Tag Archives: illness

OSHA Should Help on Infectious Diseases

OSHA’s promulgation of an infectious disease rule/standard to protect healthcare workers and employees in healthcare facilities from microorganisms that cause illness and infection would be a welcome expansion of the work OSHA has already done related to bloodborne pathogens.

A standard of national caliber would not apply any more pressure to healthcare employers than they already place on themselves to protect the patients and healthcare workers they serve. On the contrary, a rule would highlight the importance of the safety and health of healthcare workers.

However, just when we, as a nation, are designing programs to protect healthcare workers from exposure to emerging infectious diseases, like Ebola virus, small businesses say, “No thanks, OSHA, we’re all good.” Just recently, the Small Business Advocacy Review (SBAR) Panel issued a report to OSHA Assistant Secretary Dr. David Michaels that said small healthcare businesses (to include ambulatory surgery, doctors’ offices, dental offices, specialty clinics and dialysis centers, to name only a few) weren’t interested in better protections for their workforce.

Small entity representatives (SERs) decided that the guidance that is already in place is good enough and that OSHA would just be adding more requirements. The SBAR report stated:

Many SERs felt that this rule would overlap with and/or duplicate other relevant guidelines and regulations, including, for example, materials issued by the Centers for Medicare and Medicaid Services (CMS), the Joint Commission and other voluntary accrediting organizations, and state accrediting boards.

SBAR has a point: Guidance is in place from CMS, the Joint and others, like CDC. But the guidance is almost completely to protect the patient, not the worker.

The American Public Health Association (APHA) disagrees with the SBAR panel and firmly believes that an OSHA standard should be fast tracked to protect the working public. The APHA issued a national policy statement just last month.

We learned from the Ebola exposures in Dallas that those infected after exposure were the healthcare workers, not other patients. If a patient enters an emergency department feeling generally ill, it is not typically the other patients who are potentially exposed to a yet-to-be-identified pathogen; rather, it is the string of healthcare workers with whom the patient comes into contact. Those include workers who examine the patient, take vitals, take blood or other specimens, assess, diagnosis and eventually treat. In the case of the Dallas Ebola victim, that was dozens of healthcare workers both in and outside of the hospital over more than a week’s time.

The population of healthcare workers that a standard like OSHA’s infectious disease standard could protect is vast. It is typically in smaller healthcare settings that greater protections are needed, as these operations often intersect more closely with the community and have lesser controls in place compared with hospitals or larger health systems. In fact, nearly 10% of the U.S. working population is employed in healthcare settings of all sizes, and healthcare will generate millions of new jobs through the next decade (Bureau of Labor Statistics 2013). This sector of the workforce represents the largest segment of employment growth in the U.S. and serves the largest proportions of Americans, ensuring proper and timely diagnosis, treatment and care. Healthcare employment is marked as the industry sector with the largest growth (2.4%).

Better controls to protect our most important healthcare assets — its workers — are needed now.

OSHA’s bloodborne pathogens standard (BPS) alone will not address these important and constantly emerging occupational risks associated with hazards that are not often visible to the naked eye.  Promulgating an infectious disease role nationally, much like CalOSHA did with its aerosol transmissible diseases standard (ATD, §5199), would provide OSHA the opportunity to work with healthcare facilities and providers of care to develop standards that protect their employees from not just physical or chemical hazards, but biologic ones. Healthcare facilities would have the ability to control the environment of patient care and make it safer for all who enter: patients, family, friends, volunteers, contractors and caregivers alike.

This standard, if done right, has the potential to provide the following benefits:

–       Prevent transmission of microorganisms that cause illness and infection

–       Improve safety for healthcare workers

–       Make care for patients safer

–       Increase the viability of the healthcare work force and the healthcare economy

–       Reduce costs associated with workers’ compensation, time away from work, staff turnover

–       Provide a collaborative, bridge-building role with other U.S. agencies like CMS, CDC and the Food and Drug Administration (FDA)

–       Serve as a model for other countries

OSHA’s continued journey down the path of promulgating an infectious disease standard illustrates the role that it can play in bridging the gap between infectious disease and occupational safety and health experts.

IME: Success or Fishing Expedition?

Independent medical exams (IMEs) are widely used throughout the workers’ compensation insurance industry. However, as with any tool, you generally need a good carpenter or mechanic to get the best results. Because of the time required to arrange these medicolegal exams and because of the complexities of determining causation, pre-existing conditions, degree of impairment, etc., most insurance companies and third-party administrators (TPAs) outsource this function, which generates findings that can be used in the formal claims adjudication process.

