Opposing MI Bill That Keeps Medication Prices High

Posted on February 14, 2018 by Abigail RN
Biologics mean big money for pharmaceutical manufacturers

One in three medications dispensed in the US is a Biologic. Patent expiration brings attempts to protect this high-dollar market.


Testimony on Biologics, Biosimilars, and Interchangeables
Abigail Nobel, BSN, RN, MA
January 30, 2018

My name is Abigail Nobel. I’m a health policy nurse and I oppose Section 17755 (5) of HB 4472, which provides for a superfluous and protectionist notification process.

The bill came to first hearing in the other chamber when I was fully occupied with my father’s terminal cancer diagnosis. I appreciate you hearing me now.

All points in my Oct. 20, 2015 House and Feb. 16, 2016 Senate testimony against the notification provision remain true. The intervening two years have escalated the dismal facts surrounding the standard patient healthcare experience. Healthcare professionals are kept even busier with documentation requirements. Physician stress, depression and suicide continue to rise, and patients are being heard even less. Healthcare cost inflation continues to grow faster than the general Consumer Price Index. According to FRED blog, an economic data publication of the Federal Reserve Bank of St. Louis, “In the past 20 years … headline CPI has grown at an average annual rate of 2.2%, whereas the price level of medical care has grown at an average annual rate of 3.6%—about 70% faster.”

The economic recovery has not extended to healthcare, and provisions like this one are part of what stand in its way.

Why? In economic terms, HB 4472 Sec. 17755 (5) is a market barrier, pure and simple. It serves zero safety function.

  1. As industry advocates have testified, FDA is in charge of safety for these important drugs with immense potential for patient, Medicare, and Medicaid savings. Indeed it is, and it has clearly declared the approval process by which Biosimilar safety is assured and will be maintained: “The manufacturer must also demonstrate that, for a product administered to a patient more than once, there is no additional risk or reduced efficacy if a patient switches back and forth between an interchangeable product and a reference product, compared to using the reference product without switching.”
    Section (5) leaps well beyond FDA approval and usage statements. Section (5) gallops into the protectionist, market barrier end zone that benefits only those who profit from less substitution of these cost-saving Biosimilars. This provision is not needed for safety under FDA guidelines.

“All biosimilar and interchangeable products meet FDA’s rigorous standards for approval for the indications (medical conditions) described in product labeling. Once a biosimilar has been approved by FDA, patients and health care providers can be assured of the safety and effectiveness of these products, just as they would for the reference product.” – FDA website.

“Prescribers and patients can expect that the interchangeable product will have the same clinical result as the reference product. Prescribers and their patients can be assured that an FDA-approved interchangeable product has been thoroughly tested and has met FDA’s high standards for approval. Meeting these standards means that health care professionals and patients can be assured of the safety and effectiveness of an interchangeable product, just as they would be for a reference product.” – FDA website.

  1. The claim is that this notification keeps physicians in the loop regarding medication substitution. This is false on multiple levels. No physician will read it, because doing so is not mandated by this bill, and no one has time these days for anything that isn’t absolutely imperative; and because it will be buried in the blizzard of other mandated record-keeping. Digging it up will become important to the physician only when a patient complains of an undesired medication effect, and even then it will be more efficient and informative to contact the pharmacist directly by phone. Except under this provision, that professional will be more occupied by another paperwork demand and less available for the really important conversations like this one. Finally, no physician needs this notification, because long before this medication hits the pharmacy shelves, his email, professional journals, office mail, and electronic advertising will have been inundated with the information that there is a new Biosimilar substitute on the market demanding his consideration. Given the huge price differential, it will also be placed onto insurance formularies fairly early. If somehow the physician misses these notices, his patients will have heard of the lower cost option and be asking him for it. Assuming they have time in the 7-minute office visit the average patient is now allowed in our frazzled healthcare system.

In the real world of healthcare today, the claim that this provision is necessary to keep physicians informed about their patients’ dispensed meds is not merely false and superfluous. It is actually likely to distract them from the conversations that are relevant to their patients’ care, including patients themselves.

  1. Finally, Industry advocates of this provision have testified that they as manufacturers are obligated to track Biosimilar products. With this bill, they transfer their obligation and time cost to pharmacies. Pharmacies are one of the faces of healthcare patients actually see. I ask this committee to let manufacturers use one of the existing paths to meet their tracking obligation without getting between providers and patients in the prescribing and FDA-approved substitution process.

Thank you. I am happy to answer any questions.

Abigail Nobel

Testimony submitted via email.

Note: The Senate Health Policy Committee voted to pass the bill without amendment and recommending immediate effect. As of this publication on February 13, 2018, the full senate has not yet voted on HB 4472.

Readers may find Michigan senator contact information here.

March 8. Follow up note: the senate unanimously passed HB 4472 on February 15.  Governor Snyder signed it into law February 28, and it took immediate effect on March 1.

