Chapter Twenty-Two: The Right to Emergency Care
The Emergency Medical Treatment and Active Labor Act (EMTALA) is an act of the United States Congress, passed in 1986 –Wikipedia
1986 Congress passed the Emergency Medical treatment and Active Labor Act, (EMTALA)
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1305897/
Out-of-Network Emergency-Physician Bills — An Unwelcome Surprise. Zack Cooper, Ph.D., and Fiona Scott Morton, Ph.D. November 17, 2016 N Engl J Med 2016; 375:1915-1918
surprise ER bills.
https://health-access.org/wp-content/uploads/2019/06/AB1611-Fact-Sheet_updated-6.28.19.pdf
Surprise medical bills https://washingtonmonthly.com/magazine/april-may-june-2020/why-congress-cant-stop-surprise-medical-bills/
Surprise ER bills. https://health-access.org/wp-content/uploads/2019/06/AB1611-Fact-Sheet_updated-6.28.19.pdf
SURPRISE BILLING. B N Engl J Med 2020; 382:1189-1191
2020 Legislation that bans surprise bills
Balanced billing
https://www.commonwealthfund.org/blog/2019/state-efforts-protect-consumers-balance-billing
N Engl J Med 2020; 382:1189-1191
2020 Legislation that bans surprise bills
https://www.nytimes.com/2020/12/20/upshot/surprise-medical-bills-congress-ban.html
a woman is charged $3000 for lab tests
Chapter Twenty-Three: Hospitals
(additional references at end of web chapter: hospitals)
Murder or Mercy? Hurricane Katrina and the Need for Disaster Training
https://www.nejm.org/doi/full/10.1056/NEJMp068196
- Tyler J. Curiel, M.D., M.P.H.November 16, 2006 N Engl J Med 2006; 355:2067-2069
Market Place Medicine the rise of the for-profit hospital chains. Book by Dave Lindorff
Hospital charges
SUTTER
https://www.milbank.org/publications/californias-sutter-health-settlement-what-states-can-learn-about-protecting-residents-from-the-effects-of-health-care-provider-consolidation/anti trust suit for hospital charges
Khruschev meets Castro
BLACK HOSPITALS https://guides.mclibrary.duke.edu/blackhistorymonth/hospitals#:~:text=It%20still%20exists%20today%20as,and%20other%20health%20care%20facilities.
Sick from Freedom: African-American Illness and Suffering during the Civil War and Reconstruction by Jim Downs
Desegregation: The Hidden Legacy of Medicare
https://www.usnews.com/news/articles/2015/07/30/desegregation-the-hidden-legacy-of-medicare
The Power to Heal: Civil Rights, Medicare, and the Struggle to Transform America’s Health Care System by David Barton Smith
anti trust suit for hospital charges
Nurses strikes
https://www.labornotes.org/2013/10/one-day-strikes-word-wise
The veteran’s administration builds hospitals
https://www.va.gov/about_va/vahistory.asp
statistics
https://www.aha.org/statistics/fast-facts-us-hospitals
Most of the nation’s facilities have fewer than 200 beds https://www.forbes.com/2010/08/30/profitable-hospitals-hca-healthcare-business-mayo-clinic_slide.html
In 1995 around half of private hospitals were solo. Then, over the decades for profit and non-profit hospitals have increasingly merged and/or joined systems with at least one other hospital partner in the same metropolitan statistical area (MSA). https://www.healthaffairs.org/doi/full/10.1377/hlthaff.22.6.77
What insurance companies pay for services by zip code
https://www.healthcarebluebook.com/
BLACK HOSPITALS https://guides.mclibrary.duke.edu/blackhistorymonth/hospitals#:~:text=It%20still%20exists%20today%20as,and%20other%20health%20care%20facilities.
Hospital charges https://jrreport.wordandbrown.com/2019/01/10/hospitals-now-required-to-reveal-secret-prices-lists-online-for-every-medical-procedure-service/
anti trust suit for hospital charges https://californiahealthline.org/news/california-sues-sutter-health-alleging-excessive-pricing/
Surgery as a part of hospital revenue and costs https://www.healthleadersmedia.com/clinical-care/ahrq-surgical-admissions-bring-48-hospital-revenue
https://www.beckershospitalreview.com/payer-issues/america-s-largest-health-insurers-in-2018.html
As Elisabeth Rosenthal of Kaiser Health News put it: “there’s money to be made by billing for everything and anything.” And hospitals currently intentionally submit amplified bills for their services.
