ModifiedMassachusetts Executive Office of Health and Human ServicesPolicy MNG-ED_2025-01

Guidelines for Medical Necessity Determination for the Treatment of Erectile Dysfunction

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Defines medical-necessity criteria, clinical documentation, and prior-authorization requirements for erectile dysfunction treatment, including external devices, penile prostheses, and penile revascularization for MassHealth fee-for-service members.

Policy Summary

PayerMassachusetts Executive Office of Health and Human Services

PolicyGuidelines for Medical Necessity Determination for the Treatment of Erectile Dysfunction

Policy CodePolicy MNG-ED_2025-01

Change TypeNo material clinical or coverage change

Effective DateJan 17, 2025

Next Review DateN/A

Key ActionSubmit prior-authorization requests and supporting documentation through POSC or an approved waiver process.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

All ED treatmentPrior authorization

Under 55Maximum age for covered penile revascularization

36 hoursAcute ischemic priapism duration

12 monthsRequired laboratory lookback

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ModifiedMassachusetts Executive Office of Health and Human ServicesPolicy MNG-ED_2025-01

Guidelines for Medical Necessity Determination for the Treatment of Erectile Dysfunction

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Sign up for Massachusetts Executive Office of Health and Human Services Policy MNG-ED_2025-01 alerts

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Policy Summary

PayerMassachusetts Executive Office of Health and Human Services

PolicyGuidelines for Medical Necessity Determination for the Treatment of Erectile Dysfunction

Policy CodePolicy MNG-ED_2025-01

Change TypeNo material clinical or coverage change

Effective DateJan 17, 2025

Next Review DateN/A

Key ActionSubmit prior-authorization requests and supporting documentation through POSC or an approved waiver process.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

All ED treatmentPrior authorization

Under 55Maximum age for covered penile revascularization

36 hoursAcute ischemic priapism duration

12 monthsRequired laboratory lookback

15Experimental or investigational treatments

Medical Necessity and Coverage Criteria

External devices

Covered when prescribed by a physician as an alternative or in combination with other therapies for erectile dysfunction.

External penile vacuum pump: An external penile vacuum pump device is prescribed by a physician for erectile dysfunction.

Considered medically necessary durable medical equipment.

Implantable devices

Covered when ALL of the following criteria are met.

Implantable penile prosthesis

Clinical prerequisites: All of the following are present: absence of active alcohol or substance abuse; absence of drug-induced impotence related to anabolic steroids, anticholinergics, antidepressants, antipsychotics, or central nervous system depressants; absence of untreated depression or psychiatric illness; proved ineffectiveness or contraindication of nonsurgical methods; normal prolactin and thyroid hormone levels; and normal serum testosterone levels.
Qualifying organic disease
- Examples of qualifying disease or injury: Documented perineal or genital injury; major pelvic trauma affecting bladder, anal, or erection control; major vascular surgery involving the aorta or femoral vessels; retroperitoneal surgery; neurologic disease such as diabetic neuropathy or spinal cord injury; Peyronie's disease; renal failure; spinal cord injury; prostate, bladder, bowel, or spinal surgery; vascular insufficiency or venous incompetence documented by dynamic infusion cavernosometry and cavernosography; or penile venous leak.At least one

Implant removal

Covered for the following medically necessary implant complications.

Removal of penile implant: Removal of a penile implant is medically necessary for an infected prosthesis, intractable pain, mechanical failure, or urinary obstruction.At least one indication

Reimplantation

Covered when the member meets the implant medical-necessity criteria and the prior prosthesis was removed for a medically necessary indication.

Reimplantation: The member meets the medical-necessity criteria for a penile implant, and the prior prosthesis was removed for a medically necessary indication.

Surgical revascularization

Covered only when ALL of the following criteria are met.

Penile revascularization

Required findings: A focal blockage of arterial inflow is demonstrated by duplex Doppler ultrasonography or arteriography; corporeal venous function is normal; the member is not actively smoking; the member is not diabetic and has no evidence of systemic vascular occlusive disease; and the erectile dysfunction is the direct result of an arterial injury caused by blunt trauma to the pelvis and/or perineum.All conditions required

Experimental, investigational, and generally non-covered treatments

The following treatments or indications are considered experimental and investigational or generally not medically necessary.

