Veterinary Medicine

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The U.S. Food & Drug Administration (FDA) regulates cancer drugs and devices, both for use by humans and pets. Such drugs and devices must obtain FDA approval or clearance before they can be marketed or sold to consumers, so that the FDA can ensure each product is safe and effective for its intended use.

Cancer treatment
Copyright: tashatuvango / 123RF Stock Photo

The FDA is concerned about the marketing and selling of products that have not been approved, particularly because such products may contain dangerous ingredients or may cause harm by negatively impacting beneficial treatments. Often such products are advertised as “natural” or are labeled as a dietary supplement, which may be a tip-off to consumers that the products have not been approved by the FDA.

We invite you to read Fox associate Elizabeth Patton’s post describing the agency’s recent efforts to combat these fraudulent advertising claims. For additional information and guidance regarding FDA-approved drugs for cancer in dogs specifically, see the FDA’s Consumer Update page.

As recently reported by healthypaws® Pet Insurance & Foundation in Cost of Pet Care: 2016, “[v]eterinarians have a greater ability to treat and save sick animals now more than ever before.”

The AVMA offers guidance to both pet owners and veterinarians “recogniz[ing] that viable pet health insurance programs will be important to the future of the veterinary profession’s ability to continue to provide high quality and up-to-date veterinary service.”  The AVMA, while not endorsing any specific pet insurer, includes a list in its guidance to pet owners.  See Do You Need Pet Insurance?

The North American Pet Health Insurance Association, “a freestanding body comprised of reputable and experienced pet health insurance companies and pet health professionals” describes it purpose in North America is to:

  • Collectively drive growth for, and acceptance of, the pet health insurance (PHI) industry, its members, and its products through public and industry awareness initiatives, shared resources, and industry transparency
  • Be a neutral voice for the reporting and dissemination of information about the benefits of PHI, and the industry, while promoting competitive choice for consumers about how pet insurance functions as well as the spectrum of coverage options available
  • Explore and develop partnerships with other insurance, industry, animal welfare organizations and professionals who share complimentary aspects of our work and mandate
  • Provide support to individual NAPHIA member companies in educating, marketing, and disseminating information on the industry across a wide variety of audiences and markets.  See About NAPHIA.

NAPHIA currently has 13 “industry members,” and describes its members as “collectively represent[ing] more than 20 different pet insurance brands currently marketed across the US and Canada.”  See The Pet Health Insurance Industry in North America.

NAPHIA reports that ‘over 1.6 million of the 179 million pets in North America are insured by NAPHIA members.’

Many businesses have begun offering pet insurance to their employees as part of their benefit packages.  Like any other insurance plan, a careful review of the policy is essential before deciding to sign on.

Plans may include the following options: (1) Accident only plans; (2) Accident & Illness; (3) Insurance with Embedded Wellness; and (4) Endorsements.  According to NAPHIA 97% of insured pets in the U.S. “were covered either through an Accident & Illness plan or an Insurance with Embedded Wellness plan.”  See State of the Industry Report 2016 Highlights.

Since diagnostic and treatment options for pets will continue to expand, it may make sense to obtain coverage to ensure that owners are best equipped financially to provide care needed, as determined in consultation with your veterinarian-of-choice.

New Jersey Senate Bill No. 2847,  introduced on December 12, 2016 would make some important beneficial changes to the laws governing animal rescue organizations and shelters in New Jersey, but would also require the unnecessary and harmful premature spay and neuter of cats and dogs before sale from pet shops, kennels, shelters, pounds, and animal rescue organizations.

Considering the positive amendments first, the bill would require registration of all animal rescue organizations with the State Department of Health.  Registration is currently voluntary.

Pursuant to Public Law 2011, Chapter 142, the New Jersey Department of Health shall establish a voluntary registry of animal rescue organizations and their facilities.

As of November 3, 2016 there were 70 in-state and out-of-state animal rescue organizations voluntarily registered in New Jersey, as listed on the DOH website.

Registration and oversight of animal rescue organizations is sorely needed.

Another positive amendment in S2847 is the ability of shelters or pounds to euthanize an animal surrendered by its owner before the current seven-day waiting period, and the ability to euthanize a stray or an animal surrendered by someone other its owner if a veterinarian determines “that the animal is in extreme pain and cannot recover from the illness or condition that is causing the pain.”

