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Transparency in Diabetes Drug Pricing

What is transparency in diabetes drug pricing?

The word “transparency” gets tossed around a lot by people in the healthcare community (it was even one of DPAC’s top 5 buzzwords from a drug supply chain Congressional Health Subcommittee hearing in December).  When patients call for more transparency, what do they actually want? The answer varies, of course, but for most people, transparency boils down into one main idea:

Patients should be able to clearly see the price of a drug or treatment

and determine how much they will pay out-of-pocket before receiving care.

Transparency in drug pricing has many positive consequences. When pricing information is available, consumers are better able to compare prices so they can make more informed decisions about their care. A Public Agenda survey found that most people in America want greater price transparency and would compare health care prices if given the option. And drug price transparency does not only educate patients, it actually lowers the cost of healthcare in the long run, according to Health Affairs.

A page of the dictionary with the definition of "law" in lights.

How can federal and state governments help make drug pricing more transparent?

Federal efforts to increase transparency in diabetes drug pricing largely have not succeeded. Despite growing public and political outrage over pricing practices, legislation to require more federal oversight has not happened.

Rather than wait for federal assistance with drug pricing issues, states have been addressing the issues themselves. More than 176 bills on drug pricing and payment were introduced in 2017, in 36 different states, according to the National Conference of State Legislatures. States have had differing techniques for increasing transparency. Patient advocacy groups have been vocal with their suggestions to states. Public Agenda says state governments can combat price opacity by empowering providers and insurance personnel to talk about pricing and by guiding people toward reliable price information and explaining how prices vary across providers. The Catalyst for Payment Reform says states can fight price opacity through legislation and litigation. No matter how they get there, one thing is certain: state legislatures want solutions to the lack of transparency in drug pricing.

a one hundred dollar bill with the words "health care" on top

What states have transparency laws enacted and what states are currently considering them?

Most state drug price transparency bills are designed to identify the costs that contribute to drug manufacturer expenses and list prices and unveil the often opaque business practices of pharmacy benefit managers (PBMs). Some of the enacted state laws require manufacturers to justify prices, particularly for new drugs or for large increases in the price of older drugs.

Other states chose to use existing “unfair business practices” laws to impose new reporting requirements on manufacturers and PBMs. The states that currently have transparency laws are California, Colorado, Hawaii, Idaho, Kansas, Maine, Maryland, Massachusetts, Michigan, Mississippi, Nebraska, New Hampshire, New Jersey, New York, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Vermont, Washington, West Virginia, Wisconsin, and Wyoming.

Most of these same states also have legislation in process currently to strengthen their laws encouraging transparency. Many of the bills have similar provisions. Several would require public reporting of manufacturer information to justify price increases of a certain percentage over a year. Many target PBMs, requiring them to disclose conflicts of interest, financial benefit from dispensing prescription drugs, and contracts with manufacturers and labelers. Finally, many states are requiring manufacturers and PBMs to provide detailed reports on the pricing structure of prescription drugs that are popular in that state.

three insulin pens in front of a pink backdrop

Some states are specifically targeting transparency in diabetes drug pricing.

Colorado HB 1009, Hawaii HB 2668, and South Carolina H 4490 would all require drug manufacturers to submit reports to the state board of health for diabetes products when the price increases more than the increase in the medical component of the consumer price index. The bills would require manufacturers to report market analysis, research, production, and marketing costs, among other information. There are proposed financial penalties for failing to comply. Finally, the bills would require PBMs to report on the total rebates received for diabetes products, the amount of those rebates retained by the PBM, and other information. Most advocate groups agree that these bills would be good steps in the effort to produce a more transparent diabetes drug pricing system.

Medicaid Work Requirements Will Prevent People from Receiving Care

Medicaid Work Requirements Will Prevent People from Receiving Care

In January, the Centers for Medicare and Medicaid Services (CMS) issued a guidance which announced that states would be allowed to require work hours for certain people on Medicaid. This is a huge departure from what CMS has said before, and already Kentucky and Indiana (which had pending requests in at the time the guidance was released) have been approved to implement work requirements. However, there is a lot of research that shows that Medicaid work requirements will not raise people out of poverty, as CMS hopes. Instead, work requirements will lead to people falling off the Medicaid rolls (an estimated 95,000 people would lose Medicaid in Kentucky alone) because of inability to work, inability to find a job, and/or inability to complete the necessary paperwork.