Each hospital has an all inclusive list of “items billable to a person or a health insurance provider.” Called “charge masters” they have long been secret in most states; but starting in 2019 they will be posted on line. They do not include physician charges, and they are intentionally inflated–or in the “speak” of the University of California San Francisco Hospital: “they are not the amount that either you or your insurer will actually pay. Out-of-pocket costs will be impacted by insurance plan coverage, co-pays and deductibles, if any, (etc.) – so our list should not be used to estimate the actual final cost you will incur.”
Insurance companies like to flaunt them to demonstrate how much money they are saving their patrons. And hospitals can claim that overstated prices are useful when they negotiate contracts with insurance companies. The “fair” cost, the amount insurance companies (on average) really pay for most emergency and hospital visits, is accessible to anyone who has a smart phone. They merely have to open Healthcarebluebook.com or some similar service, and type in their zip code.
Medicare strictly regulates the amount the government shells out to hospitals. The agency is constantly updating what it pays for an illness or operation; 98% of American hospitals accept what the Feds dole out as payment in full.
Exaggerated bills punish the ill and wounded who are cared for in a hospital that does not have a contract. They hassle the person who is seen in an “out- of-network” facility or who was cared for by a doctor who was not covered by an agreement. And they are especially harmful to people who don’t have health insurance.
Paradoxically the people who try to collect the most exorbitant amounts of money commonly tend to blame the injured party.
I believe that once hospitals start charging people without insurance fairly, a form of BACK STOP INSURANCE makes sense. As detailed in the “alternative approach” chapter, when corporations have a big stock offering, they obtain insurance. If some of the stocks and bonds are not sold on the open market, the investment firm that is handling the transaction has to buy them.
We need to take a similar approach to people who can afford insurance but don’t have a policy. Health insurance is rarely used by some because they have a healthy life style, they’re young, and they are lucky. And because bodies have an innate ability to fight off invaders and heal wounds.
If one of these people is in a “higher income” category, and they haven’t purchased medical insurance, and they get sick or are injured, they would be best served if the system has “automatically enrolled them in a “backstop” insurance plan.” If they are seen in an emergency room or are hospitalized the facility should be able to submit a claim and it should be paid by the government. At tax time the IRS can then decide how much the person owes for a year’s worth of “backstop insurance.” (As conceived by Matthew Fielder, NEJM: May 2, 2019.)3
II. HEALTH INSURANCE: Some employer policies are unusable because the co-pays are so high. In addition to taking care of the people with pre-existing conditions, we need a law or regulations that make health insurance affordably-useable. There should be caps on premiums and co-pays; out of pocket payments should be based on income—should mirror earnings
Several of the Democratic candidates for president believe in Medicare for All. Like all “rights” this form of care must be paid for. That usually means taxes, and people who promise more taxes aren’t usually elected. In addition to something like the current payroll tax– the government would have to collect the money employers contribute to a person’s insurance and the excess insurance company profits.
As an old retired M.D. and a socialist at heart I favor Medicare for all. But as a realist I’m worried.
In the 60s and 70s affordable health care was available to those who wanted it via Blue Cross and programs like Kaiser (my people.) Then insurance companies entered the market and did what insurance companies do. They risk adjusted. People who live in the low lands near the Mississippi River pay more for flood insurance, and we in California pay more for earthquake insurance. Private insurers didn’t sell affordable policies to people with pre existing conditions. Premiums for the young and healthy were relatively cheap.
Over the subsequent decades the young, healthy and employed started choosing private insurers; people with problems joined Blue Cross and Kaiser. Year by year medical care improved and it also became increasingly costly: CAT scans; MRI’s; organ transplants; angioplasties; artificial joints; and ICU’s aren’t cheap.
As their population increasingly had fewer healthy clients and more people with costly problems, Blue Cross and Kaiser started “hemorrhaging money.” Ultimately they were on the verge. After Hilary’s very reasonable Health Care adjustments were rejected, many Blue Cross companies and Kaiser said “uncle”. They adopted a risk adjusted approach.
Over the subsequent decades people forgot that affordable health care, like the roads or schools, was once widely available. The young, healthy, and employed grew up assuming they would be able to buy insurance that was good and affordable. It was their “right.” Understandably, they don’t want to give it up. And we need their votes.
My approach: lower the Medicare age, and keep dropping it. Make affordable Medicare purchasable for those who want it. At the same time, over a few years–SUBSTANTIALLY LOWER THE MEDICAL LOSS RATIO. Under the Affordable Care act companies get to keep 15 to 20 % of premiums for expenses, bonuses and stock holders. The overhead of Medicare allegedly is 3%. If insurance companies could keep 8% of the premiums, they should still be profitable. If a yield of 5% isn’t enough, a company can leave the market. And some will. Over time healthy people will increasingly migrate to Medicare. We may never get to Medicare for All but we’ll get close.
