Infrastructure Bill Gives US Government Toehold For Drug Price Negotiations

 

Congress just passed the widely debated infrastructure bill, HR 3684, which funds much needed upgrades for the nation’s transportation and other infrastructure. One of its provisions allowed the US government to negotiate drug prices, but the entire safety net bill was stripped from the infrastructure bill. (117th US Congress, 2021) This gives big pharma a chance to cut the provision entirely from the safety net bill which provides paid family leave, childcare, and other benefits.

 The US consumes more pharmaceuticals, by a huge margin, than any other country. The government’s ability to negotiate favorable pricing for its plans, which make up 50% of all US healthcare spending, has significant potential to lower the cost of drugs across the nation over the long term. President’s Bush and Obama were not able to get any government drug negotiating power in their tenure, but the Biden Administration, thanks to Nancy Pelosi, has managed to get a toehold in one of the most abused sectors of US healthcare price gouging. This article examines those provisions and ramifications for consumers.

 Brief

HR 3684, signed by President Biden November 15, 2021 invests billions to update the roadways, railways, and digital highways of the nations. This is all good news and overdue, given that 25% of the nation’s bridges are in gross disrepair and of those, 4% are in critical condition. (American Road and Transportation Builders Association, 2021)

 *Beneficiaries of HB 3684 include Medicare recipients, who will have their prescription drug expenses capped after a $2,000 copayment maximum. (AMIRI, 2021)

 *Medicare would be able to negotiate drug prices for certain medications effective January 2023, thanks to Senator Ron Wyden of Oregon. Most drugs will have a nine-year patent limit, but biologics, because they are more expensive to produce will have twelve years. (Cochrane, 2021) There is a schedule of 50 drugs for which the government would negotiate pricing for Medicare, Medicaid, and other government programs. (O'Brien, 2021) This would commence in 2025 and result in a substantial lowering of drug costs in the US, because private sector medical insurance plans follow the government’s lead. Assuming this provision remains in tact through implementation, its effects will not be felt until 2026, when the data can be analyzed. The nation may have a new president by then, but at least reducing pharmaceutical costs is a bipartisan effort now.

 *Insulin would be capped at $35 a dose, compared to several hundred dollars

 *Waste reduction provision; drug manufacturers would be required to refund or rebate the government for any unused portion of any single-use drugs, such as injectables. There are exceptions for radiological imaging agents, biologics, and new drugs with less than 18 months approval by the Centers for Medicare and Medicaid. (Beck, 2021)

 *Health and Human Services would be authorized to conduct periodic audits and recoup up to 25% of the value of the product refunds by fines for pharmaceutical companies which are noncompliant. These rebates are to be dispersed to HHS quarterly.

 *Provision which specifies US production quotas of personal medical equipment and supplies in order to reinforce the US supply chain.

Further information on these mandates will become clear when implemented. Bipartisan efforts to reduce the astronomical cost of pharmaceutical products in the US is a welcome activity for us all.

 And this is the healthpolicymaven signing off encouraging you not to sign blanket releases when agreeing to medical procedures, do specify that for which you consent and decline. This is an independent column which accepts no payments from any sector of United States healthcare. Opinions expressed here are her own and may be freely shared with anyone to whom it may interest.

 References

117th US Congress. (2021, November 15). Transportation and Infrastructure Bill. HR 3684. Washington DC, United States of America. Retrieved November 11, 2021, from https://www.congress.gov/bill/117th-congress/house-bill/3684

American Road and Transportation Builders Association. (2021, March 23). US Bridges Need Repair Latest Analysis of Federal Data . Retrieved November 14, 2021, from https://www.artba.org/2021/03/23/over-220000-u-s-bridges-need-repair-latest-analysis-of-federal-data-finds/

AMIRI, B. L. (2021, November 3). Democrats Put Paid Family Leave, Immigration, and Tax Changes Back In Biden Bill. The Los Angeles Times. Retrieved November 14, 2021, from https://www.latimes.com/politics/story/2021-11-03/democrats-paid-family-medical-leave-back-in-bill

Beck, S. (2021, August 4). Healthcare Provisions In the Infrastructure Investment and Jobs Act. Health Industry Watch.com. Retrieved November 15, 2021, from https://www.healthindustrywashingtonwatch.com/2021/08/articles/legislative-developments/health-care-provisions-in-the-infrastructure-investment-and-jobs-act/

Cochrane, J. W. (2021, November 2). The New York Times. Retrieved November 14, 2021, from https://www.nytimes.com/2021/11/02/us/politics/prescription-drug-prices-medicare.html

O'Brien, S. (2021, August 19). Congressional Democrats want to let Medicare negotiate prices with drugmakers. Here’s what that could mean for the cost of coverage. Retrieved November 15, 2021, from CNBC.com: https://www.cnbc.com/2021/08/19/congressional-democrats-want-to-let-medicare-negotiate-with-drugmakers.html

 

 

Is the FDA Too Politicized to Make Sound Decisions-The Aduhelm-Alzheimer’s Debacle?

