Stemming the Escalating Cost of Prescription Drugs

Back in October, I wrote about escalating drug prices.  Last week, ACP President Nitin Damle was testifying before Congress about the CREATES Act (“Creating and Restoring Equal Access to Equivalent Samples Act of 2016”).  This bill, if it were to become law, would make it easier for generic drug manufacturers to get access to samples of the reference product in order to support bioequivalence testing required for an FDA application.

This was also one of the topics we discussed on Capitol Hill during Leadership Day last month.  We advocated for the development and introduction of legislation in both chambers that will include these elements:

1) Increased transparency in drug pricing by requiring pharmaceutical manufacturers to publically disclose production costs, including research and development investments for specific high‐cost drugs that the Secretary identifies through regulation. Unlike many other countries, the United States lacks regulatory authority to control the price of drugs or devices. As a result, pharmaceutical companies may price drugs at will and there is very little transparency or understanding of how companies arrive at the price of a drug.

2) Authorization to appropriate $2.74 billion in discretionary spending for the FDA to expedite, through fast-track approval, new drugs that address unmet medical need in the treatment of a serious or life threatening condition, as well as to address the back-log of pending generic drug applications. The median approval times for standard and priority review drugs in fiscal year 2013 dropped to 12 months and 7.9 months. Drugs can move through the regulatory approval process more rapidly if they qualify for fast track designation, accelerated approval, priority review, or breakthrough therapy designation. Although an FDA report showing the agency is approaching targets and commitments made by the agency to improve review times is encouraging, we continue to advocate for additional resources for the FDA so that progress can continue on clearing the backlog. ACP also supports robust oversight and enforcement of restrictions on product-hopping, evergreening, and pay-for-delay practices as a way to increase marketability and availability of competitor products. In these practices, companies prevent generic competition from entering the market by making small adjustments to a drug with no real therapeutic value that grant the company longer patent protection, or they remove the drug from market, forcing patients to switch to a reformulated version of the same drug.

3) Granting authority to the Secretary of HHS to negotiate prescription drug prices with manufacturers for high‐cost drugs and biologics covered under Part D of the Medicare program. Medicare Part D pays on average more than other federal health care programs: 73% more than Medicaid and 80% more than the Veteran’s Health Administration (VA). The VA operates as a closed system and provides care directly to veterans. They purchase drugs and other pharmaceuticals directly from manufacturers, and have a national formulary which does not exist in Medicare or Medicaid. The ACP has longstanding policy advocating for the ability of Medicare Part D to negotiate drug prices and rebates directly with pharmaceutical manufacturers as a way to keep costs to the system down. Although the Congressional Budget Office, in a 2007 letter to Senator Wyden, contended that the savings would be negligible, other recent estimates show Medicare Part D could save $15-16 billion a year if it were allowed to negotiate drug prices.

The CREATES Act could be one step in the right direction.

To read the ACP Position Paper, Stemming the Escalating Cost of Prescription Drugs, click here.

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Annals This Week: Physicians, Patients and Firearms

Last December, I wrote about ACP activity to counteract firearm violence.  This week, the Annals of Internal Medicine published a review on physician practice regarding asking about firearms. It is striking that 40% of Americans are worried they could be victims of firearm violence.  That doesn’t sound like the domestic tranquility envisioned by our founding fathers.

We are hopefully beyond the discussion of whether or not gun violence is a public health issue.  You’ll recall that the nomination of the current Surgeon General, Vivek Murthy, was contested because he dared to publicly state that it is an important issue of public health.  But physicians could do better at preventing firearm violence.  The article summarizes barriers and makes suggestions for implementing a preventive approach.

Legislative action such as Florida’s so-called “Docs versus Glocks” law have led some clinicians to be, um, gun-shy about asking questions related to firearms.  The authors point out that existing laws, even the Florida gag rule, do not prohibit the clinician from asking about firearms when that information is relevant to the care of the patient or the patient’s safety, or the safety of others.  It is the routine collection and documentation of information about gun ownership that is prohibited.  The three other states with firearm/health statutes also do not outlaw collection or recording of information about firearm ownership when it is medically necessary. More proscriptive bills have come up in North Carolina and Ohio but have not been passed as laws.