As a result of the current medical loss ratio, the heads of the health insurance companies are doing quite well. In 2018 as a result of exercised stock options and stock awards, the one year compensation of the head of 49.5 million member UnitedHealth insurance, the nation’s largest, was over $18 million. The leader of Anthem, the 40.2 million policy, second largest was $14.2 million.4
III. We should also extend some of the benefits of the Affordable Care Act (ACA) to traditional Medicare. The ACA (Obamacare) created an annual lid on the amount people are forced to pay for their care. In 2018 it was $7350. By contrast, traditional Medicare, has no cap, no maximum amount a person can be charged. When people see a doctor or are hospitalized, they are responsible for “copayments, coinsurance, and other gaps in coverage.” If someone has a very serious illness and is hospitalized for months, the government stops paying the bill “after the 150th day in the hospital.
People can buy an insurance policy that pays the bills that are not covered by Medicare. There are 10 levels of “Medigap” plans. If a person doesn’t buy one of them when they enroll in Medicare, the policies are subsequently only available (most of the year) to people who pass an insurance physical.
Medicare Advantage plugs a number of the holes in traditional Medicare. Currently (according to AARP) 44 million Americans are insured by Medicare. The number opting for Medicare Advantage rose to 20 million in 2018 and it’s going up. Advantage plans are capitated. The government gives the insurer a dollar amount per person per year, and “everything” is covered. Plans may include limited dental care and gym memberships. Out-of-pocket costs were capped at $5,215 per year in 2018. (November 14, 2018, NEJM.org.)
According to Wiki “You cannot have both a Medicare supplement (Medigap plan) and a Medicare Advantage plan at the same time.” It’s time to identify and close the Medicare gaps.
IV: Extra money for health care was supposed to come from a few additional sources. Congress recently abolished the Medical Device tax, the health insurance tax , and the tax on Cadillac plans.
I suggest re-opening the question of what happens when university and nonprofit hospitals make hundreds of millions of dollars. Should they be taxed? Should they return some of the tax funds they received from the government for use elsewhere in the health care system? Or perhaps charitable and university hospitals should (like the for-profits) generate a bill for the service rendered. The amount charged would be similar to the sum Medicare or insurance companies would actually pay. (Inflated excessive charges should be treated as potential tax fraud.) The institution’s outlay could then be deducted from the hospital’s gross income. If an institution performs a lot of charity work and has no net income they would owe no taxes. If they generate a large profit, they, like for-profit corporations, could pay a tax.
Summary: if our goal is to make quality health care affordable and available :
- We need to fix the drug price problem.
- Pevent hospitals from generating outrageous inflated bills for their services.
- Eliminate out of network charges.
- Eliminate balanced billing.
- Allow the medical loss ratio (MLR) to whither.
- Put a cap, an upper limit, on the out of pocket Medicare bills that unsuspecting seniors are sometimes forced to pay.
- And we should allow people to buy into Medicare.
- And perhaps tax the excess profits of University and Charitable hospitals.
Chapter Twenty-Four: Generic Drugs
HATCH WAXMAN
Overview of the Hatch-Waxman Act and Its Impact on the Drug Development Process
https://scholarship.shu.edu/cgi/viewcontent.cgi?article=1677&context=shlr
GENERIC DRUGS
Overview of the Hatch-Waxman Act and Its Impact on the Drug Development Process
Pharmaceutical patents and the world trade organization
http://infojustice.org/archives/42129 India patent
https://books.openedition.org/obp/3094?lang=en argument for WTO
Prior to the creation of the World Trade Organization in 1995, individual countries were free to determine their own patent laws. This position has now changed. All members of the WTO are required to adopt patent laws that comply with the Agreement on Trade-related Aspects of Intellectual Property Rights,1 including the implementation of patent protection for pharmaceuticals. The developed members of the WTO negotiated mandatory protection for pharmaceutical products and processes in the TRIPS Agreement on the basis that such mandatory protection will provide the necessary incentives for continued pharmaceutical innovation. In contrast, the developing countries and the Least Developed Countries argued that enacting patent laws that comply with TRIPS may restrict production and supply of low-cost generic medicines by their local pharmaceutical industries or by the pharmaceutical industries in other developing countries, and hence could increase the price of pharmaceuticals to the point that pharmaceuticals become inaccessible to their populations.