 

Six million people have been diagnosed with Alzheimer’s in the U.S. and though it does impact the elderly at a significantly higher rate (30% are over 80 years old), about 11% of the diagnoses are under the age of 65. (Alzheimers.org, 2021)Recently, the US Food and Drug Administration (FDA) approved a new drug treatment for this disease, Aduhelm, which was based on inadequate proof of any meaningful benefit. In fact, the decision caused such an uproar most of the experts who sat on the review panel resigned because of the decision, which they had not recommended. Briefly here is a timeline and the current state of this drug approval which would cost taxpayers $56,000 per patient per year: (Maddipatla, 2021)

 2007-Biogen purchased the worldwide rights to aducanab from a Swiss pharmaceutical company.

 2014-Biogen started late-stage clinical trials on aducanumab’s effectiveness to reduce amyloid plaque build-up in the brain, which is found in people with Alzheimer’s disease.

 2019-Biogen’s clinical trials on aducanumab were halted after showing no clinical benefit from the drug. (Melillo, 2021)

 August 20, 2020-Despite the lack of evidence in their drug treatment to mitigate dementia Biogen requested accelerated approval from the FDA. Accelerated approval was used to create and disseminate the Covid-19 vaccines, for which the regulatory exemption was intended. 

The use of accelerated approval for a nonlife threatening treatment is motivated by profit, not public health.

 November 2020-A panel of outside clinical experts voted NOT to approve aducanumab as an Alzheimer’s treatment as there was no evidence to support the claim it improved patient outcomes to slow the disease. The panel went against the recommendations of the FDA in their recommendation. 

It appears the FDA did not heed the advice of independent experts and overruled the panel to assuage Biogen.

 June 7, 2021-FDA approved Biogen’s aducanumab (Aduhelm) even though two randomized controlled clinical trials (the gold standard for research) failed to show this drug provided any clinical benefit, including delaying progression of dementia or improved cognition.

 June 11, 2021-Panel members Dr. Aaron Kesselheim, Harvard Medical School, Dr. David Knopman, Mayo Clinic, and Joel Perlmutter, Washington University all resigned in protest of the FDA’s decision. (Chappell, 2021)

 Clinical researchers, physicians, and healthcare advocacy groups were aghast at the FDA’s decision to accept specious evidence and use accelerated approval for this unproven Alzheimer’s treatment causing an explosion of conversations started throughout the country. One such organization, the Right Care Alliance.org, a part of the Lown Institute based in Massachusetts, immediately reached out to its members through its president, Dr. Vikas Saini.

 September 21, 2021-The Right Care Alliance provided a position statement on the FDA’s approval of Adulhelm. (Response to FDA Approval of Aduhelm, 2021)Their group of experts worked for free to break down the complexities of this decision and develop a clear summary of the issues and an action plan for everyone.  Here are the key points:

 1.  Diagnosis of Alzheimer’s is quite imprecise when tested against progressive cognitive failure. The two randomized control trials cited by Biogen as clinical evidence for improved cognition did not work.

2, FDA officials, who should be representing the public, partnered with Biogen to cherry-pick parts of the clinical trial data and changed the basis of the approval after the original submission . The drug was approved on the basis of a reduction in amyloid plaque deposits in the brain, but there was no improvement in patient’s symptoms.

3. Despite the lack of scientific consensus about the drug’s effectiveness the FDA approved it, which will open the door to a host of other unproven treatments with the same hypothesis. Linking something which is correlated  to a disease does not indicate causation, which is far from proven in the case of Aduhelm.     

4.  The Wall Street Journal estimates Biogen will make 40 billion dollars off Aduhelm, while it is undergoing further scrutiny in the next nine years, all at the expense of Medicare, a publicly financed healthcare program and of course, the patients, at a minimum cost of $56,000 per head.

The FDA is allowing Biogen to make money while it experiments on the public to hone their drug. FYI-the drug does have adverse side effects including bleeding and other complications. And we are going to experiment on Alzheimers patients with this-where is the ethics review?

5. Aduhelm approval needs to be withdrawn immediately and a new randomized control trial should be run by independent industry experts, before market approval. The Centers for Medicare and Medicaid should refuse to authorize this treatment or to pay for it until this is done. 

This would effectively shut down the distribution of the drug until further study as all private insurance companies and self-insured healthcare plans in the U.S. rely on CMS approval before they will accept a treatment as well. 

6.  FDA needs to be overhauled to prevent manipulation by well-heeled pharmaceutical companies bent on making a killing at the expense of us all. Dr. Janet Woodcock, current heath of the FDA should be replaced as she overruled the experts on her own panel. Clear conflict of interest was shown by Billy Dunn, head of the FDA neuroscience division, who met with Biogen privately and a lack of understanding about the principles of basic scientific evidence by Patrizia Cavazzoni, which were ignored.