A veterinarian should make this determination for animals surrendered by their owners or other individuals for at least 2 reasons: (1) proper animal ownership can be difficult to determine; and (2) the irreversible decision whether or not to euthanize an owned pet should be decided by a veterinarian, trained and licensed to make such determinations.

As for the requirement to spay or neuter a dog or cat before sale, so long as the animal is merely two months old, for reasons previously discussed, this premature, unnecessary elective surgery at so young an age exposes each animal to short and long-term injury and harm.  Increasingly, scientific evidence proves that the early removal of endocrine glands, such as testes and ovaries, increases the incidence of certain metabolic disorders, including some forms of cancer, and can decrease the lifespan of certain pets.  The decision about when to spay or neuter an individual pet should be determined by the owner in consultation with their veterinarian, after learning about the risks and benefits of such procedures.  Veterinarians are increasingly advising dog owners to wait until at least after the pet’s first reproductive cycle to sterilize their dog.  The requirement remains with each owner to ensure that their pet is not irresponsibly bred until it is spayed or neutered.

Finally, the requirement for shelters and pounds to pay owners up to $250.00 for any pet released before it is spayed or neutered could have a devastating impact on these organizations who are already struggling to compete with animal rescue organizations.

If amended to address these concerns, S2847 could be supportable.

 

The City Law includes mandatory sterilization requirements for 8 week-old puppies and kittens who weigh at least 2 pounds.

The question is not “can the surgery be performed on a 2 pound 8 week old puppy” but rather, based on the totality of the circumstances, can the veterinarian recommend the procedure for a puppy or dog housed before and after surgery in a pet store and obtain informed consent from the animal’s owner.

For the following reasons, as NYPWA experts and NYC veterinarians testified, the answer is no—not without violating the standards of veterinary practice the State requires.

The State considers it unprofessional conduct if a veterinarian fails to obtain informed consent before proceeding with any medical care or surgery, and has disciplined veterinarians who have failed to obtain informed consent.

The State requires each pet store to designate a veterinarian to provide care to pets in the store, and to provide accepted veterinary standards of care to all pets in pet stores both pre- and post-operative.  This cannot be accomplished if a veterinarian performs the mandatory surgery because, no matter the age, there are environmental stressors in a pet store that, when added to the stress of anesthesia and surgery, will harm animals.  This is most serious for puppies whose immune systems are still developing.

The Law prohibits the transfer of ownership until after the pet is sterilized.  Therefore, the pet must return to the pet store after the surgery for post-operative care, which according to veterinarians is substandard care.

“A pet store is not a suitable environment for post-surgical recovery of baby animals.”  “Post-operative care typically provided by pet owners in their home cannot be performed in a pet store.”

Recently scientists have discovered that early gonadectomy is harmful to pets.  “Gonadectomy prior to puberty or sexual maturity may make the risks of some diseases higher in certain breeds and individuals.”

The American Veterinary Medical Association, the Society for Theriogenology and the American College of Theriogenology are opposed to mandatory sterilization laws for privately-owned pets.  Based on scientific evidence, veterinarians and specialists now recommend delaying sterilization until the first heat to prevent the harm from premature removal of endocrine glands needed for proper growth and certain metabolic disorders and cancer.

According to the Association of Shelter Veterinarians, “A veterinarian should make the final decision regarding acceptance of any patient for surgery . . . [t]he surgeon should use discretion regarding minimum and maximum patient age and body weight taking into account the availability of staff expertise and necessary equipment to care for patients.  Owned pets may be best served by scheduling surgery at 4 months of age or older . . . [i]n situations involving animals that will be placed for adoption, neutering is best performed prior to adoption . . . to ensure compliance.”

The interstate pet market is based on sales of puppies between 8-14 weeks of age, the time for optimal socialization with their owners.  The City’s response to professional objections to early sterilization is that the pet stores should hold onto these puppies for a longer period of time.  According to animal behavior experts “[d]elaying sales as the City has suggested traumatizes the animals [and] increases undesirable behavioral traits that are detrimental to successful lifelong pet ownership.”

For all these reasons, the City Law creates an insurmountable obstacle for pet stores and veterinarians to comply with both the State and City Law, and should be considered preempted by State law.

