Street Address
City, State, Zip
Phone Number
The Nexus of Medical Care + Business
Your Custom Text Here
Book
For more information about the book:
The US Healthcare System: Origins, Organization and Opportunities
Reviews:
Donald M. Berwick, MD, MPP
Former CMS Administrator
Professor of Health Policy and Management, Harvard School of Public Health
President Emeritus and Senior Fellow, Institute for Healthcare Improvement, Boston, MassachusettsStudents of American health care’s history, structure, organization, management, regulation, and financing face a daunting challenge, confounded by the complexity and scale of that industry. Until now, a modern comprehensive source book covering all of that terrain and more has been missing.
The wait is over. In The U.S. Healthcare System: Origins, Organization, and Opportunities, Professor Joel Shalowitz has provided a stunningly ambitious compendium with an unequaled combination of both scope and detail. It covers both the current shape and the historical background of payment, classical and emerging organizational forms, professional roles, regulation, technology, efforts to measure, control, and improve the quality of care, and more. It takes deep dives into the epidemiology of both disease and the utilization of care – important scientific foundations for proper health care policy and management. Throughout it makes generous use of helpful figures and tables, as well as copious citations that mark this as a work of authentic scholarship.
Professor Shalowitz’s book is a must-have resource for the library of any health care scholar who wants to have ready and efficient access to the fundamental facts that shape American health care today.Lawton R. Burns, PhD, MBA
James Joo-Jin Kim Professor; Director, Wharton Center for Health Management and Economics; and
Chairperson, Health Care Systems Department, Wharton School, University of PennsylvaniaFor anyone who picks up Joel Shalowitz’s book, The U.S. Healthcare System: Origins, Organization, and Opportunities, do NOT make the common mistake of skipping the prefatory material. The first two paragraphs of the “Foreword” (p. xxi) are worth the price of admission. As far as I am concerned, anyone teaching or taking an introductory survey course on our healthcare system needs to embrace and internalize the nuggets of wisdom here, obviously gleaned over thirty years of laboring on this topic.
What are some these nuggets? First, we do not have a healthcare system. Rather, we have a series of inter-related parts that are not aligned in their goals and incentives. That means the parts don’t work together and are not meant to work together. What that means is abandon efforts to try to “align the incentives” of all the parties using payment changes and structural models; the divides go deeper than this. The lack of a system also means that the parts impact one another in sometimes opaque ways. This means that efforts to change this monster with simplistic, top-down programs that only address one part are likely to fail. Trying to get all parties to participate in some reform might resemble the idealistic scene depicted in Edward Hicks’ painting, “The Peaceable Kingdom” (with William Penn in the background!).
Second, there is nothing new in our healthcare system. As Yogi Berra reputedly said, “it is déjà vu all over again”. Many of the problems we are trying to tackle today (improving quality, increasing access, controlling cost increases) are similar to problems we have tried to tackle in the past. The fact that we are still tackling them - - without realizing that we have been down this road before, unsuccessfully - - should send out warning signs to everyone. These problems are intractable. The only problem is that managers, policy-makers, and students of U.S. healthcare don’t know the history and the lessons learned from the last time we tried to tackle these issues, and thus don’t know (to quote an old management text) “the ropes to skip and the ropes to know”.
These words are meant as praise for what Joel Shalowitz has achieved in this hefty tome. He takes nearly 700 pages to (a) present several important frameworks for understanding the U.S. healthcare system, (b) trace the history of this system, and (c) present the relevant fact base on its major sectors - - but with an emphasis on “understanding” how this system really works (or doesn’t work). Unlike other introductory texts, Joel has avoided the mindless presentation of statistics and charts. I do not think those help anyone; moreover, it is boring. Instead, his book is designed to be thoughtful and thought-provoking - - i.e., to help improve your critical thinking about our healthcare system through some important lessons.
The lessons come quickly in this book. Chapter 1 introduces the reader to the three main policy goals pursued by the U.S. (and every other country) for decades: higher quality, improved access, and restrained rate of growth in healthcare costs. This framework needs to be on everyone’s learning agenda, since every country endorses it as their strategic aim (but have not yet solved it). Joel immediately gets to the task of explaining what each of these complex goals consists of - - not an easy task, since they are multi-dimensional in nature. More importantly, he correctly (I think) characterizes this tripartite set of goals as inherently contradictory and involving tradeoffs in their accomplishment. This will come as unwelcome news to many people who want to have it all and/or do not want to make tough choices. This is critical thinking that challenges many widely-held beliefs.
