Topic: Health Care

Rauner Veto Preserves Consumer Protections in Short-Term Plans, Improves ObamaCare’s Risk Pools

Hours ago, Illinois Gov. Bruce Rauner (R) vetoed legislation that would have subjected enrollees in short-term health insurance plans to higher deductibles, higher administrative costs, higher premiums, and lost coverage. The vetoed bill would have blocked the consumer protections made available in that market by a final rule issued earlier this month by the U.S. Department of Health and Human Services, and would have (further) jeopardized ObamaCare’s risk pools by forcing even more sick patients into those pools.

Short-term plans are exempt from federal health insurance regulations, and as a result offer broader access to providers at a cost that is often 70 percent less than ObamaCare plans.

Rather than allow open competition between those two ways of providing health-insurance protection, the Obama administration sabatoged short-term plans. It forced short-term plan deductibles to reset after three months, and forced consumers in those plans to reenroll every three months, changes that increased administrative costs in that market.

The Obama administration further subjected short-term plan enrollees to medical underwriting after they fell ill – which meant higher premiums and cancelled coverage for the sick. Prior to the Obama rule, a consumer who purchased a short-term plan in January and developed cancer in February would have coverage until the end of December, at which point she could enroll in an ObamaCare plan. The National Association of Insurance Commissioners complained that the Obama rule required that her coverage expire at the end of March – effectively cancelling her coverage and leaving her with no coverage for up to nine months. The Obama administration stripped consumer protections from this market by expanding medical underwriting after enrollees get sick – something Congress has consistently tried to reduce.

Earlier this month, HHS restored and expanded the consumer protections the Obama administration gutted. It allowed short-term plans to cover enrollees for up to 12 months, and allowed insurers to extend short-term plans for up to an additional 24 months, for a total of up to 36 months. These changes allow short-term plans to offer deductibles tallied on an annual basis, rather than deductibles that reset every three months. They spare enrollees and insurers the expense of re-enrolling every three months. Most important, they allow short-term plans to protect enrollees who get sick from medical underwriting at least until they again become eligible to enroll in an ObamaCare plan the following January.

Indeed, HHS clarified that because the agency has no authority to regulate standalone “renewal guarantees” that allow short-term plan enrollees who fall ill to continue paying healthy-person premiums, “it may be possible for a consumer to maintain coverage under short-term, limited-duration insurance policies for extended periods of time” by “stringing together coverage under separate policies offered by the same or different issuers, for total coverage periods that would exceed 36 months.” As HHS Secretary Alex Azar explains, this helps ObamaCare:

Our decision to allow renewability and separate premium protections could also allow consumers to hold on to their short-term coverage if they get sick, rather than going to the exchanges, which improves the exchange risk pools.

I made that very argument in my comments on the proposed rule.

Illinois law automatically adopts whatever rules and definitions the federal government creates for short-term plans. If Illinois legislators had just done nothing, millions of Illinois residents automatically would have had a health insurance option that is more affordable and provides better coverage than ObamaCare.

But this is Illinois.

In their infinite wisdom, Illinois legislators passed legislation that once again would have exposed short-term plan enrollees higher deductibles, higher administrative costs, higher premiums, and cancelled coverage. The bill would have:

  • Required that initial contract terms for short-term plans last no longer than six months. It further provided that such plans could be extended for no more than six additional months.
  • Mandated that consumers who wish to keep purchasing consecutive short-term plans go uninsured for 60 days. Some consumers would inevitably develop expensive conditions during that period, and therefore be left with no coverage until the next ObamaCare open enrollment period. 
  • Prohibited renewal guarantees. The legislation specifically cut off this option. As a result, it would have dumped every single short-term plan enrollee with an expensive illness into the Exchanges. Ironically, Illinois legislators who thought they were bolstering ObamaCare actually passed a bill that would have sabotaged it.

Thankfully, Gov. Rauner stopped this ignorant, ridiculous effort to deny consumer protections to short-term plan enrollees. All eyes now turn to California, where Gov. Jerry Brown (D) must sign or veto legislation that would deny medical care to those who miss ObamaCare’s open enrollment period – by banning short-term plans altogether.

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The Law of Unintended Consequences Strikes Again

Late last week UPI news ran a report by E.J. Mundell with the headline, “Government efforts to curb opioid prescriptions might have backfired.” It cites two separate studies published online in JAMA Surgery on August 22 that examined two different restrictive opioid policies that fell victim to the Law of Unintended Consequences.