Who is Affected and What They Would be Required to Do

The guidance released by CMS gives states the authority to “incentiviz[e] work and community engagement among non-elderly, non-pregnant adult Medicaid beneficiaries who are eligible for Medicaid on a basis other than disability.” Let’s define some terms from that sentence to work out what the states are now allowed to require:

A manufacturing worker squats on a board with his head down

  • “work”= the guidance does not give examples of what might be work and what is not, because each state defines work on their own. Generally, states define work as an activity that generates income. Governor Bevin in Kentucky hopes to require Medicaid beneficiaries to work 20 hours a week.
  • “community engagement”= the examples the guidance gives are skills training, education, job search, caregiving, or volunteer services, substance disorder treatment, and tribal employment programs. Again, states have a lot of leeway to pick and choose what they think counts as “community engagement.”
  • “non-elderly, non-pregnant adult Medicaid beneficiaries who are eligible for Medicaid on a basis other than disability”= this language targets people who came on Medicare after the Affordable Care Act (ACA) gave states the right to expand Medicare to individuals earning up to 138% of the federal poverty line. The majority of those people were newly able to enroll in Medicaid because they did not make enough money to pay for healthcare services, not because they were pregnant, disabled, or elderly. The guidance also lists exemptions to this group of people that states could (but do not have to) apply: exemptions for age, disability, responsibility for a dependent, or participation in a drug addiction or alcohol treatment and rehab program. And again, states have leeway to decide who meets this definition.

Bottom line? Low-income people who recently joined Medicaid because they couldn’t afford healthcare without it are now targets for work requirements, which could include working for income, or any number of state-specified community involvement.

Most Medicaid Recipients Who Can Work Already Do

A pie chart showing the work status and reason for not working for medicaid adults

The Kaiser Family Foundation found that six out of ten Medicaid adults are already working, and those that are not report that they are ill or disabled, are caregivers, or are in school. That leaves only a relatively small population of Medicaid recipients who would be subject to work requirements, and that they report that they are not working because they are looking for work and unable to find a job.

The CMS guidance cites TANF, or Temporary Assistance for Needy Families, as a guide to how work requirements may work out. Fans of TANF say that it helps people get out of poverty because it imposes work requirements. However, just like Medicaid recipients, TANF enrollees work regardless of whether they are required to do so, so the work requirement has little impact on increasing employment over the long-term. And TANF enrollees work in low wage jobs and remain poor despite being employed. We can expect to see the same effect if work requirements are imposed on Medicaid beneficiaries.

A bar graph showing the work status of medicaid adults

For Medicaid recipients who are able to work, there’s also a Catch-22 in play. For some, working at minimum wage could make them financially ineligible for Medicaid in states with low eligibility levels for adults. For those people, if they DO NOT work, they’ll be kicked off of Medicaid because of work requirements. If they DO work, they’ll be kicked off of Medicaid because they make too much income. Either way, they’re loosing essential coverage for health services.

The CMS guidance makes it very clear that states must show how they are helping people meet the work requirements, by implementing programs such as job training. The state can help those trying to find work and unable to through programs and outreach. However, states may not use federal Medicaid funds for job-search support services. It is not clear how states are supposed to pay for these programs.

Complex Documentation and Administration Processes Would Make People Lose Coverage

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Implementing work requirements for Medicaid enrollees would generate huge amounts of paperwork, for the government and for enrollees. Even if a Medicaid recipient was exempt from a work requirement program because they are disabled, elderly, a caregiver, or in school, they would still have to fill out paperwork to prove that status to the government. Those Medicaid recipients who are already working would also have to document their work and provide proof to the government. A Medicaid recipient could be following the rules perfectly and still lose coverage because of incorrect or late paperwork. Studies of both Medicaid and the Children’s Health Insurance Program (CHIP) show that complex enrollment rules and documentation result in barriers to coverage, and more people enroll in programs when the process is easy.

Additionally, the economic and administrative burden on states to process all this paperwork would be extensive. States would need to pay for staff, new systems to track both verifications and exemptions, and education for individuals to complete the new paperwork.

Working May Not Make People Healthier

The guidance supposes that when people work, they become healthier, based on many studies that show correlation between health and work. However, there is a difference between correlation and causation. There is not sufficient research to say that working causes better health. It could very well be the case that these studies show that healthy people are more able to work. In other words, it is not clear whether income and work lead to better health, or whether better health facilitates income and work.

A woman rubs her temples in an office

The guidance fails to take into account studies that show that work has negative impacts on health as well. The Kaiser Family Foundation writes that “research has found some deleterious health effects of work, particularly for people in shift work positions or those with high job insecurity, and evaluations of existing work requirements in other programs find weak evidence for an effect on health and well-being.” There are some studies that show positive effects of work in programs for working people with disabilities, but the work in these programs is voluntary, and there are plentiful support services for those people. That would not be the case for Medicaid work requirements as outlined by the CMS guidance.

What You Can Do

Medicaid work requirements would prevent people from enrolling in Medicaid and would force people out of the program. Medicaid is necessary for many low-income people in order to access medical care, and having fewer people enrolled means more people going without care. Already Kentucky and Indiana have received permission to implement work requirements and Maine, New Hampshire, Wisconsin, Mississippi, Arkansas, Kansas, Utah, and Arizona have applications pending.

If you live in one of the states that has been approved for a waiver or has an application pending, write or call your state delegates and tell them how Medicaid work requirements would hurt the people in your state!

