Attacking the Opioid Epidemic: 21st Century Cures Act and America’s Reefer Referendum

Notwithstanding the Patient Protection and Affordable Care Act of 2009 (“Obamacare” or “the ACA”), the 21st Century Cures Act is the largest health care innovation treatment-based American law in over a decade. Signed by President Barack Obama in December 2016 as one of his last major acts as the head of the executive branch, the Cures Act has been hailed as a bipartisan, bicameral success. “‎We are now one step closer… helping people seeking treatment for opioid addiction finally get the help they need,” Obama said in a statement. The legislation primarily seeks to implement several approaches to improve the health industry, including establishing accelerated discovery, development, and delivery of novel treatments in the biotechnology and medical device industries, as well as cost savings plans. Yet within the primarly pharma/device focused bill, albeit awkwardly placed, comes language that addresses what has steadily become a major public health risk facing the nation’s heartland: supporting state prevention activities and responses to mental health and substance use disorder need vis-à-vis the opioid epidemic.

According to the Centers for Disease Control and Prevention (CDC), drug overdose and opioid-involved deaths continue to increase in the United States. The majority of drug overdose deaths involve an opioid. From 2000 to 2015, more than half a million people died from drug overdoses, and 91 Americans die every day from an opioid overdose. The epidemic has hit the Appalachian region particularly hard, where it has wreaked havoc in states like West Virginia, Ohio, Kentucky, and Pennsylvania; in some cases Heroin deaths have surpassed gun homicides  and car crashes. Likewise, in New England states like Massachusetts, New Hampshire, and Delaware, drug addicts are collapsing in the streets.

The Cures Act has allocated $1 billion of federal funds over two years for grants to states to supplement opioid abuse prevention and treatment activities, such as improving prescription drug monitoring programs, implementing prevention activities, training for health care providers, and expanding access to opioid treatment programs. Further, money will be appropriated toward treatment, recovery, and transition for the homeless, incarceration diversion programs, as well as grants for suicide prevention.

Outside of the Cures Act, marijuana proponents are rallying around research that seems to suggest a correlation between fewer opioid-caused deaths in states where marijuana has been legalized. Researchers have found that when legal medical marijuana dispensaries begin to operate in a state, deaths from opioid overdoses drop within that state. In what could be deemed a reefer referendum, after the 2016 election cycle in which a record number of states sought to legalize marijuana in some capacity, as of early 2017, a total of 25 states – half of the states in the Union – have legalized marijuana (for either recreational medical use). In 2014, studies suggested that states with medical marijuana laws had an overall 25% lower rate of death from opioid overdoses than other states. There was a 20 percent lower rate of opioid deaths within the laws’ first year, 24% by year three, and 33% by year six. By the end of the study in 2010, there were 1,729 fewer deaths than expected in medical marijuana states. Moreover, another study examined data from 1999 to 2013 and found  opioid abuse in states that have legalized medical marijuana was reduced. The research showed an association between a state legalizing medical marijuana and a reduction in testing positive for opioids after dying in a car accident, particularly among drivers ages 21 to 40.

 

A further study suggests that medical marijuana may simultaneously drive down prescription drug spending, and subsequently likely use. Per the CDC, “we now know that overdoses from prescription opioids are a driving factor in the 15-year increase in opioid overdose deaths. Since 1999, the amount of prescription opioids sold in the U.S. nearly quadrupled, yet there has not been an overall change in the amount of pain that Americans report.” Recent research found that states that legalized medical marijuana — which is sometimes recommended for symptoms like chronic pain, anxiety or depression — saw declines in the number of Medicare prescriptions for drugs used to treat those conditions and a dip in spending by Medicare Part D, which covers the cost on prescription medications.

On February 23, Press Secretary Sean Spicer asserted the Department of Justice will likely be further looking into marijuana in a recreational capacity. Unlike his predecessor who chose not to aggressively pursue marijuana prosecutions, the President Donald Trump has already decidedly taken a more hardnose stance. Still, it remains to be seen whether marijuana will be utilized by the public health community to mitigate America’s growing opioid.