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Reverse the MI Vaccine Waiver: HCF Testimony

Posted on May 27, 2017 by Abigail RN
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Healthcare Freedom in Michigan

5-27-17 This Thursday, the MI House Education Reform Committee held a hearing on HB 4425/26. Abigail Nobel for Healthcare Freedom in Michigan attended and submitted written testimony supporting the bills and opposing the MDHHS Vaccine Waiver Rule.

“Mr. Chairman, Committee Members, and guests:

Last year, when Michigan voted to Drain the Swamp, this is exactly the sort of overreach we had in mind.

Michigan has growing pains: conflict between traditional thought and observational challenges to the vaccine theory. Accepted wisdom alters with time, but certain truths do not.

  1. This country’s foundation is one of individual worth and rights to life, liberty, and property including conscience. Government’s task is limited to securing those rights. The theory of herd immunity backed with force of law is in direct opposition to these bedrock principles. This should be openly acknowledged, and minimized to the greatest extent possible.
  2. The family is the building block of society. Amid decline of the family, today’s parents carry huge burdens of self-doubt, insecurity, and guilt as reported by authorities on both ends of the political spectrum. Yet no one knows their children better, cares more, or is more present or able to provide for child health and welfare. And when parents retreat from their rights and responsibilities to do so, we see evidence such as the current Michigan budget process struggling to pick up families’ slack with growing social programs.
  3. Educational excellence depends upon school and family collaboration, yet this relationship is troubled by distrust and unclear lines of authority, anecdotally worsened by this rule.

“Protecting a child through immunization is a parent’s decision, taken in discussion with their doctor.” – US FDA. That is the ideal.

Michigan fiscal, educational, and health policy is best served by strong families. For the greater good in MI during this period of vaccine controversy, the state’s best position is restoring the family/societal balance by

  • working with the federal government toward consistent reporting and open publication of VAERS data for all to see and judge vaccine harm for themselves. Secrecy breeds ignorance and fear, impeding informed decisions.
  • ratcheting down the pressure upon free family choice by full reversal of the MDHHS rule
  • returning vaccine choice to private patient-physician decisions. Making government-controlled public health departments mandatory in that process is dangerously intrusive.
  • Michigan should clearly reinforce the natural parental responsibility of the entire raising of their children, including healthcare decisions such as waiver statements to public schools.

Thank you.”

(submitted document below)

HCF: Reverse the MDHHS Vaccine Waiver Rule HB 4425-6

Full report of the Hearing, including video.

Your help is needed! Healthcare Freedom Call to Action.

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Healthcare Freedom: Call to Action for Vaccine Waiver Bills

Posted on May 27, 2017 by Abigail RN
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Healthcare Freedom in Michigan

Alert:

Action is needed. The 5-25-17 House Education Reform Committee hearing showed insufficient votes to pass HB 4425/26. No floor vote is possible without further action. Some are attempting to water down the bills.

Action is required for the bills to progress. Michigan residents who support healthcare freedom, individual parental rights, and limited government are encouraged to act now.

Action:

Your Letters to the Editor targeting key legislators in their local newspapers are needed to swing this vote. Address letters to the editor using details below.
Deadline: ASAP.

Talking points

  • I support HB 4425 and 4426.
  • Parental rights of conscience are foundational.
  • The Rule has to go.
  • “The Rule impedes the right of the parent.” Sponsor Tom Barrett’s statement makes a strong impact.

Key Education Reform Committee votes, with their local newspaper(s):

Maximize your effectiveness! Write your letter according to the legislator’s position on the bills.

Strongly opposed

  • Daniela Garcia (R-Holland), Holland Sentinel
  • Brett Roberts (R-Charlotte), Lansing State Journal, The County Journal (Eaton), MLive Ann Arbor/Jackson

Uncommitted 

  • Jim Lilly (R-Park Township), Holland Sentinel, Grand Haven Tribune
  • Kathy Crawford (R-Novi), Novi News, Northville Record
  • Beth Griffin (R-Mattawan), South Haven Tribune, MLive Kalamazoo, Three Rivers News

More information about the hearing may be found at the full Healthcare Freedom in Michigan report and testimony.

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MI Vaccine Waiver Hearing: The Rule Impedes Exercise of Parental Rights

Posted on May 26, 2017 by Abigail RN

 

Vaccine Waiver Rule

Healthcare Freedom in Michigan: Drain the Swamp

Legislature Challenges Vaccine Waiver

May 27, 2017
Abigail Nobel
Thursday morning, MI House Education Reform Committee heard testimony on HB 4425 and HB 4426, tie-barred bills that reverse a 2015 Michigan Department of Health and Human Services (MDHHS) Vaccine Waiver Rule (pp 6,10) for school children.

Concerned citizens filled Lansing Capitol-area parking ramps and packed the hearing room plus two overflow rooms. Special-needs children added depth and meaning to the scene with their headsets, strollers, and crayons.