https://books.openedition.org/obp/3094?lang=en
https://www.thebalance.com/top-generic-drug-companies-266311
http://www.pewtrusts.org/en/research-and-analysis/reports/2017/01/drug-shortages
http://www.nejm.org/doi/full/10.1056/NEJMp1112633#t=article
https://www.fda.gov/media/132058/download
https://www.wisc-asc.org/news/382129/FDA-Approved-Drug-Extended-Use-Dates-List-.htm
https://www.health.harvard.edu/staying-healthy/drug-expiration-dates-do-they-mean-anything
https://www.nytimes.com/2019/12/25/health/antibiotics-new-resistance
Intellectual property
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3217699/#ref1
Chapter Twenty-Five: The Price of Everyday Drugs
How companies price medications https://www.investopedia.com/articles/investing/020316/how-pharmaceutical-companies-price-their-drugs.asp
How companies’ price drugs https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2866602/
https://medtech.pharmaintelligence.informa.com/PS017438/SENATE-MAJORITY-LEADER-WORKING-WITH-SEN-PRYOR-ON-MEDICAID-DRUG-PRICE-DISCOUNT-BILL-PRYOR-ACKNOWLEDGES-APPLICABILITY-OF-BILLampnbspBEYOND-MEDICAI THE MEDICARE CATASTROPHIC COVERAGE ACT OF 1988
https://www.cbo.gov/sites/default/files/100th-congress-1987-1988/reports/88doc140.pdf Specialty drugs—a distinctly American phenomenon
https://www.nejm.org/doi/full/10.1056/NEJMp1909513
Patient and Plan Spending after State Specialty-Drug Out-of-Pocket Spending Caps
https://www.nejm.org/doi/full/10.1056/NEJMsa1910366
biologic account for 37 percent of drug costs https://www.forbes.com/sites/theapothecary/2019/03/08/biologic-medicines-the-biggest-driver-of-rising-drug-prices/#547789dc18b0
how companies price drugs https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2866602/
Chapter Twenty-Six: High-Priced Drugs
EXPENSIVE DRUGS https://www.pharmaceutical-technology.com/features/top-selling-prescription-drugs/
https://library.cqpress.com/cqalmanac/document.php?id=cqal84-1151745
drug prices in the 1970s to 1980s https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4191468/http://plg-
https://scholarship.shu.edu/cgi/viewcontent.cgi?article=1677&context=shlr
DRUG COSTS
Biologics account for 37 percent of drug costs https://www.forbes.com/sites/theapothecary/2019/03/08/biologic-medicines-the-biggest-driver-of-rising-drug-prices/#547789dc18b0
http://www.indiatogether.org/articles/lwcstman-health/print
A congressional committee questions heads of drug companies
https://www.c-span.org/video/?458198-1/lawmakers-press-pharma-ceos-rising-drug-prices
Vagelos great debate on drug pricing https://www8.gsb.columbia.edu/leadership/ethicsofpricing
Chapter Twenty-Seven: Expensive Pharmaceuticals
https://www.pharmaceutical-technology.com/features/top-selling-prescription-drugs/
Drug prices in the 1970s to 1980s
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4191468/
Gleevec
Treatment of chronic myelocytic leukemia UPTODATE.
Gleevec generics
Gleevec in other countries.
https://www.statista.com/statistics/312011/prices-of-gleevec-by-country/
Out of pocket cost burden for certain drugs
The ethics of drug prices
https://www8.gsb.columbia.edu/leadership/ethicsofpricingt
The Emperor of all Maladies, by Siddhartha Mukeherjee, Scribner 2011
RoyVagelosTranscript.pdf
https://www.annualreviews.org/userimages/ContentEditor/1337783424709/P.
THE SWISS
http://fortune.com/2015/07/28/why-pharma-mergers-are-booming/
Post-Merger Integration: How Novartis Became No.
https://www.strategy-business.com/article/16383?gko=6321f
http://www.nytimes.com/2008/07/06/health/06avastin.html
Switzerland takes on its top drugmakers in price row Reuters Sept 16, 2014.
Making of Herceptin
http://www.nytimes.com/books/first/b/bazell-her.html
Siddhartha Mukherjee, “The Emperor of All Maladies” Scribner 2010
avastin
https://tvst.arvojournals.org/article.aspx?articleid=2503070
Judah Folkman
https://www.scientificamerican.com/article/quiet-celebrity-interview
Tumor Angiogenesis by Judah Folkman, NEJM, 197112.
