Will Humble Disease Control, Vaccination, Wills Blog

Dr. Joe Gerald’s Weekly Epidemiology & Hospital Occupancy Report

Dr. Joe Gerald’s Weekly Epidemiology & Hospital Occupancy Report

From Dr. Gerald:

“Bad news continues to compound. Cases, hospitalizations, and deaths continue to increase locally. Interestingly, our current case rates our identical to those of the same calendar week last year. While transmission is expected to rise for the remainder of the holidays, let’s hope it is not as brisk as last year. In a small glimmer of good news, transmission is shifted just a bit towards children and away from adults. Also, influenza cases in Arizona trail historical averages, so no evidence of a ‘twindemic’ yet.

Unfortunately, the WHO named another Variant of Concern this week, the Omicron variant. Identified by South African authorities it has multiple mutations to its spike and domain binding proteins which gives rise to concerns about increased transmissibility and immune escape. 

Currently, there is not enough information to understand what impact it is going to have on the pandemic’s trajectory. Anyway, we’ve got our hands full in Arizona with the Delta variant. What’s needed hasn’t changed a bit: get vaccinated, get tested, wear a mask, and avoid high risk exposures (e.g., prolonged indoor exposure where others aren’t masked). I’ve upgraded from cloth to KN-95’s myself and got my third shot booster! Hopefully, others will do the same.”

View the Full Weekly Report
Will Humble Prevention, Tobacco

Navajo Nation Goes Smoke Free- Even the Casinos

From Navajo Nation President Nez:

In case you haven’t heard, the Navajo Nation recently banned all commercial tobacco use, including smoking and vaping, in enclosed and indoor areas on the Navajo Nation, including casinos! 

Patricia Nez Henderson (our incoming President) was instrumental in passage of this legislation, as were other SRNT members and many members of the Navajo Nation. It is another great example of science, advocacy, and public policy working together to advance public health.

For additional information on the new law, here are a few links:

Congratulations to the Navajo Nation and thank you to all of those who worked for years to make this happen!

Have a Happy & Safe Thanksgiving Everybody! 
Will Humble Disease Control, Wills Blog

As Hospitals Enter Contingency Standards of Care, Brnovich Tries to Undermine CMS Vaccine Requirements

Twelve states including Arizona have filed a lawsuit in a federal district court in Louisiana challenging the Centers for Medicare & Medicaid Services interim final rule that mandates COVID-19 vaccines for workers at Medicare/Medicaid participating facilities by January 4.

Attorney General Brnovich argues that the CMS rule exceeds their statutory authority, violates the Tenth Amendment, and that the rule is arbitrary and capricious. For once, the suit doesn’t blame refugees and immigrants.

This lawsuit follows the complaint filed last week by a different group of states in a U.S. district court in Missouri also challenging the CMS interim final rule on similar grounds. For more information about the CMS rule, please refer to AzHHA’s Summary and CMS’s FAQs.

Will Humble Assurance & Licensure, Disease Control, Healthcare, Wills Blog

Contingency & Crisis Standards of Care: A Refresher

As pressure continues to mount in Arizona’s hospital system, I thought it would be good to provide a little summary in plain language about what those words mean.

Hospitals generally operate under conventional standards of care. That just really means that they’re providing patient care without any change in daily practice.  Every cold and flu season hospitals face surges in demand (like the week after Christmas and off and on during January and February in Arizona). But hospitals are still operating under conventional care standards.

They juggle space and staffing and may temporarily ask ambulances to go to alternate facilities or accelerate the discharge of healthy patients. Staff may be asked to work in a different part of the hospital than they’re used to (for example a surgeon might be asked to work in the ER) but everyone is still working in their bounds of expertise, under normal staffing ratios, and following standard protocols.

As hospitals transition to contingency standards of care (where AZ is operating right now) hospitals change their practices and do everything they can to maintain the standard level of care. 