“The right is impeded by the Rule.”

Strong objections to the bills came from committee members *Daniela Garcia (R-Holland), Brett Roberts (R-Charlotte), Winnie Brinks (D-Grand Rapids), and Adam Zemke (D-Ann Arbor).

“Parents retain the waiver right under the current Rule, correct?” Roberts repeatedly insisted.  “Yes or no?”

Unflinching, Sponsor Tom Barrett fired back, “The right is impeded by the Rule.”

Word in Lansing is that the two will also be going head-to-head for a seat in the MI Senate in 2018.

Hearing commenced with panel testimony from Barrett and supporting experts. Their objections centered on the current Rule’s overreach of department authority, and hampering parental religious and free speech rights as stated under existing law by requiring further Waiver procedures to opt out of vaccinations. At particular issue was self-incriminating language on the Waiver Form.

Panelists William Wagner and Erin Mersino of The Great Lakes Justice Center outlined constitutional law and judicial precedent requiring that states use least-restrictive means to secure state interests against individual conscientious objections. Mersino’s clear, masterful explanation of administrative law applied to past and present MI Waivers deserves special attention.

Joel Dorfman of Michigan for Vaccine Choice challenged the need for the Rule with MI statistics, asserting that parents are self-educating and Waiver rates were already rising before the Rule took effect.

Does the MDHHS Rule Protect Anyone?

General laughter erupted back in an overflow room when a committee member cited the need for herd immunity to protect public spaces for the immunocompromised. “Vaccines are no guarantee of immunity!” said some. “And for weeks the vaccinated can carry the live virus that others catch.” Others chimed in, “School is one thing, but what about in public? Both places have severe infectious diseases with no vaccine– MRSA, C. dif. or strep throat.”

*Jim Lilly (R-Park Township), Kathy Crawford (R-Novi), and Beth Griffin (R-Mattawan) were non-commital, perhaps seeking a middle road to keep the Rule, but tweaking it to streamline complaints about the waiver process.

Personal experience of Rep. Pamela Hornberger (R-Chesterfield) backs her support of the bills. “I was patient zero at the University of Michigan measles out break…. Of the 50 affected, I believe all had been vaccinated.”

Defending the department’s Rule was MDHHS Chief Medical Executive Eden Wells, MD. “We need exclusion capability,” she said. “Exclusion” is the practice of sending home healthy, unvaccinated children for up to 21 days for possible exposure to communicable disease. Oddly enough, current policy leaves that decision to parents of immunocompromised children, but not to parents who choose not to vaccinate.

Supporting the bills, Birgitte McQuisten, public health nurse from Orion, described the high social costs of exclusion during a previous outbreak. Pediatrician Rebecca Huizen, DO, appealed to current science and professional reasons to support reversal of the MDHHS Vaccine Waiver Rule. Saying that parents she has seen are highly educated on the subject, she emphasized that vaccines should not be exempt from the rule of full informed consent. She noted personally extensively researching vaccines including their ingredients and safety because “these topics are barely touched on in medical school.”

Healthcare Freedom in Michigan written testimony “Drain the Swamp” was submitted for the record, and with introduction added here.

The full hearing is available on video in two segments, Part 1 and Part 2 (begins at 10 min).

*Call to action on this issue. Please act now!

 

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Press Release: Michigan Increasing Tax on Nurses

Posted on September 19, 2016 by Abigail RN

Nurses

Press Release: Michigan Increasing Tax on Nurses

By Abigail Nobel
 9-19-16

Lansing, MI — Increasing the price nurses must pay to work in Michigan is set to impact healthcare consumers and professionals as the Michigan House Health Policy Committee hears testimony on HB 5400, “Expand Scope of Practice for Nurses” on Tuesday, September 20. 

As summarized by Mackinac Center, the purpose of the bill is “to revise the ‘scope of practice’ allowed for Advanced Practice Registered Nurse (sic), making it possible for them to provide more medical services without being under the direct supervision of a physician.”

Bill language also doubles Registered Nurses’ licensure renewal fees in this legislation sponsored by State Rep. Ken Yonker, R-Caledonia.

“This is the part of the agency budget that has consistently been running in the red,” says a source within the capitol. “LARA [Licensing and Regulatory Administration] wants this increase so that RN fees pay for the program, so it’s self-sustaining. All the nurses organizations are for this bill.”

“Not this one,” says Abigail Nobel, health policy nurse and citizen activist. “I strongly object to the RN fee increase.” She cites the addition to anti-market pressures of Obamacare, which have driven many health professionals from practice and increased healthcare prices.

License Fee as Tax on Nurses

“LARA adds zero value to care here: this is nothing more than doubling down on a tax. If anything, license fees should be reduced to encourage more nurses to practice in Michigan,” Nobel states. “Everyone’s budget is tight. Government agencies like LARA should be looking for ways to cut spending, as Michigan taxpayers have been forced to do.”

