Category: Blog

On February 15, 2017, a bipartisan group of members in the House of Representatives introduced the Military Hunger Prevention Act, a bill that would help active-duty military members qualify for the Supplemental Nutrition Assistance Program (SNAP), more commonly known as food stamps. SNAP was implemented to address food insecurity and access to a sufficient quantity of affordable nutritious food. It was also designed to improve the long-term health and economic well-being of children.

Military members face unique financial challenges inherent to being active-duty, such as costs incurred from changes of station, deployment, and underemployment among military spouses. According to a survey conducted by Blue Star Families (a nonprofit that raises awareness of issues unique to military life) and the Institute for Veterans and Military Families (an interdisciplinary academic institute that publishes research on the social, economic, and policy issues that affect veterans and their families), 75% of active duty spouses reported that being a military spouse has had a negative impact on their ability to pursue employment.

Consequently, active-duty military members have reported facing food insecurity; some have indicated that they are seeking food assistance through a food bank or charitable organization. Yet, thousands of military members and their families are disqualified from SNAP because they receive a monthly Basic Allowance for Housing (BAH), which is then counted as part of their income when their eligibility for SNAP is determined. This is inconsistent with how other federal programs treat the BAH. For instance, the Internal Revenue Service (IRS) does not consider the BAH as earned income for purposes of assessing Earned Income Tax Credit. Nor is it accounted under the Health and Human Services’ Poverty Guidelines, which determines eligibility for other federal benefits programs such as the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) nor the Head Start Program.

It is also worth noting that SNAP is a federal entitlement program, which means that everyone who is eligible for the benefits will receive them. Receiving benefits will not be at the cost of another beneficiary.

The proposed Military Hunger Prevention Act intends to alleviate the food insecurity issue prevalent among active-duty military members who would otherwise qualify if it not for the current provisions under the Food and Nutrition Act of 2008 under 7 U.S.C. 2014(d). Thus, the Act would be an amendment excluding housing allowance “from any calculation of income, assets, or resources” when determining eligibility for any federal program issuing benefits in nutrition assistance.

According to Congresswoman Susan A. Davis, a senior member of the House Armed Services Committee, the Military Hunger Prevention Act would “make good on our national commitment to take care of all those who proudly serve in our armed forces.”

The Act is currently being reviewed by the Committee on House Armed Services and the Committee on House Agriculture.

During his Joint Address to Congress on the evening of February 28, President Donald Trump denounced the decades-old prescription drug approval process, pledging to “slash the restraints” of the current regulatory landscape at the US Food and Drug Administration (“FDA”).  “Our slow and burdensome approval process at the Food and Drug Administration keeps too many advances…from reaching those in need,” President Trump said, giving a nod to his guest, 20-year-old Megan Crowley. Crowley, a college student who was diagnosed with a rare and typically terminal ailment – Pompe Disease – at 15 months old, was not expected to live past age 5. Since her diagnosis, Crowley’s father went on to launch Amicus Therapeutics, a biotechnology company that aims to be the frontrunner of advancing therapies for rare and devastating diseases.  

To many, the President’s harsh opinion of the FDA drug approval process was seen as misleading. Not only is the drug review process in the United States recognized worldwide as the gold standard, FDA is the fastest regulatory agency in the world. Today, the average total review time of a single drug is 8.5 months, down from an average of 30 months in the 1980s.

While most drug and biologic companies must successfully maneuver their compounds through three phases of clinical trials, proving not only safety but efficacy (via two “well-controlled and adequate studies”), there are several other expedited processes that may be utilized to obtain agency approval, at least preliminarily. Breakthrough, priority review, fast track, and accelerated approvals are all programs created to speed up the market availability.

Perhaps most misleading about Mr. Trump’s statements was the approval process for rare diseases like that of Megan. The term “Rare Diseases” is a term of art, defined as afflicting less that 200,000 people nationally. Drug manufacturers of potential treatments of rare diseases, like Pompe, may participate an expedited approval program depending on the seriousness of the ailment. ON the other hand, they may participate in the Orphan Drug Designation process, by which they are incentivized by the FDA to increase research and development on novel drugs via seven years of patent exclusivity, tax credits, and expanded access to Investigational New Drugs (IND). In other words, those who have rare diseases, to the extent to which therapies are being developed, have access to treatment faster than average.

