Human growth hormone (HGH) is a protein hormone secreted by the pituitary gland that stimulates growth, cell reproduction, and regeneration in humans. It plays an important role in growth and development, especially in children and adolescents. As we age, natural HGH production declines, which can lead to undesirable effects. Therapeutic use of HGH addresses growth hormone deficiency diseases in children and adults. However, HGH treatment can be very expensive, costing thousands of dollars per month without insurance coverage. Navigating insurance policies to receive coverage for HGH treatment can be challenging but is important for access to this beneficial therapy.
Insurance coverage for pharmaceuticals like HGH sits at the intersection of several key policy issues in health care – pharmaceutical innovation, insurance coverage and pricing decisions, and physician clinical recommendations. Understanding the background of HGH and examining the hurdles patients face in obtaining insurance coverage can illustrate the real-world impacts of these broad health policy debates. Access to HGH for short stature children, one of the most established uses of HGH, provides a representative case study in the impacts of coverage policies. This article provides an overview of insurance coverage issues for HGH treatment, including variations among providers, common coverage criteria, challenges to obtaining coverage, and tips for working with insurance companies and physicians to gain coverage.
Background and Policy Issues
HGH was first produced through pharmaceutical innovation in 1985 using recombinant DNA technology. Prior to this, the only source of HGH was from cadaver extraction, which carried safety concerns. The high cost of the medication, lack of insurance coverage, and limited supply from cadavers greatly restricted access to HGH treatment. The advent of recombinant HGH expanded treatment opportunities while introducing new questions around costs and insurance coverage criteria.
Pharmaceutical Innovation
The development of recombinant HGH is an example of how pharmaceutical innovation can expand treatment options for previously untreatable conditions. However, it also exemplifies how new drug therapies can be priced out of reach for many patients. The average cost for recombinant HGH is over $1,000 per month, with many formulations costing up to $5,000 a month. The high price limits access if insurance coverage is insufficient.
Insurance Coverage and Pricing
Both private and public health insurance providers face decisions around coverage and pricing for newer, more expensive therapies like HGH. They need to balance providing access to beneficial treatments while considering overall impacts on premiums and limiting expenditures. The lack of clear clinical practice guidelines for HGH therapy complicates coverage determinations.
Physician Decision-Making
The lack of definitive practice guidelines means physician discretion plays a significant role in HGH prescribing and diagnoses. However, insurance providers may have different coverage criteria than what physicians deem clinically appropriate. This discordance between physicians’ judgments and insurance decisions is a key challenge in HGH coverage.
The Orphan Drug Act
HGH obtained FDA approval in 1985 under the Orphan Drug Act, which provides incentives for development of therapies for rare diseases. This facilitated HGH drug development but also allowed for higher pricing that would likely be unsustainable for more common conditions. The trade-offs between incentives for orphan drug development and high subsequent costs are exemplified by HGH.
Short Stature Children
One of the most established uses of synthetic HGH is for increasing height in children with idiopathic short stature, estimated to impact 1 in 5,000 children. However, insurance coverage for HGH treatment in this population varies widely, illuminating issues around evaluating medical necessity, definitions of short stature, and cost-benefit evaluations around coverage.
Insurance Coverage and Reimbursement
Whether HGH treatment is covered by insurance depends on many factors, including the specific indication, insurance type, plan coverage, and insurer guidelines. Both public programs like Medicaid and Medicare and private insurance plans make distinct coverage determinations that dictate patient costs and access.
Private Insurance
Private health insurance plans consider HGH therapy on a case-by-case basis, evaluating the medical necessity for an individual. Approved indications generally include diagnoses of HGH deficiency or insufficiency with supporting clinical evidence. However, specific eligibility criteria differ among insurance providers. Many plans require regular review to assess ongoing medical need.
Public Insurance
Public insurance including Medicaid and Medicare have specific criteria for HGH coverage based on diagnosis, clinical indicators like growth velocity, and other program-specific factors. For example, for short stature children Medicaid often mandates a height below a certain percentile threshold on growth charts. Coverage through Medicare is primarily for diagnoses of adult growth hormone deficiency.
HCPCS Codes
Insurance billing and reimbursement for HGH relies on Healthcare Common Procedure Coding System (HCPCS) codes provided by the Centers for Medicare and Medicaid Services (CMS). The HCPCS J code system includes product-specific codes for HGH injections, used for billing to public and private insurance. CMS determines appropriate covered uses for HGH therapies.
Insurance Coverage Criteria
Although criteria differ among insurance providers, common considerations for HGH coverage include:
Medical Necessity
Demonstrating medical necessity through evidence of HGH deficiency or insufficiency is generally the primary factor in insurance coverage decisions. Specific benchmarks and clinical indications used to establish this necessity vary.
Age Restrictions
Many insurance plans impose age limits on coverage. For pediatric use, coverage often ends at final adult height achievement, around 16-18 years old in girls and 18-20 years old in boys. Medicare mainly covers adult-onset HGH deficiency.
