed pancellularly, transfusion independence, and (in the patient with SCD) elimination of vaso-occlusive episodes. 

A pivotal moment. Great.

Episode based payments (3)

 Medicare's Bundled Payment Initiatives for Hospital‐Initiated Episodes: Evidence and Evolution

The Impact of Medicare’s Alternative Payment Models on the Value of Care

Bundled payments have been promoted as an alternative to fee‐for‐service payments that can mitigate the incentives for service volume under the fee‐for‐service model. As Medicare has gained experience with bundled payments, it has widened their scope and increased their duration. However, there have been few reviews of the empirical literature on the impact of Medicare's bundled payment programs on cost, resource use, utilization, and quality.

Main messages:

•  Evidence suggests that bundled payment contracting can slow the growth of payer costs relative to fee‐for‐service contracting, although bundled payment models may not reduce absolute costs.
• Bundled payments may be more effective than fee‐for‐service payments in containing costs for certain medical conditions.
• For the most part, Medicare's bundled payment initiatives have not been associated with a worsening of quality in terms of readmissions, emergency department use, and mortality. Some evidence suggests a worsening of other quality measures for certain medical conditions.
• Bundled payment contracting involves trade‐offs: Expanding a bundle's scope and duration may better contain costs, but a more comprehensive bundle may be less attractive to providers, reducing their willingness to accept it as an alternative to fee‐for‐service payment.

Both articles reflect the current situation on payment systems in US. The effort to change fee-for-service is more difficult than expected. There is a lot of money at stake.

 

The Gossips by Norman Rockwell

Measuring morbidity vs. measuring episodes: Two parallel views

Clinical risk groups and patient complexity: a case study with a primary care clinic in Alberta

In order to assess the health risk of a population there are two main options: Morbidity adjustment and Episodes of care. The first one can use Clinical Risk Groups, while the latter Patient focused episodes. The morbidity adjustment is useful for adjusting at population level, it is a categorical system, while episode measurement adjusts at patient level .
In this article you'll find an interesting application to a primary care center.

CRGs have definite value with respect to predicting health care utilization, but it is important to note the limitations of the CRG as a stand-alone classification of complexity, particularly for the categorization of patients in the health status 1 through
5 categories. In order to enhance the accuracy, relevance and predictive value of the CRG classification methodology, we see great value in pursuing methods that allow for the careful and systematic inclusion of information from the care record.

The article is trying to use the CRGs for episode measurement, and this is a wrong approach. CRGs are useful as a whole picture, physicians need details, only episodes can provide such information.

Hopper

Health services research as a data science

Health Services Evaluation
Health Services Information: Key Concepts and Considerations in Building Episodes of Care from
Administrative Data
Assessing health systems

The provision of relevant, accurate, and timely performance information can play a pivotal role in ensuring the health system is able to deliver effective and efficient health services. Through its capacity to secure accountability in the health system, to determine appropriate treatment paths for patients, and to plan for future service patterns and structures, information can be used to identify and implement potential improvements in service delivery

Episode based payment systems

Unraveling the Complexity in the Design and Implementation of Bundled Payments: A Scoping Review of Key Elements From a Payer’s Perspective

After per case based payment systems (DRGs) everybody was waiting for a comprehensive system to measure health services activities. And instead of focusing on episodes, what happened is that bundling was the new frame. Unfortunately, after all these years bundling has not provided the answer because the scope of measurement is related to several diseases and it is not holistic.
When everybody was asking for an alternative to fee-for service, the answer was in my opinion "patient focused episodes of care", but the US government decided otherwise and protected the interests of those that leverage fee-for-service.
Therefore, now it is the time to fix this mistake and take the right  road. In this article you'll find some issues to consider when you have to design a payment system. It still talks about bundling, forget it, substitute it by episodes and it will be fine.