Chapter 1 also introduces you to the many stakeholders in the U.S. healthcare system. This analysis should sober readers that “alignment” - - one of the most overused words in our field - - is going to be difficult given the plurality of interests involved. Anyone one who has studied plural societies (those with many, different ethnic or religious groups) should understand the difficulties of bringing all parties together for a common goal. Indeed, one of the strengths of this book is to emphasize the presence of stakeholders and their plurality in our healthcare system. Their mere existence tells the reader that, as far as “alignment” goes, “we have trouble in River City”. Efforts to cut costs in one area of healthcare are likely to “gore someone else’s ox” (e.g., income) and therefore be opposed and perhaps thwarted.
And this is just the Foreword and Chapter 1! I could go on further about why this book makes an enormous contribution. Chapters 2 and 3 deal with epidemiology - - a topic worthy of a physician author, but also important for an MBA business school audience that is interested in marketing (the managerial version of epidemiology). This should come as no surprise since Joel has co-authored another major text with Phil Kotler. Subsequent chapters (4 and 5) deal ably with the two biggest sources of spending in our healthcare system: hospitals (and hospital systems) and healthcare professionals. Chapters 6-8 then cover the multitude of payers, the multitude of technologies that need to be paid for, and (in particular) the advances in information technology. The final chapter does a deep-dive into the whole issue of quality - - how to measure it, how to manage it, and the tradeoffs necessitated in doing so.
I should acknowledge my biases. Like Joel, I have been teaching an introductory survey course on the U.S. healthcare system for over 30 years. It may take us that long to really appreciate what working in this non-system means. And, like Joel, I believe an understanding of the history of the system is important for anyone trying to work within it, let along trying to change it. And, like Joel, I have labored at this task in major business schools trying to teach MBA students about the importance of this all. So, I am already predisposed to like this book. I wish I had written it.3.Regina E. Herzlinger, PhD
Nancy R. McPherson Professor of Business Administration, Harvard Business SchoolThe U.S. Healthcare System: Origins, Organization and Opportunities is a tour de force— a must use textbook for those seeking to solve the problems of the U.S. health care system.
It discusses each of the major stakeholders in an accessible, detailed, and authoritative voice and presents a compelling framework for understanding how they function.
Coupled with Professor Shalowitz’s daily blog, https://www.HealthcareInsights.MD, which discusses current healthcare issues, this book will make for the lively, informed discussions that students of U.S. healthcare have been looking for.4. Stephen M. Shortell, PhD, MBA, MPH
Distinguished Professor of Health Policy and Management Emeritus
Dean Emeritus School of Public Health
University of California, BerkeleyThis remarkably well-documented text provides important information and knowledge about the U.S. healthcare system within the context of historical developments and interpretative frameworks. The chapter on Managerial Epidemiology distinguishes [the book] from many other texts in the field, and there are particularly strong chapters on Payers, Technology, and Information Technology. The text will help readers understand and navigate the complexity of the U.S. healthcare system, why it has developed the way that it has, and some of the implications for its future evolution.
5.Susan Turney, MD, MS, FACP, FACPME
CEO of Marshfield Clinic Health SystemNo matter if you’re a seasoned executive or just entering the health care workforce, this book provides critical context about the history of care delivery and payment methodologies. This understanding is essential as we consider our health care future as a country, and the author has some fascinating ideas about possible paths forward for our industry.
6.Harry Kraemer, Jr., MBA
Former Chairman & CEO, Baxter International
Clinical Professor of Leadership, Kellogg School of Management, Northwestern University
Executive Partner at Madison Dearborn PartnersTo anyone who wants to really understand the U.S. healthcare system, Dr. Shalowitz’s book is a “must read”. Having participated in the healthcare industry for 40 years, this is the first time I have found a book that is comprehensive, factual and well-written.