For example, under contingency care hospitals may repurpose rooms of the hospital for different kinds of clinical care than usual, like converting surgical rooms for emergency services or using recovery rooms as a makeshift intensive care unit. Doctors, nurses, and respiratory therapists make different decisions about what therapies to use because of resource shortages too. Staffing rations may be altered, with nurses on general ward and ICU floors managing more than the standard number of patients.

Practitioners may start conserving supplies by, for example, not providing precautionary oxygen to patients who under normal circumstances would receive it, but who can survive and recover without it.

Patients are transferred between hospitals as they try to level out patient loads when they have periods of time. Some hospital systems like Banner are large enough to do interfacility transfers using their own resources and data. Others will need to contact the ADHS Surge Line, where transfers can be facilitated.

Hospitals restrict non-emergency procedures. This isn’t something hospitals like to do because patients really need these important procedures and because general surgery and elective procedures contribute much to the financial bottom-line. Nevertheless, these procedures will begin to be postponed or canceled. 

Hospitals change their admission decisions. For example, persons presenting in the emergency department may be sent home when, under normal circumstances, they would be admitted. Likewise, a patient that would normally be admitted to an Intensive Care Unit (with robust staffing rations) might instead be placed on a general ward bed.

Hospitals change their discharge decisions. People that have been admitted and who would normally stay for a couple more days will be discharged rather than observed. In some cases, persons that are in the ICU may be discharged directly to home rather than admitted to a general ward bed. Others will be discharged to a skilled nursing facility rather than a general ward hospital bed.

When the system becomes totally saturated, as may be the case at some point in December, hospitals will ask the ADHS to allow them to operate under Crisis Standards of Care. 

“Crisis Standards of Care” is basically a protocol for making healthcare decisions when the system can’t provide all of the care that everybody needs because the needs outstrip the resources. Ethics panel discussions will be held to make difficult decisions regarding who will get care and who will not.

Under Crisis standards hospitals need to make even more substantial changes to the way they provide care. For example, staff are asked to practice outside of the scope of their usual expertise. Supplies are reused and recycled. In some circumstances, resources may become completely exhausted.

Core strategies that get used under Crisis standards include substitution, adaptation, conservation, reuse, and reallocation in the areas of for oxygen, medication administration, IV fluids, mechanical ventilation, nutrition, and staffing.

The Crisis Standards of Care also provides a protocol to help healthcare providers objectively decide who gets care when resources don’t allow everyone to get treatment.  These blog posts flesh it out:

Here’s a link to the ADHS Crisis Standards of Care Planning Document. It’s 141 pages, but the real heady stuff is on pages 29 through 38 where it discusses the scoring system to prioritize which patients will get treatment and which will not and how to ration care to all patients when resources are outstripped by demand.

The ADHS also has an Addendum to the report called Arizona Crisis Standards of Care Addendum April 2021.

The Arizona Crisis Standards of Care Addendum is COVID specific and outlines specific triage protocols that hospitals should use to decide who gets care and who doesn’t. Once we get to Crisis Standards of Care (likely to happen sometime in December) doctors will be using this document to decide who gets for example the last extracorporeal membrane oxygenation (ECMO) machine or who needs to be pulled off an ECMO to make room for a patient more likely to survive.

Pretty grizzly stuff… but it will probably become a reality again this December due to the decisions that Governor Ducey made last summer to refuse to use policy interventions to encourage vaccination and universal indoor masking.

Will Humble Disease Control, Vaccination, Wills Blog

Arizona Hospital Bed Availability At It’s Lowest Point During the Pandemic

View Dr. Joe Gerald’s Weekly Epidemiological & Hospital Occupancy Report

The situation in Arizona hospitals is becoming increasingly dire. The number of available ward beds are now at the lowest point they have been during the pandemic. Access to care will continue to be restricted in the face of staff shortages in inpatient and outpatient settings. There’s undoubtedly primary and probably secondary triage happening already, and many Arizona hospitals are likely already operating under Contingency Standards of Care.

Read More About Contingency & Crisis Standards of Care

As of November 17th, 2403 (27%) of Arizona’s 8774 general ward beds were occupied by COVID-19 patients, a 14% increase from last week. Thirty-four percent (34%) of Arizona’s 1782 ICU beds are occupied by COVID-19 patients, a 12% increase from last week. 

