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.

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.

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.

New AzPHA Data Brief: Arizona is the ONLY State in the U.S. In Which COVID-19 Is the Leading Cause of Death During the Pandemic

A couple of weeks ago we published a new report establishing COVID-19 as the leading cause of death in Arizona during the pandemic.  Nationally, COVID-19 is the 3rd leading cause of death (behind cancer and heart disease).

COVID-19 is a distant 3rd (well behind heart disease and cancer) in states that had governors and health directors who made evidence-based intervention decisions and who properly executed key operational priorities.

In that initial report, we compared COVID-19 mortality in Arizona to Colorado and Washington State (two Western states with similar populations but with governors and health directors that used evidence rather than politics to drive their decision-making). COVID-19 was a distant third in those states.

Last week, we explored which other states also had COVID-19 as the leading cause of death in their state. Our new Data Brief entitled Arizona: The Only State in the U.S. Where COVID-19 Has Been the Leading Cause of Death During the Pandemic we establish that Arizona is the ONLY state in which COVID-19 has been the leading cause of death during the pandemic.

Our Data Brief displays the rate ratio for annualized crude COVID-19 death rates to heart disease death rates for all 50 states and the US, while Figure 2 in the Brief shows the rate ratio of COVID-19 deaths to cancer deaths.

There were five states in which COVID-19 was the second leading cause or virtually tied for second: Georgia, Massachusetts, New Jersey, New York, and Texas. COVID-19 was the third leading cause of death in 40 states. In 4 states COVID-19 was lower than the third leading cause: Alaska, Hawaii, Maine, and Vermont.

Editorial Note: Last week on KTAR’s Broomhead Show, Governor Ducey again made the claim that “Arizona has done as well as anybody at saving lives and livelihoods during the pandemic.” A patently false statement given the poor results as documented in our and many other reports.

He even took a veiled swipe at those of us that have been urging him to make better decisions saying that “… there will always be people throwing stones from the cheap seats”.

AzPHA 2021 Annual Members Meeting Agenda

November 10, 2020, 11:00 am – 1 pm

Program

11:00 – 11:05    

Welcome & Thank You to Our Members and Public Health Workers Pele Fischer, Outgoing President

11:05 – 11:20    

COVID-19 Update – Will Humble, Executive Director

Business Meeting

11:20 – 11:25    

Approval of the 2020 Business Meeting Minutes

Pele Fischer, Outgoing President

11:25 – 11:35     

Professional Development Report

Eric Tomlon, Director of Personal Development

11:35-11:45        

Treasurer’s Report

Sean Clendaniel, Treasurer

11:45-12:00       

Public Policy Report

Zaida Dedolph, Director of Policy

12:00-12:10        

APHA Affiliate Report

Rebecca Nevedale, Affiliate Representative to the Governing Council

12:10-12:20        

Membership Report

Kelli Donley Williams, Vice President

12:20-12:30       

Community Health Justice Committee Report

Lilliana Cardenas, Director at Large

12:30-12:45        

Executive Director Report

Will Humble, Executive Director

  • Executive Director Report (ppt)
  • Executive Director Report (document)

12:45-12:50       

Recognition of Outgoing Board Members

Pele Fischer, Outgoing President

  • Eric Tomlon, Director of Professional Development
  • Zeruiah Buchanan, Public Member
  • Michael Murphy, Marketing and Public Relations
  • Aimee Sitzler, Immediate Past President

12:50-12:55

Recognition of Recommended Slate for New Board Members

Pele Fischer, Outgoing President

  • Liliana Cardenas, Vice President
  • Felicia Trembath, Director of Academic Relations and Professional Development
  • Lauriane Hanson, Secretary
  • Holly Ward, Director of Marketing and Public Relations
  • Dr. Satya Sarma, Public Member

12:55- 1:00

Recognition of Outgoing and Incoming President

  • Pele Peacock Fischer, Outgoing President
  • Kim VanPelt, Incoming President
 

Topic: AzPHA Annual Members Meeting (2021)

Time: Nov 10, 2021 11:00 AM Arizona

OSHA & CMS Issue Vaccine Mandate Rules

5th Federal Circuit Court of Appeals Stay’s OSHA Rule Pending A Hearing this Week

The Occupational Health and Safety Administration (OSHA) issued Interim Final Rules making the COVID vaccine or periodic testing of employees compulsory by January 4th. In a separate rule, the Centers for Medicare and Medicaid Services (CMS) required facilities that provide services paid for by Medicare or Medicaid to make sure that their staff is vaccinated against COVID-19.