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Top 5 Takeaways from the White House Report on Drug Pricing

Top 5 Takeaways from the White House White Paper on Drug Pricing

On February 9th, the White House released a white paper on the causes and potential solutions to high drug prices. There are several important takeaways from the report, and we’ve compiled the top 5 for you here (just in case you don’t have time to read 28 pages!). If there’s a theme to this report, it’s dreams; the report is very aspirational, but does not give a lot of concrete steps to how these dreams would be accomplished.

1. There was plenty of blame to go around.

The White House was quick to point fingers at who may be responsible for high drug prices. According to the White House, the biggest culprits are:

two people pointing at each other accusatorially

  1. the U.S. government, because there are too many regulations that hinder competition,
  2. foreign governments that set pricing guidelines for drug manufacturers, because their guidelines give them a competitive advantage that the U.S. does not have,
  3. pharmacy benefit managers, or PBMs, because there are not enough of them, and the lack of competition means they can inflate prices, and
  4. the FDA approval process, which hinders competition in the drug market because it takes too long.

It’s not clear that all of these factors actually contribute to the drug pricing problem, and if they do, it might not be for the reasons the White House claims. For example, regarding PBMs, the report claims that:

“Policies to decrease concentration in the PBM market and other segments of the supply chain, i.e., wholesalers and pharmacies, can increase competition and further reduce the price of drugs paid by consumers.”

But the report does not say how to actually reduce the concentration in power. The government could block acquisitions that would increase the power of the largest PBMs, but that would not reduce the already-present imbalance. For most things proposed in this report, there are ideas, but no directions on implementing them.

2. The White House thinks other countries are “free-riding.”

A one hundred dollar bill with the words "health care" on top

The report attacks the way European countries reimburse drug manufacturers. It says the U.S. is hurt by “unfairly low” drug prices in those countries, and that they are relying on the U.S. to subsidize drug development. The report states:

“Meaningful reforms could address the free-riding that takes unfair advantage of American innovation, whether through enhanced trade policy or policies that tie public reimbursements in the United States to prices paid by foreign governments that free-ride or other methods.”

It isn’t clear what that language actually means. It would be difficult for the U.S. to get other countries to spend more on drugs, so there’s no obvious way to develop the reforms the report calls for.

3. Changes to Medicare and Medicaid are Proposed

Woman testing her blood sugar.

The report suggests several changes to Medicare drug reimbursement. It targets Medicare Part B and Medicare Part D. For Medicare Part B, the report says we should eliminate payment policies that are price-based and give doctors more money for prescribing more costly drugs. For Medicare Part D, the report claims that the requirement which guarantees coverage of certain drugs causes higher prices because it limits the ability of Part D insurance companies to negotiate for lower prices. These programs have been called out before, by the Obama administration, but the it didn’t go anywhere. The administration backed off due to public outcry.

Pills flowing out of a tipped blue plastic bottle

4. The White House Wants to Speed Up the FDA Drug Approval Process

Last year, the Food and Drug Administration (FDA) approved over 1,000 generic drugs, the highest amount approved in one year in the history of the FDA’s drug approval program. The agency accomplished this by expediting applications for certain drugs that are the second or third drug in a particular drug category. The report proposes expanding this practice to drugs that are second or third drugs in a class that does not have a generic alternative. There are differing views as to whether this proposal would actually lower drug prices or if the approved drugs would simply cost the same as their “leader” drug. But speeding up the approval process could also have safety implications for patients – something that the report does not discuss.

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5. Notable: What’s Missing from this Report

There is a lot in this report, but perhaps what is most surprising is what is not in it. The report gives a full 28 pages on how to reduce drug costs through public programs, but does not give any recommendations or policies focused on lowering the costs for patients who get their health insurance through their employer. Over half of U.S. citizens get their insurance through their employer than through any other method, yet those people are not addressed by this report.

Next Steps:

Download our app! Make advocacy easy for yourself!

If you’ve got some time to spare, read the full report here.

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How Closed Formularies Hurt Patients

How Closed Formularies Hurt Patients

Insurance providers have a problem: how do they balance the cost of drugs to patients versus the cost of drugs to themselves? Drug costs can pile up quickly on either side of the scale (or both!). To try and find the balance, many healthcare plans opt to reduce their costs by implementing a drug formulary method. But drug formularies hurt patients when they deny access to important medications. 

A picture of a man in a suit holding a sign that says "no"

What is a closed formulary?

Drug formularies are lists of medications created by medical professionals that correspond to certain diseases or conditions. Formularies can be open, limited, or closed.

  • Open Formulary: drugs that are “non-formulary” can still be accessed by patients, but they require a larger copayment.
  • Limited Formulary: has components of both open and closed models by using cost levels. For instance, you may find that the insurer will allow you to purchase different brands of test strips, but they may have a “preferred” brand that is the lowest co-payment or co-insurance cost to a patient. Other test strips may be listed, but you will pay more to access them. If you wish to use a brand of test strip not found on the formulary, you will pay out of pocket. 
  • Closed Formulary: access to medications used for a particular condition are restricted. The drug list (formulary) can be limited to specific prescribers, geographic areas, or severity of condition. This means you either use the brand/generic listed on the formulary or you pay out of pocket. Often, you may have only one or two choices for a drug. 