The authors then outline three conditions for which, even if a physician was having difficulty incorporating firearm discussions as a matter of routine, there should be selective implementation.  First, when a patient is at acute risk for harm to self or others: suicidal or homicidal ideation or intent.  Second is the presence of individual risk factors for engaging in future violence, including a history of violence; certain phases of mental illness such as recent discharge from an ED or inpatient facility, or experiencing a first psychotic episode; and cognitive disorders.  Third, there are high risk groups: for suicide, middle-aged or older white men; for homicide, young African-American men.

The authors identified lack of familiarity with the benefits and risks of firearm ownership, with how to counsel about firearm and with firearms themselves as the most significant barriers.  Little has been done to assess specific interventions.  But there is advice about how to counsel.  They advocate for respectful conversations recognizing the cultural aspect of gun ownership, best occurring in the setting of an existing patient-physician relationship.  They give other suggestions for the content of such conversations.  Finally, they remind us that disclosure of protected health information to authorities is permissible when harm to self or others is imminent.

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ACP’s Position Paper on Climate Change and Health

In case you missed it, last week in conjunction with Earth Day the ACP released a position paper on the impact of climate change on human health.  By now, you are familiar with the details: fossil fuel consumption, clearing of forests at an unsustainable rate, power plant emissions contribute to greenhouse gases, resulting in increased global temperatures.  Potential health effects of the rising temperatures include higher rates of respiratory and heat-related illness, elevated prevalence of vector-borne diseases, and increased food insecurity and malnutrition related to poor growing conditions.  This is compounded by the more severe weather which leads to immediate loss of life.  The WHO acknowledges climate change as one of the greatest health risks of the 21st century.  In 2012, they estimated as many as 7 million people died from air pollution-related diseases, primarily from the products of combustion of fossil fuels.  Climate change is also anticipated to cause 250,000 more deaths per year between 2030 and 2050 from malaria, diarrhea, heat stress and under-nutrition. (1)

The position paper reiterates that taking action now to reduce greenhouse gases will have a significant impact on health.  Individual actions, such as walking or cycling instead of motor vehicle use, have individual health benefits as well in terms of cardiovascular fitness and reduction of obesity.  It issues a challenge of sorts to physicians to adopt lifestyle changes that have a favorable environmental impact and to educate patients and the public on the health consequences of climate change.

There will continue to be those who deny the existence of global warming.  As of 2015, only 8 (of 278) congressional Republicans were on record as accepting that we, as humans, could be responsible for climate change. (2)  This is unfortunate.  One could say this is akin to Nero fiddling while Rome burns (although the good people at History.com have debunked that as legend).  It is doubtful that our voting populace will turn the 2016 election, and congressional elections that follow, into a referendum on science.  Perhaps the large (non-elected) segment of the U.S. that does not engage in such irrational anti-scientific thought is hoping their elected officials will come to their collective senses.  But comments like this: “I absolutely do not believe in the science of man-caused climate change. It’s not proven by any stretch of the imagination. It’s far more likely that it’s sunspot activity or just something in the geologic eons of time” from Wisconsin Senator Ron Johnson, should make you understand that such a coming-to of senses will be improbable. (3)

But I digress.  Please review the ACP position paper, particularly the expanded background and rationale.  If you didn’t understand the importance of addressing climate change before, you hopefully will afterwards.

(1) http://www.who.int/globalchange/mediacentre/news/country-profiles/en/ accessed April 25, 2016

(2) http://www.nytimes.com/2015/12/04/opinion/republicans-climate-change-denial-denial.html?_r=0 accessed April 26, 2016

(3) http://www.jsonline.com/multimedia/video/?bcpid=13960334001&bctid=590004292001 accessed April 26, 2016

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The Core Quality Measure Collaborative Measure Sets

The Centers for Medicare and Medicaid Services (CMS), with Americas Health Insurance Plans (AHIP), last month announced seven sets of core measures that represent an attempt to achieve alignment across practice settings and multiple payers.  This comes after 18 months of collaboration with other stakeholders to develop the measure sets.  There are separate measure sets for Primary Care (and ACO/PCMH), Cardiology, Medical Oncology, Gastroenterology, HIV/hepatitis C, Obstetrics and Gynecology, and Orthopedics.  The measures can be seen at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityMeasures/Core-Measures.html.