COVID-19 hospital occupancy is holding steady and will likely exceed 25% of all beds in the general ward and 30% of beds in the ICU for the remainder of the year. Because ADHS uses licensed beds in the denominator of their occupancy statistics rather than staffed beds- there’s less room at the inn than meets the eye. 

Arizona also continues to experience high levels of community transmission. Test positivity also remains high reminding us that test capacity, accessibility, and/or uptake is inadequate. Increasing case rates among older, highly vaccinated groups serves as a warning that major behavioral shifts and/or waning immunity could result in future increases in not only cases but also hospitalizations.

New cases were being diagnosed at a rate of 347 cases per 100K residents per week. The rate was increasing by 13 cases per 100K residents per week. Navajo, Greenlee, and Gila counties have case rates nearing their previous pandemic highs.

Meanwhile, Governor Ducey & Interim Director Herrington continue to nonchalantly shrug their collective shoulders.

View Dr. Joe Gerald’s Complete Weekly Epidemiological & Hospital Occupancy Report

Will Humble Disease Control, Vaccination, Wills Blog

Who’s At Highest Risk for a Bad Breakthrough Case?

This study in the British Medical Journal analyzes who is at highest risk of death even after having been vaccinated

The authors of this article use a risk prediction model to stratify risk of severe covid-19 outcomes among people that are already fully vaccinated. They found that the dominant risk factors for breakthrough hospitalization and death are people with:

  • Down syndrome
  • Kidney transplantation
  • Sickle cell disease
  • Nursing home residents
  • People undergoing chemotherapy
  • People with a recent bone marrow or solid organ transplant
  • People with HIV/AIDS, dementia, Parkinson’s disease, neurological conditions, and liver cirrhosis.

Everybody in all of these categories should get a booster shot 6 months after they were fully vaccinated.

Will Humble Air Quality, Climate Change, Federal Budget, Wills Blog

Climate Change & the Federal Build Back Better Act (BBBA)

Democratic Leadership in the House started last week with a goal of passing the BBBA and the bipartisan infrastructure bill by the weekend. They ended the week with the bipartisan infrastructure bill passed but a vote on the larger Build Back Better Act is on hold until this week or later. 

The initial regular infrastructure bipartisan bill will be signed into law this coming week, which is a good thing. This initial infrastructure bill does little to transition to U.S. to carbon free energy sources and doesn’t do anything for the human infrastructure pieces like making childcare more affordable etc.

I’ll keep my eye out for critical control points this week so we can do what we can to keep up the pressure to seal the deal on the Build Back Better Act. In short, the initial bipartisan infrastructure package that will be signed this coming week is not a climate bill! We need the BBBA bill to pass, which does have several important climate change provisions built into it.

We need to reach priority members of congress this week like Senator Sinema and Kelly to shore up support for the Build Back Better Act. I’ve had conversations with their office staff in the last couple of weeks about climate and prescription drugs.

If any of you have relationships with the staff, I urge you to make appointments and make your voice known- and make sure to mention that you are a member of AzPHA. Here’s a toolkit to reach moderate members. 

 Climate Change Talking Points to help you:

  • To fight the climate crisis, create millions of new good-paying clean energy jobs, and build the foundation of an equitable and thriving clean energy future: we need the Build Back Better Act.
  • The bipartisan infrastructure bill that just passed makes no meaningful reductions in carbon emissions, and commitments on other key environmental justice and climate issues.
  • Key parts of the bipartisan infrastructure bill (like electric vehicle charging stations, power infrastructure, and climate resilience) can only be unlocked if passed with the complementary, transformative climate investments in BBBA.
  • Climate action is the only fiscally responsible choice. Climate-fueled disasters are already costing us hundreds of billions of dollars every year—Hurricane Ida alone resulted in more than $64.5 billion in damages across the country—we can’t afford to wait to act any longer.