 

Effective client communications is the key to success in many professions, including the practice of veterinary medicine. While serving on the New Jersey State Board of Veterinary Medicine for nearly a decade, I was continuously surprised by the number of complaints filed against veterinarians for what amounted to a failure to adequately communicate with client.  The care provided by the veterinarian usually met or exceeded the required standard of care, so the complaint could have been avoided if the veterinarian had ensured that what they had intended to communicate with the client was the information that was actually received.

Of course, in many cases it is difficult to obtain that goal, particularly when a beloved pet is critically sick or injured.

That is why a recently published study on topic was of interest to me.

Jane R. Shaw, et al. recently published “Outcomes assessment of on-site communication skills education in a companion animal practice” see J. Am. Vet. Med. Assoc. 2016:249:419-432.

The objective of the assessment was

“to evaluate veterinarian-client communication and veterinarian and client satisfaction with veterinary visits before and after veterinarians underwent a 6-month communication skills training program in a practice setting.”

The results as reported were impressive:

“After the intervention, appointments were 5.4 minutes longer and veterinarians asked 60% fewer closed-ended lifestyle-social questions, provided 1.4 times as much biomedically related client education, and used 1.5 and 1.24 times as much facilitative and emotional rapport communication, respectively, compared with before the intervention.”

By altering the quality of the communication, the veterinarians received more medically-relevant information from their clients, and both veterinarians and clients felt that enhanced communications benefited the pet being treated.

Adequate communication between veterinarians and their clients is not only considered a “core clinical skill” by the AVMA Council on Education while evaluating colleges of veterinary medicine for accreditation purposes, it forms the basis of requirements by most States for veterinarians to obtain informed consent from clients before providing veterinary services to their patients.

The AVMA approved a policy on informed consent[1] in 2007.

“Informed consent better protects the public by ensuring that veterinarians provide sufficient information in a manner so that clients may reach appropriate decisions regarding the care of their animals.”

“Veterinarians, to the best of their ability, should inform the client or authorized agent, in a manner that would be understood by a reasonable person, of the diagnostic and treatment options, risk assessment, and prognosis, and should provide the client or authorized agent with an estimate of the charges for veterinary services to be rendered. The client or authorized agent should indicate that the information is understood and consents to the recommended treatment or procedure.”

“Documentation of verbal or written informed consent and the client’s understanding is recommended.”

States, including New York have disciplined veterinarians for failure to obtain informed consent.

 

Also, cases in several states have discussed the requirements for veterinarians to obtain informed consent from their clients.

 

In Lawrence v. Big Creek Veterinary Hosp., L.L.C., No. 6-2737, 2007 WL 2579436 (Ohio App. 11 Dist. Sept. 7, 2007), the court stated that the informed consent doctrine required for other medical professionals “is clearly indicative of the veterinarian’s duty of care.”

 

In Hines v. Alldredge, 783 F.3d 197 (5th Cir. 2015), the court cited Tex. Med. Providers Performing Abortion Servs. v. Lakey, 667 F.3d 570, 584–85 (5th Cir.2012) (Higginbotham, J., concurring) for the conclusion that “[t]he doctor-patient relationship has long been conducted within the constraints of informed consent to the risks of medical procedures, as demanded by the common law, legislation, and professional norms.”

 

In Emes Stable v. University of Pennsylvania, 1988 WL 33893 (E.D.Pa. April 4, 1988) the court discussed the requirement for veterinarian to obtain informed consent from clients which includes informing their clients of the “alternatives that a reasonable man such as the owner would deem significant in making a decision whether to undergo the recommended treatment.”

 

Whether to comply with state veterinary practice acts, or to prevent unwarranted complaints, veterinarians (and their clients) are best served when their communication skills remain a priority in their practice.

 

[1] As of November 2007, the AVMA discontinued use of the term “informed consent” in matters relating to veterinary medicine replacing it with the term “owner consent”.

FDA, gearing up for the implementation of the Veterinary Feed Directive (VFD), recently “issued a letter reminding retail establishments that sell medically important antimicrobials for use in feed or water for food animals that the marketing status of those products will change from over-the-counter (OTC) to prescription (Rx) or to veterinary feed directive (VFD) at the end of calendar year 2016.”

As reported in the Daily Herald, those servicing livestock producers in Utah have also been trying to spread the word:

“Local veterinarians, feed suppliers and livestock producers gathered in Lehi on Thursday to learn how the federal feed directive, which goes into effect on Jan. 1, will affect their operations.