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Reducing Prescription Drug Prices

President Trump has publicly announced that pharmaceutical companies “are getting away with murder” with their drug price offerings. Prominent examples include, Mylan’s six fold price increase for EpiPens, Daraprim’s overnight increase from $13.50 a tablet to $750,  and Marathon Pharmaceuticals announcement that charging $89,000 a year for a drug that’s widely available abroad for about $1,000 a year.  With that said, there has been bipartisan support in curbing costs of prescription drugs. With the repeal of Obamacare on the Republican agenda and consumers displaying outrage at town hall meetings, lawmakers will have to face the task of reducing drug prices in effort to please their constituents.  This article will discuss different ways Congress and the President can work together to reduce drug prices. Specifically, it will discuss the pros and cons for each solution.

Negotiating Medicare Drug Prices

Lawmakers are discussing the option of negotiating drug prices for Medicare Part D. The Kaiser Family Foundation conducted a study where 82% of the public were in favor of allowing the federal government to negotiate drug prices for Medicare beneficiaries.  Further, Democrats (92%), Republicans (68%) and Independents (85%) all support the negotiation of Medicare drug prices. The only problem with this solution is that under the non-interference clause, Health and Human Services (HHS) is prohibited from negotiating drug prices with drug companies for Medicare Part D.  The Medicare Modernization Act of 2003 (MMA) included the non-interference clause to address concerns about CMS using their leverage in purchasing power to pay less for drugs. In response, the non-interference clause was used a bargaining chip to attract market-oriented republican votes.

Although, even if there was a change to the current law, the Congressional Budget Office (“CBO”) asserts that the authority to negotiate prices alone would have a “negligible effect on federal spending”. The CBO suggests that savings can be achieved in defined circumstances. Specifically, CBO recommends establishing a formulary that includes some drugs and excludes others and to impose other utilization management restrictions. However, stakeholders would take issue with the process of HHS deciding what drugs would be included or excluded.  In 2014, HHS proposed a process that included and excluded drugs from a protected list but failed due to backlash. At the time, House republicans were concerned about CMS “disrupting care” and “unnecessarily interfering” with a successful program. The lack of political feasibility may make this solution hard to implement despite its recent support.

Drug Importation

Drug importation is the process of importing drugs from other industrialized countries because their drug price offerings are typically cheaper than the United States. Senator Bernie Sanders is a huge proponent of drug importation and more specifically from Canada. For example, EpiPens cost more than $600 in the U.S. while it costs $290 in Canada.  In January, Bernie Sanders proposed a bill that would allow pharmaceutical distributors and pharmacists to import cheaper prescription drugs from Canada.  On January 17, the bill lost by a 52-46 vote, but not along party lines. Opponents of drug importation often argue drug importation presents numerous safety concerns. For example, other countries may not have a comprehensive drug approval process like the U.S.  and could thus subject Americans to harm.  Another mechanism to import drugs is allowing Americans to personally buy drugs from Canada.  Senator Klobuchar and Senator McCain introduced, the Safe and Affordable Drugs from Canada Act that would allow Americans to order personal prescriptions from Canada creating another option to import drugs to the United States.

Cost Transparency

Lastly, transparency can be used to reduce drug prices. In Maryland the legislature proposed a bill that aims to prevent price gouging by requiring manufacturers to disclose the cost breakdown of drugs that have  $2,500 or more annual price tag, including costs associated with marketing and promotion.  In turn, this would create public pressure on the pharmaceutical industry to lower costs on life-saving medications. However, there are complications with this method because pharmaceutical supply chains are complex.   The supply chain includes many actors who affect the cost of drugs. These actors include pharmacies, wholesalers, distributors, health insurance plans, and the pharmacy benefit managers.