Our framework provides a structured overview of the principal, literature‐based elements of the design and implementation of bundled payment contracts from a payer's perspective. We identified 53 elements that involve all procurement phases and relate to actors on all levels of the health care system. A better understanding of these elements can help payers and other actors devise a strategic approach and reduce the complexity of implementing these contracts. Compared with traditional FFS models, bundled payment contracts introduce an alternative set of financial incentives that affect the entire health care system, involve almost all aspects of governance within organizations, and demand a different type of collaboration among organizations. This is what makes the design and implementation of bundled payment contracts complex and is why they should not be strategically approached by payers as merely the adoption of a new contracting model but, rather, as part of a broader transformation to a more sustainable value‐based health care system, based less on short‐term transactional negotiations and more on long‐term collaborative relationships between payers and providers.

Episode groupers: a crucial tool for population health management

A practical guide to episode groupers for cost-of-illness analysis in health services research

Summary of analytic components in selected episode groupers.

Product	Episode example	Sample conceptual focusa	Number of episodes	Clinical setting	Public episode definition	Linked risk-adjustment approach
3M Patient-focused Episode Software	Not reported.	• Event-based episodes per patient • Cohort-based episodes among patients with a shared condition or characteristic	>500	All	No	3M Clinical Risk Groups
Cave Grouper	Urinary tract infection	• Physician relative efficiency and effectiveness scores • High-cost patient prediction	>500	All	No	CCGroup MediScreen
CMS-BPCI	Urinary tract infection	Inpatient and post-acute care	~50	Inpatient, skilled nursing facility, inpatient rehabilitation facility, long-term care hospital or home health agency	Yes	No
McKinsey & Company	Perinatal	Principal Accountable Provider	>100	All	Yes	Yesb
Optum Symmetry Episode Treatment Groups	Pregnancy, with delivery	• Patient total cost of care by condition categories • Provider profiling	>500	All	Yes	Optum Symmetry Episode Risk Groups
OptumInsight Symmetry Procedure Episode Groups	Radical hysterectomy	• Medical and surgical procedure cost • Provider profiling	~200	All	No	Optum Symmetry Episode Risk Groups
Prometheus Analytics	Pregnancy	Potentially avoidable complications	~100	All	Yes	Prometheus Analytics risk adjustment
Medical Episode Grouper	Cardiac arrhythmias	• Population profiling • Provider profiling	>500	All	No	Disease Staging and Diagnostic Cost Groups

Information as of January 2019 in public documentation reviewed for this article, which comprised peer-reviewed articles and Internet searches for vendor product names; sources as cited in the References list. Readers are encouraged to check those and related sources for more details and updated information on the groupers briefly summarized here.

CMS-BPCI Centers for Medicaid and Medicare Services’ Bundled Payments for Care Improvement.

aAs highlighted in public documentation primarily from vendors; this is not an exhaustive list of conceptual orientations among profiled groupers.

bNot detailed in public documentation reviewed for this article in cited sources.

Health microsystems as the unit of performance analysis

A comparative performance analysis of a renowned public-private partnership for health care provision in Spain between 2003 and 2015

A deep study has been released on performance of public-private partnerships in healthcare in Valencia compared to Spanish NHS. It is an:

Observational study on secondary data from virtually all hospital care episodes produced in 51integrated providers (i.e., administrative healthcare areas) and 67 hospitals, in 2003 and 2015. Alzira’s2015 performance (and its variation since 2003) was compared with all public-tenured peers in the SNHS,using 26 indicators analysing the differences in age-sex standardized rates of events or risk-adjusted mortality, severity-adjusted hospital expenditure and hospital technical efficiency

And the conclusion is:

 In this comprehensive comparative study on Alzira’s performance, this PPP has not generally outperformed public-tenured providers, although in some areas of care its developments have been outstanding.

I agree on the methodology, I can't asses the results and its conclusions because it requires data replication. What it is crucial is the clinical decision making within the health organization (the microsystem and its episodes of care), forget generalizations on public and private and focus on drivers for efficiency in each setting.

