Relevant and even prescient commentary on news, politics and the economy.

CHIPS Funding

CBO Director Keith Hall responded to a request from House Majority Leader Kevin McCarthy to project the impact of the $7 billion CHIP rescission package. The CBO letter estimates that the rescission “would not affect outlays, or the number of individuals with insurance coverage.”

Well this is good news, I guess? Except, the key here is this is based upon the present number of children enrolled in CHIPS. However, “In its estimates, CBO doesn’t (and can’t) assume recessions or natural disasters will happen. So while the CBO expects that the Contingency Fund dollars being rescinded will not be needed by some states, it is critical for sufficient funding to remain available in the event of an unforeseen recession or natural disaster.”

Part of the funds being clawed back by Trump and Republicans are in the Contingency Fund which is maintained the same as what states do in establishing a rainy-day fund. It is a reserve set aside to meet economic or catastrophic events. If we depended upon Congress to allocate funding immediately after catastrophic events, we would be waiting a long time. Even Texas was complaining about a slow response by Congress after a hurricane hit recently. And Puerto Rico, Puerto Rico is the result of deliberate negligence on the part of the President. Neither Dems or Repubs will protest the president’s discrimination.

Joan Akers at the Georgetown University Center for Children and Families had this to say:

“Two billion dollars in cuts would come from the Child Enrollment Contingency Fund.” As I said, the Contingency Fund is a reserve put in place to help and prevent states from running out of money. In a case of disaster or shortfall, there is little time to react. Unforeseen disasters and shortfalls do not wait for the politics of Congress to turn. Having a reserve available to cover unforeseen circumstance makes sense.

The other $5 billion comes from the actual funding. Over time some of the CHIP funding authorized is not spent leaving an excess. In the past, a fully aware Congress of the excess has reached a bipartisan agreement to allow allocation of the excess and unspent funds authorized solely for CHIPS to be used for other children’s programs. Trump’s clawback violates the bipartisanism on Congress to use these funds solely for children’s programs. A clawback of these funds is unlikely to impact states’ CHIP programs unless there is a shortfall; however, it does take away the bipartisan history of a Congress to utilize these funds in ways to continue to help low income children and families.

OMB Deputy Director Russ Vought had this to say: “Rescinding these funds will have no impact on the program. At some point Congress will likely ‘rescind’ those funds as a budget gimmick to offset new spending elsewhere (the elsewhere in the past has been other programs benefiting children), as it did on the recently passed omnibus. Instead Congress should rescind the money now.”

This statement comes after the past budget contingency funds were used to keep CHIPS afloat after the regular funding lapsed while Trump and Repubs held CHIPS hostage in a plan to force Dems to support ACA changes . . . a Sophie’s choice so to speak. Furthermore, a rescission of money not spent would not reduce the deficit created by the tax cuts according to David Super, a law professor at Georgetown University.

run75441 @ Angry Bear Blog

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Medical Risk Pools, ACA/Medicaid Waviers, Hypocrite State Senator, CMC Director, CSRs, and Tom Price

Charles Gaba: Why Risk Pools are Bad

Charles Gaba at ACA Signups.net has an excellent explanation on how Risk Pools work and how they harm those amongst us who depend upon a community rating system to balance out cost.

Michigan Medicaid Wavier Strikes at the Poor

The Center on Budget and Policy Priorities reported on how Michigan’s Medicaid Proposal would lead to “Large Coverage Losses” harming Low Income Workers.

The coverage reduction in Michigan would be in the range of 150,000 people. Those impacted would lose coverage Michigan’s proposal and would also be denied coverage for a year after they were eligible for coverage once they met the the work requirement. It is called revenge. Many of the Michigan Medicaid enrollees subject to the new policy already work in unstable jobs with fluctuating hours, in industries like retail, restaurant work, home health, construction, or in seasonal jobs such as in the state’s tourism industry. The Michigan Senate Fiscal Agency initially recommended the state squirrel away the excess from the federal subsidy to extend the ability of the state to cover Medicaid expenditures until 2027.

Cities such as Michigan’s Detroit with unemployment higher than 8.5% would still be ineligible for unemployment as the county they reside in has an unemployment rate lower than 8.5%. The determination is county based. 15 of 17 counties with Unemployment hire than 8.5% are under Republican legislators with the remaining 2 being under Democrat legislators.

The same state agency estimates it would cost the state between $20 million and $30 million a year to administer a work requirement and with an increased number of uninsured would result in increased uncompensated care provided by hospitals and in the end increase state costs for public hospitals. I suspect the state spent the excess Medicaid funds.

One Hypocritical Michigan State Senator

Allow me to introduce you to “I am nauseated with the passage of the Medicaid Expansion in Michigan,” Michigan State Senator Joseph Hune.

In 2012, first term Michigan State Senator Joseph Hune voted ‘yea’ for life time healthcare insurance coverage without contribution by present Senators (himself included).

One year later, Michigan State Senator Joseph Hune opposed passage of the Medicaid Expansion. “This is simply bad policy. I am utterly disappointed in this legislation, I voted no because I could not stomach pushing this garbage forward.”

In 2018, Senator Joe Hune is no longer nauseated as the Republican legislature passed a bill requiring all Michigan able-bodied-people to work 29 hours per week. The bill does not take into account people with disorders or illness which may prevent them from working 29 hours per week. Of course Joe Hume who has worked very little outside of government voted “Yea.”

This pudgy face is a self declared expert on working in the private sector although he never did.

CMS Administrator Seema Verma

April 30, 2018 MedPage Today editorial entitled “CMS Chief Slams Administration Critics, Obamacare ‘failing long before Donald Trump became president.”

“‘Health insurers have fled the exchange markets after losing millions of dollars’, ‘half the counties in America, and 10 states in our country, don’t even have a choice of health insurer’, ‘ Congress repealed the mandate’, ‘with one insurer offering policies, half of the counties in America and 10 states in our country do not have a choice of health insurer’.” etc., etc. etc. None of this is Trump’s or Republican’s fault.