The first study, by researchers at the University of Michigan, evaluated the impact of the Drug Enforcement Administration’s 2014 rescheduling of hydrocodone (Vicodin) from Schedule III to Schedule II. Prescriptions for Schedule III narcotics may be phoned or faxed in by providers, but Schedule II narcotics require the patient to see the prescriber in person in order to obtain a prescription. The DEA’s goal was to reduce the number of Vicodin pills, popular with non-medical users, available for diversion to the black market.

The study looked at 21,955 post-surgical patients across 75 hospitals in Michigan between 2012 and 2015 and found that the number of hydrocodone pills prescribed after the 2014 schedule change increased by an average of seven 5mg tablets. The total Oral Morphine Equivalent of prescribed hydrocodone did not change significantly after the DEA made hydrocodone Schedule II. However, the refill rate decreased after the change. The study’s abstract concluded, “Changing hydrocodone from schedule III to schedule II was associated with an increase in the amount of opioids filled in the initial prescription following surgery.”

As a practicing general surgeon, my initial reaction to this study was: “Tell me something I don’t know.” Prior to the 2014 schedule change, I would often start off prescribing a small amount of hydrocodone to some of my post-op patients (depending upon the procedure and the patient’s medical history) with the knowledge that I can phone in a refill for those patients who were still in need of it for their pain after the initial supply ran out. Once it was rescheduled, I changed my prescribing habits. Not wanting any of my patients to run out after hours, over a weekend, or on a holiday—when the office is closed and their only recourse would be to go to an emergency room or urgent care center to get a prescription refill—I increased the amount I prescribe (based on my best estimate of the maximum amount of days any individual patient might need hydrocodone) to reduce the chances of them needing a refill. This results in some patients having leftover Vicodin pills in their medicine cabinet. On the other hand, fewer of those patients need refills.

Not surprisingly, many of my clinical peers have done the same thing. It’s not a surprise because most physicians place the interests of their patients ahead of the interests of regulators and bureaucrats. So the adjustment made in postoperative hydrocodone prescribing was basically a “no brainer.” 

New FDA Initiative Implies CDC Opioid Guidelines Are Not Evidence-Based

On August 22, Food and Drug Commissioner Scott Gottlieb issued a press release announcing the FDA plans to contract with the National Academies of Sciences, Engineering, and Medicine (NASEM) to develop evidence-based guidelines for the appropriate prescribing of opioids for acute and post-surgical pain. The press release stated:

The primary scope of this work is to understand what evidence is needed to ensure that all current and future clinical practice guidelines for opioid analgesic prescribing are sufficient, and what research is needed to generate that evidence in a practical and feasible manner.

The FDA will ask NASEM to consult a “broad range of stakeholders” to contribute expert knowledge and opinions regarding existing guidelines and point out emerging evidence and public policy concerns related to the prescribing of opioids, utilizing the expertise within the various medical specialties. 

Recognizing the work of the Centers for Disease Control and Prevention for having “taken an initial step in developing federal guidelines,” Commissioner Gottlieb diplomatically stated the FDA initiative intends to “build on that work by generating evidence-based guidelines where needed” that would differ from the CDC’s endeavor because it would be “indication-specific” and based on “prospectively gathered evidence drawn from evaluations of clinical practice and the treatment of pain.”

The CDC guidelines for prescribing opioids, released in early 2016 and updated in 2017, have been criticized by addiction and pain medicine specialists for not being evidence-based. Unfortunately, these guidelines have been used as the basis for many new prescribing regulations instituted at the state-level and proposed on the federal level. The American Medical Association and other medical specialty organizations have spoken out against proposed federal prescription limits that are based upon an inaccurate interpretation of the flawed CDC guidelines. 

In May, Commissioner Gottlieb, in a blog post, mentioned he was aware of criticisms as well as complaints by patient and patient-advocacy groups and was interested in developing more “evidence-based information” on the matter of opioids and pain management. 

Now it appears he is taking the next step. While the press release language was diplomatic and avoided any notion of disrespect for the CDC’s efforts, it is difficult not to infer that the Commissioner agrees with many who have been criticizing the CDC guidelines over the past couple of years.

 

Prohibition Is the Obvious Cause of Opioid Crisis as CDC Releases Preliminary Casualty Numbers for 2017

Earlier this month the Centers for Disease Control and Prevention released preliminary estimates of the opioid overdose rate for 2017. The total overdose rate rose to approximately 72,000, up from a total overdose rate of 63,600 in 2016, an increase of roughly 10 percent. The total overdose rate includes deaths from numerous drugs in addition to opioids, such as cocaine, methamphetamine, and benzodiazepines. The opioid-related overdose rate increased as well, from a little over 42,000 in 2016 to over 49,000 in 2017. This increase occurred despite a 4 percent drop in heroin overdoses and a 2 percent drop in overdoses due to prescription opioids. A 37 percent increase in illicit fentanyl-related overdoses explains the jump in the death rate.