7.Ann Minnick, PhD, RN, FAAN
Julia Eleanor Chenault Professor of Nursing
Vanderbilt University School of Nursing, Vanderbilt UniversityThe book fills a gap for those teaching an introductory course about the healthcare system. In my field (nursing), this book… would certainly be useful at the masters and doctor of nursing practice levels where there is required content about the health care system, management and quality. It will also be useful for those teaching the introductory course in health services research…
Two strengths of the book are its emphasis on presenting the past and detailing the most salient initiatives and factors influencing healthcare in the US now. Students need to understand the past… in order to better assess the situation today as well as why some interventions used in the past may or may not work in the twenty-first century. The neutrality with which the material is presented, especially in terms of the various programs, initiatives and solutions that have been or are being proposed is refreshing. The organization is very clear and the brief summaries at the ends of the chapters are helpful in keeping the reader in tune with the big “take-away.”
Chapter 1: Understanding and Managing Complex Healthcare Systems
Study questions:
The FDA approves a breakthrough treatment for the world's deadliest infectious disease — now what?: The FDA approved a breakthrough drug to treat TB. More money needs to be raised for the treatment, but even if available, there is still the problem of distribution (access). How can we get the drug where it is needed at a reasonable cost? What parts of the access equation need to be addressed to make sure distribution is successful?
Chapter 2: Determinants of Utilization of Healthcare Services
Updates:
Sign up on this website for the Population Health Assessment Engine [PHATE™], which has elements of Social Determinants of Health by geographic location on an interactive map.
Addenda:
Hidden in Plain Sight — Reconsidering the Use of Race Correction in Clinical Algorithms (June 17, 2020):This article is an excellent summary with examples of how race influences interpretation of clinical algorithms.
Case discussions:
How brands can inspire doctors to take more action (January 16, 2020): “Our qualitative research, validated though quantitative research, identified four major motivators for physicians, one rational and three emotional.” Key on pages five and six of the report. Think about how you would market products and services to physicians given this decision-making information.
2019 Cleveland Clinic MENtion It® Survey Results Overview (April, 2019): Why do men use healthcare resources less than women? This survey provides an excellent insight into contributing factors. How would you design a program to enhance male participation in beneficial healthcare activities? Note also that the opinions in the study vary among age groups.
Chapter 3:
Managerial Epidemiology
Study questions:
Association Between Maternal Fluoride Exposure During Pregnancy and IQ Scores in Offspring in Canada [August 19, 2019]: This study found that “maternal exposure to higher levels of fluoride during pregnancy was associated with lower IQ scores in children aged 3 to 4 years. These findings indicate the possible need to reduce fluoride intake during pregnancy.” What kind of study was it? What are the major criticisms of this type of study? Lowering fluoride concentrations in the water can have profound effects on the incidence of dental caries (cavities). Would you recommend the change be made based on this study?
Marine Omega‐3 Supplementation and Cardiovascular Disease: An Updated Meta‐Analysis of 13 Randomized Controlled Trials Involving 127 477 Participants[September 30, 2019]: “Marine omega‐3 supplementation lowers risk for myocardial infarction, CHD [coronary heart disease] death, total CHD, CVD [cardiovascular disease] death, and total CVD…” There was also a dose-response effect. Does this met analysis prove causation? What are problems with this kind of analysis? Would you recommend use of Omega-3 supplements as a public health measure based on this study?
Addenda
[January 29, 2020] This issue of JAMA Surgery has a series of articles exploring different methodologies in health services research. Start with the editorial (and Table) that summarizes the pros and cons of each approach.
[April 23, 2020] How coronavirus spreads through a population and how we can beat it. This excellent article has interactive graphics explaining the spread of a contagion given such factors as infectivity, susceptible population and mortality rates.
[May 13, 2020] FDA Calculator for Population Testing: This link connects you to an FDA-formulated spreadsheet that calculates positive and negative predictive values given test sensitivity, specificity and disease prevalence. It also allows you to use two tests to figure out population data.
[May 20, 2020] Adaptive designs in clinical trials: why use them, and how to run and report them: With the increasing need to develop tests and treatments more rapidly, this study design is coming into more use.
Chapter 4:
Hospitals and Healthcare Systems
Updates:
25 largest health systems by hospital beds [December 2024]
Information for Critical Access Hospitals [February, 2023] An update from CMS
See August 27, 2019 blog post for research on Medicare patients discharged to LTACHs.
Hospital Price Transparency Final Rule (December 3, 2019): Hospitals are required to list prices for commonly used services. This Final Rule explains what they need to do to comply.Hospitals challenged the rule but the Supreme Court upheld the requirement in June 2020.