Unfortunately Ms. Verma, it is Trumps and Republican’s fault. The only thing you can blame Obama and Democrats for is not making sure Congress allocated the money through Congress. From day one of the Obama administration, Republicans made it their objective to block everything Obama did and make him a one term president. From day one of Trump’s administration, Trump has over turned anything he could by Executive Order and the Republican House and Senate made it their objective to repeal the ACA. The ones who are hurting from the Republican vindictiveness are those in the unsubsidized individual market, those who bought off the exchanges, and those who live in states where Medicaid was not expanded.

In the end, Colorado Rep. Jack Kingston’s one sentence in Section 227 of the 2015 Appropriations Act (dated December 16, 2014) created a $2.5 billion shortfall in the Risk-Corridor program in 2015 as the HHS had collected $362 million in fees. Insurers who had misjudged the market sought nearly $2.9 billion in payments. Gerhart’ canary in a coal mine played out with many nonprofit insurance Co-ops failing due to a lack of reimbursements for losses, for-profit healthcare insurance companies lost money, healthcare insurance companies began to raise premiums to compensate, healthcare insurance companies recognizing an untenable environment created by Republicans took their losses and left the healthcare exchange market, and consumers were left without policies.

Ms. Seema Verma, you are using Ms. Sarah Huckabee Sander tactics to deny the truth.

New Choices in the ACA resulting from the CSR Cancelation

An excellent article is on the blogosphere analyzing the impact of Trump killing the CSR, “Rational Choice in the ACA Market Place.” What did Trump and Republican’s cancellation of the CSR cause in the market place? Simple answer, not what they expected. Andrew Sprung at Expostfactoid explains the result of Trump’s Executive Order.

Chart by David Anderson at Balloon Juice. So, what is going on here? Trump stops the CSR subsidies going to people 150% to 300% FPL and states responded by allowing or requiring insurers to concentrate the cost of CSR in premiums for silver plans only. What Balloon Juice is showing in its chart in the decrease in the numbers of Silver plans for Bronze plans and Gold plans that are now less costly and not required anymore due to cancellation of the CSR.

xpostfactoid’s Andrew Sprung:
Since ACA premium subsidies are keyed to the price of the benchmark (second cheapest) silver plan in each rating area, subsidies rose to cover inflated silver premiums, generating often dramatic discounts in non-silver plans, i.e. gold and bronze (platinum availability and purchase is negligible). In many states, steep increases in silver plan premiums resulted in zero-premium bronze plans becoming available to many buyers (or nominal $1-3/month premiums), and gold plans that were either cheaper than silver or close in price.

Cheap gold plans were a particular boon to enrollees with incomes between 200% and 400% of the Federal Poverty Level (FPL). These buyers are not eligible for strong CSR, which makes silver plans roughly equivalent to platinum plans for buyers up to the 200% FPL threshold. Normally, enrollees in the 200-400% FPL range would pay between 6% and 10% of their income (percentage rising with income) for a benchmark silver plan with an actuarial value of 70%, i.e. with an average deductible of around $3600). With CSR priced into silver plans in 2018, gold plans (80% AV, with an average deductible of around $1100) came within reach of many in this income range. Gold plan selection quadrupled in Maryland in 2018.”

Bronze plans could be free and Gold plans cheaper than Silver plans. Again, David Anderson at Balloon Juice presents an excellent chart detailing state by state a Silver to other Metal comparison. Click on the link to see Least Expensive Spreads.

ACA Signups, xposfactoid, and Balloon Juice will all tell you and I would also, the impact on people 150% to 400% FPL was not catastrophic. The impact of Trump’s cancellation of the CSR was felt on those making greater than 400% FPL and getting their insurance on and off the exchanges. Trumps and Republican’s cancellation will cause their premiums to rise the same as the cancellation of the mandate.

Former Secretary of HHS Tom Price

May 1, 2018, Med Page Today Former HHS Sec. Price Calls Individual Mandate Repeal a Mistake. Funny thing, Price never said it would be a problem while he was HHS Secretary. While Price criticized the GOP-led Congress for repealing the individual mandate, he also said they did little else to repeal or reform the ACA, suggesting the action might do more harm than good and was not enough.

run75441 @ angry bear blog

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Why States Should Not Be Allowed to Alter the ACA with Waivers

CMS is allowing states to seek waivers to alter parts of the ACA. According to Republicans, state government knows better than the federal government the needs of its citizens and can design a better healthcare plan for them. Michigan along with Kentucky and another state have applied for waivers. Michigan and Kentucky have been approved. The Michigan bill has made it through the Republican legislature and will go to the governor to be signed (hopefully vetoed). The troublesome part of Michigan State Senate Bill 0897 (2018) can be found in SEC. 107B.

(E) If A COUNTY’S UNEMPLOYMENT RATE REACHES 8.5%, ALLOW A RECIPIENT IN THAT COUNTY TO MEET THE WORKFORCE ENGAGEMENT REQUIREMENT IN THIS SECTION BY ACTIVELY SEEKING EMPLOYMENT ACCORDING TO THE MICHIGAN EMPLOYMENT SECURITY ACT, 1936 (EX SESS) PA 1, MCL 421.1 TO 421.75. IF, ONLY AFTER A COUNTY’S UNEMPLOYMENT RATE HAS REACHED 8.5%, THE COUNTY’S UNEMPLOYMENT RATE SUBSEQUENTLY DROPS TO 5.0%, THE RECIPIENT MUST, AGAIN, MEET THE WORKFORCE ENGAGEMENT REQUIREMENTS AS REQUIRED UNDER THIS SECTION.