All of this is happening while the prescribing of high-dose opioids continues to decrease dramatically—over 41 percent between 2010 and 2015, with a recent report showing a further decrease of 16 percent during the year 2017.

This is more evidence, if any more was needed, that the opioid overdose problem is the result of non-medical users accessing drugs in the black market that results from drug prohibition. Whether these users’ drug of choice is OxyContin or heroin, the majority have obtained their drugs through the black market, not from a doctor. A 2007 study by Carise, et al in the American Journal of Psychiatry looked at over 27,000 OxyContin addicts entering rehab between the years 2001 and 2004 and found that 78 percent never obtained a prescription from a doctor but got the drugs through a friend, family member, or a dealer. 86 percent said they took the drug to “get high” or get a “buzz.” 78 percent also had a prior history of treatment for substance abuse disorder. And the National Survey on Drug Use and Health has repeatedly found roughly three-quarters of non-medical users get their drugs from dealers, family, or friends as opposed to a doctor.

Media and policymakers can’t disabuse themselves of the false narrative that the opioid problem is the product of doctors hooking their patients on opioids when they treat their pain, despite the large number of studies showing–and the Director of the National Institute on Drug Abuse stating—that opioids used in the medical setting have a very low addiction rate. Therefore, most opioid policy has focused on decreasing the number of pills prescribed. Reducing the number of pills also aims at making less available for “diversion” into the black market. This is making many patients suffer from undertreatment of their pain and causes some, in desperation, to turn to the black market or to suicide.

Since 2010, opioid policy has also promoted the development of abuse-deterrent formulations of opioids—opioids that cannot be crushed and snorted or dissolved and injected. As a just-released Cato Research Brief as well as my Policy Analysis from earlier this year have shown, rendering prescription opioids unsuitable for abuse has only served to make non-medical users migrate over to more dangerous heroin, which is increasingly laced with illicit fentanyl. 

This is how things always work with prohibition. Fighting a war on drugs is like playing a game of “Whac-a-mole.” The war is never-ending and the deaths keep mounting.

The so-called “opioid crisis” has morphed into a “fentanyl and heroin crisis.” But it has been an unintended consequence of prohibition from the get go.

There Is More Than One Way to “Spin” a Stat

I recently wrote about how ideology and confirmation bias has infiltrated research into the opioid overdose issue. I spoke about how researchers can “spin” their findings to comport with the prevailing narrative and improve the likelihood of getting published in peer-reviewed journals.

An example occurred yesterday, when the University of Michigan’s Institute for Healthcare Policy and Innovation announced, with the headline “Unwise opioids for wisdom teeth: Study shows link to long-term use in teens and young adults,” the publication of a research letter in JAMA that day by a team of its researchers.

The study of over 70,000 dental patients, ranging from 13 to 30 years in age, who had wisdom teeth extracted between 2009 and 2015 found, 

In all, 1.3 percent of 56,686 wisdom tooth patients who filled their opioid prescription between 2009 and 2015 went on to persistent opioid use, defined as two or more prescriptions filled in the next year written by any provider for any reason. That’s compared with 0.5 percent of the 14,256 wisdom tooth patients who didn’t fill a prescription.” 

Set aside the fact this study shows prolonged use is very low. Is there something inherently bad about refilling opioid prescriptions and staying on opioids longer than the average person if one is not addicted? Since we know that opioids have very few harmful effects on organs compared to alcohol, acetaminophen, or NSAIDs (with prolonged use), and since the addiction and misuse rate is somewhere around 1 percent, why are the authors so upset if some people stay on the drug longer than others. The lead author calls this a “long term ill effect.” Really?

Meanwhile, on the same day, another research letter was also published in JAMA by researchers at Brigham and Women’s Hospital in Boston that looked at 1.3 million patients who received 22 types of surgical procedures between the years 2004 and 2015. The study found a 30-day post-discharge overdose rate of 10.3 per 100,000 patients (0.01 percent), dropping to 3.2 overdoses per 100,000 patients (0.0032 percent) for those 61 to 90 days post-discharge. The authors found overdoses within 30 days post-discharge were very low in patients who were “opioid naïve”—2.8 per 100,000 patients (0.0028 percent)—as opposed to patients who were receiving opioids prior to surgery. In patients who were chronically receiving high-dose opioids prior to the operation (defined by the authors as greater than the equivalent of 100mg of morphine per day) that rate jumped to 142.5 per 100,000 patients (0.14 percent).