Addenda
[April 23, 2020] The Post-Pandemic Style This article explains how architectural design changed following past pandemics.
Vertical Merger Guidelines (June 30, 2020): This update from the U.S. Department of Justice &
The Federal Trade Commission applies to hospital and health system merger and acquisition activity.
Changes in Hospital Income, Use, and Quality Associated With Private Equity Acquisition(August 24, 2020): “Hospitals acquired by private equity were associated with larger increases in net income, charges, charge to cost ratios, and case mix index as well as with improvement in some quality measures after acquisition relative to nonacquired controls. Heterogeneity in some findings was observed between HCA and non-HCA hospitals.”
Charity Care: Do Nonprofit Hospitals Give More than For-Profit Hospitals? (September 1, 2020): “While the average for-profit hospitals spent less in total charity care than nonprofit hospitals, there was no significant difference between for-profit and nonprofit hospitals in charity care as percent of total expenses. When stratified by size, small for-profit hospitals spent less than small nonprofit hospitals while large for-profit hospitals spent more than large nonprofit hospitals.
We found no differences in charity care as percent of total expenses between for-profit and nonprofit hospitals located in lower-income zip codes, middle-income zip codes, or higher income zip codes.”
Chapter 5:
Healthcare Professionals
Updates:
State of the World’s Nursing- 2020 [April 6, 2020]: The World Health Organization (WHO) designated 2020 as the “Year of the Nurse and Midwife,” in honor of the 200th birth anniversary of Florence Nightingale. This site provides a link to an excellent monograph on this subject.
The Complexities of Physician Supply and Demand: Projections From 2019 to 2034 [June 2021]: From the AAMC: “Many of the data used in this study were collected pre-COVID-19. We do know the pandemic has highlighted many of the deepest disparities in health and access to health care services, contributed to a rising physical and emotional toll on physicians and other health workers, and exposed vulnerabilities in the health care system….” Summarizing projections:
—A primary care physician shortage of between 17,800 and 48,000 is projected by 2034.
—A shortage of non-primary care specialty physicians of between 21,000 and 77,100 is projected by 2034, including:
Between 15,800 and 30,200 for Surgical Specialties.
Between 3,800and 13,400 for Medical Specialties.
Between 10,300 and 35,600 for the Other Specialties category.
Implementing High-Quality Primary Care: Rebuilding the Foundation of Health Care. [April, 2021] National Academies of Sciences, Engineering, and Medicine , DC: The National Academies Press. https://doi.org/10.17226/25983.
This monograph is an excellent update about primary care in the U.S.
2021 Fall Applicant, Matriculant, and Enrollment Data Tables: Applications to medical school are up to record numbers for all categories. Currently, 52.7% of enrollees are women. “Black or African American” enrollment is up almost 10%.
Physician Management Companies—Should We Care? (2/28/22) A good summary of the headline topic.
Projecting Health Workforce Supply and Demand ( March 8, 2024) An excellent source of information from HRSA. One of the main findings is: “Over the next 15 years (through 2036), NCHWA projects an overall shortage of 139,940 physicians.” This number includes about 68,000 primary care physicians.”
Chapter 6:
Payers
Updates:
1. Summary of 2020 changes to the Medicare Physician Fee Schedule, Quality Payment Program, and other federal programs:
This monograph from the American College of Physicians is an excellent resource to understand many changes in Medicare payment schemes for 2020. It is of further importance because private payers often follow Medicare methods.
2. The 2020 budget repeals the ACA's Cadillac tax, health insurer tax and medical device tax at a cost of nearly $400 million.
3. Top 10 health insurance companies in the US- 2020
4. Patient-Driven Groupings Model: Starting in 2020, the basis for paying home care changed to this model. For more information, check the CMS website and this summary explanation.
5.Individual coverage Health Reimbursement Arrangements (HRAs):Starting in 2020, employers can offer employees the option of enrolling in individual/family health plans that are not employer-sponsored. Employers can still contribute to premiums and out-of-pocket expenses through employee pre-tax payments. Certain conditions apply.
6.CMS Innovation Center Models COVID-19 Related Adjustments: Because of the COVID-19 pandemic, CMS modified the financial methodology, quality reporting terms, and timelines of many value-based models, e.g., ACOs and bundled payments. The chart in this CMS document provides a summary of these changes and updates information in the text.