The problem with outsourcing IMEs is that it typically removes from the process the only stakeholder who actually knows the injured worker: the employer.

The employer can make better decisions about whether to request IMEs — which are very expensive — by looking for red flags that, in many cases, only the employer could know about.

The most basic reason is if there is a legitimate question as to whether an injury or illness was caused by a work-related accident or industrial exposure. Red flags that might indicate the need for an IME include: The accident/injury wasn’t witnessed by other employees; reports of how the injury occurred are vague; or the injury was not promptly reported. Other triggers that only the employer would know include: a history of disciplinary, attendance or other HR issues; prior work history and the possibility that the employee is working a second job; or participation in sporting and recreational activities outside the workplace.

Other flags could be: Healthcare providers indicate that the employee may not be able to return to work, based on subjective complaints, or have proposed treating plans that are open-ended, with no clear-cut goals.

Other key issues that should be identified early in the claims process are: pre-existing conditions; any unauthorized medical treatment; any treatment by known “provider mills”; all litigated or potentially litigated claims; any potential subrogation opportunities; any doctor shopping; prescriptions for opioids; recommendations for elective surgery, such as on the back or for carpal tunnel issues; and any plain, old-fashioned tips from other employees.

IME providers often miss three fundamental questions: Can this injury or illness be caused by the workplace? Under what circumstances? Did these circumstances exist in this case?

Medical providers performing IMEs often make decisions in a vacuum, with little, if any, input from the employer. Leading medical experts who routinely perform IMEs state they are often “flying blind” and would have conducted a whole different physical exam or diagnostic testing if they only had more information. They tell me that they often have no idea why an IME has been scheduled. Miscommunication is common, and prior medical reports are often delayed or even lost.

IMEs should be conducted within a well-planned strategy at both the local level and the corporate level, between an employer and its insurer or TPA. The success or failure depends on active involvement and strong communications by all involved, including employers, IME providers, injured workers and insurance carriers and claims administrators.

As noted in previous articles, employers may consider using an OSHA-sanctioned “contemporaneous” medical exam – conducted at the moment of injury/illness notification but done outside the workers’ compensation system. Employers may consider this approach when they suspect a difficult or potentially litigated claim in states where they have little control over the choice of medical provider or face other jurisdictional or claim-specific challenges.

Employers, whether they are fully insured or self-insured, should ask detailed questions about how IMEs are handled on their behalf. Most insurers and TPAs outsource some, if not all, of the process of scheduling and arranging IMEs. There are dozens of questions I would ask about IME panel selection and quality assurance, including; credentialing, board certification, training, continuous education, experience, expertise, reputation, affiliation with university-based teaching hospitals or sports teams, along with knowledge and utilization of AMA impairment guidelines, evidence-based treatment protocols and application of disability guidelines from state workers’ comp, the Americans with Disabilities Act  (ADA) and others.

The only true stakeholder in what can be a very expensive, time-consuming and frustrating process to obtain quality IMEs is the employer. It is the employer that should be asking about “other” workers’ compensation costs and whether IMEs, which often include “hidden” costs, are actually having a positive outcome in successfully denying, closing or settling difficult and contentious workers compensation claims.

The 80/20 rules applies in both workers’ compensation and healthcare — 20% of claims will generate 80% of the costs. Employers need to have strategies in place both early and often to help confirm the relationship between reported injuries and illnesses and the workplace.

The employer’s ability to obtain credible and authoritative medical opinions is key to containing workers’ compensation costs from medical, indemnity (lost-wage replacement), permanent disability awards and administrative, legal and other fees.

Employers need to take a much more active role in ensuring high-quality healthcare while addressing waste, fraud and abuse in the system. Employers should avoid fishing expeditions but rather use these expensive tools wisely and put them in expert hands. If you are going fishing, make sure you have the right bait, deck hand and captain.

IMEs can be a great tool or waste of time and money. It’s more up to you than you think.

Ebola and Beyond: Protecting Self-Insured Work Comp Plans

Epidemic diseases such as Ebola present a significant threat to the safety of both victims of the disease and the individuals who come into contact with those who are infected. Even with advanced medical facilities and protocols, healthcare workers are particularly vulnerable to outbreaks of infectious diseases because they work in close proximity to the victims for extended periods. Further, the facilities themselves tend to be densely populated with workers who run the risk of secondary exposure from medical equipment and other workers who may have been exposed to the disease. Self-insured workers’ compensation plans are very popular among the large health facilities that are likely to deal with these outbreaks. It is therefore important for risk managers and hospital executives at these facilities to not only prevent these infectious diseases from spreading to their employees, but to protect the hospital financially if such an outbreak does occur.