The meeting is just one of a series of meetings being held across the state to make sure livestock producers aren’t taken by surprise when the new directive takes effect. It is expected to affect almost everyone who raises animals for human consumption — from 4-Hers to turkey farmers to bee keepers.”

The VFD sets forth “the process for authorizing use of VFD drugs and provides a framework for veterinarians to authorize the use of medically important antimicrobials in feed when needed for specific animal health purposes” as reported by Lydia Zuraw on JUNE 3, 2015 at Food Safety News.

FDA announced that the final rule is:

“an important piece of the agency’s overall strategy to promote the judicious use of antimicrobials in food-producing animals. This strategy will bring the use of these drugs under veterinary supervision so that they are used only when necessary for assuring animal health.”

Notably, as previously discussed here, the rule memorializes the concept that veterinarian may only prescribe antibiotics to animals “within the context of a veterinarian-client-patient relationship (VCPR), which includes sufficient knowledge of the animal, visits to the farm, and follow-up evaluation or care.”

While many states include that requirement in state veterinary medical practice acts, not all states include a definition of or specifications for the “veterinarian-client-patient relationship.”  (See table of state laws compiled by AVMA).

The VFD will require veterinarians to follow state-defined VCPR requirements as long as the state requirements include the key elements in the final VFD.

FDA requires:

“the veterinarian engage with the client (i.e., animal producer or caretaker) to assume responsibility for making clinical judgments about patient (i.e., animal) health, have sufficient knowledge of the animal by conducting examinations and/or visits to the facility where the animal is managed, and provide for any necessary follow-up evaluation or care.”

However, “where the FDA determines that no applicable or appropriate state VCPR requirements exist, veterinarians will need to issue VFDs in compliance with federally defined VCPR requirements.”

FDA issued a draft revised guidance for industry, “General Principles for Evaluating the Human Food Safety of New Animal Drugs Used In Food-Producing Animals” in July 2016 that “described the type of information that the Food and Drug Administration’s (FDA’s) Center for Veterinary Medicine (CVM) recommends sponsors provide [the agency] to address the human food safety of new animal drugs used in food-producing animals.”

In addition to proving that drugs are safe and efficacious in the targeted livestock species, drug companies (sponsors) face increasing hurdles to prove that “food derived from treated animals is safe for human consumption.”

FDA has already begun implementing other changes to “the way medically important antibiotics have been used in animal agriculture for decades.” See FDA’s Guidance #213.

As reported on its website, FDA explains:

“[o]nce the changes are fully implemented, it will be illegal to use these medically important antibiotics for production purposes, and animal producers will need to obtain authorization from a licensed veterinarian to use them for prevention, control or treatment of a specifically identified disease.”

Food animal veterinarians and livestock farmers are concerned about their ability to treat animals with antibiotics appropriately when needed. In response,

“[t]he FDA acknowledges the important role medically important antimicrobials play in treating, controlling, and preventing disease in food-producing animals. However, the agency has been actively engaging veterinary organizations, animal producer organizations and other stakeholders to express our position that medically important antibiotics labeled for continuous or undefined durations of use is not consistent with judicious use principles, as outlined in previously-released guidance documents.”

In “General Principles for Evaluating the Human Food Safety of New Animal Drugs Used In Food-Producing Animals” FDA “provides, in one document, an overview of the overall process for the human food safety evaluation of new animal drugs used in food-producing animals, including:

  • Determining an acceptable daily intake (ADI);
  • Calculating safe concentrations;
  • Assignment of a tolerance;
  • Calculation of a withdrawal period and a milk discard time; and
  • Evaluation of carcinogenic compounds.”

In addition to analyzing the appropriate withdrawal times for meat, milk, and eggs, the agency evaluates the proposed drugs for their potential to create additional pressures on antibiotic resistance in humans.

However, FDA has identified drugs that may not have to undergo this analysis if it (and its metabolites and excipients) are not:

  • “regularly considered to have properties that would exert pressure towards the emergence or selection of bacteria of public health concern;
  • used to treat zoonotic gastroenteritis or other bacterial diseases in humans;
  • under development to treat bacterial diseases in humans; or
  • indicated for a bacterial disease in food-producing animals (i.e., indication is instead antifungal, antiprotozoal, anthelminthic, etc.).”