Senator Sinema Contact Info: @SenatorSinema

3333 E. Camelback Rd, Suite 200
Phoenix, Arizona 85018
Phone: 602-598-7327

317 Hart Senate Office Building
Washington D.C. 20510
Phone: 202-224-4521

Senator Kelly Contact Info: @SenMarkKelly

2201 E. Camelback Rd
Suite 115
Phoenix, AZ 85016
Phone:  602-671-7901

Hart Senate Office Building
Suite 516
Washington, DC 20510
Phone:  202-224-2235

Will Humble Affordable Care Act, Federal Budget, Federal Public Health Bud, Health Insurance, Healthcare, Wills Blog

Modest Drug Pricing Reform May Finally Be On the Way

Final Deal is an Improvement but a Missed Opportunity for More Meaningful Drug Pricing Reform

For the last 20 years, all Americans have been getting ripped off by pharmaceutical companies. The heist began when a prescription drug benefit was added for Medicare enrollees (Medicare Part D). Drug company lobbyists made sure Congress wrote the law to prohibit Medicare from negotiating drug prices.

As a result, Medicare pays 300% more for prescription drugs than in Europe or Canada, and close to 10x higher than in developing nations. That means every American who gets a paycheck is paying way more than necessary for prescription drugs.

We’re ALL being scammed, not just Medicare beneficiaries, because Medicare is financed with a (regressive) payroll tax.

Medicare Part D is financed by Medicare Trust Fund payroll tax revenue (71%), Part D premiums (17%) and state payments for people dually eligible for Medicare and Medicaid (12%). Employers & employees each pay a 1.45% tax on wages up to $200,000 (2.9% total) into the Trust Fund. Individuals (not employers) pay a 0.9% tax on income above $200,000 per year (no upper limit).

Because Medicare is paid for by a payroll tax, everybody who earns a paycheck is getting ripped off by drug companies- even if they’re not enrolled in Medicare and even if they don’t even take prescription drugs!

Compromises that were reached last week in the Senate make it look like modest prescription drug pricing reform might now survive the intense lobbying that the pharmaceutical industry has been doing, but not before the proposal was greatly watered down.

Previous AzPHA Blog Posts:

The latest version of the plan before congress would reduce some out-of-pocket costs for seniors enrolled in Medicare Part D, but the Medicare Trust Fund will continue to be fleeced, unnecessarily draining the Medicare Trust Fund.

Here’s a summary of what the weakened compromise bill looks like:

If the compromise bill passes, the first changes would come in 2023 when there will be a limit on annual price increases for existing drugs and out-of-pocket cost limits for insulin for Medicare beneficiaries.

There will be modest penalties if companies raise prices faster than inflation. The formula for penalties will consider prices charged to private health insurance to prevent them from shifting exorbitant prices to private health insurance.

In 2023, Medicare enrollees with diabetes will only have to pay $35 monthly copays for all insulin products covered by their prescription plan. People with private insurance would be able to also have their insulin co-pays capped a $35 copay.

Note: This policy will help the actual patients but will raise private health insurance premiums because the actual price that the drug companies charge health plans will continue to be unreasonable.

In 2024, there will be a cap on out-of-pocket costs for people enrolled in Medicare Part D (the prescription drug part of Medicare). The people that will benefit the most from the out-of-pocket caps will be folks with cancer, diabetes, multiple sclerosis, rheumatoid arthritis, and those who take combinations of expensive medicine for complicated health problems. Out-of-pocket caps would be $2,000 a year (the current annual out-of-pocket average for Part D people is $3,200 (2019).

A year later (2025), Medicare would FINALLY begin to be able to negotiate price with drug companies on a handful name-brand drugs, but drug companies will still be able to set launch prices for new meds. Medicare will only be able to negotiate the price for 10 drugs that year. The number of medicines with negotiated prices will slowly grow over time reaching 100 in several years.

The drug company lobbyists were able to get to certain members of the Senate to get huge concessions on what would have otherwise been a strong bill:

  • Drug companies will still be able to set launch prices for new meds under Medicare;
  • Drug companies were able to limit the number of drugs whose prices can be negotiated (10 drugs beginning in 2025, but slowly increasing to more drugs over the years);
  • Numerous super-expensive medications are exempt from negotiation (half of the top 25 Medicare drugs care can’t be on the negotiation list); and
  • The initial negotiation start date was pushed back several years (to 2025).