Genentech by Sally Smith Hughes, University of Chicago Press; 2011
Rituximab and Ivor Royston
https://libraries.ucsd.edu/sdta/histories/royston-ivor.html https://libraries.ucsd.edu/sdta/companies/idec.html https://libraries.ucsd.edu/sdta/transcripts/royston-ivor_20081014.html
THE SWISS:
Michael Houghton hepatitis C
MICHAEL HOUGHTON INTERVIEW https://www.youtube.com/watch?v=Bc61-nzuZSo&list=PLkLWuDKntM8vMGKvKBC-gSGx6PO6V5S23&index=1
https://www.journal-of-hepatology.eu/article/S0168-8278(09)00535-2/fulltext
michael houghton hepatitis C https://www.youtube.com/watch?v=Z-JCT6ifmMA&list=PLkLWuDKntM8vMGKvKBC-gSGx6PO6V5S23&index=4https://www.youtube.com/watch?v=Bc61-nzuZSo&list=PLkLWuDKntM8vMGKvKBC-gSGx6PO6V5S23&index=1
Lipitor:
Akira Endo moulds
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3108295/
Atherosclerotic plaque
https://www.nejm.org/doi/full/10.1056/NEJMra2000317
Monoclonal antibodies
https://www.immunology.org/kohler-and-milsteins-hybridoma-technology-1975 https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(05)72025-0/fulltext
Cytokines –“Love and Science” by Jan Vilcek
BIOSIMILARS AND CYTOKINE BLOCKERS
Abbvie and biosimilars
Transgenic mice
https://www.ncbi.nlm.nih.gov/books/NBK231336/
toclizumab for overzealous release of toclizumab https://www.thelancet.com/journals/lanrhe/article/PIIS2665-9913(20)30173-9/fulltext
Richard Gonzalez AbbVie https://www.chicagobusiness.com/article/20150306/NEWS03/150309840/bored-by-golf-and-cancer-cured-abbvie-ceo-gonzalez-came-back-to-work
AbbVie and biosimilars
pros and cons of 12 years exclusivity for biologics https://repository.library.northeastern.edu/files/neu:cj82rb53g/fulltext.pdf
European handling of biosimilars
In much of Europe biosimilars can be marketed as soon as they have been shown to perform as well as the original drug, but they are usually not thought of as interchangeable or a generic version of an existing medication. They are instead treated like a competitor or a therapeutic alternative, and outside of a small number of Eastern European countries pharmacists can’t substitute a biosimilar for a designated medication without permission from the prescribing physician. When the biosimilars begin to significantly price compete attitudes will probably change, but for now in France and Italy, at least, “biosimilar adoption rates have been low.”
Used in place of the some european hospitals In the hospital setting, however, there are also coordinated efforts to switch patients, with reports of U.K. hospitals switching >95 percent of their rituximab patients in just six weeks since the biosimilar for rituximab was introduced. All stakeholders in the hospital (including patients) realize how, by switching, they are able to generate savings ion, and
(e.g., Estonia, Latvia, Poland), while France recently introduced legislation allowing substitution in treatment-naive patients under specific conditions (although in practice, this is still uncommon). But in most other European markets, biosimilars have been treated as competitors of the originator products in much the same way blood products such as factor agents, immunoglobulins, and other high-cost treatments are handled.1 This is evidenced by the widespread use of tenders to drive procurement decisions across Europe, although these can take many guises ranging from exclusive to nonexclusive contracts.
Immunotherapy
Movie Jim Allison –Breakthrough
Tasuku Honjo nobel prize pd1 apan
https://www.kyoto-u.ac.jp/en/news/2018-12-11
CAR-T
https://pharmaboardroom.com/infocus/big-pharmas-quest-for-blockbuster-car-t/
https://www.nytimes.com/2011/09/13/health/13gene.html
Transformed Cell by Steve Rosenberg M.D.
Rosenberg CAR-T
https://learningenglish.voanews.com/a/what-it-takes-steve-rosenberg/4226596.html
Zelig Eshhar CAR-T Israel
The Scientist. The CAR T cell race. April 2015
https://www.the-scientist.com/bio-business/the-car-t-cell-race-35701
https://ww w.addgene.org/107226/
(CAR) T-cell therapy has shown remarkable clinical efficacy in B-cell cancers.
https://www.nejm.org/doi/full/10.1056/NEJMoa1910607
https://www.goldmansachs.com/insights/talks-at-gs/arie-belldegrun.html
https://blogs.timesofisrael.com/sugar-coated-memories-of-rehovot/
https://www.the-scientist.com/bio-business/the-car-t-cell-race-35701
https://boards.fool.com/macro-view-of-the-car-t-cell-sector-32661956.aspx?sort=wholeedit”car-t”
https://thewinnower.com/papers/2626-addgene-an-open-access-success-story
http://dx.doi.org/10.1257/aer.101.5.1933
www.addgene.org.