Take Action With Unbiased Information

The Right Care Alliance has been on the frontline of the pharma-wars, including an effort for which I have been involved, reducing the high cost of insulin in the U.S. Recently, Eli Lilly announced it was cutting the price of insulin by 40% in the U.S. This grassroots organization is responsible for the fast and thorough analysis of yet another drug approval issue, Aduhelm. I have participated in multiple Right Care Alliance Conferences and advocacy initiatives and strongly urge you to follow them in your social media. For a copy of their easy-to-understand white paper go to their site.

 https://rightcarealliance.org/article/the-rca-position-statement-on-aduhelm/

For a clear path on what you can do as a citizen advocate who is interested in taking control of our health care and making it more effective, I strongly urge you to join or donate to the Right Care Alliance. Here are links to their organization:

https://rightcarealliance.org/

And since it is a nonprofit consider making a contribution to an organization that is working to make sure you have access to quality information and affordable health care to inform your decisions.

 https://secure.everyaction.com/uCm8ND9g80GwjQSmla5WMw2

And this is the healthpolicymaven signing off encouraging you not to sign blanket releases when you are admitted for procedures. This column does not provide any medical advice.

Roberta Winter is an independent journalist and healthcare advocate based in Washington State. This column has been in continuous publication since November 2007 and accepts no payments from any healthcare industry or insurance company.

References

Alzheimers.org. (2021, September 30). Alzheimer's Facts and Figures. Retrieved from Alz.org: https://www.alz.org/alzheimers-dementia/facts-figures

Chappell, B. (2021, June 11). 3 Experts Have Resigned from an FDA Committee over Alzheimers Drug Approval. Retrieved from NPR.org: https://www.npr.org/2021/06/11/1005567149/3-experts-have-resigned-from-an-fda-committee-over-alzheimers-drug-approval

Maddipatla, M. (2021, June 7). TIMELINE-The long road to approval of controversial Alzheimer's treatment from Biogen. Reuters, p. 2. Retrieved September 30, 2021, from https://www.reuters.com/article/biogen-alzheimers-fda-history-idCNL3N2NL3GJ

Melillo, G. (2021, July 14). How Biogen’s Aduhelm Approval Marks a Precipitous Turning Point for the FDA. AJMC.com. Retrieved September 30, 2021, from https://www.ajmc.com/view/how-biogen-s-aduhelm-approval-marks-a-precipitous-turning-point-for-the-fda

(2021). The F.D.A.'s Aduhelm Approval: Position Statement of the Right Care Alliance. Needham: Right Care Alliance.org. Retrieved September 21, 2021

 

 

House Appropriations Act of 2021-Insurance Brokers and Agents Must Disclose All Compensation from Insurance Companies

 

Finally-some good news for employers who provide medical insurance and other employee benefits to their workers. Buried in the House Appropriations Act of 2021 is a requirement that insurance agents and brokers disclose compensation and inducements from insurance companies to employers whose contracts they represent. (States, 2021) Agents will be required to disclose direct and indirect compensation they receive from insurance companies and they must do so at the time a contract is negotiated. (Allen, 2021) 

As a former insurance broker who specialized in employee benefits, this is long overdue and I always disclosed my compensation to clients in an annual report at the time of contract renegotiation. One of the reasons I left that industry was my behavior, which did not include gouging my clients and assiduously representing their interests was considered “naïve”. One of the more financially successful brokers in the Seattle area was in fact a broker who sold products to clients which the employees would have to pay for, but were no substitute for actual medical insurance, yet highly lucrative. None of these voluntary sickness and accident plans would protect employees in the event of a major illness. I hated to see employees having to pay more and more of their hard-earned money for medical plans with no improvements in care.

 Worse yet, prior to the approval of the Affordable Care Act in 2010, employers could discriminate against employees based on their health and some sought to do just that, not accepting a client if there were employees with medical needs above their stop loss target. In other words, insurance companies or in this case, reinsurance companies want to avoid any potential loss. I suspect in the world of reinsurance this practice is still ongoing though probably more subtle. Reinsurance is  used in self-insured health plans, which are exempted from laws that fully insured plans are subject to because it is not considered insurance under ERISA (US Department of Labor, 1974) It is always about the money not someone's health.

Moving at the glacial pace of the insurance industry, people have finally caught on to the conflict of interest these well-paid client representatives have between direct corporate incentives with their employers and indirect incentives to sell certain products from the insurance industry. Of course, the two largest brokerage firms, each worth a billion, Marsh McClennan and Willis Towers Watson are keeping mum on this. Afterall, their clients may ask for discounts when they see how much money they have been raking in, especially for health care plans.

In my 2013 book, Unraveling US Healthcare-A Personal Guide I wrote about the insurance industry fee rip offs, from excess reserves, to high administration costs, and of course what employers pay to their agents or brokers is plan overhead. (Winter, 2013)

However, in the last decade more people in the insurance industry became turned off by the perverse incentives to make insurance companies and their representatives wealthy but at the customer’s expense. A better way to do business with someone negotiating your employee benefit plans, including medical insurance, is on a fee basis, not commission. The fee is paid by the employer, the client directly to the broker’s firm. It is not always possible to get products without commissions in them, especially for life and disability plans, as these depend on the state product filing requirements, but it is completely feasible for corporate medical plans for employers with fifty or more employees.  