7.Medicare Advantage[2024]: A Policy Primer An excellent monograph from The Commonwealth Fund.
8.OIG’s Top Unimplemented Recommendations: Solutions To Reduce Fraud, Waste, and Abuse in HHS Programs (August 2020): This annual report from the HHS OIG reviews unimplemented recommendations for all HHS programs, ranging from Medicare/Medicaid/CHIP to the NIH to the Indian Health Service. Well worth at least reviewing the list, which starts on page 4.
The recommendations are good topics for discussion or term papers.
9.CMS releases Part I of the 2022 Medicare Advantage and Part D Advance Notice(September, 2020): “The CY 2022 Advance Notice is being published in two parts due to requirements in the 21st Century Cures Act that mandate certain changes to Part C risk adjustment and a 60-day comment period for these changes…
For CY 2022, CMS is proposing to fully phase in the CMS-HCC model first implemented for CY 2020 (i.e., the 2020 CMS-HCC model), as required by the 21st Century Cures Act. Specifically, per the 21st Century Cures Act, the 2020 model adds variables that count conditions in the risk adjustment model (“payment conditions”) and includes for payment additional conditions for mental health, substance use disorder, and chronic kidney disease. This represents a change from the blend for 2021 of 75% of the risk score calculated using the 2020 CMS-HCC model and 25% of the risk score calculated using the older 2017 CMS-HCC model.
CMS calculates risk scores using diagnoses submitted by MA organizations and from Medicare fee-for-service (FFS) claims. Historically, CMS has used diagnoses submitted into CMS’ Risk Adjustment Processing System (RAPS) by MA organizations for the purpose of calculating risk scores for payment. In recent years, CMS began collecting encounter data from MA organizations, which also includes diagnostic information. CMS began using diagnoses from encounter data to calculate risk scores for CY 2015, and has since continued to use a blend of encounter and RAPS data-based scores through 2021, when risk scores will be calculated with 75% encounter data and 25% RAPS data.
With the proposed full phase-in of the 2020 CMS-HCC model, which is designed to calculate risk scores using diagnoses from encounter data submissions, the Part C risk score used for payment in 2022 would rely entirely on encounter data as the source of MA diagnoses.”
10.Biden admin to end Next Gen ACO model after this year (May 2021): “The Biden administration has decided to not extend the Next Generation Accountable Care Organization Model, which is expected to end at the end of 2021.
The decision… ends a program that called for ACOs to take on more financial risk than the Medicare Shared Savings Program (MSSP). The model was originally expected to end at the start of 2021 but was extended by the Trump administration due to the pandemic.”
11. CMS overhauls Direct Contracting model to include new requirements on governance, health equity in 2023: “The Centers for Medicare and Medicaid Services announced [February 24, 2022] that the professional and global Direct Contracting model will transition in 2023 to the Accountable Care Organization Realizing Equity, Access and Community Health (REACH) Model. In addition, the geographic Direct Contracting model on pause since March 2021 will be eliminated immediately.”
The changes are summarized here: CMS gives ACO model a makeover: 7 things to know: “The ACO REACH model has three main principles. The first is to improve health equity and bring the benefits of accountable care to underserved areas. CMS will do this through better support care delivery and will require model participants to create a health equity plan to be implemented in underserved communities.
The second principle is to promote provider leadership and governance, which will make sure doctors and healthcare providers play a vital role in accountable care, according to CMS. At least 75 percent of each ACO is to be controlled by participating providers and their designated representatives; the Global and Professional Direct Contracting model only required 25 percent. It also requires at least two beneficiary advocates on the governing board, with one being a Medicare beneficiary and one a consumer advocate.
The third principle is to protect beneficiaries and the model through more participant vetting, monitoring and transparency. More information on applicants' ownership, leadership and governing board will be required. There will be more up-ront screening of applicants, monitoring of participants and more transparency while the model is implemented. There will also be stricter protections against incorrect coding and risk score growth.”
The CMS Fact Sheet is here: Accountable Care Organization (ACO) Realizing Equity, Access, and Community Health (REACH) Model
12. Growth Of Value-Based Care And Accountable Care Organizations In 2022 (December 2022)
An excellent update on the growth and types of ACOs.