Closed formularies became popular in the 1990s, died out, and are now making a comeback in many states across the nation because they are popular with drug manufacturers. Some manufacturers see cost savings of 10 – 25% with formulary management services.

The resurgence of the closed formulary model is especially notable for diabetes drugs. According to Managed Care Magazine, some payers were not willing to limit options for diabetes patients as recently as a few years ago. Now, however, times have changed. Closed formularies are becoming increasingly popular for diabetes medications (and test strips).

A photograph of a doctor's hand giving a prescription

How does it affect patients?

Closed formularies may sometimes force patients to frequently change drugs, and they may not be able to get their preferred medications. Closed formularies are based on the assumption that all drugs will act the same with anyone who has a particular affliction. But as we know, diseases do not affect each person in the same way. A drug that effectively manages one person’s condition may not work for another individual with the same diagnosis.

Closed formularies also disable a patient’s ability to work with their physician to freely choose the best treatment for their particular symptoms. Remember, part of the formulary design is categorization by prescriber, by area, or condition, so there may not be an obvious reason to who has access to certain medications.  A patient living in one area may have access to a drug that helps their symptoms, but if he or she moves to a home on the other side of town, it may be barred from them. And the patient of one endocrinologist may not have access to drugs that another endocrinologist could prescribe for them simply because their endocrinologist is not on the formulary list. 

Which states have closed formularies?

As of February 2018, Montana, Texas, Oklahoma, Arizona, Ohio, New York, and Tennessee have adopted closed drug formularies within certain state programs. California is also slated to implement a closed formulary in 2018. Closed formularies are spreading as well; already four more states have made moves to implement the system, and two are considering it.

An outline of the United States of America filled in with a dollar bill

  • Indiana: S.B. 369 (authored by state Senator Randall Head) would require adopting a closed drug formulary for injured employees by 2019. It would also require insurance prior authorization for any drug not on an employer’s formulary.
  • Massachusetts: As of February, Massachusetts has a pending waiver that would allow adoption of a closed formulary for Medicare patients statewide. What is horrifying is they wish to restrict their formulary to one drug per class of medications. (Think one brand of basal insulin and one brand of rapid insulin. One brand of test strips. One brand of cholesterol drugs.)
  • Arizona: As of December 2017, Arizona’s state Medicaid Agency requested a waiver from the Centers for Medicare & Medicaid Services that proposes implementation of a closed formulary.
  • Pennsylvania: S.B. 936 was introduced in February 2018 and would require a closed formulary for the state’s Workers Compensation program.
  • Florida and Louisiana are also considering implementing closed formularies as well, mainly due to increasing statewide pressure to limit opioid prescriptions.

What is being done to fight closed formularies?

There has been public pushback across the country to stop states from implementing closed formularies. California is the best example of the effectiveness media campaigns can have on state legislation or requests for Medicare waivers. The state has promoted multiple periods of public comments and a highly structured stakeholder feedback event, resulting in changes to the proposal and delay of implementation.

If you are in one of the states mentioned above, where they’re trying to or considering putting a closed formulary in effect, make your voice heard! Contact your state delegates (click here to find your state delegates’ contact information) and tell them how harmful closed formularies can be for their citizens!

 

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How the FDA Drug Approval Process Works

The FDA Drug Approval Process

The FDA Center for Drug Evaluation and Research (CDER) is the watchdog for potential medications seeking approval for use in the United States. In order for CDER to begin evaluating a drug, pharmaceutical companies must first do extensive testing and document the results.

Those results are sent in to the CDER, who assigns a team of doctors, chemists, pharmacologists, and other scientists to review the evidence. From initial formulating to FDA approval, most drugs take around 10 years to make it to the market. This may seem unnecessarily long, but the result is that only the safest drugs make it to the pharmacy.

Phases of Drug Development

picture of clear test tubesPhase I: Discovery & Development

Discovery involves researchers finding new possibilities for medication through testing molecular compounds, noting unexpected effects from existing treatments, or the creation of new technology that allows novel ways of targeting medical products to sites in the body. Drug development occurs after researchers identify potential compounds for experiments.

Studies are conducted on appropriate dosage; methods for administration; side effects and how they may vary within different demographic groups; how the drug is absorbed, metabolized, and excreted; drug interactions, and how effective it is compared with similar compounds.

Phase II: Preclinical Research

Once researchers have examined the possibilities a new drug may contain, they must do preliminary research to determine its potential for harm (toxicity). This is categorized as preclinical research and can be one of two types: in vitro or in vivo.

In vitro refers to experimenting within a controlled environment outside of a living organism, while in vivo means the experiment occurs in a living organism. Both kinds of preclinical research must follow regulated laboratory practices, known as Good Laboratory Practices (GLP), which outline basic requirements for researchers, facilities, equipment, etc.

Preclinical studies are smaller than most clinical trials, but they must provide detailed evidence about appropriate dosing and toxicity levels. If researchers review the findings and determine it is safe to test in humans, drug development moves on to Phase III.