Marshall Allen, a healthcare advocate and Pro Publica reporter has just written a book which guides employers and every day consumers through the pitfalls of insurance contracts and ways to save money, Never Pay the First Bill And Other Ways To Fight The Health Care System And Win came out last month. (Allen, Never Pay The First Bill) In the event you don’t have time to read the book, here is a handy list of things you can do, as a financial officer, owner, or benefits purchaser for an employer:

1.       Know what your broker or agent representative is getting paid from your firm. Ask your representative directly for this information and if they stall or refuse to give it to you, find another representative.

2.        If your company pays Marsh McLennan $50,000 a year in commission, determine how this compares for your size firm and total plan contributions annually. If you are paying your representative more than 3% of the gross contributions for your medical plan, you are probably overpaying.

3.       Understand that the services you are getting which are bundled with the brokerage firm could possibly be less expensive by unbundling them and finding a consultant or third-party administrator for some of the services.

4.       There are brokers who will represent clients for flat fees, which could really save a client money. If you can find someone to negotiate your contracts for $15,000 instead of $50,000-why not!

5.       There is an organization which certifies consultants who follow best practices, avoiding agreements which generate conflicts of interest called the Health Rosetta, a clever play of words on the Rosetta Stone. (The Health Rosetta, n.d.) 

6. Do background checks on anyone you are entrusting with costly and confidential information about your company by checking client references and the Office of the Insurance Commissioner for any complaints before you contract with them. 

7. Know what you are buying, a health and accident plan is NOT major medical insurance and should not be represented as such. 

8.  Participate in employer groups which share experience and strategies for saving money without sacrificing care. 

9.  Read information from health care advocacy groups like LeapFrogGroup.org and the Lown Institute.org. 

10. Review your claims statements for fraud as your insurance company is probably not doing a good job of fraud prevention, especially for smaller claims, which are going to be anything less than $50,000 or more.

      The insurance industry is still a very flawed mechanism to deliver health care, but it remains the main vehicle to finance and direct treatment for about half the US population. The US is wedded to the insurance industry for now, so hopefully this piece provided some utility value for my readers.

 And this is the healthpolicymaven signing off encouraging you not to sign blanket releases when you consent to procedures, to designate that for which you agree and those treatments you decline. Your health care should be based on your values not some institutions.

 Roberta Winter is a healthcare analyst and journalist and she accepts no money for any of her opinions in this column, which has been under continuous publication since 2007.

References

Allen, M. (2021, January 9). Health Benefits Brokers Will Have to Disclose What They Receive From the Insurance Industry. Salon.com. Retrieved July 25, 2021, from https://www.salon.com/2021/01/09/health-benefits-brokers-will-have-to-disclose-what-they-receive-from-the-insurance-industry_partner/

Allen, M. (n.d.). Never Pay The First Bill And Other Ways To FIght The Health Care System And Win. Portfolio/Penguin. Retrieved July 25, 2021, from https://www.nyjournalofbooks.com/book-review/never-pay-first-bill

States, 1. C. (2021). Consolidated Appropriations Act 2021. Federal Register of the United States. Retrieved July 25, 2021, from https://www.congress.gov/bill/116th-congress/house-bill/133

The Health Rosetta. (n.d.). Retrieved July 25, 2021, from Health Rosetta.org: https://healthrosetta.org/

US Department of Labor. (1974). Employee Retirement Income Security Act of 1974. Retrieved July 25, 2021, from https://www.dol.gov/general/topic/health-plans/erisa

Winter, R. E. (2013). Insurance101. In R. E. Winter, Unraveling US Healthcare-A Personal Guide (pp. 171-176). Rowman and Littlefield. Retrieved July 25, 2021, from https://www.amazon.com/Unraveling-U-S-Health-Care-Personal/dp/1442222972

 

  

 

Biden's Proposal for New Government Agency On Disease Specific Research is a Bad Idea and Here's Why

 President Biden’s 2021 discretionary budget request includes 6.5 billion for the creation of a separate government healthcare research agency, outside the purview of Health and Human Services. The agency, entitled Advanced Research Projects Agency-Health (ARPA-H) is modeled after the defense agency DARPA. This analysis reviews why this proposal is a bad idea for healthcare, public spending and for governmental oversight. Here are the criteria the Biden Administration outlined for ARPA-H:

1. Research funding would not be subject to the normal Health and Human Services Agency grant vetting process

 2. The focus would be on research that would not necessarily have a foreseeable payoff

 3.  Initial research would focus on three diseases Alzheimer’s, Diabetes, and Cancer

The creation of ARPA-H balloons federal spending for an unnecessary healthcare agency with no clear mandate and porous accountability, while competing for resources from existing healthcare research initiatives, which have been vetted. Healthcare research in the U.S. is still largely funded by Health and Human Services (HHS) through grant awards mostly to universities and nonprofit research groups. The annual medical research allocation for all government agencies was 39.5 billion in 2017. (Research America An Alliance For Discoveries in Health, 2018) In 1991, the U.S. funded 83% of all biomedical research in the nation and by 2017 U.S. investment in scientific research had fallen to less than half. (Mervis, 2017)  Though the U.S. has always been the global leader in medical research, China is catching up, as well as other nations. It could be argued that the world’s leading scientists chose to open their labs in other countries due to the Trump Administration’s arcane immigration policies. Our neighbor to the north, Canada is a beneficiary of this short-sited policy and Toronto is now a hotbed for medical research.