This is a relief valve for “counties” with high unemployment. In effect if Michigan counties have a high unemployment rate (8.5% or above), the unemployed workers in that county can have Medicaid until such time as the Unemployment Rate drops to 5%. Then the workers are expected to seek employment to be eligible for Medicaid. Ok, that should cover Detroit, Flint, Saginaw, Muskegon, etc. high unemployment rate. which exceeds 8.5%. Or does it qualify them?

The issue with SEC 107B is the word “Counties.” By using solely the word counties, SEC 107B does not make an exception for townships, villages, or cities. For example, Wayne County has an unemployment rate of 5.5% and not 8.5% or greater. As a result, Detroit which does have an unemployment rate greater than 8.5% does not qualify because it is not a county. Neither would the other Michigan cities in other counties with low unemployment rates qualify. Set this aside for a moment.

As many of you may know, Amazon rejected Detroit as a site for HQ2. While mentioned in the Amazon response, the claim of a lack of talent can be refuted as there are 52 million people living within 5 hours of Detroit, plenty of schools of higher education located in and around the Detroit, and also far more of each than exists Seattle. What Fortune Magazine pointed out as the primary issue for Detroit being rejected was the lack of a regional transportation system similar to what may be found in Chicago. Dan Gilbert fleshes out the bones of the reason with this detail:

“What became crystal clear to us from countless surveys, discussions, observations, studies, and even Amazon itself, is that having a strong mass transit solution is the ante to play for a ‘millennial’ workforce, as well as for the most successful and dynamic companies in the world.

Amazon conducted an internal survey of their employees, and the results showed that the ability to move seamlessly around a city with strong mass transit was a critical priority.

Companies like Amazon and their employee base require and depend upon a dynamic and reliable transit. If we are determined to attract exciting opportunities to metropolitan Detroit, then it’s time to get in a room and figure it out.”

The last go-around for a mass transit system was rejected.

The largest citizen cohort in the US wants to utilize public transportation rather than tool-around in pickup trucks to get to work. Amazon and other companies are looking beyond the baby boomer generation requirements to satisfy this new and larger cohort of citizens – Millennials. Automotive OEMs are in for another rude awakening in the next decade after they cut back on building smaller vehicles in favor of ever larger SUVs and Pickups. Gasoline sits at $2.90 today. If demand goes away and gasoline goes up in price, the OEMs will be retooling again.

Now back to high unemployment rates in cities as compared to the counties in which they reside.

Detroit Free Press, Nancy Kaffer:

Sen. Patrick Colbeck, R-Canton, who is a gubernatorial candidate, told Gongwer that there were 31,000 job openings within an “easy commute” of his district. Colbeck, an Islamophobe and general holder of screwy beliefs, failed to mention that Canton opts out of SMART, the regional bus system. Commuting how, Senator?”

If Amazon believes there is not enough Public Transportation available for its “desired” labor force to get back and forth to work, then why would the legislature believe it is possible for the residents of cities to be able to travel outside of city limits? The cost and insured ownership of an automobile is expensive by national standards. Senate Bill 0897 will require residents in high unemployment cities to travel a distances even if there is no regional transportation available or a community with jobs opts out if the already low income and unemployed want Medicaid. It begs a question:

Is the failure to allow Michigan cities the same exemption as counties a feature or a bug?

The Great Lakes Beacon’s Danielle Emerson had this to say about the application of the exemptions.

So, who will get exemptions? Based on the unemployment information collected, there are 17 counties with unemployment rates meeting or exceeding 8.5 percent: Kalkaska, Oceana, Alcona, Iosco, Lake, Emmet, Chippewa, Ogemaw, Ontonagon, Arenac, Schoolcraft, Roscommon, Alger, Montmorency, Presque Isle, Cheboygan and Mackinac.

The majority of those counties (15) are represented solely by the Republicans with only parts of two counties being represented by Democrats.”

It is a feature and meant to penalize cities of which, by-the-way, the population is predominately minority. SEC 107B pits cities against rural areas. Michigan is going back to pre-ACA when it penalized single adults and under employed married adults with or without children if they were not working enough hours to satisfy the state mandated minimum. In the end the hidden costs of no insurance surpass the cost of Medicaid.

In 2013 upon the passage of Medicaid Expansion in Michigan, Michigan State Senator (Fowlerville) Joe Hune said; “I voted ‘no’ because I could not stomach pushing this garbage forward.”

Here is what Senator Joe Hune had to say in 2018 on Senate Bill 0897: “Making people reliant on the government for life’s necessities does not empower them or improve their situation, I heard a lot of absurd language calling this bill disgraceful. What I think is truly disgraceful is trapping people in a cycle of poverty and victimhood so that they have no choice but to relinquish their God-given freedom to certain politicians who genuinely disdain them.”

During his first term, Senator Joe Hune voted himself and other Senators a lifetime of taxpayer paid-for healthcare insurance in 2012. Soon to be citizen Joe Hune has had little experience in the private sector; but, he has little to worry about as his healthcare will still be intact if he loses a job there.

Of course the trapping of people in a cycle of poverty only applies only to cities with a predominantly minority population and not those populations living in rural areas outside of cities. Go figure what the reasoning is . . .

HT to Charles Gaba at ACAsignups.net whose article caught my attention.

run75441 at angry bear blog

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Opioids, the Quiet Killer

There are no loud guns shots in the middle of the night. No screams for help or sounds of cars speeding away. No police sirens or flashing lights. It is pretty quiet when someone ODs on Opioids unless someone finds them before it is too late.

As I wrote earlier; “From 2006 to 2015, pharmaceutical companies spent $880 million in lobbying state and federal legislatures and contributing to campaigns to prevent laws restricting Opioid prescriptions. Opioid manufacturer lobbying expenditures has outstripped those such as STOPPNow advocating for greater controls on Opioids and prescriptions by 200 times at the state level.”

In comparison, only the NRA and its gun lobbying efforts in legislatures displays a similar capability to oppose and defeat any and all laws for bullet-spewing-weapons laws the same as the Opioid industry efforts to block legislation. Legislators pay attention when either industry or lobby calls on them.