The proposal won’t use drug prices in the G7 nations as Medicare’s yardstick (greatly weakening the ability of Medicare to use overseas drug costs as a yardstick to compel honest negotiations).

For the handful of drugs that will be able to be negotiated (only 10 at first) there will be a ceiling on the Medicare price that’s 60% of the existing market price. If the drug manufacturer doesn’t accept the negotiated price, the federal government can take up to 95% of the gross receipts from all sales (not just Medicare). But remember, this provision only applies to 10 of the thousands of drugs Medicare covers.

In the end, it looks like we will get modest reform to drug pricing. Not what we could have achieved, but it’s better than nothing.

Addendum: More Meaningful Reform That Could Have Been

The US House of Representatives previously passed a measure called “H.R. 3, the Lower Drug Costs Now Act of 2019” which would require HHS to negotiate the price of between 25-125 brand-name drugs without generic competitors. That negotiated price would be available Medicare, Medicaid, and private payers. Importantly, HR 3 also provides negotiating leverage to HHS.

It would have established an upper limit for the negotiated price equal to 120% of the Average International Market price paid by Australia, Canada, France, Germany, Japan, and the UK.

It would have also imposed financial penalties on drug companies that don’t comply with the negotiating process. Manufacturers that fail to negotiate would face an escalating excise tax on the previous year’s gross sales of the drug in question, starting at 65% and increasing by 10% every quarter to a maximum of 95%.

President Biden’s plan went even further than H.R. 3 by allowing Medicare to negotiate drug prices across the board, not just on 25–125 drugs (ending the drug companies into a panic).

He proposed allowing Medicare to negotiate a fair drug price for all drugs – including the costs of the research and development and a reasonable profit. Drug companies could then only set prices based on the rate of inflation after it’s determined how much they’ve invested and what a reasonable profit constitutes. Once Medicare negotiates a lower drug price, employer-based plans would get access to the same drug for the same price as Medicare.

Will Humble Disease Control, Vaccination, Wills Blog

Arizona Back on an Exponential COVID-19 Growth Curve

View the 11/13/21 Arizona Epidemiology & Hospital Occupancy Report

Excerpts from Dr. Joe Gerald’s Weekly Epidemiology & Hospital Occupancy Report:

Arizona continues to experience high levels of community transmission with case rates unexpectedly climbing 62% in the past 3 weeks. Test positivity remains high reminding us that test capacity, accessibility, and/or uptake is inadequate. Increasing case rates among older, highly vaccinated groups serves as a warning that major behavioral shifts and/or waning immunity could result in future increases in not only cases but also hospitalizations.

As of November 7th, new cases were being diagnosed at a rate of 328 cases per 100K residents per week. The rate was increasing by 54 cases per 100K residents per week. For most counties, current rates exceed those observed at the height of the summer 2020 wave.

COVID-19 hospital occupancy is holding steady and will likely exceed 20% of all beds in the general ward and 25% of beds in the ICU for the remainder of the year. Access to care will continue to be restricted in the face of staff shortages in inpatient and outpatient settings.

Waning vaccine efficacy and a short duration of acquired immunity means the unvaccinated cannot “free ride” on high levels of community immunity. At this time vaccine mandates for adults are warranted for their protection as well as the community’s. Persistently high levels of community transmission, and more importantly hospitalizations, are possible for an extended time until the supply of unvaccinated, previously uninfected adults is exhausted. https://www.science.org/doi/10.1126/science.abm0620

Waning vaccine immunity also makes it imperative that those who were previously vaccinated obtain a third shot booster, particularly those 50+ years of age. While vaccination provides greater durability of protection for severe illness than mild reinfection, a third dose booster provides important incremental benefits to individuals, families, and communities. https://jamanetwork.com/journals/jama/fullarticle/2786040

Risk factors for breakthrough hospitalization and death were recently elucidated in the British Medical Journal: Down’s syndrome, kidney transplantation, sickle cell disease, nursing home residents, chemotherapy, recent bone marrow or solid organ transplantation (ever), HIV/AIDS, dementia, Parkinson’s disease, neurological conditions, and liver cirrhosis. https://www.bmj.com/content/374/bmj.n2244

Vaccination remains the most important public health priority to reduce transmission and severe illness; however, mask mandates, restrictions on indoor gatherings, and targeted business mitigations are needed to reduce/control transmission in the short-run with the primary goal being to avoid overwhelming our critical care facilities.