With the emergence of new methods of disease treatment and  prevention (using, for example, genetically immune livestock) hopefully veterinarians and farmers will not have to rely on antibiotics to treat animals and keep them healthy, since it will be increasingly difficult to obtain and retain the ability to use these drugs in livestock.

Attorney Talk - Veterinary Law with Nancy Halpern

I’m pleased to have been able to participate in Attorney Talk, a podcast centered on casual conversations about the law. Hosted by Kenneth W. Thayer, a partner at Gaylord Popp, LLC, each episode features discussions with individual lawyers about themselves, their practices, and what they love about the law and legal profession.

I invite you to visit the episode page on the Attorney Talk website to hear my wide-ranging interview. You can also visit the show’s iTunes page to listen to full episodes, subscribe and provide a rating (5 stars, of course.)

Thanks to Ken for the wonderful conversation!

Originally published by Trina Wood on May 26, 2016 in Human & Animal Health

Republished with permission from Trina Wood/UC Davis School of Veterinary Medicine

This article discusses new research that will help veterinarians and dog owners identify the best time to sterilize dogs while minimizing the harm resulting from the premature removal of reproductive organs that are important for normal growth.

Renowned for their intelligence, obedience and loyalty, German shepherd dogs are often the preferred breed for police and military work, as well as popular service dogs and family pets. But as most handlers, breeders and veterinarians are aware, joint disorders are a big concern in these animals.

A new study in the journal Veterinary Medicine and Science finds that neutering or spaying these dogs before 1 year of age triples the risk of one or more joint disorders — particularly for cranial cruciate ligament, or CCL, tears.

“Debilitating joint disorders of hip dysplasia, CCL and elbow dysplasia can shorten a dog’s useful working life and impact its role as a family member,” said lead investigator Benjamin Hart, a distinguished professor emeritus in the UC Davis School of Veterinary Medicine. “Simply delaying the spay/neuter until the dog is a year old can markedly reduce the chance of a joint disorder.”

Dog owners in the United States typically choose to spay or neuter their dogs prior to 6 months of age, in large part to prevent pet overpopulation or hoping to avoid unwanted behaviors. In Europe, however, neutering is generally avoided by owners and trainers and not promoted by animal health authorities, Hart said.

During the past decade, some studies have indicated that spaying or neutering can have several adverse health effects for certain dog breeds. For example, a 2014 study published in PLoS ONE and also led by Hart, examined the health records of over 1,000 golden retrievers and found a surprising fourfold increase in one or more joint disorders associated with spay or neuter before 1 year of age. In the same paper, joint disorders in Labrador retrievers were found to be increased by just twofold in dogs spayed or neutered in the first year.

For this current study, researchers examined veterinary hospital records over a 14.5-year period on 1,170 intact and neutered (including spayed) German shepherd dogs for joint disorders and cancers previously associated with neutering. The diseases were followed through 8 years of age, with the exception of mammary cancer in females, which was followed through 11 years.

The dogs were classified as intact (not neutered), neutered before 6 months, neutered between 6 to 11 months, or neutered between 12 to 23 months and 2 to 8 years. Joint disorders and cancers are of particular interest because neutering removes male and female sex hormones that play key roles in important body processes such as closure of bone growth plates.

  • Seven percent of intact males were diagnosed with one or more joint disorders, compared to 21 percent of males neutered prior to a year of age.
  • In intact females, 5 percent were diagnosed with one or more joint disorders, while in females neutered prior to 1 year of age this measure was significantly increased to 16 percent.
  • Mammary cancer was diagnosed in 4 percent of intact females compared with less than 1 percent in females neutered before 1 year of age. (The occurrence of the other cancers followed through 8 years of age was not higher in the neutered than in the intact dogs.)
  • Urinary incontinence, not diagnosed in intact females, was diagnosed in 7 percent of females neutered before 1 year of age.

“In addition to dogs suffering pain from joint disorders, the condition may also disqualify the dog as a working partner in military and police work,” Hart said. “We hope these findings provide evidence-based guidelines for deciding the right age to neuter a puppy to reduce the risk of one or more joint disorders.”

Other researchers on this UC Davis study were: Lynette Hart and Abigail Thigpen, School of Veterinary Medicine; and Neil Willits, Department of Statistics.

The research was supported by the Canine Health Foundation and donors to the Center for Companion Animal Health.