Michigan has seen the numbers of actively-practicing RNs drop by almost 14% since 2012. RN license holders must renew every two years. Since 1989, the RN renewal fee has tripled to the current level of $60. HB 5400 doubles this to $120. This levy increase upon RNs in Michigan will gain LARA over $7 Million in revenue, assuming HB 5400 passes with the fee provision intact.

The Real Cost is Patient Access to Care

Nobel, a bachelors-prepared nurse with a Masters in Politics from Hillsdale, supports the stated purpose of the bill. “APRNs are long overdue for Michigan law to allow them to function to the level of their educational and training,” she maintains. “Expanded scope of practice also improves access to care for the public, especially if Nurse Practitioners were allowed to run a real business for profit.”

But for the greater good in Michigan’s healthcare market, she does call for the RN fee provision to be pulled from the bill. “Expanding practice for specialized nurses does not justify increased fees for over 100,000 working RNs. The state is taking with one hand, while it gives with the other. Lansing needs to hear from all of Michigan on this.”

To give feedback on this legislation before it reaches a floor vote, contact:
Bill Sponsor: Ken Yonker 517-373-0840.
MI House Health Policy Chair: Mike Callton 517-373-0842
Your MI State Representative search

 Thank you for making a difference for Healthcare Freedom in Michigan!

Best,
Abby
Abigail Nobel, BSN, RN, MA
If you’d like to help with this or similar efforts, you can reach me at 616-970-3926

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Interchangeables: Cheaper Biologics on Track for Michigan

Posted on March 3, 2016 by Abigail RN

Biologics took a big step toward affordability when HB 4812 had a second hearing before the MI Senate Health Policy Committee a few weeks ago. At issue was the prescribing process for interchangeables, the newer, cheaper versions of the expensive biologic drugs.

Capitol Building, Lansing, MI Fall, 2015 photo: Abigail Nobel

Capitol Building, Lansing, MI Fall, 2015 photo: Abigail Nobel

Patients who depend upon biologics for symptom control of diabetes, rheumatoid arthritis, and other disorders have waited a long time for more-affordable interchangeables to reach the market. Anticipating this event, manufacturers, pharmacies, disease-advocacy groups, and professional organizations have been lobbying state capitols for a variety of prescription rules. (More difficult rules “chill” the switch to new medications.) In short, competition has entered the legislative halls in search of market share, with lower prices as the forfeit.

Interchangeables: Testimony to Remove Red Tape

The original bill required pharmacies to notify prescribers of any substitution of interchangeables. This went beyond FDA guidelines. Citing patient safety concerns, manufacturers and disease advocacy groups pushed for the heavier requirements. Michigan pharmacies provided excellent testimony in support of lower-regulation, lower-cost patient access.

My goal is the greatest access possible for interchangeables through patient-centered, free market policy. For more background, plus my bill testimony before the House Health Policy Committee, see my October 5, 2015 blog post here.

When HB 4812 came to the Senate, my focus narrowed. I aimed my written submission to committee members toward one point: keeping prescriptions simple by removing HB 4812 notification requirements.

Section 17755 (5)

Why is the “simple” notification of sub-section 5 such a problem? Today’s clinicians are swamped in documentation requirements under Meaningful Use and other provisions of the ACA, Medicare, and other third party payers. Some studies indicate up to 70% of clinical time is spent meeting non-care tasks, and mindless documentation is one of the major factors listed in recent studies of medical depression and early retirement. Medical office busyness has a major downside for patients: visits take longer to schedule, and calls to clarify or correct prescription problems are delayed or even lost in the blizzard of data. Far more important than every biologic interchangeable medication having a back-check “just in case,” is that a patient with a real prescription problem can actually reach the doctor for resolution in a timely manner.

Summary
I ask the committee to reject any burden of time, documentation, or data-collection that is not absolutely required under current federal law. Notification requirements, by adding even more unnecessary data communication and filing to the pharmacy and prescriber roles, disrupt the flow of care by competing for valuable time. As such, I strongly oppose this provision and request that it be stricken. Let’s allow healthcare to get back to the point of it all: patient care.

Please take Section 5, the extra documentation mandate, out of HB 4812 before reporting this otherwise excellent bill to the floor of the Senate.

Abigail Nobel, BSN, RN, MA

My full submission can be seen on the formal record here.

Senate Health Policy Hearing

The MI Senate Health Policy Committee discusses HB 4812 starting at 35 minutes in this video.

Chairman Mike Shirkey (R, Clarklake) called for a roll call vote on adopting S-1, a substitute bill. This removed Sections 5, 6, and 7– every provision of the bill regarding special notification requirements. In their place, S-1 inserted one sentence requiring pharmacies to keep record of an interchangeable substitution for two years. The vote to accept the change was unanimous.