An excess workers’ compensation policy provides reimbursement to self-insured employers for any workers’ compensation claim that exceeds the policy’s self-insured retention (SIR). Under most policies, a claim is defined as an occurrence or event that causes a loss. This provision allows the self-insured employer to combine the losses from multiple individuals injured in the same event under a single SIR rather than individually for each employee. Most policies however, require a separate SIR per employee for claims of occupational disease and illness. Therefore, if 10 employees contract the same disease in the course of their employment, the self-insured employer would be required to retain the SIR 10 times (once for each employee) under most basic policy forms. Clearly, this is an area of potential concern for self-insurers especially because most excess workers’ compensation carriers require minimum SIRs of $500,000 (or more).

To help self-insured employers manage the expense of occupational disease claims, many excess workers’ compensation carriers offer a communicable disease coverage either as part of their policy form or as an endorsement to the underlying policy. A communicable disease coverage combines the losses of multiple employees suffering from the same disease or illness under a single claim and, therefore, a single SIR. Unfortunately for self-insurers, not all communicable disease coverage is created equally. Unlike traditional workers’ compensation policies, where carriers use the same policy form, each excess workers’ compensation policy is unique.

My current excess policy has a communicable disease endorsement, so I don’t need to worry… right?

Just because an excess workers’ compensation policy contains a communicable disease provision doesn’t mean the policyholder is fully protected from this exposure. Communicable disease coverage is unique to the underlying policies to which it is attached and the carriers that issue them. In many instances, the only consistency between various carriers’ coverage forms for this potentially serious exposure is the name of the coverage itself.

Each communicable disease coverage has its own set of definitions, rules and limitations, so it’s important for the policyholder to understand the key provisions that determine how the coverage is triggered and how it responds to potential claims. In general, communicable disease coverage can be compared using four basic criteria: covered diseases, transmission sources, symptom manifestation and coverage limits.

 What’s in a name?

The definition of a communicable disease is extremely important. Some coverage forms define communicable disease in very broad terms while others define such illnesses very narrowly. Forms that use the terms “disease” or “illness” generically but do not specifically enumerate covered or excluded diseases are most favorable to the policyholder. Forms with non-specific definitions can provide the policyholder with coverage for virtually any type of work-related communicable disease ranging from the common cold to meningitis.

Some carriers’ communicable disease forms will specifically list the names or types of diseases that will be covered or the types of diseases that will be excluded under the policy. Much like a named-peril insurance policy, a communicable disease form that lists specific illnesses will only respond if two or more employees contracted a disease that was listed on the coverage form. If the policyholder suffers a claim that does not appear on the list of covered diseases, it’s not likely to be subject to the communicable disease coverage. Narrow definitions of covered losses can be particularly problematic when an outbreak of a previously unknown illness occurs. Again, if it isn’t listed, it’s probably not covered. Conversely, coverage forms that exclude specific diseases not only prevent the self-insurer from seeking coverage for such losses under the communicable disease provisions but may also exclude coverage under the basic occupational illness section of the underlying excess workers’ compensation policy, as well.

Consider the source

One of the few universal components among communicable disease coverage forms is that the disease must be transmittable between individuals to be covered. Diseases such as black lung and asbestosis are often considered to be occupational illnesses but are not subject to communicable disease coverage because they cannot be transmitted from person to person. These specific diseases can only be contracted by prolonged exposure to coal dust and asbestos, respectively, and not merely by being in close contact with someone suffering from those diseases.

The term “transmission” (or some similar term) appears in all communicable disease forms, but the manner in which the disease is transmitted is far more important. Generally speaking, some policies require a disease to be transmitted directly from one person to another to qualify for communicable disease coverage while others allow for both direct and indirect transmissions. Indirect transmissions are commonly referred to as source-to-source exposures. Forms that require a disease to be transmitted directly from person to person are far more restrictive than those that permit diseases to be transmitted from source-to-source. For example, if a group of hospital workers contracts swine flu after being exposed to an infected patient or even another co-worker who was previously exposed, the incident would likely be covered under both the person-to-person and source-to-source rules. If, however, a janitor and a nurse contracted swine flu after handling a soiled pillowcase, communicable disease coverage would only be triggered under a policy with a source-to-source provision because the individuals contracted the disease from an object and not directly from another person.