The ARPA-H agency creation proposal is not even supported by many leading scientists, which are concerned that a huge introduction of funding without clear guidance and controls would be harmful to healthcare research initiatives. (Winter L. , 2021)

Top Causes of Death in the United States

Further, the number one killer in the U.S. is heart disease, which is largely preventable through public health education and early intervention. (Kenneth D. Kochanek, n.d.) Though cancer deaths rank number two for overall mortality, respiratory disease is third, meaning Chronic Obstructive Pulmonary Disease, people who can’t breathe because of their disease etiology which is linked to environmental pollution and smoking. Efforts to reduce particulate pollution caused from diesel vehicles have been shown to improve population health outcomes for those with respiratory disease. Why not throw the 6.5 billion into research to clear the air of climate warming health harming pollutants? Accidental injuries are the fourth cause of death for adults, so prevention of accidents through public education and resourcing would seem to be a good public health investment. Fifth place on the-cause-of-mortality list is stroke and there have been innovative ideas from the Centers for Disease Control and Prevention, an HHS Agency to reduce harmful impacts of stroke, by rapid administration of tPA (tissue plasminogen activator) to prevent long term health impairment. Alzheimer’s is the sixth leading cause of death and Diabetes is seventh, however kidney or nephritis is eighth on the all-cause mortality list and it is closely linked to long term Type 1 Diabetes. Pneumonia is ninth and frequently occurs in patients who have been hospitalized and is not always preventable.

Suicide, ranks as the tenth leading cause of death in the U.S. According to the Center for Health Statistics suicide rates for America’s young people increased by 57% between 2007 and 2018, including children as young as ten. If that isn’t enough to wake you up, I don’t know what hole there is where your heart should be. Even children can’t stand to live in the United States of America. This factoid should be considered a public health crisis and scarcely receives a mention. All we hear about are corporate profits and how we can’t afford to provide healthcare or school lunches for everyone.

Creating competition versus cooperation for funding resources among healthcare agencies is not in the best interest of public health. The tired idea that competition makes everything better and lowers costs in healthcare is not true. The U.S. has the most expensive healthcare system in the world, with results that are no better than other countries and it spends 40% more than most other industrialized nations. Yet, the U.S. doesn’t even provide healthcare to all of its people, including children, whose distribution is immorally dependent on their parentage and birthplace. The current profit-taking healthcare climate has produced nonprofit hospitals making so much money they have their own venture capital funds. (Drucker, 2020) This capitalistic climate has occurred in part because of increased government funding through the Affordable Care Act in 2010 and due to hospital consolidation in this sector. Hospital closures do have an adverse impact on community health, but often book a positive outcome for the financial statements of huge hospital corporations. The pandemic hospital bailouts exposed how poor rural hospitals were not given funds but rich hospital corporations received billions. (Winter R. , 2020)

Creating Effective Healthcare Investment

All investments and interventions in national healthcare should ask these three questions:

1.  Is this necessary?

2. Who does it harm?

3. Should we be doing it?

An amorphous healthcare agency without the same rules for government oversite is not the answer to improving population health for ALL of the American people, who actually finance all government endeavors. Before we saddle our children with another government agency, let’s fund and improve the ones we already have which have demonstrated their value.

 And this is the healthpolicymaven signing off encouraging you not to sign blanket releases when undergoing medical procedures, do stipulate that for which you consent and which you decline. This column has been in continuous publication since 2007 and accepts no money from any healthcare entity. All research and opinions are those of Roberta Winter, an independent journalist and healthcare advocate. Her guidebook on the U.S. healthcare system was published by Rowman and Littlefield in 2013, which focused on state health rankings, disparities in care, and discerning quality at the consumer level. https://www.amazon.com/Unraveling-U-S-Health-Care-Personal/dp/1442222972

 References

Drucker, J. (2020, June 8). Wealthiest HospitalsGet Billions in Payouts for Struggling Providers. The New York Times.

Kenneth D. Kochanek, M. J. (n.d.). Mortality in the United States, 2019. (N. C. Statistics, Editor) Retrieved June 2, 2021, from Centers for Disease Control and Prevention: https://www.cdc.gov/nchs/products/databriefs/db395.htm

Mervis, J. (2017, March 9). Data check: U.S. government share of basic research funding falls below 50%. Retrieved June 2, 2021, from National Science Foundation: https://www.sciencemag.org/news/2017/03/data-check-us-government-share-basic-research-funding-falls-below-50

Research America An Alliance For Discoveries in Health. (2018, October 1). US Investments in Medical and Health Research Development 2013-2017. Retrieved June 2, 2021, from Research America.org: https://www.researchamerica.org/sites/default/files/Policy_Advocacy/2013-2017InvestmentReportFall2018.pdf

Winter, L. (2021, April 12). President Biden Proposes Creating Two DARPA-like Agencies. Retrieved from The Scientist.com: https://www.the-scientist.com/news-opinion/president-biden-proposes-the-creation-of-two-darpa-like-agencies-68660

Winter, R. (2020, October 13). Unintended Consequences of Pandemic Hospital Bailouts May Hasten Their Demise. Retrieved from Straight Talk on Health Care: http://healthpolicymaven.blogspot.com/2020/10/unintended-consequences-of-pandemic.html

 

 

Hospital Pricing Transparency-New Rules What Patients Can Expect To Be Charged

This article was originally published May 4, 2021.