Any particular article advocating greater regulation of Opioids or reporting of Opioid dangers on medical blogs such as Medscape, centers such as Public Integrity, news agencies such as Associated Press are met with a resistance (if they still have a comments section) the same as what is found on sites when they advocate for greater “gun control.” The evidence is overwhelming that there is an opioid epidemic in the nation resulting from usage and is similar to the epidemic of injury and deaths resulting from guns. Quietly, the industry and their lobbyists work the legislatures to stymie any effort to control opioids.

Latest Findings by the CDC

Today, Medscape reported:

Emergency department (ED) visits for suspected opioid overdoses rose by 30% throughout the U.S. in a year, according to the CDC.

“All five regions of the U.S. saw significant increases during this time period,” said Anne Schuchat, MD, acting CDC director, in a CDC tele-briefing Tuesday.

If you come back later to Medscape article, you will see the comments section flooded with what appears to be an organized opposition to what supported facts MedScape presents and consequently any and all suggested Opioid control. Many of the posters appear to be the same ones time and time again. It is pretty apparent the pharma industry is attuned to any medical backed article going up advocating for Opioid control.

The analysis backing the increase in Opioid ER visits can be found in a new CDC Vital Signs report. The basis of its findings are from ~91 million ED visits in 52 jurisdictions in 45 states from July 2016 to September 2017. The data is reported in the CDC’s National Syndromic Surveillance Program (NSSP) Biosense Platform. The 142,557 visits to the ER reported as suspected opioid overdose cases equate to a 29.7% increase from the previous 1-year period.

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1000% increase in Drug Addicted Babies in Florida – 2016

Janet Colbert of Stop The Organized Pill Pushers Blog:

“The death rate from Opioids continues to escalate year over year due to Florida ignoring the opiate epidemic for so long. Since STOPPNow (Stop The Organized Pill Pushers) started posting, the death rate went from 7/day in Florida. to 14/day. To keep the pressure on the legislature, I (Janet Colbert) will keep the Stoppnow.com site updated when we have bills that will need support to become law.”

Janet Colbert is a Neonatal Nurse in a Florida hospital caring for newborns who are addicted to opioids at birth.

Sun Sentinel; Gov. Rick Scott has called for $50 million and new legislation to fight the opioid abuse epidemic that has killed hundreds and overwhelmed morgues in South Florida.”

Click on the picture to enlarge it.

If you recall my way-to-long post: How Pharma Influences . . .

The first line of the post:

From 2006 to 2015, pharmaceutical companies spent $880 million in lobbying state and federal legislatures and contributing to campaigns to prevent laws restricting Opioid prescriptions. Their lobbying expenditures has outstripped those advocating for greater controls on prescriptions by 200 times giving them greater influence at the state level.

Pharmaceutical companies spend almost twice as much every year as compared to what Florida will spend to fight the Opioid epidemic in Florida over a period of time.

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Big Pharma Influence in State, Federal Government, and Everyday Life

How Pharma Influences Legislation They Do Not Like

From 2006 to 2015, pharmaceutical companies spent $880 million in lobbying state and federal legislatures and contributing to campaigns to prevent laws restricting Opioid prescriptions. Their lobbying expenditures has outstripped those advocating for greater controls on prescriptions by 200 times giving them greater influence at the state level.

In 2015, 227 million prescriptions were written for opioids such as OxyContin, Vicodin, and Fentanyl. This was enough prescriptions to give nine of ten adults a bottle of pills. With its aggressive lobbying, the pharmaceutical industry maintains the “status quo of aggressive prescribing of opioids and reaping enormous profits” according to Dr. Andrew Kolodny of Physicians for Responsible Opioid Prescribing.

Opioids are used to interact with the receptors (protein molecule that receive chemical signals from outside a cell causing a cellular/tissue response) in the body. They work with sites in the brain and nervous system known as opioid receptors to stop pain messages from reaching the brain effectively telling you to not feel pain. Opioids are used to counter pain from injuries, surgery, and chronic pain.

While campaigning for a law limiting the initial prescription quantity of an Opioid, Jennifer Weiss-Burke came to realize the strength of the pharmaceutical lobby in New Mexico. Her son Cameron was sent home with a bottle of Percocet to combat and dull the pain from a broken collar bone. A few years later, Cameron died of a heroin over dose.

Jennifer Weiss-Burke had lobbied the New Mexico legislature to limit “initial” pain-killing opioid prescriptions to seven days outside of the needs of chronic pain patients. The bill died in the New Mexico legislature. There was no open discussion of its merits, suggested improvements, proposed compromises, or discussed safeguards to protect those using Opioids for chronic pain. Instead, the Pharmaceutical Lobbyists privately called on each legislator to discuss why they should oppose the bill Weiss-Burke was advocating.

One of the manifestations of substance abuse in New Mexico was prescription drug overdose death. It was not a significant problem ten years before; but, it was developing and unidentified as a significant problem. In 2011, Cameron Weiss Burke died of a heroin overdose. Between 1992 and 2013, New Mexico was at or near the top for drug overdose deaths nationwide. In 2013, New Mexico had a drug overdose death rate of ~ 22 per 100,000 ranking third nationally behind West Virginia and Kentucky (CDC). Yet, the New Mexico legislature chose not to react to this plague and take action?

The pharmaceutical industry is profitable and wields influence across both sides of the aisle in
Congress and at the state level. In the past its lobbying efforts paid off with Congress blocking Medicare, Part D, and the ACA from negotiating directly with Pharma on pricing. Just how strong and profitable is pharmaceuticals? As Dr. Perry Wilson explains; “Different chronic diseases have different patterns of price increases. The biggest increase was seen in diabetes care (1993 – 2013) and driven largely by the rising prices of pharmaceuticals” of which the cost of manufacturing did not increase. Now Secretary of HHS, Alex Azar as the CEO of Eli Lilly raised the price of the century old drug Humalog used to treat diabetes by 345% taking it from $2,657.88 per year to $9,172.80 per year.