Weekly COVID-19 deaths continue to exceed 200 per week and will once again reach, and likely exceed, 300 per week in the coming weeks. So far, 21,651 Arizonans have lost their lives to COVID-19.

Will Humble Federal Budget, Health Insurance, Healthcare, Wills Blog

Pharma’s Big Con: Keep the Scam Going by Confusing Prescription Drug Prices with Out of Pocket Costs

For the last 20 years, all Americans have been getting ripped off by pharmaceutical companies.  The heist began way back when a prescription drug benefit was added for Medicare enrollees. Drug company lobbyists got Congress to write the law so that Medicare is prohibited from negotiating drug prices.

As a result, Medicare pays 300% more for prescription drugs than in Europe or Canada, and close to 10x higher than in developing nations. That means every American who gets a paycheck is pay way more than necessary for prescription drugs.

Why are we ALL being scammed (not just Medicare beneficiaries)? Simple: because Medicare is paid for by a payroll tax.

Employers & employees each pay a 1.45% tax on wages up to $200,000 (2.9% total) into the Medicare Trust Fund. Individuals (not employers) pay a 0.9% tax on income above $200,000 per year (with no upper limit).

Because Medicare is paid for by a payroll tax, everybody who earns a paycheck is getting ripped off by drug companies- even if they’re not enrolled in Medicare and even if they don’t even take prescription drugs!

The gravy that the drug companies are taking from us is tremendously expensive. Last year, Medicare paid out $129 Billion dollars for prescription drugs. If Medicare were allowed to negotiate prices, taxpayers could save about $60B per year (enough to pay for dental and vision benefits for Medicare recipients).

Because healthcare costs in private health insurance plans is often driven by Medicare reimbursement, people in employer and other private health insurance plans are paying way too much too (resulting in higher monthly premiums).

Previous AzPHA Blog Posts on this Subject:

Fortunately, there’s a simple market-based solution. 

The president’s Build Back Better plan includes a provision that would save the federal government and everyday consumers billions of dollars per year by finally allowing Medicare to negotiate brand name drug prices with manufacturers.

The US House of Representatives already passed a measure called “H.R. 3, the Lower Drug Costs Now Act of 2019” which would require HHS to negotiate the price of between 25-125 brand-name drugs. That negotiated price would be available to Medicare, Medicaid and private payers.

It would establish an upper limit for the negotiated price equal to 120% of the Average International Market price paid by Australia, Canada, France, Germany, Japan, and the UK.

The plan would impose financial penalties on drug companies that don’t comply with the negotiating process. Manufacturers that fail to negotiate would face an escalating excise tax on the previous year’s gross sales of the drug in question, starting at 65% and increasing by 10% every quarter to a maximum of 95%.

The Big Con

The drug companies are trying to confuse the public and seniors by substituting real drug pricing reform (Medicare negotiation) with a cosmetic plan to lower out-of-pocket costs at the pharmacy counter for Medicare enrollees. 

Under the con, prescription drug prices would appear to be lower because Medicare recipients would have lower co-pays. The scam is that that the Medicare Trust Fund would continue to pay 300% more than necessary for drugs.

The Medicare Trust Fund would continue to be unnecessarily drained, and private health plans would also continue to pass along extra costs to their customers in the form of increased premiums.

It’s frustrating that even though 94% of the public supports this common-sense market-based reform (allowing Medicare to negotiate prices), has been significantly watered down in the latest plan being negotiated in Congress. I’ll have a blog post next week on the details of that watered down plan.

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