Effective January 1, 2021 there are new rules for hospital charges or prices and how this is communicated to customers in the United States. Hospitals must host their negotiated prices and chargemaster (gross prices) in a machine-readable file online. (Health and Human Services Agency of United States, 2019) In an effort to see how compliance was going for this gargantuan task, I surveyed a number of hospitals throughout the country.  

 Methods: Data was extracted for two cardiac procedures with major complications, installation of a shunt and a stent, through verification of the diagnostic code and procedure description. Chargemaster is the universal guide that US hospitals use for procedure charges. Prices were analyzed for the gross price, cash payer or uninsured individual payor payments, and private insurance company reimbursements. Only Virginia Hospital Center Health System provided detailed data by each insurer contract, the rest were aggregated, based on a median or an average, depending on what the hospital provided. A table was made to show the variance between the self-pay and insurance reimbursed prices. Since the hospitals are in different regions of the country the price per hospital comparison reflects cost factors on the East coast, Midwest, and the Pacific Northwest. All hospitals are nonprofit entities.

Procedures by Price	Ventricular shunt with major complications	Stent with major complications, 4 arteries
Hospital	Virginia Hospital-Arlington	Virginia Hospital-Arlington
Price-Chargemaster	$52,999.45	$68,262.05
Price-Self-Pay	$42,399.56	$54,609.64
Price-Insurance Contracts	$35,968.97 (average/all payers)	$27,973.02 (average/all payers)
Hospital	Mayo Clinic-Rochester	Mayo Clinic-Rochester
Price-Chargemaster	$40,370.55	$84,190.96
Price-Insurance Contracts	$17,453.37 (median value)	$30,194.61 (median value)
Hospital	University of Washington-Seattle	University of Washington-Seattle
Price-Chargemaster	Search did not provide	$158,736.00
Price-Insurance Contracts	Search did not provide	$100,004.00 (gross less discounts)
Hospital	Virginia Mason Hospital-Seattle	Virginia Mason Hospital-Seattle
Price-Chargemaster	$61,42.33	$101,811.59
Price-Insurance Contracts	Not provided	Not provided

 

Results Best to Worst for Transparency

1. Virginia Hospital Center Health System-Arlington (DC area)-This east coast health system provides an extractable EXCEL file which discloses; gross price in the chargemaster, what the uninsured might pay, and each insurance companies payment by procedure. This was easy to use and thoroughly complied with hospital pricing transparency and is included in the price comparison table. https://www.virginiahospitalcenter.com/patients-visitors/billing-financial-assistance/price-transparency/

 2. Mayo Clinic-Rochester-Provides a machine-readable CSV file of its entire chargemaster file, which can be converted to EXCEL and takes 30 minutes to download, but this would allow analysis by procedure. However, the data does not allow for discernment by insurer or by self-pay customers. Finally, the file size is so large most individual users would not be able to extract and save it, but analysts will love it. https://www.mayoclinic.org/patient-visitor-guide/billing-insurance/price-estimates/chargemaster

3.  University of Washington Medical Center-This Seattle hospital provides a downloadable file of its average DRG code charges per case, but no information on insurance company prices. There was some information on average discount per procedure offered in aggregate, but it was not possible to discern how this would impact privately insured customers versus those without medical insurance. This might comply with the 2021 pricing transparency ruling. I was able to make a rough calculation of the cost at the patient level per procedure, by calculating the aggregated discount it provided for all payors. https://www.uwmedicine.org/patient-resources/billing-and-insurance/charge-description-master-codes

 4. Virginia Mason Medical Center-Seattle- Provides their chargemaster and median insurance payor reimbursement data. Therefor this data may meet the legal requirements of the transparency law but it will not be helpful to consumers because it doesn’t differentiate between insurer contract prices and what cash payers are charged. https://www.virginiamason.org/virginia-mason-standard-charges

5.  Kaiser Permante Foundation Hospital-Central-Hosts a limited tool to assess procedure costs, but does not show its entire chargemaster schedule from which to gauge baseline costs and actual costs paid by insurers by diagnostic code or procedure. It provides a very limited list of inpatient procedures and I was unable to find a match for a common cardiac procedure when I searched the EXCEL file. https://wa.kaiserpermanente.org/html/public/health-plans/hospital-charges

 Analysis

Determining what you will actually end up paying for medical procedures in the US is fraught with risks and this regulation, created under the Trump Administration is a step towards greater transparency. The prices are based on the Medicaid and Medicare diagnostic codes and the hospital chargemaster data, but do not necessarily reveal all that a patient might pay. A median charge is not the same as what you might actually pay. However, if an organization wants to review price and quality rankings when contracting for services it is a baseline. Each hospital has a department which advises the patient on her financial responsibility at the time of admission. Of course, in the event of an emergency this is moot, because your life, presumably is more important.