Annual Reviews
Continued coverage may require periodic assessments of growth and treatment response, recommended at 6 to 12 month intervals. Criteria for ongoing therapy show continued benefit without significant adverse effects.
Insurance Coverage Challenges
Despite established benefits for certain conditions, several factors create difficulties in obtaining insurance coverage for HGH:
Discordance Between Physicians and Insurers
In some cases, the patient’s endocrinologist may deem HGH medically necessary based on potential benefits, but insurers deny coverage based on their criteria. These policies can contradict clinical judgment, leaving patients without access.
Heterogeneous Policies
Because criteria differ among insurers, patients with the same condition and clinical indications may have very different coverage outcomes depending on their insurance provider. The lack of consistency creates unequal access.
Patient Factors
Aside from diagnosis, factors like the patient’s underlying health, treatment history, height, bone age, growth velocity, and hormone levels also influence medical necessity assessments. This can lead to variations even within one insurer.
Off-Label Uses
While FDA approved uses for HGH are straightforward, coverage can be denied for off-label but potentially beneficial therapies without strong evidence of efficacy from clinical trials. Younger children may also be denied based on age.
Tips for Navigating Insurance Coverage
Patients and doctors can take several steps to get the maximum coverage:
Understand Insurer Policies
Review medical policies from the insurer for growth hormone treatment coverage details, criteria, clinical indicators, and required supporting evidence. This knowledge can strengthen appeals.
Coordinate with Doctors
Work closely with endocrinologists and primary care physicians to document clinical rationale and medical necessity in patient records to support coverage appeals.
Appeal Denials
For denials, carefully review the reasons cited by the insurer. With physician support, methodically address each reason in a written appeal requesting the insurer reconsider coverage.
Case Studies and Examples
Understanding how coverage decisions apply in real patient situations can illuminate the process:
Idiopathic Short Stature
A 12-year old male with idiopathic short stature, no underlying diagnosis, and a height in the 1st percentile will likely have variable coverage across different insurance plans. Some insurers may approve coverage based on low projected adult height while others will deny coverage for lack of an established underlying disease.
Growth Hormone Deficiency
A 9-year-old female with growth hormone deficiency confirmed through stimulation testing results and a low growth velocity will have a high likelihood of approval, as these clinical indicators clearly establish medical necessity across most major insurance plans.
Denied Appeal
A 15-year-old male with idiopathic short stature denied initial coverage was later approved upon appeal after his endocrinologist provided detailed growth charts and testing evidence of low IGF-1 levels indicative of growth hormone deficiency.
Off-Label Adult Use
A 62-year-old male seeking coverage for off-label HGH treatment to improve body composition and energy was denied due to lack of FDA approval and insufficient evidence of efficacy for this indication.
Tables and Statistics
This table compares common insurance coverage criteria for HGH treatment:
| Aetna | Cigna | UnitedHealthcare | Humana |
|---|---|---|---|
| Diagnosis of HGH deficiency required | Diagnosis of HGH deficiency required | Diagnosis of HGH deficiency required | Diagnosis of HGH deficiency required |
| Stimulation testing required | Stimulation testing required | Stimulation testing required | Stimulation testing required |
| Peak GH level <5 ng/mL | Peak GH level <5 ng/mL | Peak GH level <10 ng/mL | IGF-1/SDS < -2 |
| No coverage for anti-aging | No coverage for anti-aging | No coverage for anti-aging | Height <5th percentile |
| Ends at final adult height | Ends at final adult height | Ends at final adult height | Review every 6 months |
Key statistics on potential beneficiaries of HGH treatment:
- 1 in 4,000 to 1 in 10,000 children are diagnosed with growth hormone deficiency
- Estimated 1 in 5,000 children (60,000 in U.S.) have idiopathic short stature that could benefit from HGH
- Only 10% of adults with HGH deficiency are diagnosed and treated
Quote
“Although improvements have been made in insurance coverage of growth hormone therapy in recent years, significant obstacles still remain for many patients in accessing this beneficial treatment. Navigating insurance requirements can be complex and frustrating, but working closely with knowledgeable healthcare providers offers the best chance of obtaining coverage.” – Endocrinologist specializing in growth disorders
Conclusion
In summary, obtaining insurance coverage for human growth hormone treatment involves demonstrating medical necessity to the satisfaction of insurance plan criteria. While HGH has proven benefits for growth disorders, conflicting perspectives between providers, insurers, and regulators regarding appropriate use hinder access for some patients. Improvements in clinical guidelines and increased alignment between physicians, patients, and insurance plans could enable more consistent coverage decisions. Patients and doctors play an important role advocating for favorable policies and appealing adverse decisions. With the help of dedicated healthcare providers, it is possible to overcome insurance hurdles to make HGH treatment accessible for appropriate patients. The case of HGH highlights how insurance coverage policies for emerging and expensive drug therapies have far-reaching impacts for patients and providers.