For the OSHA standard, all covered employers must ensure that their employees have received either two doses of Pfizer or Moderna, or one dose of Johnson & Johnson by January 4th.  Any employees who have not received the necessary shots will need to produce a verified negative test weekly. Noncompliant employees must be removed from the workplace. The reporting and recordkeeping requirements are spelled out here.

Last weekend, the 5th U.S. Circuit Court of Appeals temporarily halted implementation of the OSHA vaccine requirement by granting an emergency stay. It’s unclear what will happen next. It’s possible that the U.S. Supreme Court will ultimately determine whether the new vaccine rule is consistent with OSHA’s authority. 

CMS is requiring workers at health care facilities participating in Medicare or Medicaid (almost every healthcare facility) to have received the necessary shots to be fully vaccinated by January 4th. The rule covers approximately 76,000 health care facilities and more than 17 million health care workers. Here’s a link to the CMS requirements: Medicare and Medicaid Programs: Omnibus COVID-19 Health Care Staff Vaccination. The 5th Circuit’s ruling applies only to the OSHA mandate (not the CMS requirement).

Editorial Note: Enforcement of the new provisions will be largely up to state governments. Given the fact that Governor Ducey is hostile to vaccine requirements I’m concerned that he will instruct the Arizona Occupational Health and Safety Commission and the Arizona Department of Health Services to ignore and not enforce the new requirements.

State Supreme Court Slaps Down Ducey’s Harmful Ban on Compulsory School Masking

It took the Arizona Supreme Court less than two hours last week to slap down the Legislature and Doug Ducey’s law micromanaging schools by prohibiting them from requiring masks indoors in classrooms. It was a unanimous ruling from the 7-judge court (the majority of the court has been appointed by Ducey).

The ruling means dozens of policies that were crammed into the budget reconciliation bills (BRBs) are now void (including the harmful micromanagement of K-12, university and community college mitigation measures).

The Court will release a detailed opinion that will become an important part of Arizona case law in the coming weeks. Doug Ducey, through his flack, described Cooper as a “rogue” judge interfering with the affairs of the executive and judicial branch. Perhaps he has forgotten the basics of civics?

Judge Cooper had ruled that Ducey’s ban on school mask requirements violates Arizona’s constitution because the Budget Reconciliation Bill (HB2898) that contained the harmful ban violates the Title Requirement of the Constitution- which says that the title of the Bill needs to reflect the contents therein.

Here are direct excerpts from the Superior Court Ruling:

The Arizona Supreme Court apprised the Legislature that the single subject and title requirements apply to budget-related bills. And, in Hoffman, the Court specifically stated the single subject rule applies to every act considered by the Legislature. Despite these warnings, the Legislature passed four budget reconciliation bills that fail to meet the constitutional requirements of Section 13. For the reasons stated, the Court finds that the BRBs violate the title requirement and SB1819 also violates the single subject rule.

Universities, K-12 schools, and community colleges can now ignore the anti-mitigation portions of those BRBs. Importantly, the Legislature will no longer be able to cram unelated pieces of legislation into budget bulls in the future. If they do, a lawsuit could quickly be filed, and any judge will be able to look at this Supreme Court ruling to quickly void a noncompliant law.

COVID Vaccine for Kids 5-11 Rolling Out

Things moved swiftly in the last week. FDA authorized the use Pfizer’s pediatric (10ug mRNA) vaccine, CDC’s Advisory Committee for Immunization Practices (ACIP) unanimously urged the CDC Director to recommend the vaccine, which she did late last week.