With greater profitability comes the ability to employ lobbyists who can call on state and congressional legislators. The Opioid industry, associated companies, and their allies have contributed to many candidates at state-level offices and employ an army of lobbyists covering the 50 state legislatures. From 2006 to 2015, the Pain Care Forum, a loose coalition of drugmakers, trade groups and dozens of nonprofits supported by industry funding, spent $740 million to stop laws governing the prescription of opioids. Up from 2016, the pharmaceutical and health products industry spent a record $78 million in 2016.

Because of their lobbying strength in Congress and states, laws and regulations are skewed to benefit the pharmaceutical industry. Medicare, Part D, and the ACA are blocked from negotiating directly with Pharma while insurance companies are too small to take on Pharma and often resort to using Medicare pricing plus a markup. With the appointment of nominee for HHS secretary Alex Azar, the environment for lower pharmaceutical costs by allowing Part D, Medicare, and the ACA to negotiate directly looks dim.

What If They Like a Piece of Legislation?

The pharmaceutical industry can block state legislation by lobbying. If they like a piece of legislation, they can also lobby for it. Fifty-eight pharmaceutical and 26 biotech companies spent $192 million to push the 21st Century Cures Act bill through Congress in 2016. The bill potentially saves drug and device companies $billions in bringing products to market. The Food and Drug Administration will have new authority and tools to speed up approvals and shortcut the process.

– Medical schools, hospitals, and doctors will see increased research dollars coming from a $4.8 billion windfall to the NIH biomedical research organization subject to annual appropriations. “60 schools, 36 hospitals, and several dozen groups representing physician organizations” spent $120 million in lobbying efforts.

– Over two years, $1 billion in state grants will be spent to address Opioid abuse and addiction most of it going to treatment. Mental health and Research got a boost with $millions for old and new programs. Mental health, psychology, and psychiatry groups spent $1.8 million in lobbying disclosures including the 21st Century Cures bill.

– Specialty disease and patient advocacy groups supported the legislation and lobbied Congress. Many of these groups get a portion of their funding from drug and device companies. The bill includes more patient input in the drug development and approval process. The passage of the bill shows off the clout of such groups in their spending of $6.4 million in lobbying.

– More than a dozen computer, software and telecom companies also kicked in for Cures Act lobbying totaling $35 Million in lobbying on the Cures Act as well as other legislation. It will benefit hospitals and groups requiring new technology and programs.

– Funding for the giveaways? The ACA lost $3.5 billion or 30% of its funding taken from its Prevention and Public Health Fund established to promote the prevention of Alzheimer’s disease, hospital acquired infections, chronic illnesses and other ailments.

The bill does nothing to address the rising cost of pharmaceuticals. It promotes unproven and unsafe drug and device approvals which groups such as Public Citizen, Consumer Safety Org., The Associated Press, The Center for Public Integrity, and the National Center for Health Research fought against. The bill leaves the FDA under funded with a miserly boost of $500 million through 2026 to take care of the additional priorities imposed upon the FDA.

And The Politics?

Michigan Representative Fred Upton’s sponsored 21st Century Cures which will save drug and device companies $billions in bringing products to market by short circuiting FDA testing. The Food and Drug Administration will have new authority and tools to bypass studies and speed up approvals. Translated what this means is; the bill allows the FDA to approve new uses, or indications, for existing drugs without rigorous clinical trials and tests now being conducted following proven practices. This would include not taking randomized samples to prove the new drugs are safe and effective. Instead, the FDA could rely on “real world evidence,” which includes observations, safety and side-effect claims, and other data not subject to rigorous analysis. According to Public Citizen’s Michael Carome this a much lower level of evidenced and proven usage.

No friend to the ACA, Michigan Representative Fred Upton sabotaged the ACA Rick Corridor Program and continues to weaken it by taking $3.5 billion or 30 percent of the funding from the Prevention and Public Health Fund to fund the 21st Century Cures Act, a continuation of the Republican attack on the ACA. Since 2000, Representative Fred Upton has received pharmaceutical contributions in excess of $1 million according to Open Secrets Org.

Besides weakening the testing of new pharmaceuticals, the 21st Century Cures does “nothing” to fight the rising cost of pharmaceuticals. Henry Azar took Eli Lilly’s Humalog diabetes drug and increased the pricing of it from $2,657.88 per year to $9,172.80 per year. After acquiring Vimovo, Horizon Pharma increased the price of it from $138 to $2,979 per 60-pill bottle. This is not the end of the story with Horizon. They will sell to customers at a much lower price and bill insurance at the higher price. Turing Pharmaceuticals Martin Shkreli bought the rights to the 62 year old drug Daraprim and immediately increased the price for it from $13.50 to $750 a pill. The same as other drugs, EpiPens will also rise and fall in price at the discretion of its manufacturer with little regard for actual cost.

In the December 15, 2015 JAMA publication, an article (Industry-financed Clinical Trials on the Rise as the Number of NIH-funded Trials Falls) by Stephan Ehrhardt, MD, MPH1; Lawrence J. Appel, MD, MPH2; Curtis L. Meinert, PhD suggests a growing influence of clinical trials conducted by companies with a vested interest in the outcome and a dilution of the impact of government-funded trials. “The number of newly registered trials doubled from 9,321 in 2006 to 18,400 in 2014 (Table 1). The number of industry-funded trials increased by 1965 (43%). Concurrently, the number of NIH-funded trials decreased by 328 (24%).”

While results from NIH-funded clinical trials are more apt to provide the basis for prevention and treatment recommendations; industry-backed studies can produce biased results leading to an increased concern for patient safety. Such was the case with Johnson & Johnson and Bayer’s anticoagulant Xarelto. Data was withheld during its industry-sponsored trial that would have deemed it less safe than traditional warfarin. It was approved without an antidote to bleeding complications in 2011. Thousands of Xarelto lawsuits have been filed against the manufacturer because of the medication’s severe internal bleeding complications.