PS. Opioid Epidemic CDC data

Natalia Goncharova at Tate Modern 

The outcomes of a bundled payment system

Evaluation of Medicare’s Bundled Payments Initiative for Medical Conditions

The measurement of episodes of care is a precondition for understanding the cost-effectiveness of health care. Unfortunately there are few experiences on this issue. The largest demonstration in US, The Medicare Budled Payment for Care Improvement Initiative started in 2013 and finished in 2017. The NEJM publishes an article that evaluates the outcomes of such experience.

In summary, hospital participation in five common medical bundles under BPCI, as compared with nonparticipation, was not associated with changes from baseline in total Medicare payments per episode, case complexity, length of stay, emergency department use, hospital readmission, or mortality.

If this is so, it is necessary to understand the reasons behind such failure. The article provides some of them. My guess is that the episodes were not holistic in the scope of services (not including post-acute care i.e.) and were constrained to several episodes. Unless a holistic approach is taken into account (all episodes and all services), incentives will not be working in the appropriate way, the cost-effective one. Excellent article and research effort that explains an unexpected and unfavourable result, no bias of publication. Good example.

Maya Fadeeva

Allocating expenditures to diseases

Guidelines for Measuring Disease Episodes: An Analysis of the Effects on the Components of Expenditure Growth

One of the most interesting reports by OECD was produced 15 years ago. The title was "A Disease-based Comparison of Health Systems What is Best and at what Cost?". The approach was clear, in order to compare health systems we do need to focus on specific diseases and its costs and outcomes.
Now you can read in Health Services Research an interesting article that shows what and how you should do to measure episodes. The comparison between person based and episode based approach is useful and it depends on the goals of research. For insurers and health population managers: episode-based. For officials and statistical offices: person-based
All the stuff on decomposition of health expenditures should be readjusted after reading this article. A hard work forward.

PS. OECD made an update on 2013. Good news.

Behavioral provider payment systems: the next step

Impact of Provider Incentives on Quality and Value of Health Care

Experimenting with incentives for quality is a risky task. The variable requires a precise measure and it must indicate the appropriate signal to the provider to have impact in decisions and behaviour. Usually, rational behaviour is assumed int the models. A recent review highlights this is issue:

Advocates of pay-for-performance in health care maintain that its early failures are the result of inadequate design, a failure to incorporate a more sophisticated understanding of provider motivation into program design (26). On the basis of evidence from early schemes and readings of economic and psychological theory, several researchers have produced blueprints for secondgeneration pay-for-performance frameworks. Their recommendations for designers include making rewards large enough to be meaningful; using penalties in addition to rewards; aligning incentives to professional priorities; using absolute rather than relative performance targets; providing frequent, discrete rewards or punishments; and making an explicit long-term commitment to incentives

But the authors admit that: " Some of these solutions are difficult to implement, are contradictory, or introduce further unintended consequences". And this paves the way to a pessimist view:

Programs are slowly becoming more sophisticated, but unless clear evidence for cost-effectiveness emerges soon, the incentive experiment may have to be abandoned. Many commentators see this abandonment as inevitable, believing incentive programs to be fundamentally flawed. Some concerns are technical in nature and relate to the difficulty of accurately defining and measuring the most important aspects of quality with the greatest impacts on patient outcomes

My impression is that the unit of analysis is usually wrong. Until we are not able to measure patient focused episodes of care properly, in a holistic way, will miss something. This should be the first concern. Of course, this is an overwhelming task, not an easy one.

Camille Pissarro in Sant Feliu de Guixols right now

Measuring quality of episodes of care

Episode-Based Approaches to Measuring Health Care Quality

I have always thought that all the efforts to link payment to performance need to define first what is the unit of analysis. In my opinion, episode is the crucial one. Unfortunately there are very few settings that are measuring episodes. If performance and value is not linked to the episode, then forget about the impact, it may be anything.
A new article emphasizes the need for episodes in measuring quality, and provides a useful framework:

Episode-based measures could assess changes in health outcomes (“delta measures”), the amount of time during an episode in which a patient has suboptimal health status (“integral measures”), quality contingent upon events occurring previously (“contingent measures”), and composites of measures throughout the episode.

After reading this article somebody should do something (...) on current and available measures of quality.