The vaccine comes in 10 dose vials with 30 vials to a box. Because HHS contracted with Pfizer for an adequate supply it won’t be necessary to use lower doses of the adult vaccine to immunize kids.

Providers and county health departments pre-ordered the vaccine over the last couple of weeks. Shipments began last Sunday with vaccine and the ancillary kits arriving last Tuesday.

Most Arizona county health departments are using pediatric practices and community health centers (medical homes) as the Plan A locations to vaccinate kids-. They are also organizing community events. Additionally, pharmacy chains are ordering and vaccinating.

Vaccines are free, and no identification, proof of residency, or insurance is required. Maricopa County has a complete list of vaccination sites on their website at www.Maricopa.gov/COVID19VaccineLocations. ADHS also has a website with the locations statewide: ADHS – Find COVID-19 Vaccines.

National data suggests that about 1/3 of parents plan to vaccinate their children as soon as the Pfizer-BioNTech vaccine becomes available. With about 600,000 kids aged 5-11 in Arizona, expect families of about 200,000 kids to seek vaccine in the first couple of weeks.

The pediatric Pfizer COVID-19 vaccine, which is one-third the dosage given to teens and adults, will still require two shots at least three weeks apart.  Vaccination of children age 5-11 with two doses is  91% effective in preventing symptomatic COVID-19.

Arizona’s Delta Wave Back on the Upswing

View Dr. Gerald’s Full Epidemiologic & Hospital Occupancy Report

From Dr. Joe Gerald this week:  The past 2 weeks has seen a reversal of past trends with cases rising 25% or more. The cause is uncertain. but the list of culprits includes fall break for many K – 12 schools, a welcomed cold front that cooled things downs for a week or so, waning vaccine and acquired immunity, sporting events, loss of individual mitigation behaviors.

Ultimately, these triggers don’t matter as much as our poor individual and collective efforts to do the hard work necessary to adapt to pandemic living: getting vaccinated, getting tested, wearing a mask, avoiding high risk exposures, and crafting GOOD public policy. Unlike the movies, in the real world, undisciplined teams with poor coaching get crushed, time and time again.

In that spirit, a new report to be published by the Arizona Public Health Association tomorrow shows that Arizona will hold the unique distinction as the only state where COVID-19 has been the leading cause of death during the pandemic.

The data are now overwhelming that vaccination doesn’t provide durable immunity to reinfection. If you are on the fence, now is the time to get your third shot booster! While protection against severe illness is more long-lasting it wanes as well. Check out the updated links in the attached report for a number of major publications this past week that shed light on the way forward with our vaccination strategy.

In a bit of good news, ADHS is making it possible for our 3 data teams (UA, ASU, and NAU) to link vaccine and case data. Hopefully, it will allow us to make more sense of conditions on the ground. A note of appreciation to Dr. Rich Carmona who advocated on our behalf in his new advisory role with the Governor’s office.

The Health Insurance Marketplace Is Now Open

The Health Insurance Marketplace (HealthCare.gov) where consumers can shop for comprehensive health insurance is open from November 1, 2021, to January 15, 2022. Arizonans have more insurance companies to choose from, new plans, and greater financial help. Because of the American Rescue Act, consumers will find several changes, including:

  • If taxable family income is not more than 150% of Federal Poverty Level ($32,940 family of 3) consumers can choose a plan with no monthly premium, plus reduced costs when you get medical care.
  • For consumers earning more than 400% Federal Poverty Level ($87,840 family of 3) they will not pay more than 8.5% of income for monthly premiums. This can save some higher income consumers thousands of dollars. Older Arizonans have higher monthly premiums than younger people and will benefit more than younger people. Older Arizonans with higher income may find coverage is more affordable than previous years.

For no-cost, unbiased, bilingual help from certified helpers” (Assisters and Navigators) Call 800.377.3536 or go to www.CoverAZ.org.