NIH trials are down by 24% and commercial trials are up 43% many (71%) of which were also foreign funded. Funding for the NIH has fallen 14% since 2006 when adjusted for inflation and will decrease more as adequate funding has not been provided for the 21st Century Cures Act.

In a letter to Democrats Reid and Pelosi from various organizations, it was asked the 21st Century Cure Act be delayed until such time as rising prescription prices are addressed. “ Moving forward with this legislation now would be a missed opportunity to address unaffordable prescription drug prices. There is no justification for moving forward with legislation providing substantial benefits to the drug industry without achieving something in return.”

Again, pharmaceutical company lobbying Congress plus efforts by people such as Michigan’s Representative Fred Upton, has helped the industry reap substantial government sponsored benefits with little reciprocation in lower pricing. Michigan Representative Fred Upton was also the recipient of $597,000 from the Pharmaceutical/Healthcare Industry from 2014 into 2018. The initial bill was started in 2014.

With the 21st Century Cures Act underfunding of the NIH, increased commercial funding of clinical trials, and the relaxing of the need for clinical trials; can the pharmaceutical industry be counted on to be diligent in its testing of new products using “a lower level of evidence than the gold standard, which is randomized controlled trials” (Public Citizen’s Michael Carome)?

It appears the provisions of the 21st Century Cures Act are another stepping stone leading to the erosion of the ability of the FDA to certify the safety of new drugs and their manufacture which began in 1992 with the Prescription Drug User Fee Act (PDUFA). This allowed pharmaceutical companies to pay user fees to the agency in exchange for speedier reviews of their products. The new fees comprise 42% of the FDA’s budget today having grown from 8.5% in 1997. Companies would not be paying these fees if there were not a return for the cost in the market.

One might not think this would increase the danger the safety of new drugs; however, the 10-month time limit assessed does have its negative results. “For every 10 month of reduced review time, there is a correlated 18% increase in serious adverse reactions, 11% increase in hospitalizations, and 7% increase in deaths related to an approved drug.”

How Pharma Avoids Following the Law and the Penalties

The cost of doing business in pharmaceuticals includes paying the fines resulting from getting caught promoting drugs improperly or illegally. There are many prescriptions being written for Opioids for which there are alternate treatment strategies. When challenged, the industry and spokes people are quick to react to any calling for different strategies or limitations of usage.

For example, in 2001 Pfizer’s was ready to put Bextra on the market as a new class of painkillers known as Cox-2 inhibitors, supposedly safer than generic drugs, many times more expensive as ibuprofen, and translating into higher profits. Late in 2001, the FDA placed a qualifier on the use of Bextra for patients with extreme pain. The FDA found it was not safe for people with a risk of heart attacks or strokes and limited the usage of Bextra to people with arthritis and menstrual cramps.

This did not stop Pfizer and its partner Pharmacia from marketing Bextra as safe to use up to a 40 mg dosage. The same as what many healthcare insurance companies do with using doctors for approval of prescription, the companies hired expert doctors. Except these doctors in sales were to call on and convince other doctors (customers) of the safety of Bextra. After all, who argues with a doctor of medicine? Pfizer and its soon to be owned partner pushed the envelope with their claims of safe usage.

In the end what prevented Pfizer from a severe punishment was its size and the many other Pfizer drugs sold to and used by Medicare, Medicaid, and more then likely the VA. “Any company convicted of a major health care fraud is automatically excluded from Medicare and Medicaid. Convicting Pfizer on Bextra would prevent the company from billing federal health programs for any of its products. It would be a corporate death sentence.” The punishment stopped at fines for the illegal selling of a dangerous drug with Pfizer, again a TBTF or Too Big To Ban scenario? To comply with the law; the newly incorporated Pfizer subsidiary Pharmacia & Upjohn Co. Inc., on the same day prosecutors and Pfizer agreed Pharmacia would plead guilty, was banned from billing Medicare or Medicaid. Pfizer continued to do business as normal. Pharmacia & Upjohn Co. Inc. took the fall not once for Pfizer but twice and Pfizer walked away unscathed except for a fine.

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Competition Is for Losers

The Wall St. Journal quoted Peter Thiel’s business plans. It is mostly behind a paywall.

Competition is for Losers

If you want to create and canpture lasting value, look to build a monopoly, writes Peter Thiel

What valuable company is nobody building? This question is harder than it looks, because your company could create a lot of value without becoming very valuable itself. Creating value isn’t enough—you also need to capture some of the value you create.

New Republic points us to the politics of Democrats of monopoly:

What drives monopolization is not business know-how or technological innovation, but public policy—a political environment that permits or even enables an investor like Jeff Bezos to engage in a massive accumulation of economic power. Not that long ago in America, no company as large and destructive as Amazon would have been allowed to exist. Preventing and breaking up such corporate behemoths, in fact, was at the very center of the Democratic Party’s agenda. “Private monopolies are indefensible and intolerable,” the party’s platform declared in 1900. “They are the most efficient means yet devised for appropriating the fruits of industry to the benefit of the few at the expense of the many.”

In the late 1970s, however, the Democrats began to abandon the idea that big is bad. Over the past four decades, the party has stood by as giant supermarket chains replaced local grocery stores and Too Big to Fail banks replaced local lenders. As monopolies broke up unions and drove down wages, Democrats increasingly came to rely on campaign contributions from the very corporations that were consolidating their control over the American economy. The Obama administration, like the Bush administration before it, declined to bring a single major monopolization suit against U.S. companies. Even The Washington Post, that exemplar of political opposition to Donald Trump, is now owned by Jeff Bezos. Dissent, brought to you by monopolists.