The authors stated in their concluding discussion:

This study demonstrated that opioid overdose after surgical discharge was rare. Patients were at risk of experiencing an overdose after leaving the hospital, especially in the first month. Furthermore, patients using high quantities of opioids preoperatively were at a heightened risk compared with those not receiving high-dose opioid therapy prior to the operation.”

The big takeaway from this study is that overdose rates in patients discharged on opioids postoperatively are extremely low—even in those who had been chronically receiving high-dose opioids preoperatively. But the authors of the study spent most of the time discussing the fact that overdoses can and do occur in patients discharged from surgery on opioids and occur more frequently in patients who had been on opioids preoperatively.

Give credit to the medical news service MedPage Today for providing dispassionate, no-spin coverage to both studies by covering them together in a story on August 7 entitled: “Post-Surgery Overdoses Are Rare—but higher odds of persistent use seen following some procedures.”

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Politics, Confirmation Bias, and Opioids

This post co-authored with Rafael Fonseca, MD, Chairman of the Department of Medicine, Mayo Clinic, Phoenix, AZ

Much has been written about how politics and ideology influence research funding, suppress research in certain areas, and lead to the cherry-picking and misrepresentation of evidence in support of a narrative or agenda. Science journalist John Tierney explored “The Real War on Science” in an excellent essay in City Journal in 2016. Reflecting on this phenomenon in 2011, Patrick J. Michaels stated:

The process is synergistic and self-fulfilling. Periodicals like Science are what academia uses to define the current truth. But the monolithic leftward inclination of the reviewing   community clearly permits one interpretation (even if not supported by the results) and not another. This type of blatant politicized science is becoming the norm in the environmental arena, and probably has infiltrated most every other discipline, too.

It certainly has infiltrated research into the emotionally charged opioid overdose problem afflicting the US and many other western nations. Policy decisions have been rooted in a narrative seemingly immune to the facts: that the problem is largely the result of greedy pharmaceutical companies manipulating careless and poorly-trained doctors into “hooking” patients on highly addictive opioids and condemning them to a nightmarish life of drug addiction.

Tierney writes of confirmation bias—the tendency of people to seek out and accept information that confirms their beliefs and prejudices. He bemoans the “groupthink” that allows confirmation bias to infiltrate the peer review process. He cites a well-known study that demonstrated reviewers were more likely to find problems with a study’s methodology if the findings were contrary to their prejudices yet overlook methodological shortcomings if the findings were confirmatory.

Sometimes investigators try to “spin” their findings to make them comport to the narrative and appear confirmatory, increasing the likelihood that their research gets published. 

Both of us are practicing physicians, and each of us recently experienced reminders that research into the opioid overdose issue is not exempt from politicization and confirmation bias. We would like to present two recent examples where this confirmation bias became self-evident. 

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Short-Term Plans Rule Flips the Political Narrative on Health-Insurance Protections

The usual narrative is that Democrats support consumer protections and Republicans oppose them. Today’s short-term plans final rule flips that narrative: Republicans are expanding consumer protections, and Democrats are opposing them.

Today’s rule reverses a 2016 Obama rule. The Obama rule reduced consumer protections in short-term plans by exposing sick patients to medical underwriting. Before that rule, consumers could purchase short-term plans that lasted 12 months. If they developed a serious illness, their plan could cover them until the next ObamaCare open enrollment period, when they could purchase coverage without medical underwriting. The Obama rule restricted short-term plans to 3 months. It prohibited “renewal guarantees” that protect enrollees who fall ill from medical underwriting when they purchased a new short-term plan. As a result, the Obama rule left short-term plan enrollees who got sick with no coverage for up to 9 months: those who purchased a plan in January, and developed a serious illness in February, would lose their coverage at the end of March, and have no coverage until the following January. (Source: NAIC) This was by design: the Obama administration wanted to expose sick people in short-term plans to medical underwriting and lost coverage as a way of forcing consumers to buy ObamaCare coverage instead. That’s at least a little messed up.

Today’s rule allows short-term plans to last 12 months and offer renewal guarantees. It therefore allows short-term plans to protect the sick from medical underwriting for an additional 9 months—indeed, “issuers may offer coverage under a short-term, limited-duration insurance policy for up to a total of 36 months, without any medical underwriting or experience rating beyond that completed upon the initial sale of the policy”—and allows renewal guarantees to protect them from medical underwriting indefinitely. Protecting the sick from medical underwriting has long been a goal of Congress.

So, to recap, Republicans are expanding consumer protections, and Democrats are opposing an expansion of consumer protections.

Weird, isn’t it?