Tell me the truth – how long do I have?

Communicable disease coverages typically require individuals to contract the same disease or manifest symptoms within a specified period to be eligible for the coverage. If two employees treat a patient suffering from SARS and both exhibit symptoms of the disease a couple of days later, this would likely meet the coverage triggers required under most communicable disease forms. Conversely, if one employee develops SARS within a few days of exposure and the second begins to exhibit symptoms eight weeks later, the communicable disease coverage would be unlikely to respond. The incubation period for this particular disease is normally seven days, therefore, even though both employees ultimately contracted the same disease, it is highly unlikely that they contracted it from the same exposure. Thus, their claims would not be combinable.

Illnesses with long incubation periods are sometimes more difficult to classify under communicable disease coverages because of the time constraints required under some forms. Some forms set forth very specific time frames in terms of hours or days between the time when a group of employees is first exposed to a particular disease and the time the symptoms manifest. Coverage forms that allow symptoms to be manifested at some point during the policy period are generally more favorable to the policyholder. Such forms can combine losses for a successive string of employees infected by one another over a prolonged period (weeks or even months) as long as the infections took place during the policy period and their respective illnesses can be traced back to the same original source.

One potential downside to the policy period provision can occur when the event straddles two different policy periods. If an infection occurs during one policy period and continues to affect employees through a second policy period, it is likely that two separate claims would be developed, thus requiring the employer to satisfy the SIR twice. In this instance, the communicable disease coverage from the first policy would respond to the employees who exhibited symptoms from the time of exposure up until the end of the policy period. Any employees who exhibit new symptoms after the effective date of the new policy period would constitute a separate claim under the new policy’s communicable disease coverage.

Take it to the limit

Coverage extensions and endorsements sometimes share the same limits as the underlying policies to which they are attached. In other cases, coverage extensions carry their own limits in addition to the underlying policy limits or sub-limits, which may erode the underlying excess policy’s shared limit. These limits can be provided on an occurrence basis, aggregated basis or both. Communicable disease forms that carry coverage limits outside of the underlying policy’s basic limits can pose a very significant (and hidden) exposure to the policyholder and therefore should be examined closely.

If communicable disease coverage shares its limits with the underlying policy, the policyholder need only determine an adequate coverage limit for the underlying policy. If, however, the communicable disease coverage carries its own limits, it’s important for the policyholder to make certain those limits will provide adequate protection in the event of a loss.

In some instances, communicable disease coverage can carry per-occurrence or aggregated limits as low as $1 million. Although the policyholder gets the benefit of combining multiple claimants under a single SIR, the collective losses can also serve to erode the occurrence limit very quickly, especially for diseases that require significant amounts of treatment and lost time. Aggregated limits are typically shared over the course of a policy period and are likewise eroded by each communicable disease claim filed during the policy period, thus leaving less coverage available for future claims. More importantly, once the limit is exhausted under communicable disease coverage, any amounts exceeding the coverage limit would be ineligible for reimbursement under the communicable disease coverage and possibly the underlying excess policy, as well. Depending on the circumstances of a given loss and the coverage provided under the applicable communicable disease form, it is possible that the communicable disease coverage could actually end up costing the employer more than a basic, unendorsed policy.

That’s great information, but what can I do with it?

Many excess insurance carriers do allow at least some flexibility in the coverage they offer. In many instances, limits are negotiable on the underlying coverage, and those limits can sometimes be increased even after the policy has been issued. There may be an additional premium required to add communicable disease coverage to an underlying excess policy or to increase the limits on existing communicable disease coverage but the cost is typically modest as compared to the excess policy and the overall self-insurance program. Self-insurers may also want to consider adding aggregate excess coverage to limit the collective unreimbursed costs resulting from multiple occupational disease or communicable disease claims occurring during a single policy period.

Lastly, it may be prudent for self-insurers to take the terms and limitations of various communicable disease coverage forms into consideration when choosing an excess workers’ compensation policy. Epidemic diseases represent potentially one of the greatest financial risks to self-insured employers with exposures to such claims, especially hospitals and other healthcare providers. It is therefore important for those self-insured employers to make the communicable disease and occupational disease coverage a priority and not simply an add-on. Again, not all communicable disease coverage forms are created equally. Choose carefully.

What Do New Workers' Compensation Reforms Sweeping the Country Have in Common?