13.Notice of Methodological Changes for Calendar Year (CY) 2024 for Medicare Advantage (MA) Capitation Rates and Part C and Part D Payment Policies: CMS February 1, 2023 Pages 126-139
14. Federal Subsidies for Health Insurance: 2023 to 2033 From the CBO [September, 2023]: Net federal subsidies for health insurance (that is, subsidies minus certain payments, such as Medicare premiums, amounts paid to providers and later recovered, and penalty payments) are projected to total $1.8 trillion in 2023 and $3.3 trillion in 2033. Measured as a share of gross domestic product (GDP), those subsidies are estimated to amount to 7.0 percent and 8.3 percent, respectively.
What to Know About How Medicare Pays Physicians [March 8, 2024] An excellent review.
Medicare Physician Fee Schedule Reform An excellent 2024 review of the background, current status and proposals for reform for physician payment schemes.
ACO Primary Care Flex Model [March 20, 2024] “Beginning January 1, 2025, the CMS Innovation Center will test a new payment model for primary care,the ACO Primary Care Flex Model (ACO PC Flex Model), within the Medicare Shared Savings Program (Shared Savings Program). ACOs that participate in the model will jointly participate in the Shared Savings Program and the ACO PC Flex Model. They will receive a one-time Advanced Shared Savings Payment and monthly prospective, population-based payments, the Prospective Primary Care Payments (PPCP). The model will test whether improved payment for primary care will empower participating ACOs and their primary care providers to utilize more innovative, team-based, person-centered and proactive approaches to care and positively impact health outcomes, quality and costs of care.”
Addenda:
No Surprises Act [April 2023] A great summary and update from The Urban Institute.
The Economics of Medicare Advantage vs Medicare Supplement Enrollment [March 2023] Highlights
—Satisfaction is high for both Medicare Advantage and Medicare Supplement enrollees: 89% of Medicare Advantage and 87% of Medicare Supplement enrollees are satisfied with their plan, but Advantage enrollees are more likely than Supplement enrollees to say their satisfaction has increased in the past year (41% vs. 20%).
—Medicare Advantage and Medicare Supplement enrollees differ starkly by income: 73% of Medicare Advantage enrollees live on $50,000 or less per year, with 39% living on less than $25,000. By comparison, 50% of Medicare Supplement enrollees live on more than $50,000, with 31% living on $75,000 or more.
—Medicare Supplement is unaffordable for most Medicare Advantage enrollees: 52% of Medicare Advantage enrollees cannot afford any monthly premium at all; an additional 18% can afford no more than $25 per month.
—Medicare Supplement enrollees are less vulnerable to out-of- pocket costs: 61% of Medicare Supplement plan enrollees say they have savings sufficient to cover their out-of-pocket costs in case of hospitalization, compared to only 37% of Medicare Advantage enrollees.
—Medicare Advantage and Medicare Supplement enrollees have different worries for the future: The biggest worry for Medicare Advantage enrollees is not being able to afford their medical care in the future, while Medicare Supplement enrollees’ biggest worry is seeing their Medicare benefits reduced.
40 Years of the RAND Health Insurance Experiment: This article from RAND is a great historical perspective a this classic study.
Evaluation Of Medicare Alternative Payment Models: What The Data Show (November 2020): This article is an excellent update evaluating the success of these different models.
The inside story of how John Roberts negotiated to save Obamacare: (March 25, 2019) An excellent article going “behind the scenes” to tell how the ACA outcomes were negotiated amongst Supreme Court justices.
Moral Hazard in Health Insurance: What We Know and How We Know It An excellent, in-depth review of this topic.
Study questions:
Sustaining Rural Hospitals After COVID-19The Case for Global Budgets: This article suggests that paying rural hospitals fixed periodic payments as part of an annual global budget will save them from financial ruin. Comment on the proposal considering the ways hospitals are paid (Chapter 4) and pre-DRG hospital payment methods explained in this chapter.
Chapter 7:
Healthcare Technology
Study questions:
1. In India, Breast Cancer Screening Goes High-Tech (Retrieved Oct 2, 2019): “One in every two Indian women breast cancer do not survive. Only 66 percent live past five years of being diagnosed, compared to rates of around 90 percent in the U.S., Australia, and other Western countries.” Impediments to early diagnosis are access (a large rural population), cost, and cultural issues (like modesty with mammography). This article explains several point of care technologies with lower costs and higher sensitivities/ specificities than mammograms. What is these technologies were imported into the US? Who are the affected stakeholders and what would their positions be about implementing these technologies? For comparison, total costs for a mammogram in the US is at least $100 (and often much more).