Meanwhile, for the last 18 months, the Quality Council of the Connecticut State Healthcare Innovation Model has been engaged in a similar process.  The state has a grant to support payment reform for the Medicaid program and the development of core measures is key to establishing a value-based payment initiative.  The council consists of physicians, healthcare advocates, and insurance company representatives; this group developed a preliminary set of core measures, focusing on things relevant to the Medicaid population including oft-ignored issues like behavioral health.  With the announcement of the CMS-AHIP measure set, the state Quality Council will be looking to align the set they have developed as much as possible.

Both of these endeavors rely heavily on existing measures.  This is one of the major criticisms of the CMS-AHIP set.  The current state of quality measurement doesn’t seem to be capturing the most important aspects of care.  McGlynn and colleagues suggested 3 guiding principles for measurement: integration with care delivery; acknowledgement of clinical challenges such as multi-comorbidity and uncertainty; and reflection of patient preferences, goals of treatment and heterogeneity of care related to this (1).

ACP has commented on the broader CMS draft proposal that preceded the announcement of the measure set [CMS Quality Measure Development Plan: Supporting the Transition to the Merit-based Incentive Payment System (MIPS) and Alternative Payment Models (APMs)], as required by MACRA (the Medicare Access and Children’s Health Insurance Program (CHIP) Reauthorization Act of 2015).  The letter to CMS is a thoughtful, thorough document (albeit a significant read at 42 pages!) and was the work of the Medical Practice and Quality Committee (MQPC), chaired by former CT Chapter Governor and current Board of Regents member Dr. Robert McLean.  The letter asks CMS to use the MACRA as an opportunity to “build a learning health and healthcare system” which reflects learning from prior programs and emphasizes “the need to constantly monitor the evolving measurement system to identify and mitigate any potential unintended consequences.” Like McGlynn, ACP recommends a patient-centered approach that recognizes the patient-physician relationship.  The College also “strongly recommends that CMS collaborate with specialty societies, frontline clinicians, and EHR vendors in the development, testing, and implementation of measures with a focus on decreasing clinician burden and integrating the measurement of and reporting on performance with quality improvement and care delivery.” I invite you to review the entire document.

  1. McGlynn EA, Schneider EC, Kerr EA. Reimagining quality measurement. N Engl J Med. 2014 Dec 4;371(23):2150-3.
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Reflections Regarding Opioid Prescribing After Nonfatal Overdose

This post is authored by CT Chapter Council Member Daniel G. Tobin, MD, FACP, Assistant Professor of Medicine, Yale University School of Medicine

Clinicians frequently prescribe opioids for chronic non-cancer pain despite their questionable therapeutic efficacy and having little or no formal training in pain management.1-3  Not surprisingly, this has contributed to an epidemic of unintentional overdose deaths.  Highlighting this crisis, in 2009 the risk of dying from an unintentional overdose exceeded the mortality risk of motor vehicle accidents, making it the leading cause of accidental death in the United States.4  Now, a recent study further elevates the level of concern.

In a startling retrospective cohort study by Larochelle and colleagues5, they found that more than 90% of chronic pain patients who present to the emergency room or hospital with a non-fatal opioid overdose continue to receive opioids after the event, typically prescribed by the same provider, and 7% had a subsequent overdose event during the study period.  This data undoubtedly underestimates the true frequency of this phenomenon since the authors excluded patients who suffered an overdose death or did not present to a health care facility.  Additionally, the mean daily opioid dosage in the 60 days prior to overdose was quite high (ranging from a morphine-equivalent dose of 152-164 mg), and increased rapidly in the week prior to the event.  As alarming as these findings are, they suggest a number of opportunities for intervention.

First, the authors rightly point out that in many cases the prescriber may have been unaware that the opioid overdose happened, as evidenced by the fact that 70% of the patients continued to receive opioids from the same prescriber as before the event.  In most states (including Connecticut), there is currently no standardized mechanism to report such an event back to the prescriber through their central Prescription Monitoring and Reporting System.  Similarly, providers do not routinely receive event notification from insurance carriers despite the availability of claim data that could identify such episodes.  Furthermore, direct contact between the hospital and the outpatient prescriber is sporadic and the information does not automatically follow the patient who chooses to go elsewhere for their future care.  Addressing these shortcomings is a critical step toward improving safety.