Phase III: Clinical Research

After the safety of a drug is determined, researchers must examine the ways in which drugs interact with the human body. Clinical research involves trials of the drug on people, and it is one of the most involved stages in the drug development and approval process. Clinical trials must answer specific questions and follow a protocol determined by the drug researcher or manufacturer. To design a study, researchers must determine its length and scope, as well as who can participate and how the data will be collected and analyzed.

There are four sub-phases of clinical trials:

  • Phase 1 involves 20 – 100 study participants and lasts several months. This phase is used to determine the safety and dosage of the drug, and about 70% of these drugs move on to the next clinical research phase.
  • Phase 2 involves up to several hundred people, who must have the disease or condition the drug supposes to treat. This phase can last from a few months to two years, and its purpose is to monitor the efficacy of the drug, as well as note side effects that may occur. Only around 30% of these drugs move on to the next clinical research phase.
  • Phase 3 involves 300 – 3000 volunteers and can last up to four years. It is used to continue monitoring the efficacy of the drug, as well as exploring any longer-term adverse reactions. About 25% to 30% of these drugs move on to the last phase of clinical research.
  • Phase 4 involves several thousands of volunteers who have the disease or condition and continues to monitor safety and efficacy. If a drug passes this phase, it goes on to FDA review.

Pills flowing out of a tipped blue plastic bottlePhase IV: FDA Review

Once the pharmaceutical company can prove (through preclinical research and clinical trials) that a drug is safe and is effective in treating a condition, they can file an application to allow marketing of the drug. The application contains clinical results, labeling information, safety information, drug abuse potential, patient information, and directions for use.

The FDA review team ensures that each application is complete, and then takes the next 6 – 10 months to make a decision. The application is reviewed, as well as the clinical study sites. Often, there are issues that must be resolved before approval; the review team may request further data before they make a final decision. If the FDA review team greenlights the drug, they work with the applicant to develop prescribing information and then move on to the next phase.

Phase V: FDA Post-Market Safety Monitoring

Although researchers and applicants must work for many months to determine the safety of a potential drug, there are still issues that may arise only after the drug is on the market.

The last phase of drug approval is an ongoing one while the drug is on the marketplace. If a developer wants to change anything about the drug formulation or approve it for a new use, they must apply with the FDA. The FDA also frequently reviews the drug’s advertising and its manufacturing facility to make sure everything involved in its creation and marketing is in compliance with regulations.

New drugs are protected by patents when they are approved for marketing, and generic drugs can only be manufactured once the patent expires. Generics must contain the same dosage form, strength, safety, quality, and intended use.

Will It Always Take This Long?

The FDA approval process can be long, tenuous, and frustrating, especially for patients waiting on new or generic drugs to hit the market. Although the intention of the process is to ensure patient safety and drug effectiveness, there are some elements that may prove unnecessary and can be expedited under critical circumstances. The FDA has developed four methods to speed up the approval process for drugs designated as such.

  • Fast Track: this process is designed to speed up development and expedite the review of drugs that treat serious conditions and “fill an unmet medical need”.
  • Breakthrough Therapy: this process expedites drugs that are found to be substantially more effective for a certain condition than others on the market.
  • Accelerated Approval: this process is for drugs that fill an unmet medical need and have evidence of potential clinical benefit (although they don’t yet prove clinical benefit).
  • Priority Review: this designation means the FDA has a goal of making a decision on a drug application within six months.

For more information:

U.S. Food & Drug Administration Drug Approval Process

Drugs, Devices, and the FDA: An Overview of Approval Processes for Drugs

Development and Approval Process (Drugs)

 

Are You A Passionate Diabetes Advocate? Join the DPAC Patient Advisory Board!

DPAC Patient Advisory Board

A picture of a diverse group of people smiling.

After this year’s tumultuous ride in diabetes policy advocacy, you may feel like we need a break.

Nope. This is when we mobilize – and we need you. We have so much work still to do, especially in the states where bills are introduced to stop insurers from switching our medications.

If you are interested in rolling up your sleeves and helping to guide our community in diabetes policy advocacy, we have a new way for you to help make things happen and raise our voices.

Apply to the DPAC Patient Advocacy Board Today!

What is the DPAC Patient Advisory Board?

The DPAC Patient Advisory Board (PAB) will be a diverse group of people from the diabetes community who support DPAC’s mission and further its goals. From identifying and weighing in on diabetes policy advocacy issues on a federal and state level to advising on educational training content, the Diabetes Patient Advocacy Coalition’s PAB will play an integral role in ensuring the diabetes patients’ voices are heard. These members will represent DPAC at policy meetings, testimonies, and events that need a personal diabetes perspective.  

DPAC was founded by patients in the diabetes community to ensure that there was a trusted voice that represented all 30.3 million American families impacted by diabetes in the United States.It is important to DPAC that all facets of our community are represented, since people being personally invested in our voice is essential. Drawing from all corners of our community, we seek parents, patients, and significant others from all types of diabetes. 