Parov Stelar new album

The value of vaccination

Valuing vaccination

A PNAS article sets a broader perspective on valuing vaccines. It is of interest in light of current difteria case. My position is clear, no doubt about mandatory vaccination if its cost-effectiveness is proven.
Suggestions from the article:

Three general recommendations flow from our arguments and related synthesis of existing evidence on broad benefits of vaccination. First, many economic evaluation studies of vaccinations should be redone to capture the full benefits generated by the vaccination in question. Second, the evidence to date on the full value of vaccination has been focused on measuring the total social benefits generated. It would also be useful to explore the distribution of vaccination’s benefits among different possible beneficiaries. Third, the primary empirical evidence on broad vaccination benefits will need to be considerably expanded and improved

Framework of vaccination benefits

Perspective		Benefit categories	Definition
Broad	Narrow	Health care cost savings	Savings of medical expenditures because vaccination prevents illness episodes
		Care-related productivity gains	Savings of patient’s and caretaker’s productive time because vaccination avoids the need for care and convalescence
		Outcome-related productivity gains	Increased productivity because vaccination improves physical or mental health
		Behavior-related productivity gains	Vaccination improves health and survival, and may thereby change individual behavior, for example by lowering fertility or increasing investment in education
		Community health externalities	Improved outcomes in unvaccinated community members, e.g., through herd effects or reduction in the rate at which resistance to antibiotics develops
		Community economic externalities	Higher vaccination rates can affect macroeconomic performance and social and political stability
		Risk reduction gains	Gains in welfare because uncertainty in future outcomes is reduced
		Health gains	Utilitarian value of reductions in morbidity and mortality above and beyond their instrumental value for productivity and earnings

 

Patient focused episodes

We all know that no measurement means no management. In health care the measurement of the burden of disease is not that easy. Fortunately at a global level there is the recent study published at Lancet and quoted in this post. If we need to be precise in the measurement with consequences for health care management then we need better tools. Diseases finally appear around episodes, and we may have three type of episodes: event based, disease cohort and population based. The definition of episode needs to be patient-focused rather than disease centered. If you want to know the details of the newest approach to morbidity measurement have a look at this document. It is the evolution of former Clinical Risk Groups towards a new model that will be extremely helpful for management decision making and the definition of appropriate incentives.

PS. Some months ago I explained that new payment systems were in train of being defined. An impact analysis may be found here. My post was titled: A retrofuturist payment system. Now, I would like to change the title once I've seen the details, my proposal is: A complete MESS that needs to be rebuilt from scratch. (to be continued)

PS. Yesterday I attended a book presentation: "I am not Sidney Poitier", by Percival Everett. It was at La Central bookstore. Percival explained the rationale of the book and its subliminal messages.  This is not the kind of novel I'll read.

Objectius

NHS Outcomes Framework 2012-13

La formalitat dels britànics els porta a fer públics els resultats esperats del sistema de salut i la seva mesura per als propers dos anys, i això ho fan abans que s'acabi aquest. Això està molt bé. Han definit cinc àmbits i els seus indicadors:

Domain 1: Preventing people from dying prematurely
Domain 2: Enhancing quality of life for people with long-term conditions
Domain 3: Helping people to recover from episodes of ill health or following injury
Domain 4: Ensuring people have a positive experience of care
Domain 5: Treating and caring for people in a safe environment and protecting them for avoidable harm.

Els trobareu amb tot detall a l'apèndix. Si després d'aquest esforç, el que se n'obté és un resultat acceptable o fins i tot exitós, benvingut sigui pels britànics. Per aquí fem una Central de Resultats amb esforç considerable però amb impacte menor, i com que no ens fixem objectius precisos, aleshores la seva mesura és simplement una foto fixa sense conseqüències.

PS. Les variacions britàniques a la pràctica mèdica són notícia a FT i The Guardian. Aquí quan es publiquen passen gairebé desapercebudes.

PS. I més sobre UK. La política de competència s'ha enfocat a la sanitat privada. Cal seguir-ho d'aprop.

PS. És el moment de la prescripció prudent.