AOECOE – Not Just Another Acronym

California Senate Bill 863 was passed in the fall of 2012 and went into effect on January 1, 2013. Senate Bill 1062 was just signed into law by Governor Mary Fallin of Oklahoma and will take effect January 1, 2014. On April 30, 2013, Tennessee Governor, Bill Haslam, signed into effect Senate Bill 200. House Bill 154 is expected to go into effect in Georgia in July, 2013. What are these bills? The first of many sweeping Workers' Compensation reforms. A common theme in these bills and other pending reforms is to level the playing field for employers and accept only those claims that arise out of the course and scope of employment, AOECOE.

A well-known term of art in the Workers' Compensation arena, AOECOE is not just an acronym. It is transitioning from a term of art to a statement with teeth, as reforms are actually including such wording into bills. The purpose of doing this is to establish whether an employee's alleged injury is work-related and happened in the course and scope of employment, or whether the injury is non-industrial or affected by third parties.

Workers' Compensation is a no fault system and thus benefits the injured worker, as, in order to receive benefits, he or she does not need to prove that the employer was negligent. However, it is the injured party's burden to show that the injury did, in fact, occur while at work, while employed as an employee and while undertaking some activity for the benefit of the employer. The injury itself must have been caused by the accident or employment conditions, and not from some other non-industrial related factors or degenerative factors.

The determination of AOECOE has long been an OSHA policy. OSHA's Injury and Illness Recordkeeping Regulation Section 1904.5: Determination of work-relatedness contained under section (a) basic requirement states in order for an injury or illness to be work-related an event or exposure in the work environment is either caused or contributed to the resulting condition or significantly aggravated a pre-existing injury or illness. Work-relatedness is presumed for injuries and illnesses resulting from events or exposures occurring in the work environment.

California's SB 863 was signed into law by Governor Brown on September 18, 2012, for a January 1, 2013, effective date. While certainly not the first bill to consider AOECOE issues, it is one of the most significant Workers' Compensation reform bills to specify AOECOE language. SB 863 calls for an Independent Medical Review (IMR). While this process may be problematic for an employer, since an IMR can be requested only by an injured worker following a denial, modification, or delay of a treatment request through the utilization review (UR) process, the bill specifically states that this does not apply if the injury is in question for AOECOE reasons.

On May 8, 2013, Oklahoma Governor Fallin signed into law historic Workers' Compensation reform, Senate Bill 1062. The bill defines compensable injury as arising out of the course and scope of employment and does not include: any strain, degeneration damage or harm to disease or condition of the eye or musculoskeletal structure or other body part resulting from the natural result of aging, osteoarthritis, degenerative process or pre-existing, except if a treating physician clearly confirms an identifiable and significant aggravation arising out of AOECOE.

On April 29, 2013, Tennessee Governor Haslam signed a Workers' Compensation reform bill into law, SB 200. It specifies that injuries arise out of and in the course and scope of employment only if proven by a preponderance of evidence that employment contributed more than 50% to causing the injury, AOECOE.

In my experience, the majority of injuries are real, but they are not AOECOE. Injured parties may exaggerate the severity and extent of their injuries or may attempt to hide pre-existing conditions. So how do any employers determine if injuries are AOECOE? The answer is simple. They need to ascertain what the employees' statuses are pre-injury. This is effectively done with baseline testing.

Baseline testing is a bookend solution. To be effective, it should be objective, meet the criteria for evidenced-based medicine, be job related and consistent with medical necessity. It needs to be specific to the metrics being evaluated. A good example of a specific baseline test that is recognized in some jurisdictions by statute is audiometric testing. Hearing tests are routinely done in environments with high noise exposure to determine a baseline that is referenced once a claim is filed. This is commonly referred to as the lock box defense.

Audiometric testing is beneficial for documenting hearing loss but is not designed to address other conditions such as musculoskeletal disorders (MSD). MSDs are the most frequent and costly claims for an employer. In order for a baseline test to be utilized for MSD, it must not only be objective and reproducible, it must contain measurements to ascertain electromyography (EMG), range of motion (ROM) and function.

In addition, baseline testing must be legally defensible. In 1990, Congress enacted the Americans with Disabilities Act that outlines what makes a legally defensible test. To be legally defensible, the testing needs to be job-related and consistent with business necessity i.e. the employer must show that it “substantially promote[s]” the business' needs. It must be repeatable, objective and address functionality. Also, since baseline testing is considered to be a medical exam, it needs to evaluate some functions of the job.