The diverse viewpoints from the DPAC PAB members will ensure that DPAC representing all voices of the diabetes community. The input from the PAB will help ensure that DPAC continues to be the foremost organization in the diabetes advocacy space.

 

A bunch of hands touching

How Can You Get Involved?

We’re looking for people to join the DPAC PAB now! You can apply by filling out a short application, which will ask for you to answer a few questions. Applications are open between now and March 15th. 

In order to ensure transparency and promote DPAC as the trusted patient advocacy voice, there are a few requirements for being a PAB member. If selected, you will: 

  • Attend online meetings quarterly
  • Promote DPAC policy efforts and calls for campaign participation
  • Be able to travel a minimum of once per year to Washington, D.C. for policy advocacy training or meetings on Capitol Hill
  • Act as spokespeople in DPAC’s advocacy efforts, and promote DPAC’s mission and efforts within their own online and in-person communities
  • Be independent from conflicting diabetes advocacy messaging to ensure there is no fiduciary conflict of interest. (You can review DPAC’s statements here.)
  • Be U.S. citizens and registered voters over the age of eighteen. (We know there are some teens out there who’d be great advocates for DPAC, and we’re planning volunteer opportunities for youth advocates soon!)

See the DPAC Patient Advisory Board application for details on the requirements and apply today! (You can upload your resume, letters of recommendation, and a cover letter in the application.)

We know that as a strong community, we’ve already done so much.

Let’s make sure that our policy makers continue to hear from us!

A picture of a man touching the words "apply today"

 

Drug Importation Isn’t The Long-Term Solution

 Drug Importation Isn’t The Long-Term Solution

Though drug importation may seem like a logical solution to a very real drug pricing problem, importing drugs from Canada or other foreign sources is not good for individual consumers or the American economy. There are two main reasons:

When drugs flow through Canada (or other countries) into the U.S., there’s no regulatory body making sure that the medicines someone orders are the medicines they receive. In fact, 85% of drugs sold on “Canadian pharmacy” websites are not actually from Canada. Instead, these drugs come from countries that lack strict safety guidelines. This means drugs may be stored at unsafe temperatures, formulated with unsafe ingredients, or may be completely counterfeit with no therapeutic ingredients at all.

Two people standing next to one another, one holds a heart and the other holds a stack of money

(You may be wondering, “What about drugs imported from Canada? Doesn’t the Canadian government check the drugs to make sure they’re safe?” Yes, but only for Canadian citizens. When a drug flows through Canada and into the U.S., Canada does not regulate or certify the safety of that drug. And the FDA also does not regulate these drugs, since it is left out of the supply chain completely.) There is no agency, government or otherwise, that can certify that the drug is what it says it is and is safe. 

 

Counterfeiters have gotten sophisticated.

Many people think counterfeit drugs have tell-tale packaging or labels. However, improvements in counterfeiting technology has made it cheaper and easier to produce fake packaging and labels, making it nearly impossible for consumers and even authorities to detect counterfeits.

Life-essential medications, like diabetes prescription drugs, are counterfeited more often because of the high price counterfeiters can charge for them.

And it’s not just diabetes drugs. In 2006, more than a million counterfeit test strips were sold to U.S. consumers in 35 different states. Nobody along the U.S. supply chain was able to tell the counterfeit strips from the real ones. It’s easy to imagine the harmful effects that ineffective diabetes medicines or supplies could cause. These counterfeit drugs have deadly consequences, as was the case when a woman in Nigeria died of hyperglycemia after being treated with fake insulin.

Exportation Limits

People in favor of legalizing drug importation often say it would strengthen the drug markets or free trade. Generic drugs make up 90% of U.S. drug sales, and generic drugs already cost less in the U.S. than in other developed countries. Importation would not reduce all U.S. consumer costs in meaningful ways. And for drug reimportation, there are exportation issues from outside the U.S.

a one hundred dollar bill with the word "healthcare" written on a scrap of paper

Drug reimportation is when U.S.-manufactured drugs are exported for sale to other countries and then sold back to U.S. consumers at the price negotiated between the government of the other country and the manufacturers. Contracts between the other country and the manufacturer may impose export limits or regulatory caps on the amount of drugs given to that country. If there is a significant increase in the sales of certain prescription drugs, the country may choose to discontinue any exportation of those drugs to ensure there is enough for their own citizens.

We need to keep looking for other solutions.

Drug importation is not a long-term solution to address the pricing of prescription drugs in the United States. DPAC is committed to continue working with stakeholders to find both short- and long-term solutions that will keep people with diabetes safe and provide access to affordable prescription drugs. 

Read our Drug Importation Statement for more information.

 

Many People Holding the Red Word Thank You, Isolated

Big Win for Diabetes Medicare Beneficiaries & Thank You!

Big Win for Diabetes Medicare Beneficiaries & Thank You!

group of people crowded together to make a man flexing musclesOn February 9, 2018, the President signed the Bipartisan Budget Act of 2018, which included a big win for our diabetes Medicare community who receive their diabetes testing supplies through the National Mail Order supply program. Language from the Protecting Access to Diabetes Supplies Act of 2017 (H.R. 3271/S. 1914) was included, strengthening the rules surrounding the distribution of testing supplies to those on Medicare.