I was delighted with the deletion, but how burdensome was the replacement? I called my small local pharmacy to find out. They informed me that their current computer system stores prescription substitution records for ten years. The new interchangeables mandate should cause not even a ripple to their operations.

I’m good with that.

Next Hurdle: Full Senate Vote

With this vote, interchangeables are much closer to cost savings under an open market prescription policy in Michigan. The Senate Health Policy Committee voted unanimously to report S-1 to the full Senate with recommendation for passage. I applaud them for removing pharmacy notification in favor of a token record-keeping requirement. According to opposition testimony, if successful, Michigan would be the first state to pass a notification-free bill. Fiscal agency analysis showed significant savings for the state, meaning taxpayers benefit as well.

You can help Michigan set free market precedent by contacting your MI Senator today to request a no-amendment vote for HB 4812 on the senate floor.

The final challenge will be a concurrent House vote on the Senate amendment to the bill before it can proceed to signing by the governor.

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Home Birth Freedom Lobby Day

Posted on November 26, 2015 by Abigail RN

November 12, 2015 was Home Birth Freedom Lobby Day in Lansing, MI. The issue at stake: new regulation through licensure. Blustery weather didn’t deter families and midwives from turning out to defend their way of life. They even brought their children:

Children Leading the Way

Children Leading the Way

 

More than thirty adults turned out to lobby for home birth freedom at the state capitol building. They coordinated their efforts and delivered their message to the office of nearly every state representative, as well as many senators. Despite the early adjournment of session for Thanksgiving Break, citizen lobbyists were glad to find many elected officials available and ready to hear their concerns.

Home Birth Lobby Group

Home Birth Lobby Group A

 

Midwives had taken advantage of the day to schedule meetings about home birth freedom with their state representatives. With passion and intimate knowledge of their subject, they described in detail how the bill would interfere with their ability to serve their clients.

Afterwards, they enjoyed the view and some fresh air on the capitol steps. (We were thankful the rain and snow didn’t hit until the end of the day!)

Taking a moment

Taking a moment

 

Finally, midwives joined a few families for a commemorative moment before heading back inside to plan for the future. It was a good day defending healthcare freedom!

Midwives and Families on the Capitol Steps

Midwives and some supporters on the Capitol Steps

More about Home Birth Freedom

Home birth with a midwife has a long history the world over, and its free exercise is one of the benchmarks of freedom. You can learn more about the worldwide movement here.

Midwifery is making a comeback in many areas of the US like Michigan. However, as in the other healthcare professions, access is limited and prices rise when practitioners from different philosophies of care attempt to pass legislation to enforce their views or gain market share.

A loose coalition has formed in Michigan to support two freedoms: the right of lay midwives to practice, and the right of parents to contract with their chosen practitioner. If you are interested in joining, we would love to hear from you through the form below.

More about Healthcare Freedom in Michigan

My name is Abigail Nobel. I combine a lifetime of nursing with a passion for faith and freedom, backed by a Hillsdale master’s degree in politics. Tracking state-level health policy allows me to make a difference by alerting others to current issues that affect us at the most intimate level: our health, and our access to care. Ultimately, my goal is to alert fellow Michigan residents, with the information they need, in time for them to take action to affect the direction of state health policy.

It was my honor and pleasure to help organize this event. Kudos to the families, individuals, and midwives who took part in so many ways! If you are interested in supporting this cause, or would like my help with your own healthcare freedom issue, please contact me here.

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Press Release: Lay Midwives, Families Fight Back

Posted on November 11, 2015 by Abigail RN

Lobby Day: Home Birth Freedom 11/12/15

Lay Midwife Advocates

Home Birth Freedom

By Abigail Nobel
11-11-15

Lansing, MI — In a major win for opponents of Midwife Licensure bills in Lansing, the House failed to reach a vote on HB 4598 before adjournment for Thanksgiving Break.

Despite cancellation of session on Thursday, activists for Home Birth Freedom plan full turn-out for their Lobby Day, with activities planned from 10 am – 2:30 pm and photo op 1:30-2:30 on the East Steps of the Capitol Building to be sure that parent and lay midwife voices are heard in Lansing. Legislators familiar with the conflict have made appointments with constituents on that day, and promise that their offices will remain open for visitors to the Capitol.

Opposing Lay Midwife Exclusion via Licensure

Parents and lay midwives see midwife licensure as an attempt to force them into a medical model of care. Home birth offers a different philosophy of care, one with its own cheering section for safety and success. They are committed to freedom to choose the full range of birth options without state interference or control from others in the health professions.