The practice of veterinary medicine remains a noble profession but it is increasingly out of reach for many aspiring veterinarians.

One of the best sources of information for students interested in a veterinary career is the Association of American Veterinary Medical Colleges (AAVMC), “a non-profit membership organization working to protect and improve the health and welfare of animals, people and the environment by advancing academic veterinary medicine.”

The history and mission of this association is described on its website, in part as follows:

The Association of American Veterinary Medical Colleges (AAVMC) was formed in 1966 by the deans of the 18 U.S. and three Canadian veterinary colleges. During the 1970s, AAVMC’s membership expanded to include the departments of veterinary science in colleges of agriculture. Angell Animal Medical Center was granted membership in the mid-1980s, and the category of membership expanded to “other veterinary medical education organizations” in 2001. Departments of comparative medicine were added in the mid-1990s. International AVMA-accredited schools were first admitted in the 1990s as non-voting affiliate members; they became voting members in 2007. Non-AVMA-accredited schools were granted non-voting affiliate status in 2007 as well.

Today, the Association of American Veterinary Medical Colleges coordinates the affairs of all 30 U.S. veterinary medical colleges, all five Canadian colleges of veterinary medicine, eight U.S. departments of veterinary science, eight U.S. departments of comparative medicine, eight international veterinary schools, three veterinary medical education organizations, and four affiliate international veterinary schools. The association represents more than 4,000 faculty, 5,000 staff, 10,000 veterinary students, and 3,000 graduate students at these institutions.

A major concern to veterinarians, veterinary associations, and educators is the continued escalating cost of a veterinary medical education.

According to Dr. John Baker, dean of the MSU College of Veterinary Medicine, “the ratio of student debt to graduate starting salary is the biggest challenge facing veterinary medicine, and is increasing to a level where it may impact the number and quality of students applying for a veterinary medical education.”

The AAVMC, American Veterinary Medical Association (AVMA), and Michigan State University (MSU) College of Veterinary Medicine, convened to discuss this issue in Spring 2016, and, as reported in a press release, recommendations from these thought leaders included, in part:

To explore and implement a five-to-six-year program for students to earn a D.V.M. degree; by working with local undergraduate institutions on refining the curricula, this would enable students to have two extra years to earn income;

To encourage creation of national partnerships and campaigns to raise funds for scholarships;

To work with the AAVMC and AVMA in advocating for legislation to help reduce student debt; and

To document actual educational costs and charge accordingly, which would, among other things, create greater transparency in revenue lines for research and education.

. . .

To reconsider compensation packages for new graduates/associate veterinarians;

. . .

To create a national campaign around student debt; and

To include student debt as a regular follow-up agenda item at annual events such as the AVMA Economic Summit, AVMA Convention and AAVMC Conference; the purpose of this would be to monitor progress on efforts to reduce the DIR and to hold each other accountable.

. . .

To personally engage deans, their peers and future students in conversations about financial literacy and student debt; and

To inform pre-veterinary students about the current student debt issue and discuss what is being done to address it.

In New Jersey legislators have been trying to revamp a pre-existing program, that has since lost its funding, to assist veterinary students who are New Jersey residents by establishing contracts “with out-of-state schools of veterinary medicine for the acceptance of 30 New Jersey students for the 2017-2018 academic year and to increase the number of contractual agreements for an additional 30 students in each of the next three subsequent academic years, until the total number of contractual agreements supports the education of 120 students in the 2020-2021 academic year.”

The veterinary medicine education program, originally established through statute in 1971, provides contracting schools with “a capitation subsidy toward the cost of education in return for reserved spaces for New Jersey students.”

 Between the FY 2007 and FY 2011 fiscal years, funding for the program was reduced and then eliminated. This lack of State support has restricted the ability of New Jersey students to study veterinary medicine, which is significant in light of the fact that such programs are not available within the State.

Previously, students attending veterinary school as part of a New Jersey-secured seat were not obligated to return to New Jersey to practice.  The current bill, S 2251, would:

establish a service requirement for students whose education is supported through these contractual agreements. Upon completion of a student’s veterinary medical education, the student will be required to work in a veterinary medicine position in New Jersey for a period of 18 months for each year of contract funding provided for the student. If this service requirement is not met in whole or in part, then the student is obligated to refund to HESAA the portion of the funding that has not been redeemed through service in the State.