Baseline testing is not a post-offer, pre-placement test, as it can not identify disability because the data is not read and no hiring decisions are made with baseline evaluations. When a work-related injury occurs, a post loss test is conducted, at which time the baseline test is read and compared to the post loss results, hence the bookends.

When compared, the results can determine if an injury exists and if it has arisen out of the course and scope of employment, thus determining an employer's true responsibility. Good baseline testing is non-discriminatory and prevents “false” claims. The sweeping Workers' Compensation reforms allow for a new definition of “false” claim: one that is not AOECOE. A false claim no longer means fraud! A proven example of an effective baseline test is the EFA-STM.

Workers' Compensation statutes are helping employers by allowing them to accept the claims that are only AOECOE. Employers need to see that they comply with legislation, and baseline testing now gives them an objective assessment to do just that.

To Cure Rare Diseases, Unleash Orphan Drug Innovations

In September of 2012, the City of Pittsburgh hosted the 35th annual Great Race, a charity run that raises money for the Richard S. Caliguiri Amyloidosis Research Fund. Caliguiri, a former Pittsburgh mayor, died of this rare protein disorder, and a portion of the race proceeds are used to help find a cure.

It should have been an uplifting event. Yet the Pittsburgh Post-Gazette reported that “despite the rally of support … the research fund created in Caliguiri’s name has had little impact on the effort to find a cure.”

Those familiar with the challenges of treating rare conditions like amyloidosis won’t be surprised by this news. The sad truth is that the economic incentives for developing life-saving treatments for rare disorders are less than optimal.

But that doesn’t mean that we’re powerless to fight rare diseases. Policymakers can dramatically improve incentives for researchers and biopharmaceutical firms to create drugs that treat rare conditions — treatments known as “orphan drugs.” And they should. Rare diseases collectively represent a major public-health threat.

Rare diseases — conditions like Huntington disease and Burkitt lymphoma which afflict fewer than 200,000 people — cost Americans more than $474 billion a year.

Over 7 percent of Americans — or more than 25 million people — suffer from the roughly 7,000 illnesses that fall into this category.

So the overall market for treatments for rare diseases is large. Indeed, total global spending on orphan drugs runs between $50 billion and $85 billion — or between 5.7 percent and 9.7 percent of what the world spends on pharmaceuticals, according to “A Primer on the Orphan Drug Market: Addressing the Needs of Patients with Rare Diseases,” a new paper by economist Dr. Wayne Winegarden, senior fellow at the Pacific Research Institute.

But the potential number of beneficiaries for each individual orphan treatment is relatively small. A narrow market of potential buyers can make investing in orphan drugs perilous.

Part of the problem is that developing a treatment for any illness is a long and expensive process. It takes anywhere from 10 to 15 years to usher a treatment from the research phase, through the Food and Drug Administration (FDA) approval process, and into patients’ hands.

At every step of the process, drug firms must spend more money — and face the distinct possibility that their research will fail. According to the best estimates, a single successful drug costs well over $1 billion to develop.

And once a drug goes generic, the firm that created the medicine must deal with fierce competition from other manufacturers.

It’s hardly surprising, then, that pharmaceutical firms tend to bet on treatments that will be useful to the largest number of patients. This state of affairs often leaves those suffering from rare diseases with few treatment options.

Fortunately, policymakers have found ways to improve the incentives for pharmaceutical firms to invest in orphan drug research.

Consider the Orphan Drug Act, passed in 1983. It provided drug developers seven years of market exclusivity for their inventions, ensuring that they would have a reasonable amount of time in which to make back their hefty investment, free of competition from other pharmaceutical firms.

The law also lessened the economic burden of drug development by offering a 50-percent tax credit for the costs incurred during the clinical trial phase. On top of that, the Act waived the fees associated with applying for FDA approval.

The results? In the past decade, the number of new drugs — or New Molecular Entities (NME), as they are called in the trade — released in the United States for the treatment of rare diseases has increased dramatically. In fact, more new NMEs were launched in 2011 than in any of the last ten years.

This is encouraging evidence that those who suffer from rare illnesses shouldn’t give up hope.

It’s now up to our leaders to find new ways to lower the barriers to developing these valuable treatments. They should start by taking the Orphan Drug Act — already over a quarter-century old — and using it as a model.

Drug companies should be rewarded for developing orphan drugs. It’s the only way to guarantee that, no matter how uncommon an illness, there will be somebody, somewhere working to find a cure for it.