Decisions

Lawmakers have quite a few options to curb the costs of pharmaceutical drugs. Additionally, PhRMA has a strong lobbying arm and could affect lawmaker’s choices. Nonetheless, with any policy decision, negative externalities and unintended consequences should be reviewed and evaluated. Only time will tell what option lawmakers choose to reduce drugs

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Veteran Urgent Access to Mental Healthcare Act

On February 7, 2017, bipartisan members of the House of Representatives introduced the Veteran Urgent Access to Mental Healthcare Act to Congress. The current veterans’ bill under U.S. Code Title 38 only provides health care access to combat veterans who were discharged with an honorable status. The proposed bill purports to extend access to urgent mental health care services to combat veterans discharged from the military with a status that would have otherwise made them ineligible for them.

However, the bill is not without reservations. It still excludes veterans who did not deploy in combat or received a “dishonorable” or “bad conduct” discharge. However, it does extend access to noncombat veterans who were victims of sexual assault and battery and sexual harassment. In addition, the bill proposes access to health care services and to facilities outside of the Department of Defense (DOD) healthcare network in cases where the DOD mental health care professional advises or where service would not be economically feasible because of geographical inaccessibility. Still, pressing issues with regards to the number of available mental health providers and funding remain.

According to the Department of Veterans Affairs (VA), an average number of 20 veterans per day commit suicide. With the Veterans Urgent Access to Mental Healthcare Act, its sponsors are hoping to decrease the number of veteran suicides each year. If passed, the Act would require an independent report based on a study comparing the rate and methods of suicide among combat and noncombat veterans, and between those who have received mental heath care services from the Veterans Health Administration and those who have not.

Besides the significant number of suicides, the bill aims to address the controversies surrounding discharges that are “other than honorable.” Representative Mike Coffman, the bill’s principal sponsor and a combat veteran himself, questions “the nature of the discharges in the first place, and [is] exploring that” issue. In 2015, the National Public Radio reported from its study that about 22,000 Army veterans diagnosed with post-traumatic stress disorder (PTSD) or traumatic brain injury (TBI) were discharged as less than honorable. As a combat veteran from two branches of the military, Representative Coffman believes that the stigma surrounding personality disorders has led to inappropriate disciplinary measures and consequently delayed access proper health care.

Last year, Representative Coffman proposed a similar bill. However, it did not pass the House. The previous bill purported to expand mental health care access to combat veterans that received dishonorable charges or bad conduct discharges; it did not gain much favor then. Now, with fourteen cosponsors, and the current VA Secretary David Shulkin’s assurance that there will be “greater accountability…improved access, responsiveness and expanded care options,” it is curious to see whether the bill will in fact help serve those who have served.

 

 

 

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The Technology That Can Edit Genes

As biotechnology continues to advance, policies must catch up in order to properly regulate the safety and efficiency of technology. One of the popular and controversial advances in the scientific community is genome editing, which occurs when DNA is inserted, deleted or replaced in the genome of a living organism. While genome editing has mainly been used to modify foods, it has also been used on animals, and lately, on human embryos.

The new technology that is advancing gene editing is called clustered regularly interspaced short palindromic repeats (CRISPR). CRISPR allows scientists to alter DNA much more quickly than before, drastically impacting the health industry, since a parent can choose to decrease the risk of high cholesterol, or minimize the risk of getting cancer. According to Randall Lutter, a professor at University of Virginia, CRISPR is different from previous technologies because it can be used to affect heritable traits and thus create organisms with a variety of desired traits. The changes made in human cells could actually be passed down to future generations and would allow individuals to basically choose the traits they want for their children.

Despite some of the advantages of CRISPR, there are some concerns with how it can be used to engineer human embryos. This caused a dispute in the scientific community when the embryos used did not result in a live birth. Some scientists want to continue experimenting with the benefits and risks of genome editing, but others are fearful of the disruption it could cause in the ecosystem.