2. FDA Clears First Transdermal Patch for Schizophrenia (Retrieved October 16, 2019) : This announcement is a great marketing case discussion. Assuming drug effectiveness, what was is the most important problem that needs to be addressed in this population? (Hint: it is not needle injection avoidance.) Will the patch form of medication solve this problem?
3. 2020 Disruptive Dozen (Retrieved May 12, 2020): Faculty at Mass General Brigham came up with this list and explanations of each item. Are these technologies truly disruptive? How do you think they will change the delivery/practice of health care? Any others you would add?
4. Patient and Plan Spending after State Specialty-Drug Out-of-Pocket Spending Caps (August 2020): High out of pocket charges usually work to discourage unnecessary, discretionary care. However, specialty medications are usually used for serious conditions out of the patient’s control. So it is no wonder that this research found that putting caps on patient out-of-pocket spending saves them money and does not cost the plans more. Cost controls in these cases require different strategies. See the section in this chapter covering cost containment strategies for specialty pharmaceuticals and discuss how they would succeed or fail in lowering costs for these drugs.
5. Syringe technology could enable injection of concentrated biologic drugs (September 2020): A truly disruptive technology that would enable patients to self-inject the medication, rather than going to an infusion center or physician’s office. See the video in the article for the best explanation of how it works. Which stakeholders would promote this technology and which would oppose it?
Addenda:
White Bagging, Brown Bagging, and Site of Service Policies: Best Practices in Addressing Provider Markup in the Commercial Insurance Market Read the Introduction to understand this strategy for lowering the cost of specialty pharmaceuticals.
Naming drugs
Ever wonder what the suffixes for generic drug names mean? Here is a list that explains them.
For general guidelines on naming drugs, here is the US Pharmacopeia document.
FDA Approval and Regulation of Pharmaceuticals, 1983-2018
This article is a nice summary of the title’s subject and includes useful graphics.
Fair Allocation of Scarce Medical Resources in the Time of Covid-19: Although this article was written to provide guidance for the COVID-19 current pandemic, the principles are much older. It can serve as an excellent template for future public health catastrophes when resources are scarce.
Accelerating Regulatory Product Development and Approval for Drugs and Biologics in the US: This monograph is very timely as many products are being approved through this process to combat the COVID-19 pandemic.
Updates:
Provision in Spending Bill Paves Way for Follow-On Insulins: Buried in more than 1,500 pages of the fiscal 2020 spending bill is an expanded definition of a biological product that now includes chemically synthesized polypeptides, such as insulin. The change makes it easier for competitors to introduce biosimilar insulins so prices can be lowered.
Prescription Drugs: Spending, Use, and Prices [January 2022]: A comprehensive update from the CBO (through 2018) about trends in drug costs.
Chapter 8:
Information Systems
Addenda:
January 17, 2024
CMS finalizes prior authorization rule expected to save $15B “CMS has finalized a rule to streamline the prior authorization process and improve the electronic exchange of health information that it estimates will save $15 billion over 10 years.
The requirements generally apply to Medicare Advantage organizations, state Medicaid and Children's Health Insurance Program agencies, Medicaid managed care plans, CHIP-managed care entities and qualified health plan insurers on the federally facilitated exchanges…
Beginning primarily in 2026, certain payers will be required to include a specific reason when denying requests, publicly report certain prior authorization metrics and send decisions within 72 hours for urgent requests and seven calendar days for standard requests.
The rule also requires affected payers to implement a Health Level 7 Fast Healthcare Interoperability Resources standard application programming interface to support electronic prior authorization.”
July 28, 2023
Preparing for the International Classification of Diseases, 11th Revision (ICD-11) in the US Health Care System A really good update on the ICD.
February 24, 2023
Social Determinants of Health Information Exchange Toolkit
This Toolkit is intended to support conveners, facilitators, implementers, and the health IT community in the process of collaborative assessment, design, implementation, and governance to integrate information systems across sectors.
December 20, 2019.