The Protecting Access to Diabetes Supplies Act was introduced this summer. DPAC provided expert testimony on Capitol Hill about this issue and asked our community to contact their representatives in Congress to cosponsor this bill. It was the hard work of advocates throughout the community and the tireless efforts of Congressman Tom Reed’s and Congresswoman Diana Degette’s offices that helped to bring this into law.

The two main functions of the language from the Protecting Access to Diabetes Supplies Act are the 50% Switching Rule and Anti-Swiching Rule.

For people with diabetes on Medicare, the option to receive their testing supplies by mail order is convenient and cost-effective. However, in the past, they were often sent meters and strips that were not their trusted brand, which caused some beneficiaries to give up testing their blood glucose levels. If they attempted to get their supplies at a local pharmacy, they often found that the automatic shipments (without their knowledge or permission) prevented them from getting reimbursed for their purchases.

A picture saying bait and switch50% Rule

Suppliers bid to get contracts with Medicare, so it was to their advantage to get the cheapest testing supplies available on the market, which has been shown through studies to not always meet FDA accuracy standards. These were not the meters and strips that our diabetes Medicare community were trained to use.

With the 50% rule now in place, after January 1, 2019 all suppliers must make available at least 50% of all types of diabetes testing supplies on the U.S. market. This means better choices and trusted meters will now be available for mail order customers.

Anti-Switching Rule

As mentioned above, many diabetes Medicare beneficiaries received meters that they didn’t want, but felt pressured to use or told there were no other options. The anti-switching provision requires all suppliers to give the meters and test strips they were prescribed by their medical professional and prevents suppliers from influencing or giving incentives to switch. Suppliers must also contact the beneficiary before they ship out supplies and must accept returned supplies if they were sent without confirmation.

Advocacy For The Win

It took the efforts of many organizations to raise this issue to Congress. The American Association of Diabetes Educators completed several secret shopper surveys to show that trusted meters weren’t being supplied. The National Minority Quality Forum published studies showing the the Competitive Bidding Program for Diabetes Testing Supplies caused access issues and increased mortality rates for those in some areas. Many advocates in our own DPAC community called, tweeted, and spoke to their representatives to ask for these rules.

Advocacy works. You have helped to make the U.S. diabetes community safer for those using Medicare and we are so grateful to so many of you – and the organizations that worked collaboratively to make this a reality.

 

Affordable Insulin Project Helps People Advocate!

The new year brings some wonderful things: renewed optimism for the future, resolutions that may or may not be abandoned by February, and plans for a year that seems full of potential. But the dreaded deductible reset also accompanies the new year for many people. Paying for insulin, drugs, and devices at the beginning of the year is often difficult for people whose insurance deductible resets on January first.

Most people get their insurance through their employer, and they may feel that they have to “take or leave” the insurance plan that is presented to them. There are other options, however, and the Affordable Insulin Project can help people advocate for an exemption to the insulin deductible from their employer. Read on to see how what such an exemption does and how to advocate for one or jump to the Affordable Insulin Project page!

What is an Insulin Deductible Exemption?

A picture of hands using a calculator and writing in a notebook.

Many workers are covered by high-deductible insurance plans, which means they are paying deductibles between $1,300 and $7,150 for single coverage and between $2,600 and $14,300 for family coverage. Having a high deductible means that the insurance company may not cover the cost of the worker’s insulin until the they have paid at least $1,300. That can be crippling for some people using insulin.

It doesn’t have to be this way. Insurance plans and employers can exempt some medications from the deductible, meaning some or all of the cost of insulin would be covered by the insurance company regardless of whether the person has met their deductible yet. It may seem like insurance companies and employers have no reason to exempt insulin from deductibles, but in reality the cost of insulin is less than the cost of someone not having access to it and experiencing complications. For instance, if a person with diabetes does not have access to insulin, they could have to go to the emergency room and miss work, and that could cost their employer more than providing the insulin in the first place.

Advocating to Your Employer

A picture of a hand stamping "approved" on a piece of paper. The Affordable Insulin Project helps people make this argument to their employer. Employers can make this change to the insurance program they offer any time in the year, so there’s never a bad time to advocate for a change in policy. Most employers do not understand the costs associated with diabetes, so the Affordable Insulin Project includes a Worksheet that provides a place for you to fill in your medical costs and show your employer how difficult it is to afford insulin with such high deductibles. There is also an Employer Guide that you can give to your employer, benefits manager, or HR representative directly, which presents statistics and arguments for an insulin deductible exemption specifically for them. There’s never a bad time to advocate for lower insulin costs. Remember that if you bring this information to your employer, you’re not only helping yourself, you’re helping everyone in your organization who uses insulin.