The 2017 updated version of the Coordinated Framework for the Regulation of Biotechnology describes the current statutory authority and regulatory programs, such as EPA, USDA, and FDA, as well as the safety and efficiency of biotechnology products. Under National Strategy for Modernizing the Regulatory System of Biotechnology Products, also known as The Strategy, the FDA will continue to update and clarify its policies in regards to gene editing, as well as finding new ways to improve coordination with federal research agencies.

Unlike previous technology, CRISPR doesn’t involve transgenics (which is when genes are inserted from foreign species into an animal or plant). Thus, the U.S. Department of Agriculture allowed it to be sold in the market place. However, this doesn’t mean the new device gets approval from the FDA. FDA’s process for approval of new products is somewhat slow. If the FDA does not approve this life changing technology, scientists will be forced in continuing to use older technologies that are not as efficient.

Even though genome editing can save lives, many are still skeptical on whether it should be used on human embryos. More research must be done in order to minimize the risks.  While CRISPR has made modifying DNA much less costly, it continues to raise regulatory and ethical concerns.

 

 

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What Can We Expect from a Trump Presidency?

A week after the presidential election, many Americans are wondering what a Trump presidency means for them.  More specifically, what does it mean for their health insurance? Three days after the election, more than 300,000 people have selected plans from the Exchanges.  The Exchange is the online marketplace where consumers can compare and buy individual health insurance plans.  However, an increase in premiums coupled with a Republican majority House, Senate, and White House places the Affordable Care Act (ACA) in jeopardy.  On the campaign trail, President-Elect Trump has called the ACA “unworkable.” However, in recent interviews, he has favored continued coverage for children on their parents’ insurance policies and prohibits discrimination for those with pre-existing conditions.

Dismantling the ACA
There are a few ways Republicans could dismantle the ACA.  First, Republicans can repeal the Act in its entirety.  This method of dismantling the ACA would require a 60-vote majority in the Senate. Further, this method is subjected to filibusters by Democrats, thus delaying voting.  As a general matter, this method seems highly unlikely given the Republicans hold 54 seats in the Senate.” The second way Republicans could dismantle the ACA is through a method called budget reconciliation.  Budget reconciliation would create revenue related challenges for the implementation of ACA.  For example through the budget reconciliation process, Republicans could remove premium tax credits for consumers. This method only needs a simple majority and does not have a filibuster option.  Budget reconciliation has a greater likelihood of undoing parts of the ACA.  However, this process would take at least two years for substantial change to affect consumers.

The New Plan
This leads to our next question, what do we replace the ACA with? President-Elect Trump hasn’t provided the public with substantial policy changes, however we can look towards the Republican’s plan entitled, A Better Way, to identify what may happen. There are three changes we can reasonably anticipate.  First, we can reasonably anticipate changes in Medicaid. Due to Medicaid expansion, the federal government covers about 90% of the costs related to covering childless adults.  A Better Way promulgates shifting to block grants for the states. This invariably means that states would receive lower funds and therefore may have to reduce coverage and may adopt plans similar to those seen in Indiana. In Indiana, Medicaid participants are required to pay into accounts in order to benefit from Medicaid. The amount could be as low as a dollar, but participants must pay into the program.  Additionally, it requires participants to pay copays, which can cost up to $25. These measures support the concept of individual responsibility.

The second substantial change we can anticipate is a decrease in coverage options. Currently, essential benefits require plans to offer specific coverage such as, maternity care, birth control, preventive screenings, and mental health. Republicans will most likely remove or decrease what some considered an essential benefit. This of course is in an effort to make coverage more affordable, but at the determinant of quality.  The third substantial change we can anticipate is the use of high risk pool plans. High risk pool plans cover individuals who have been locked out of the market by pre-existing conditions. However, traditionally, the premiums for those in high risk pool plans were twice high as those individuals who are healthy.

Although we are unclear about what will happen on January 20th, we can anticipate substantive changes. Republicans promulgate to make changes on day one of Trump’s Presidency and Democrats will have to act in defiance or work with the Trump administration to salvage parts of the ACA.

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