To learn more about this event, contact:
Abigail Nobel
Healthcare Freedom in Michigan
2794 1/2 142nd Ave.
Dorr, MI
C: 616-970-3926
amnhchrn@yahoo.com

 

Lay Midwives

Home Birth Freedom

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Lansing Battles over Biologics

Posted on October 30, 2015 by Abigail RN
Capitol Building Lansing, MI Fall, 2015

Capitol Building
Lansing, MI
Fall, 2015

House Health Policy This Week

Ever notice how two people can read the same words and come away with opposite meanings? I watched that spring to life in the House Health Policy Committee on Tuesday, October 27, in a dispute over medications. Horrendously expensive Biologic Drugs ($1000+ per dose for some) are starting to come off patent, and less-expensive Biosimilars are coming down the pike. Of these Biosimilars, the FDA will clear some for Interchangeable status.

The question before states is whether to allow pharmacists to substitute Interchangeables when filling a Biologics prescription, the way generics may be substituted for brand-name medications. Some say Yes, just follow FDA guidelines that recommend it; others say No, additional requirements for physician notification must be written into MI  law to ensure safety. For thousands of patients, life-changing medications may soon become more affordable. For manufacturers, that high per-dose price translates into Big Money at stake over every decimal point of marketshare.

The lines had been drawn at last weeks’ Health Policy Committee Meeting. Standing on the side of  less regulation were pharmacists, large dispensing pharmacies, Michigan Associated Health Plans, Spectrum Health, and MI Retailers representing their storefront pharmacies. Standing for the more-regulative option were global patient access groups, a few county medical societies, and pharmaceutical Biologics manufacturers such as Amgen and MichBio. So-called “patient groups” (more about that later) representing  diagnoses such as Epilepsy, Muscular Dystrophy, Rheumatoid Arthritis, Lupus, Colon Cancer, and Cancer in general, ranged on both sides of the issue. Each side has a bill they prefer; the first bill introduced was under consideration today.

The language seemed fairly clear there on pages 5 and 6 of the bill:

(1)… A PHARMACIST WHO RECEIVES A PRESCRIPTION FOR A BRAND NAME DRUG PRODUCT OR A BIOLOGICAL DRUG PRODUCT SHALL DISPENSE A LOWER COST GENERICALLY EQUIVALENT DRUG PRODUCT OR LOWER COST  INTERCHANGEABLE BIOLOGICAL DRUG PRODUCT IF AVAILABLE IN THE  PHARMACY….
(3) IF A PHARMACIST DISPENSES AN INTERCHANGEABLE BIOLOGICAL DRUG PRODUCT UNDER SUBSECTION (1), THE PHARMACIST SHALL INDICATE THE INTERCHANGEABLE BIOLOGICAL DRUG PRODUCT NAME AND THE FULL NAME OF THE MANUFACTURER, IF AVAILABLE, OF THE INTERCHANGEABLE  BIOLOGICAL DRUG PRODUCT  DISPENSED ON THE FILE COPY OF THE  PRESCRIPTION.

Yet a pattern emerged as people stepped forward to testify. Those who opposed the bill criticized it for allowing pharmacist substitution of Biologics with Biosimilars. Not so, said supporters– only those particular Biosimilars approved by the FDA to be Interchangeables were permitted to be substituted. Up would come the next bill opponent, repeating support for the other bill and expounding upon the necessity to protect patients and keep doctors informed of which drug is dispensed. The Chair patiently repeated his request to speak only to the bill under consideration. I began to wonder if opposition had gotten the wrong bill. Surely no one would stick to a narrative that had been refuted numerous times before their very eyes, unless they had a solid reason to do so… would they?

My testimony card was the last to be announced:
“Abigail Nobel, who partially supports and partially opposes the bill.” A titter went around the room, and I had to smile. Okay, so it was unorthodox. But I really did partially support and partially oppose the bill.

My Testimony:

My name is Abigail Nobel. I am a bachelors-prepared nurse with a masters in politics. My interest here today as a health policy nurse is in state-level policy that impacts patient access and healthcare costs. Biologics constitute one third of drugs dispensed nationwide. Thousands in MI are currently using them; many more could benefit if they were more readily available and affordable. Having read both bills, I believe HB 4437, despite some clarity issues*, does best represent patients’ wishes, and their best interests.

Access problems related to price have been addressed in previous testimony. In context, Healthcare inflation has risen faster than the US Consumer Price Index for nine of the past ten years, exceeding it by 3.2% for the first five months of this year. This is due primarily to high regulation and low levels of competition, according to Forbes.

The committee has heard about FDA guidelines for pharmacists to be able to substitute Interchangeables, their safety, and the likely dramatic savings from the generic effect of substitution.

Specific to this bill is a brief FTC [Federal Trade Commission] quote from the Commerce Committee hearings for the original Biologics Act, showing the Congressional information available at the time, which assumed there would be no substitution in the Biosimilar market:

“… market dynamics will contrast sharply with the market dynamics of generic drug competition, where lower-cost generic entry plus automatic substitution lead to rapid erosion of the branded drug’s market share. When the first generic drug enters the market, it generally offers a 25 percent discount off the branded drug’s price. As additional generic firms enter, and often there are 8 or more of them, the price discounts reach as high as 80 percent.”