But with Republicans in control of all three branches of government, and with the big business ethos espoused by Hillary Clinton in tatters, Democrats may finally be returning to their anti-monopoly roots. Leaders within the party are once again looking to the aggressive antitrust movement launched during the Progressive era and extended through the New Deal, which propelled America into three of its greatest decades of rising prosperity and economic equality. The question now is: Can Democrats find a way to rechannel the popular outrage unleashed by Trump, and to repurpose the party’s traditional opposition to monopoly in the age of Amazon?

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Healthcare Notes

National Health Spending at $3.5 Trillion in 2017, CMS Says:

CMS is reporting healthcare spending was $3.5 trillion in 2017. National healthcare spending grew by 4.6%, up 3 tenths of 1% from 2016. The increase was blamed on increased spending for Medicare and higher premiums for healthcare insurance. The increase in healthcare premiums can be partially attributed to Republicans blocking the Risk Corridor – Reissuances Programs which eliminated competition through withdrawal of insurance companies and bankruptcy of Coops.

Some contributing factors:

• Spending on physician, clinical care increased 5%, to $698 billion. This is a decline from 5.4% in 2016. High deductible plans have more than likely caused this reduction. Price increases for both were 2.4% and expected to increase in 2018.
• Healthcare spending as a portion of GDP is expected to grow from 17.9% to 19.7% between 2018 and 2026. Much of this will be the result of increased prices for medical supplies and services, income growth, and increased enrollment in Medicare.
• The insured portion of the population is expected to drop to 89.3% from 91.1%.
• Private healthcare insurance spending is expected to have grown at 4.7% in 2017 due to higher deductible plans, employer management of their plans, and an aging baby boomer population.
• Hospital Care is expected to grow at 5.5% annually over the decade. It is expected to be at $1.1 trillion in 2017 or a 4.6% increase over 2016 and similar in growth. Private healthcare insurance payments to hospitals is expected to slow by almost 1%.
• Pharmaceutical spending is expected to increase at a rate of 6.6% annually from 2017 to 2026. “Growth in pharmaceuticals is expected to take a bit of a jump soon, from an estimated 2.9% increase in 2017 to a 6.6% increase in 2018.”

Report: Use, Not Price, Drives State Health Costs

“In healthcare, costs of individual services and products make less of a difference in state-level spending than the overall use of those products and services, a new report indicated.” A report of rising costs at the state level being attributed to use as opposed to the rising cost of healthcare products/pharma, hospital/clinal care, and a service for fees cost model impact cost. As I wrote in answer to this perspective:

“If this is leading to people being the cause of higher costs, this is certainly the first time it is being raised in such a manner. One of the much-maligned factors in the ACA was having, as Congress called it, “skin-in-the game” which spells out in the form of higher copays, deductibles, and no discount to charge master and other pricing till the deductible is paid. It is a drag on usage by those with lower income and not qualifying for Medicaid.

Speaking of which (Medicaid) was expanded in 33 states with 18 states abstaining. Dependent upon what time period this study covers, the increased usage and state costs could be the result of such. Maryland is in a unique situation in that it uses an all payer system to control costs. I do not believe the other states intrude upon healthcare costs the same as there.

So what is the direction of this study, lower usage to control cost? It is already being done with the deductibles, copays, and payment schemes. Limit healthcare to those who can pay? If the current administration has its way, the Medicaid experiment will end. I need to see more of the detail. The article cites 3 years of data which would mean from 2014. Are we going to base rising costs upon the implementation of Medicaid and not look at time periods before 2010?

Healthcare costs are still rising at a faster rate than inflation with only the cost of getting an education beating it out from time to time. Pharma is able to raise pricing whenever they choose with little interference other than the media. Services for fees business model still exists. Hospitals and clinics are in a mad dash to consolidate to bargain better. Non-profit hospitals disappeared a long time ago.

Caring for Ms. L. — Overcoming My Fear of Treating Opioid Use Disorder

New England Journal of Medicine had an article on the human side treatment of opioid addiction by a PCP. This story does not end well for the patient. Feeling normal again is what many work towards and never quite get there. Intermingled are the political interests protecting the commercial interests who spend inordinate amounts of money to influence decisions. Pharmaceutical companies have spent $880 million in lobbying all 50 state legislatures and in state campaign contributions to influence politicians to prevent laws restricting Opioid prescriptions. Their spending has outstripped those advocating for greater controls on prescriptions by 200 times giving them greater influence at the state level.

“Ms. L. always showed up 10 minutes early for her appointments, even though I always ran late. Her granddaughter would rest her cheek against Ms. L.’s chest, squishing one eye shut, and scroll through Ms. L.’s phone while they waited. After reviewing her blood sugars, which Ms. L. recorded assiduously in a dog-eared blue diary, we’d talk about smoking cessation. That was a work in progress. ‘There’s just nothing like a cigarette,’ she’d sigh. “Don’t you ever start,” she’d admonish her granddaughter, kissing the top of her head.

One day, I knew something was wrong the moment I opened the door. Ms. L. was alone. Sweat dotted her lip and forehead. She closed her eyes and looked away, and tears fell onto her lap. ‘I need help,’ she whispered, and it all came out: she had taken a few of the oxycodone pills prescribed for her husband after a leg injury, then a few more from a friend. And like a swimmer pulled into the undertow, she was dragged back into the cold, dark brine of addiction. I tried to hide my shock. I’d known she was in recovery from opioid use disorder (OUD), but it had simply never come up. She hadn’t used in decades.

‘No one can know that I relapsed,’ she said. ‘If my kids find out, they won’t let me see my granddaughter.’ She wanted to try buprenorphine and was frustrated to hear that I could not prescribe it. ‘Why not?’ Annoyed, she rocked in her chair. ‘I just want to feel normal again, and I know you. I don’t want to tell anyone else.’”

Just a few short notes on what I have been reading as of late. If you have some time, please click on the links and read the articles. They are not lengthy. More to come as I finish up.