Additionally, these data again correlate higher prescribed opioid doses with increased risk of overdose, as has been demonstrated previously6.  Pharma-sponsored publications have pushed back on this idea7, but most authorities recommend caution as the dose rises.  It is also notable that in this study the mean opioid dose escalated significantly in the week prior to overdose, suggesting that rapid increase in opioid use may have overcome tolerance, even in patients already receiving high doses of opioids chronically.  Dose increases should be made cautiously, even for experienced opioid users.

Although not discussed by the authors, this study also highlights the importance of access to the opioid-reversal agent naloxone (Narcan).  Treatment with naloxone was undoubtedly lifesaving in this cohort, and enhanced access and use of this drug in the outpatient setting is of profound importance.  This is particularly relevant since many overdose victims never present to the hospital setting.  Connecticut now allows via Public Act 15-198 certified pharmacists to directly dispense, without a physician’s prescription, the opioid antagonist naloxone, but prescribing and counseling patients about the risk for overdose and appropriate use of naloxone remains a core responsibility of the prescriber.  Like a fire extinguisher that one hopes to never use, having naloxone on hand is a very important preventative measure.

Opioid therapy will continue to have a role in the treatment of chronic non-cancer pain for the foreseeable future, but we should reflect on these findings and improve overdose prevention efforts whenever possible.  In addition, once it becomes clear that the risk for harm outweighs the expected benefit for an individual patient, prescribers should carefully taper and discontinue opioid therapy.  When appropriate, referral for treatment of opioid abuse and dependence should also occur.  We should always strive to treat pain, but we must first do no harm.

References:

  1. Chou R, Turner JA, Devine EB, et al. The Effectiveness and Risks of Long-Term Opioid Therapy for Chronic Pain: A Systematic Review for a National Institutes of Health Pathways to Prevention WorkshopEffectiveness and Risks of Long-Term Opioid Therapy for Chronic Pain. Ann Intern Med. 2015;162(4):276-286.
  2. Roehr B. US needs new strategy to help 116 million patients in chronic pain. BMJ. 2011;343:d4206.
  3. McCarberg BH, Nicholson BD, Todd KH, Palmer T, Penles L. The impact of pain on quality of life and the unmet needs of pain management: results from pain sufferers and physicians participating in an Internet survey. American Journal of Therapeutics. 2008;15(4):312-320.
  4. Paulozzi L, Dellinger A, Degutis L. Lessons from the past. Injury Prevention:Journal of the International Society for Child and Adolescent Injury Prevention. 2012;18(1):70.
  5. Larochelle MR, Liebschutz JM, Zhang F, Ross-Degnan D, Wharam JF. Opioid Prescribing After Nonfatal Overdose and Association With Repeated Overdose: A Cohort Study. Ann Intern Med. 2016;164(1):1-9.
  6. Dunn KM, Saunders KW, Rutter CM, et al. Opioid prescriptions for chronic pain and overdose: a cohort study. Ann Intern Med. 2010;152(2):85-92.
  7. DeVeaugh-Geiss A, Coplan P, Kadakia A, Chilcoat H. Is opioid dose a strong predictor of the risk of opioid overdose? Important confounding factors that change the dose-overdose relationship. Drug & Alcohol Dependence. 2015;146:e265.

 

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ACP Targets Growing Physician Paperwork Burden

This entry was submitted by Keith vom Eigen, MD, PhD, MPH, FACP, who is Chair of the Health and Public Policy Committee for the Connecticut Chapter.

A local pharmacist called recently to tell me that the glucose test strips my patient had been using were no longer covered by her insurance.  He couldn’t determine which brand her insurance might cover, and I was unable to find the information on-line.  I swallowed hard and resigned myself to the dreaded insurance company phone call.  After winding my way through several automated menus, I was finally able to get to a real person — who then transferred me to a different company administering the pharmacy plan.  I tried to remain calm as I repeated my, and the patient’s, identifying information multiple times, speaking with four different people.   It took half an hour, much of it on hold, to finally get an answer to my simple question.  I suppose the insurance company saved a few dollars by shifting the patient to a different glucometer brand, but at what cost to the pharmacist, the patient and the physician?  How long will it be before they decide to switch to yet another brand, requiring the same ordeal all over again?