That’s a lot of savings. Of course, most do not expect the percent to be as high with Interchangeables. However, early this year, upon the first FDA panel’s approval of an Interchangeable, some predicted up to 90% savings with biosimilars if pharmacists are allowed to substitute. A 2011 Rand study predicted that biosimilars would lead to a $44.2 billion reduction in direct spending on biologic drugs from 2014 to 2024 with the caution that actual savings will hinge on the level of competition.

The second area of access is where I believe I have new testimony for you today; that is, access problems related to the regulatory burden. There are two ways to approach health policy that have been called fortress and frontier. We are used to thinking of the bad things that can happen, and making laws, rules, and regulations to guard against them. That is the fortress mentality. The problem is that not all the solutions are inside the fortress.

Every day, hundreds of MI residents awake to face symptoms for which they have no effective treatment. Treatment can be complicated by individual patient variation in metabolism, blood type, genetic makeup, and other physical characteristics. Especially in the area of Biologic drugs, trial and error are the norm in the quest for the ideal plan of care for individual patients.

It is impossible to centrally master the immense quantity of data needed to determine what is best for each of these thousands of individual patients, while eliminating all risk of failure or unintended effect. The good news is, patients do a pretty good job of figuring out what does and does not help them. The difficulty these days is for them to convey their feedback to the prescribing physician, who spends up to 70% of his time meeting regulatory requirements.

I’d like to conclude by reading into the record testimony from a patient remarkable both for the severity of her disease, and for her spirit in fighting for her right to access the medications that allow her to live as normal a life as possible. Diana Brown had hoped to be here today to speak for herself, but is instead honoring a work commitment—itself a tribute to the effectiveness of this class of medications. I hope you can hear the passion of her words as she speaks for the many other patients who will benefit from an open-door health policy in MI, to free competition and reduce health cost inflation.

[Due to time limits during the meeting, I excerpted Diana’s letter in testimony and later submitted the complete letter for the record. I insert the entire letter here.]

To whom it may concern:

            My name is Diana Brown and I am 33 years old.  I was diagnosed with rheumatoid arthritis in 2010.  The next 5 years would be a revolving door of pain, medications, and doctors offices.  I started taking biologics in October of 2011 after all other treatments had failed miserably.  I fully understood the side effects and possible things that are all associated with taking a biologic medicine.  The first biologic took me over 2 months to finally get; due to all the paperwork that my rheumatologist had to fill out just so that my insurance would allow me to take the drug. 

They really are very highly regulated. [Aside to the committee.]

That was Humira.  A drug that most people have heard of due to the commercials on television.  I was losing hair and throwing up for hours daily the first 2 weeks that I took the medicine.  Then, came the time to give myself another shot.  Now I know that many of you are asking why I would even take a drug that caused these side effects.  My life was a day to day thing.  I couldn’t work and most days were great if I even could walk when I went to get out of bed.  My children had to help me get dressed and do things around the house.  My husband was having to do more things and even help me bathe. 

Biologics were my only hope.  After the first biologic did nothing but make me sick we went to the next, and the next, and the next.  Each with its own side effects, and most not helping me at all.  Now when I say side effects I don’t mean throwing up each time.  In fact, I have gone into anaphylactic shock 2 different times when receiving an infusion, and had to quit 2 other biologics because my system decided that it could have me develop issues breathing on 2 others.  Yes, side effects are a part of life for me.  All 3 different biologics that caused breathing issues for me worked though.  That’s the saddest part.  I could plan things, do activities with family and friends.  Start working again even! 

So, now I am on Orencia. Again, a drug most people have seen commercials for.  It doesn’t work quite as well as a couple others, but I can work and live a pretty normal life.  Except for every 6 months when my insurance company wants my doctor to spend 30-45 minutes on the phone with him to make sure that I “really still need this biologic medication.”  This can delay me being able to get my biologic for 2 months.  So, for 2 months I slowly have the medicine leave my body and the excruciating pain start again.  All because of restrictions on this medication. 

I understand the risks.  I know the side effects too well.  I have to give myself a shot into my stomach every week.  Not because it is fun or I enjoy it.  I do it so that I can be a mom, wife, and friend.  So that I can have a life that most people take for granted.  PLEASE, please do not make it harder than it already is to get these drugs.  Without them I have a life, yes; but not one that anyone should have to live! 

Thank You for listening to my story.

