Category: Blog

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.

 

 

 

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.

 

 

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 20^th, 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.

The U.S. Department of Veterans Affairs (VA) has an infamous reputation for providing poor service to U.S. Veterans. Stories of veterans failing to receive adequate care for serious illnesses, or even dying while waiting for care, are ubiquitous. The situation erupted in 2014 when whistleblowers revealed that records of deceased veterans had been changed or physically altered to hide how many people died while waiting for care at the Phoenix VA hospital. “Deceased” notes on files were removed so veterans would not be counted as having died while waiting for care, but that was only one situation in one hospital.

Take, for instance, the story of Barry Coates. Mr. Coates was having excruciating pain and rectal bleeding in 2011. He went to several VA clinics and hospitals in South Carolina trying to get help. Eventually, a VA hospital diagnosed him with hemorrhoids, prescribed simple pain medication, and told him he might need a colonoscopy. As the pain worsened, Mr. Coates begged VA officials for colonoscopy, but found himself on a waiting list. Finally, about a year after complaining to his doctor about the pain, Mr. Coates got a colonoscopy where doctors discovered a cancerous tumor about the size of a baseball. Mr. Coates underwent chemotherapy for his Stage 4 cancer, but it was too progressed. Mr. Coates passed away in January 2016.        

Responding to these scandals, Congress and the VA came up with a solution—the Veterans Choice Program. Veterans Choice was a $10 billion program that was supposed to give veterans a card that would let them see a non-VA doctor if they were more than forty miles away from a VA facility, or they were going to have to wait longer than thirty days for a VA provider to see them. This solution hasn’t seemed to work. Wait times have gotten worse, and compared to early 2015, there are 70,000 more appointments that took vets at least a month to be seen. While the VA says there has been a massive increase in demand for care, it seems the problem has more to do with the way Veterans Choice was set up. The program is confusing and complicated, and veterans and doctors don’t understand it.

To address these continued problems, the VA proposed a new rule that would expand the scope of practice of advanced practice registered nurses (APRNs) who work for the agency. Under the proposed rule, the VA said it intends to expand the pool of qualified healthcare professionals who are authorized to provide primary healthcare and other services to the full extent of their education and abilities without the clinical supervision of physicians.

More than sixty organizations, including veterans’ groups, healthcare professional organizations, and eighty Democratic and Republican members of Congress, have voiced support for the proposed rule. For example, the American Nurses Association released a letter in support of the proposal consistently reiterating that the proposal is in line with best practice recommendations. There have also been studies that have shown that granting nurses greater authority would have significant benefits such as achieving healthcare cost savings and increasing access to care. However, support has not been unanimous. For instance, the American Medical Association released a statement saying it was disappointed by the VA’s “unprecedented proposal,” and that the rule would significantly undermine the delivery of care within the VA.

If the VA does implement this proposed rule, it could become a leader in the occupational licensing arena and spur state governments to follow suit. Currently, a majority of U.S. states limit what nurse practitioners can do, requiring them to work under the direct supervision of a doctor and prohibiting them from prescribing drugs. One thing is certain—the VA needs to take substantive steps to address the problems that have been rampant for years. Perhaps, this proposed rule is a step in the right direction.

During the last week of October, the State of California’s Occupational Safety and Health Administration (Cal/OSHA) approved regulations to protect health care workers from workplace violence.  These regulations are being heralded by many in the healthcare community, as setting a standard and were passed unanimously by Cal/OSHA. These regulations are seen by the nurses’ unions and many in the health care community as a step towards alleviating a problem that does not get much attention- violence against healthcare workers.

U.S. Occupational Safety and Health Administration  found in a study done between 2002-2013, that healthcare workers were four times more likely to be the victims of serious work place violence than other workers in private industry.  The study found that 21% of registered nurses and nursing students reported being physically assaulted and over 50% of the same group reported being verbally abused in a 12-month period. The Center for Disease Control and Prevention (CDC) also did a study on occupational traumatic injuries among health care workers. The study took reported data from 2012-2014 and found that nurses’ assistance and nurses are most vulnerable to injury and the number of reported incidents rose steadily over the two-year period of the study. As alarming as these numbers are, they may not even reflect the whole story because such injuries often go unreported or under-reported. OSHA’s report states this might be due to certain cultural factors in the health care industry. The report states:

“caregivers feel a professional and ethical duty to ‘do no harm’ to patients. Some will put their own safety and health at risk to help a patient, and many in healthcare professions consider violence to be ‘part of the job.’  Healthcare workers also recognize that many injuries are caused by patients are unintended, and are therefore likely to accept them as routine or unavoidable. Another consideration is unwillingness among healthcare workers to stigmatize the perpetrators due to their illness or impairment.”

The push for action in California came after the tragic death of Donna Gross, a psychiatric technician working at Napa State Hospital. Donna was murdered by a patient while working at the hospital in 2010.

The regulation hopes to lower work place violence in private health care facilities, by requiring such facilities to implement a Workplace Violence Prevention Plan.  The regulation requires health care facilities to implement a plan in writing that evaluates risks to workers. It also calls for the facilities to provide greater training and easier reporting for its employees. The regulation also requires facilities to identify and evaluate patient-specific risk and assess visitors or other persons who are not employees. The regulation also requires facilities to provide procedures for post-incident response and investigation. The post-incident evaluation includes identifying all employees involved, making available individual trauma counseling, conducting a post-incident debriefing, and reviewing whether appropriate corrective measures under the plan were effectively implemented. If plans are not implemented and protocols are not followed leading up to or following an incident, Cal/OSHA can give a citation to the facility.

There has been little discussion so far on how these new regulations will affect patients.

These regulations are a first step in helping to reduce an epidemic of workplace violence that has long permeated the health care profession, but got little attention.