The growing burden of paperwork and regulatory hassle is sapping the joy out of medical practice, especially in Primary Care.  Many of us are frustrated by the bureaucracy that limits the time we can spend with patients and that adds little value to patient care.  Excessive paperwork and regulation are significantly adding to physician “burn-out.”  Of course we need to do something about the rapidly escalating cost of care, but it seems that every cost-saving measure comes with another form to fill out or hoop to jump through.  Doctors struggling with the rapid adoption of EHRs often feel more like data entry clerks, and have to scale back their time with patients to manage the information flow and data reporting requirements.  And who can figure out, let alone comply with, Medicare and Medicaid regulations?

I was pleased to learn recently that ACP is actually trying to do something about the problem.  A new initiative called Patients Before Paperwork aims to “reinvigorate the patient-physician relationship by challenging unnecessary practice burdens.”  ACP has developed the program to identify administrative burdens, gather evidence to support advocacy and educational efforts, and assist physicians in implementing mitigation strategies.  Through a survey and focus groups, ACP has identified three priority areas to target: EHR Usability, Quality Reporting and Dealing with Insurance Companies.  The College is currently working on a policy paper that will outline recommendations to address the problem, as well as a toolkit for ACP Chapters to facilitate discussion and help identify solutions.  If you would like to help in the effort, you can send information to ACP (policy-regs@acponline.org) on how the practice burdens you are facing impact your ability to care for patients, as well as solutions that you have developed in your own practice, and how you think ACP can help address the problem.  Let’s work together to reduce these burdens to make health care more effective for patients, as well as more meaningful and satisfying for physicians.

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Gun Violence: Still A Public Health Issue

The three-year anniversary of the Sandy Hook Elementary School shooting in Newtown is cause for reflection here in Connecticut.   Sadly, little has changed since then.  However, for the first time in 19 years we’ve seen a glimmer of hope to lift the ban on funding for gun violence prevention research.  The American College of Physicians is advocating strongly for lifting this ban.  Our organization joined together with 23 others to urge Congress to act (see the letter).

I live in one of the 25 U.S. cities or towns named Madison, after the Father of the Constitution and primary author of the Bill of Rights.  I bring this up because the second amendment has become such a source of polarity in our country. While you will frequently hear people debate the “intent of the founding fathers” when it comes to constitutional questions, one cannot argue with the fact that the world was a different place in 1789 when the Bill of Rights was crafted.  In the late 18th century, there was suspicion that a federally controlled military force might overthrow state governments; Madison himself felt it was important to have state militias that could protect the public from the federal army.  However, during the War of 1812, civilian militias were largely ineffective and it was determined that a strong standing army was required.  In the 21st century, the states and federal government have a different relationship.  For the most part, we have been secure within our borders.  We have a strong standing military.  The idea that all able-bodied men between 19 and 45 will need to be called upon to quell an insurgence related to imperial designs by another country or by terrorists (or maybe zombies?) is far-fetched.

On the other hand, the statistics about gun related deaths seemingly speak for themselves. So far, in 2015, gun violence is responsible for 12,533 deaths in the United States [this data is available at http://www.gunviolencearchive.org/]. We’ve already had 353 mass shootings in 2015 (defined as the shooting of four or more people); a list can be found at http://www.shootingtracker.com/wiki/Mass_Shootings_in_2015.  National data on causes of death in 2013, reported by the CDC, also reveals that of the 33,169 gun-induced deaths, 21,175 were self-inflicted.  Since the horror of Newtown, 555 children have succumbed to firearm violence; that is one every other day.  How could we not be outraged?  The 12,533 gun homicides this year are more than Ebola virus has killed worldwide (11,315); not only that, only 1 of those Ebola deaths has occurred in the U.S., yet Ebola elicits much more angst and hand-wringing than gun violence.  Nonsense perpetrated by the NRA about self-defense does not justify the ongoing slaughter.  If you need to be convinced, read the Violence Policy Center’s analysis of FBI and National Crime Victimization Survey Data.  In it, you will learn that in 2012, only 259 gun-related justifiable homicides were recorded against over 8,000 criminal homicides and 20,000 suicides or unintentional deaths caused by firearms (in CT, there were 0 justifiable homicides).

This country’s irrational love affair with firearms continues, at the expense of thousands of American lives.  We have to make it clear that firearm violence is a public health issue.  It’s preposterous that we cannot make substantive progress towards addressing the problem.  Let Congress hear your outrage.

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