Artificial Intelligence in Healthcare: A great monograph on the subject by the National Academy of Medicine
Strategy on Reducing Regulatory and Administrative Burden Relating to the Use of Health IT and EHRs
-FINAL REPORT, As Required by the 21st Century Cures Act Public Law 114-255, Section 4001:
This report, from the Office of the National Coordinator for Health Information Technology, outlines three primary goals “for reducing health care provider burden:
1) Reduce the effort and time required to record information in EHRs for health care providers during care delivery.
2) Reduce the effort and time required to meet regulatory reporting requirements for clinicians, hospitals, and health care organizations.
3) Improve the functionality and intuitiveness (ease of use) of EHRs.”
The latter category addresses interoperability.
2020-2025 Federal Health IT Strategic Plan (October 2020): This document is a detailed outline of the mission, vision and goals for the Office of the National Coordinator for the next five years.
Iqvia Digital Health Trends 2021: An excellent, updated report, including therapeutic apps and wearables.
As TEFCA goes live, HHS hits major interoperability milestone: [January 19, 2022]“Five years in the making, the nation's top health IT agency released… the Trusted Exchange Framework and Common Agreement, a critical step in establishing a nationwide data-sharing network.
The long-awaited interoperability framework (PDF), called TEFCA, was mandated by the 21st Century Cures Act back in 2016 and was designed to improve data sharing between health information networks.
The Office of the National Coordinator for Health, within HHS, released the first draft of the TEFCA back in January 2018. The framework provides the policies, procedures and technical standards necessary to exchange patient records and health information between providers, state and regional health information exchanges and federal agencies."
Latest update on hospital interoperability (from 2021) January, 2023
Chapter 9:
Quality
Updates:
August 16, 2023:
Joint Commission acquires National Quality Forum
“The Joint Commission has acquired the National Quality Forum with the goal of consolidating quality measures.
The NQF will maintain its independence in developing consensus-based measures, implementation guidance and practices that benefit stakeholders but both will build on measuring quality and rationalizing the measurement landscape, according to an Aug. 16 news release from the organization.”
December 21, 2021:
Strategies to Improve Patient Safety: Final Report to Congress Required by the Patient Safety and Quality Improvement Act of 2005: “As required by the Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act),a the Secretary of the Department of Health and Human Services (HHS) has prepared this Final Report to Congress on effective strategies for reducing medical errors and increasing patient safety in consultation with the Director of the Agency for Healthcare Research and Quality (AHRQ). It includes measures determined appropriate by the Secretary to encourage the appropriate use of effective strategies for reducing medical errors and increasing patient safety, including use in federally funded programs. As the Patient Safety Act also required, a draft of this report was made available for public comment and submitted for review to the Institute of Medicine, now the National Academy of Medicine. This Final Report, which is required to be submitted to Congress no later than December 21, 2021, includes updates and additions made to address feedback received from members of the public and the National Academy of Medicine.”
A “must-read” for those in charge of patient safety activities at their institutions.
August 20, 2020:
HHS Releases Healthy People 2030 with National Disease Prevention and Health Promotion Objectives for the Next Decade: “Today, the U.S. Department of Health and Human Services released Healthy People 2030, the nation's 10-year plan for addressing our most critical public health priorities and challenges…
This decade, Healthy People 2030 features 355 core – or measurable – objectives with 10-year targets, new objectives related to opioid use disorder and youth e-cigarette use, and resources for adapting Healthy People 2030 to emerging public health threats like COVID-19. For the first time, Healthy People 2030 also sets 10-year targets for objectives related to social determinants of health.”
August 1, 2019: After careful consideration, the Centers for Medicare & Medicaid Services (CMS) is discontinuing the Medicare Advantage Qualifying Payment Arrangement Incentive (MAQI) Demonstration because of the rates of low participation. CMS will not be accepting applications for MAQI for 2019.”
June 25, 2019:The National Quality Forum (NQF) released “The Care We Need: Driving Better Health Outcomes for People and Communities, a National Quality Task Force report that provides a roadmap to consistent and predictable high quality care for every person by 2030. Underscored by the current COVID-19 pandemic, the report specifies opportunities to improve the health outcomes of people and communities with recommendations that focus on the importance of a seamless system of comprehensive, accessible care designed to keep people healthy and well.”
Discussion questions:
Low staffing at HealthOne hospitals in metro Denver contributed to patient death, preventable harm (August 31, 2020): Read the article and make recommendations that will avoid such problems in the future. The plan should assume you cannot hire more people, at least in the short run.