For Those Without Employer-Based Insurance

People who buy their health insurance off the markets or those who do not have insurance coverage at all are not left out of the Affordable Insulin Project. The site has a page dedicated to copay cards and discount programs for major insulin companies: Lilly, NovoNordisk, Sanofi, and MannKind. These cards and programs can help make insulin more affordable (though you may need to jump through a few hoops!). The Affordable Insulin Project is the first site to put all these resources together, and for many it is invaluable information.

Check Out the Affordable Insulin Project Today!

The Affordable Insulin Project Logo

College Diabetes Network Connects a New Generation of Activists!

Most diabetes advocates are inspired by their involvement in the diabetes community, and many young adults get their start in the diabetes community through amazing support organizations like the College Diabetes Network.

The College Diabetes Network, or CDN, was formed in 2009 by Christina Roth. She, like many people with type one diabetes, found the transition into independent college life difficult, and she wanted a group of people with whom she could discuss her challenges and victories. After having trouble promoting the group on her campus, she started the CDN website, which now connects college students across the country.

The College Diabetes Network Logo with Text: For the Highs and Lows of College Life

I talked with Dan Browne, a program coordinator with CDN. He said “[CDN] is a nonprofit organization organization whose mission is singularly focused on providing young adults with T1D the peer connections they value, and expert resources they need, to successfully manage the challenging transition to independence at college and beyond.

I first got involved with CDN as a senior in college when I started a Chapter on my own campus. After graduation, I was offered an internship position at the CDN headquarters which grew into a full-time position overseeing the Chapter Network and helping students across the country start and lead Chapters.”

Browne explained the purpose of CDN as an organization that “provides programs that empowers students and young professionals to thrive with diabetes. Our largest program is our Chapter Network – a web of over 115 student-run groups on college campuses across the country, growing all the time. Peer support is invaluable in an environment where so many other variables are changing and students are often tasked with managing their disease independently for the first time.”

A screenshot of resources on the CDN website.

CDN Provides Tools and Resources

CDN doesn’t just provide a network for young people with diabetes to connect. They also provide tools, like blog posts, an e-newsletter, and information on preparing for college, dealing with diabetes in college, and transitioning into the workplace. “We also publish informational resources for students, their parents, and clinicians and campus professionals who work with young adults with type 1 diabetes. These resources include our Off to College booklets for students and parents getting ready for the transition from home to campus and our newest resource for those diagnosed with type one as a young adult. Stay tuned for an exciting new resource coming this spring!” Additionally, CDN has what they call an “ecosystem” support network that targets parents and other family members, clinicians, campus administrators and staff, friends, and roommates of people with diabetes.

A picture of the Political Advocacy Guide cover.

Training a New Generation of Advocates

DPAC’s favorite part of the website (not surprisingly!) is the Diabetes 24/7 section on political advocacy for people with diabetes. Browne talked about how members of CDN advocate for themselves and on a bigger, community level: “At the core of every CDN Chapter is the idea that people with diabetes are better off together than alone. Our potential to drive change and make the world a better place for people with diabetes is only limited by our ability to organize and act together.

All of our Chapter Leaders are community organizers who bring people affected by diabetes on their campus together so that they can have a collective voice. We see Chapters all the time using their platform to advocate for themselves on Campus in ways big and small, from requesting sharps containers in restrooms to educating peers and professors about how they can be supportive.

Our new Political Advocacy Guide encourages Chapters to take it to the next level and think beyond their campuses to their cities, states, and country.” CDN does a great job breaking down the steps to political advocacy in their guide. The guide includes information on finding your passion and people who share it, building an action plan, and ways to take action, like contacting representatives and going to town halls. Because DPAC collaborated with CDN when creating the Political Advocacy Guide, it meshes well with the information we provide here on our blog and website.

An image of the Off to College brochure

CDN Has Something for Everyone

Browne noted that different parts of CDN were important to people in different stages of life. “All of our programs work together to support T1D students and their network, so I would say they are all important.

For the student choosing a college, the Off to College booklets could be most important, for a student living on a campus with a CDN Chapter, the support they receive from their peers could be most important, and for the 22 year old just diagnosed with type one, our You’ve Got This guide could be most important.

We have resources for each stage of this time of life, so students can access what is relevant for them.” Browne also pointed out that CDN was the first organization to bring attention to young people’s issues within the diabetes community: “Of all our accomplishments, I would say bringing the young adult voice to the diabetes sector is the most important. Before CDN, there were no resources for this group and no one was considering what a challenge this time of life was for so many. Now this is a common topic of discussion among clinical providers, pharmaceutical and device companies, and other diabetes organizations!”

Getting Involved with CDN

It’s very easy to become involved with CDN. “Anybody can visit collegediabetesnetwork.org for access to all of our informational resources, all of which are absolutely free. If a student wants to start a Chapter on their college campus, or connect with an existing Chapter, they can email chapters@collegediabetesnetwork.org to get started or fill out the Start a Chapter form on our website,” says Browne.  

Most everyone knows a young person who is off to college soon, is in college now, or has just entered the workforce. CDN is serving the next generation of diabetes advocates, so be sure to visit their site and support their programs!

Check out CDN today!

Disclosure: Christina Roth serves on the Board of Directors for DPAC.

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