Moreover, many biotech and pharmaceutical companies are skeptical of the deregulation of the industry. “People often argue that the FDA is too restrictive, [but] [w]e have the sense that the balance is pretty right … you have to have a well-characterized risk/benefit profile,” said Roger Perlmutter, head of Research and Development at pharmaceutical heavy hitter Merck. Similarly, Alnylam Pharma CEO John Maragarone stated what, to some, may be obvious: while deregulation seems like a good idea, “payors are looking for evidence of value.” As it is, insurance companies have already shunned some approved treatments that have not demonstrated strong effectiveness.

In 1962, in response to several children dying from ingesting elixir, Congress enacted the Drug Efficacy Amendment to Food, Drug and Cosmetic Act of 1938, explicitly requiring the pre-market approval process to include not only safety profiles, but proof of effectiveness by a showing of substantial evidence. Deviation from this would deem the product false and misleading if placed on the market, and likely open the manufacturer up to liability.

President Trump announced Neil Gorsuch as his Supreme Court nominee in late January 2017.  Judge Gorsuch, a 49-year-old federal appellate judge based in Colorado, currently sits on the Tenth Circuit Court of Appeals.  His legal career reflects a rapid ascent to the upper echelons of the American judicial system.  After graduating from Harvard Law School in 1991, Judge Gorsuch clerked for the Supreme Court, worked at a high-profile Washington law firm, and served as a Principal Assistant to the Deputy Attorney General in the Department of Justice.  Then, in 2006,  President George W. Bush appointed him to the Tenth Circuit.

Since his nomination, public health advocates have been anxious to understand where he stands on key public health issues.  Judge Gorsuch has a reputation for being an originalist, and many hail Judge Gorsuch as the “most natural successor to [the late] Justice Antonin Scalia.”  In his eleven years on the 10^th circuit, Judge Gorsuch has stuck to conservative values and support of religious freedom.  But he also has a history of pushing back on federal agencies and regulations—including the centers for Medicare and Medicaid Services.

So where does Judge Gorsuch stand on key healthcare issues?  First, he’s against assisted suicide.  In fact, Judge Gorsuch authored a book, The Future of Assisted Suicide and Euthanasia, which argued against the practice.  In The Future of Assisted Suicide and Euthanasia, Judge Gorsuch railed against assisted suicide, with the argument that all human life is fundamentally valuable and that it’s always wrong to intentionally kill.  Unsurprisingly, organizations that support assisted suicide publicly opposed Judge Gorsuch’s nomination.

Second, he’s against the ACA Contraceptive Mandate.  In two separate 2013 cases, Judge Gorsuch sided with the corporations’ right to exemption of the Affordable Care Act’s contraceptive mandate on religious grounds.  See Hobby Lobby Stores v. Sebelius, 723 F.3d 1114 (10th Cir. 2013); Little Sisters of the Poor Home for the Aged v. Burwell, No. 13-1540 (10th Cir. July 14, 3015).  According to Judge Gorsuch, “[t]he ACA’s mandate requires them to violate their religious faith by forcing them to lend an impermissible degree of assistance to conduct their religion teaches to be gravely wrong.”

Third, Judge Gorsuch supported defunding Planned Parenthood in Utah.  In October 2016, the 10th Circuit sided with Planned Parenthood holding that Utah Governor Gary Herbert had likely pulled $270,000 in grants from Planned Parenthood in retaliation for the group’s abortion advocacy.  Judge Gorsuch dissented, however, arguing that Governor Herbert had lawfully defunded Planned Parenthood because he believed the group was involved in fetal tissue trafficking.

Finally, Judge Gorsuch’s stance on abortion is unclear, however, his opinions on contraception and assisted suicide signal that he opposes it.  Gorsuch’s ruling in favor of Hobby Lobby and Utah’s Planned Parenthood further support this assumption.  Thus, his nomination is concerning for abortion rights advocates.

Congress has yet to confirm Judge Gorsuch, but whoever becomes the ninth Supreme Court Justice will undoubtedly affect public health law and policy.  Advocates on both sides are holding their breath to see what happens next.  At the moment, all eyes are on Judge Gorsuch.

Notwithstanding the Patient Protection and Affordable Care Act of 2009 (“Obamacare” or “the ACA”), the 21^st 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.

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

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.