 And this is the healthpolicymaven signing off encouraging you not to sign blanket releases when you consent for procedures, do indicate that for which you consent and which you decline. This is absolutely critical now when more hospitals are Catholic owned enterprises which apply Catholic law in their health practices, regardless of your theology. If you have specific end-of-life instructions, make sure you have an advanced medical directive in place, so your life is not held in the balance because of an ethics committee decision.

 This column has been in continuous publication since 2007 and does not purport to provide medical advice and does not accept remuneration from any company in the  healthcare industry.  Healthpolicymaven is a trademark of Roberta Winter and her company.

 References

Health and Human Services Agency of United States. (2019, November 27). Price Transparency Requirements For Hospitals To Make Standard Charges Public. (H. a. Department, Editor) doi:84 FR 65524

 

Healthcare Reform Proposals Under the Biden Administration

Healthcare costs are constraining US households and the national economy, because the amount of government investment and private sector payments are the highest in the world, for results that are no better than the rest of the industrialized countries. This article reviews three different approaches, from the Democrat and Independent political spectrum for healthcare reforms. There is no Republican inclusion because that group has never managed to develop any comprehensive proposal for healthcare reform. To make it easier on those challenged with long text, here is a table summarizing the Medicare X, Biden Public Option Plan, and Bernie’s Medicare for all.

Plan	Medicare X-Kaine/Bennet (Medicare X Choice Act, 2021)	Biden Public Option (Biden Unveils Health Care Plan, 2021)	Bernie Medicare for All Single Payor (Sanders, 2021)
Focus	Emphasizes rural America and could be in the small healthcare market by 2025. Provides healthcare coverage where there is a lack of providers. Uses the same network as Medicare, adds primary care and obstetrics for families.	Offers a public option into the federal employees type plan(luxe) for uninsured people and expands eligibility for those age 55 and up. Also expands subsidies for families within 300% of the FPL for Medicaid. Wants the federal gov to finance 75% of all catastrophic care bills. Throws another billion at EMR. Provides support for 100K more nurses.	Provides a national healthcare plan, based on Medicare expansion for everyone in the US. This plan would be like the Canadian plan, which works well and is less expensive than the US healthcare system.
Financing	Uses the current insurance premium structure and expands tax credits to pay for medical insurance for those within 400% of the FPL.	Finances the entire thing off the general budget allocation-no specific tax hits for targeted groups yet. Would have to increase taxes.	Would require a combination of insurance premiums and higher taxes for employers. Medicare is less expensive than private insurance by far. Restores the marginal tax rate to 52% from the current rich-give-away of 37%. Corporate taxes would increase too from 21% to ?
Benefits	Targets rural communities and offers 125% of Medicare reimbursement rates to entities serving them.	Expansion of healthcare for families is a good idea and the public option may end up being efficacious for the nation.	Providing national healthcare would mean everyone in the nation would have basic healthcare and the opportunity to eliminate wasteful healthcare spending.
Infrastructure changes	Starts a national reinsurance plan which would lower premiums by using the large purchasing power of the US than reinsurers from Lloyds of London.	Would make the federal government responsible for catastrophic healthcare costs over $50,000.	Would make the federal government responsible for healthcare planning, distribution, and resourcing. But Medicare already does this very well.
RX Impact for consumers	Will give the head of Health and Human Services the power to bargain with drug companies	Nothing specific yet, but Biden supports Health and Human Services negotiating with pharma to lower drug prices for public plans.	Will give the head of Health and Human Services the power to bargain with drug companies to lower drug costs and the US gov is the largest customer.
Cost	Supposed to be cost neutral because premiums would pay for it.	Shores up the Affordable Care Act so funded through premiums and fee assessments.	Employees would pay 4% more in a payroll tax, but would no longer have to pay for medical insurance (equal to at least 10% of gross pay now). Employers would no longer have to pay for private insurance, but they would have to pay an additional 7.5% in payroll tax, making that 16.15% if the current SSI and Medicare taxes are in place. Self-employed people would pay 22.8%.

 

Analysis

The Bernie Sanders plan may actually be less expensive (when you consider systemic improvements) than President Biden's and has a clear path to finance the deployment of healthcare to everyone in the US. Every other industrial country in the world has a national healthcare plan and spend a lot less than the US, up to 40% less, which is a lot of money to use for education and infrastructure. The US spends over $10,000 per person on healthcare, which is more than twice what Australia, Canada, France, or the UK spend.