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The Risk of Opioid Addiction

I have been writing on healthcare for a while now and started to look at various topics with regard to pharmaceuticals. In my researching other topics, I found this particular correspondence to the Editor of the New England Journal of Medicine. Illuminating, if one might call it such? “A 1980 Letter on the Risk of Opioid Addiction

The NEJM published 1980 letter:

Addiction Rare in Patients Treated with Narcotics

Recently, we examined our current files to determine the incidence of narcotic addiction in 39,946 hospitalized medical patients who were monitored consecutively. Although there were 11,882 patients who received at least one narcotic preparation, there were only four cases of reasonably well documented addiction in patients who had no history of addiction. The addiction was considered major in only one instance. The drugs implicated were meperidine in two patients, Percodan in one, and hydromorphone in one. We conclude that despite widespread use of narcotic drugs in hospitals, the development of addiction is rare in medical patients with no history of addiction. Jane Porter; Herschel Jick; MD Boston Collaborative Drug Surveillance Program, Boston University Medical Center, Waltham, MA.

In a more recent June 1, 2017 letter to the NEJM editor, the authors dealt with the broad based and undocumented assumption in the 1980 letter of Addiction Rare in Patients Treated with Narcotics and the realization of the addiction and deaths of many people using Opioids. “from 1999 through 2015, more than 183,000 deaths from prescription opioids were reported in the United States and millions of Americans are now addicted to opioids.” Signed by four researchers exploring the reasons why Opioid addiction and deaths have risen, one of the conclusions reached was doctors being told “the risk of addiction was low when opioids were prescribed for chronic pain.” Supplementary Appendix.

From the 2017 correspondence to the Editor entitled; “A 1980 Letter on the Risk of Opioid Addiction,” the authors, by utilized bibliometric analysis of data derived from the number of citations of the 1980 letter from the date of its publication until March 30, 2017. The authors analyzed the relationship between the 1980 letter and it’s conclusion(s) with other document’s conclusions citing the 1980 letter. The analysis can be seen in Figure 1.

608 citations of the 1980 letter were identified (Figure 1) of the index publication. Also noted was a sizable increase in citations after the introduction of OxyContin (a long-acting formulation of oxycodone) in 1995. 439 (72.2%) authors of articles cited the 1980 letter as evidence addiction was rare in patients treated with opioids. 491 (80.8%) authors of articles did not note the patients described in the letter were hospitalized at the time they received the prescription and left readers to assume these were out-patients. As an aside to the citation of the letter, some authors grossly misrepresented the 1980 letter’s conclusion(s) in various comments as shown in Section 3, Supplementary Appendix. In comparison to the 1980 letter citations, the researchers also compared the number of times other letters published in the NEJM were cited: “11 other stand-alone letters taken from the same time period were cited at a median of 11 times.” To be redundant, the 1980 letter was cited 608 times.

The researchers concluded:

a five-sentence letter published in the Journal in 1980 was heavily and uncritically cited as evidence that ‘addiction was rare with long-term opioid therapy.’ Furthermore, they believed the citation pattern contributed to the North American opioid crisis by helping to shape a narrative lessening prescribers’ concerns about the risk of addiction associated with long-term opioid therapy. In 2007, the manufacturer of OxyContin and three senior executives pleaded guilty to federal criminal charges they had misled regulators, doctors, and patients about the risk of addiction associated with the drug. Our findings highlight the potential consequences of inaccurate citation and underscores the need for diligence when citing previously published studies.”

As I have been doing my research on another piece to which this is almost a prelude to it, I have found an overwhelming resistance to any type of control being placed on prescriptions for Opioids of which there are limitations on the number of days a prescription is given for short term pain. The naysayers always go back to the issue of chronic pain.

Whereas one perspective written in the NEJM Reducing the Risks of Relief — The CDC Opioid-Prescribing Guidline comes right out and states; “The few randomized trials to evaluate opioid efficacy for longer than 6 weeks had consistently poor results. In fact, several studies have showed that use of opioids for chronic pain may actually worsen pain and functioning, possibly by potentiating pain perception. A 3-year prospective observational study of more than 69,000 postmenopausal women with recurrent pain conditions showed that patients who had received opioid therapy were less likely to have improvement in pain (odds ratio, 0.42; 95% confidence interval [CI], 0.36 to 0.49) and had worsened function (odds ratio, 1.25; 95% CI, 1.04 to 1.51).”

The resistance to quantity limitations of Opioid prescriptions for non-chronic pain can be felt strongly in both state and federal legislatures by pharmaceutical companies lobbying. In a ten-year period from 2006 to 2015 Pharmaceutical companies have spent $880 million in lobbying all 50 state legislatures and in making campaign contributions in an effort to prevent laws restricting Opioid prescription quantities. In the end, it is just a matter of profits disguised as concern for chronic patient pain care.

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David Dayen reminds us opioid emergency ends in a couple weeks

Lest we forget:

Politico notes today that the 90-day emergency declared actually ends in a couple weeks, and we’re in essentially the same place that we were before the declaration.
Trump has not formally proposed any new resources or spending, typically the starting point for any emergency response. He promised to roll out a “really tough, really big, really great” advertising campaign to spread awareness about addiction, but that has yet to take shape. And key public health and drug posts in the administration remain vacant, so it’s not clear who has the authority to get new programs moving.

A senior White House official said that the president has used the “bully pulpit” to bring urgency to the crisis, and if there’s one thing you want for your cause these days, it’s Donald Trump talking about it. Also it’s the equivalent of thoughts and prayers. By the way, Congress hasn’t really appropriated anything either, so this is a whole-of-government neglect.

Meanwhile, there’s a class divide among those suffering. Those with the means can get better treatment, in New York City and likely nationwide. The poor have to line up for their methadone treatment every day, putting extreme hassle into their lives.

The story is that an epidemic affecting white people would lead to a far more robust response than one that only affects minorities. With the opioid epidemic that’s only partially true.

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