Diana M. Brown

Disease seems likely to keep researchers, physicians, and patients guessing well into the future. The greatest health for the greatest number of patients lies in the greatest number of treatment choices available. I believe the best role of regulators is to get out of the way and maximize patient autonomy.  What may seem a minor regulation and reasonable safety precaution in Lansing can be harmful when its effect is multiplied upon hundreds of physicians and thousands of patients across our state. I ask the committee to reject any burden of time, documentation, or data-collection that is not absolutely required under current federal law. Thank you for hearing my testimony. I am happy to answer any questions.
[Conclusion of testimony]

*Audience laughter here at the expense of those who (seemingly deliberately) misrepresented the bill language was, I thought, well deserved. But my primary meaning was actually improvement  for other segments of the bill, and I clarified that with the bill sponsor at the first opportunity.

So What Happened to the Bill?

Naturally, the issue is complicated by politics. There was no committee vote on Tuesday. Why? Two opposing bills on this issue had been introduced and assigned to the same committee. Two opposing bills— by Republicans. Both of whom are members of the committee. You see the problem: who wants to risk alienating a fellow committee member by voting against his bill? It can mean losing his support for your bills well into the future.  I don’t envy the Chair as he polls the committee for their votes before next week’s meeting. The results will determine whether the first bill is released for a floor vote, or whether the second bill proceeds to committee hearing.

And then there’s the Senate. Stay tuned.
ACTION: Please call your legislators to request the bill be passed with no notification of substitution of Biologics with Interchangeables.

Please share this post. The health of your family, friend, or neighbor may depend on it.

And if you like this post, please consider supporting my work  in Lansing. Thank you!
~ Abby

10-31-15 Edited for clarity and to add two links.

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High Health Insurance? Three Questions to Remember

Posted on August 6, 2015 by Abigail RN

Christine blinked, and checked again. It was no mistake. Her health insurance was going up 40%. She hadn’t really expected it to go down, but this was ridiculous! 

Christine is one of millions of Americans waking up into the nightmare of overpriced healthcare. Most of us never realize how much we depend upon having many choices, and an open market, to enjoy low prices and high quality .

For the best burger, it helps to have not only Burger King and McDonald’s, but also Wendy’s, Hot and Now, and the local burger joint. And Pizza Hut. Healthcare is not so different: more options give competition and innovation, which translate to higher quality and lower prices.

But healthcare leaders don’t think this way. When mergers are proposed, they talk about economies of scale and future savings. Hundreds of mergers later, prices continue to rise, and savings never seem to trickle down to those of us paying the bills. The trend involves both hospitals and insurance in a seemingly inevitable plunge into a single system. Motives to merge are here; the connection between consolidation and high prices is documented here.

So, I have some questions. Last week’s proposed health insurance mergers  would shrink the American market even more, from five to three companies. Promises of future savings are back again. But mergers do seem as though they could enable efficiency more than maintaining separate entities.

So when prices continue to rise, is the new Mega-Corp necessarily taking advantage of the lack of competition, and hogging the extra savings? Or is there some natural limit to economies of scale that we blew past years ago without anyone bothering to tell us?

One healthcare CEO assumes the natural limit is indicated by falling credit rates when the market dings organizations for structural weakness. Health economists might give another answer, and anyone with experience or a common sense might have their own take. Maybe we’ll never get a complete answer.

One certainty of basic economics, however, is that the trend to monopoly owes its existence to a regulatory environment of mandates, subsidies and tightly-defined plans. The contrast is stark. Never would an open market system allow this narrow selection of expensive, unstable options to survive unchallenged.

After all, security is what we expect of insurance, and for different people that means different things. Your needs at 20 are not his at 80 or mine in rural Michigan or hers in New York City. Demands for choices of price and coverage are simply too broad to be satisfied with a single system of limited options.

The real question is, do we still have a choice?

Yes, we do.

Americans need not accept expensive monopolies, much less a British, Canadian, or another version of national healthcare. Christine’s story has a happier ending, and so can yours.

… the premiums were bad enough, but her out-of-pocket medical expenses were far below the sky-high deductible. She’d never see a dime of pay-out, and she had other claims on her income. All those premiums down the drain…. Something had to give. What could she do?

Christine thought, and began to search online. In the end, she found a consultant who confirmed some of her findings, and found her even more options for saving.

Christine’s Questions:
1. What if… she could cut her premiums in half, without incurring the penalty?
She can. The sharing organizations welcome new members every day, and they are exempt from the ACA penalties. Their monthly payments average half the price of ACA-compliant premiums.

2. What if… she could safely eliminate health coverage entirely?
She probably can. Many qualify for the 20+ ACA exemptions, and for those who don’t, the individual penalty is usually far cheaper than ACA-compliant insurance premiums. That leaves a lot of cash for her own personal emergency fund. (If she decides to enroll after all, the ACA says she cannot be turned away.) She can gauge her risk/comfort level for self-funded coverage by using this information.

Do you have questions or suggestions for future blogs? I love comments from readers. In case I address your question in a future blog, be sure to subscribe so you don’t miss it!

For private individual and small business consultations, you can reach me at abby.healthcarefreedom@gmail.com.

 

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