Biden’s plan would make the nation responsible for all medical costs above $50,000 which would be a costly disaster if the current private insurance system is still in place (AKA subsidizing insurance company avaricious behavior and profits). Capping costs above 50K is also too low, based on exhorbitant healthcare costs in the US. The annual cost of Zolgesma, a drug used to treat a motor neuron disorder for those with spinal atrophy is over two million. I don't see any indication of reforming drug approval processes, like the orphan drug rule or applying population health measures to drug company reformulations, which is a ruse to replace drugs whose patents are expiring. Passing this debt on to everyone else is not the answer UNLESS there are meaningful reforms in the drug approval process and the US government finally starts negotiating with big pharma for lower prices, which is what every other nation does. 

The correct response is to REFORM the US healthcare system which would include; cutting waste, curbing unnecessary procedures, using the full power of the massive US government to negotiate contracts and increasing investment in primary care. Bernie Sander's plan would do all of these things, but there would be a significant upfront cost, with savings realized over time. The problem is Americans have the attention span of gnats and Congressmen get elected every four years, which doesn't bode well for patience to see results mature. 

Of these major proposals for healthcare reform, the Kaine/Bennet proposal has the optimal approach, because it addresses the serious shortfall of rural healthcare with a reasonable approach and wouldn’t cost that much. One of the crying problems in US healthcare is the fact health services are very limited in rural areas thanks in large part to the huge hospital groups eliminating “unprofitable facilities from their portfolios.” In other words, they don’t make enough money from serving your needs, which is EXACTLY the reason the government needs to intercede in healthcare, whenever there is a private market failure. By demonstrating that we care about people outside the tech centers and the beltway the nation may just be able to start reforming our healthcare system.

 And this is the healthpolicymaven signing off encouraging you not to sign blanket waivers at hospitals or surgical facilities, do stipulate that for which you consent and for which you don’t. 

 Roberta Winter is the healthpolicymaven and is an independent journalist who has been publishing this column since 2007. The opinions expressed here are her own and are not paid for by any sector of the US healthcare system.  She is the author of a guidebook to the US healthcare system which was published in 2013 by Rowman and Littlefield.

https://www.amazon.com/Unraveling-U-S-Health-Care-Personal/dp/1442222972

 References

Biden Unveils Health Care Plan. (2021, March 6). Retrieved from Commonwealthfund.org: https://www.commonwealthfund.org/publications/newsletter-article/biden-unveils-health-care-plan

Medicare X Choice Act. (2021, March 6). Retrieved from Bennett.Senate.gov: file:///C:/Users/Roberta%20Winter/Downloads/B62E7A3B8A60C537EB62A11FCC018684.medicare-x-2019-one-pager.pdf

Sanders, B. (2021, March 6). How Does Bernie Pay His Major Plans. Retrieved from Bernie Sanders.com: https://berniesanders.com/issues/how-does-bernie-pay-his-major-plans/

 

 

 

 

Consumer Impacts of Biden Administration Repeals of Trump Administration Environmental Protection Agency Changes

 Still feeling whiplash from the past four years? This table explains the actions President Biden has taken to rollback Trump Administration edicts that adversely impacted your air, water, and health in his first few days in office.

Metric	Trump	Biden	Impact for Consumers
Fuel Efficiency	Reduced fuel efficiency standards to 40 MPG	Reinstates fuel efficiency standards for cars to 54 MPG by 2025, overrules Trump	Greater fuel efficiency means we pay less at the pump and less CO2 go into the air; additional cost to car buyers is nominal
Auto Emission Standards: California has had some of the strictest auto emissions standards, for 30 years, which manufacturers must meet	Attempted to circumvent the CA stricter emissions rules and overrule states rights to adopt the loser federal standards of the Trump Administration, even though many automakers objected	The court case against California standards, which are adopted by 15 states and the DOC, will be dropped	Good news for people living in:  California, Colorado, Connecticut, Delaware, Maine, Maryland, Massachusetts, New Jersey, New Mexico, New York, Oregon, Pennsylvania, Rhode Island, Vermont, and Washington, as well as the District of Columbia.
Sale of Alaska Wilderness Oil Leases	Approved for January 2, 2021, subject to a 30-day comment period, but Trump tried to accelerate this to 16-days to avoid Biden’s reversal	Not in favor of drilling in the pristine and fragile Arctic National Wildlife Refuge, leases will not be approved	There is a glut of oil already in the US, this is just an industry grab, at the expense of the environment, no leases are better for ANWR.
Government Accountability	Trump’s Cabinet has rewritten myriad rules in government agencies, including the EPA. Trump created the onerous Cost/Benefit methodology which diminishes public health impacts and prioritizes business considerations for adopting environmental rules.	Biden has put a freeze on implementation of any Trump rules until further analysis. Aims to prevent the midnight regulatory changes pushed by a lame duck president.	The scientific community was uniformly opposed to the Trump cabinet ignoring and weakening scientific findings to create rules favorable for a few. This will prevent unhealthy changes from taking effect and adversely impacting public health through ground water, air, and product contaminants.

Happy New Year!

This posting was written by Roberta Winter, author, independent journalist, and healthcare advocate, who has continuously published this column since November 2007.