Non-covered ED treatments and indications: Any of the following is requested: exogenous testosterone replacement therapy; topical creams or gels containing vasodilators; external penile pumps for indications other than the covered erectile dysfunction indication, including prevention of erectile dysfunction following prostatectomy; implantable penile prostheses or penile revascularization for indications other than those specified in the coverage criteria; acupuncture; Alpha Wave SwissWave acoustical wave therapy; botulinum toxin; endovascular treatment such as angioplasty or drug-eluting stent placement for vasculogenic erectile dysfunction; epalrestat; extracorporeal shock wave therapy; gene therapy; pelvic floor muscle training for erectile dysfunction following radical prostatectomy; percutaneous electrostimulation of the perineum; stem cell therapy, including adipose-derived or mesenchymal stem cells; or tacrolimus.Any listed treatment or indication

Effectiveness has not been established or the treatment is generally not considered medically necessary.

External penile pumps are not covered for indications other than the covered treatment of erectile dysfunction, including use to prevent erectile dysfunction following prostatectomy.

Implantable penile prostheses and penile revascularization are not covered when requested for indications other than those specified in the clinical coverage criteria.

The following treatments or indications are considered experimental, investigational, or generally not medically necessary: exogenous testosterone replacement therapy; topical vasodilator creams or gels; acupuncture; Alpha Wave SwissWave acoustical wave therapy; botulinum toxin; endovascular treatment, including angioplasty or drug-eluting stents; epalrestat; extracorporeal shock wave therapy; gene therapy; pelvic floor muscle training for erectile dysfunction after radical prostatectomy; percutaneous perineal electrostimulation; stem cell therapy, including adipose-derived and mesenchymal stem cells; and tacrolimus.

Clinical Thresholds and Coding Details

Serum prolactin and thyroid hormone

Required statusNormal

Serum testosterone

Required statusNormal

Age for penile revascularization

Age requirementUnder 55 years old

Required laboratory timing

Laboratory timingWithin the preceding 12 months

Prior Authorization and Submission Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for all erectile dysfunction treatment. MassHealth reviews requests for medical necessity; approval remains subject to member eligibility, other insurance, and all general MassHealth program restrictions.

Prior Authorization

Submit PA Through POSC or Approved Waiver Process

Submit PA requests and all supporting documentation electronically through the Provider Online Service Center (POSC), unless the provider has a currently approved electronic claims waiver. Waiver users must submit the PA-1 form with all supporting documentation.

Questions about POSC access: MassHealth Customer Service Center at (800) 841-2900; TDD/TTY: 711.
The request must be submitted by the MassHealth-enrolled qualified health professional performing the treatment or procedure.

Policy Background

Erectile dysfunction is the consistent or recurrent inability to attain or maintain a penile erection sufficient for sexual satisfaction or satisfactory sexual performance. Risk factors include smoking, diabetes, hypertension, dyslipidemia, obesity, cardiovascular disease, neurologic injury, pelvic surgery, and pelvic or genital trauma. Treatment generally progresses from oral PDE5 inhibitors to injectable medications or vacuum devices; penile prosthesis implantation is generally reserved for failure or contraindication of less invasive options.

Key Definitions

Erectile dysfunction

DefinitionThe consistent or recurrent inability to attain and/or maintain penile erection sufficient for sexual satisfaction, including satisfactory sexual performance.

Semi-rigid penile prosthesis

DefinitionA device with semi-rigid rods implanted into the corpora cavernosa to provide penile rigidity.

Inflatable penile prosthesis

DefinitionA prosthesis consisting of inflatable cylinders implanted in the penis, a fluid reservoir implanted in the abdomen, and a manual pump implanted in the scrotum.

DICC

Policy Summary

PayerMassachusetts Executive Office of Health and Human Services

PolicyGuidelines for Medical Necessity Determination for the Treatment of Erectile Dysfunction

Policy CodePolicy MNG-ED_2025-01

Change TypeNo material clinical or coverage change

Effective DateJan 17, 2025

Next Review DateN/A

Key ActionSubmit prior-authorization requests and supporting documentation through POSC or an approved waiver process.

SourceLink

On This Page

Morning testosterone collection

Collection timeBefore 10:00 a.m.

Acute ischemic priapism

Duration thresholdGreater than 36 hours

Prior ischemic priapism

Duration and treatment requirementGreater than 24 hours with failed medical therapy

Step Therapy

Conservative Therapy Before Prosthesis

Before requesting an implantable penile prosthesis, document a conservative-treatment sequence and address underlying causes when possible. Oral PDE5 inhibitors are generally first-line unless contraindicated, followed by injectable medication or a vacuum device when oral therapy is insufficient.

Document trials or contraindications for oral therapy, injectable therapy, and external/vacuum devices.
For testosterone deficiency, testosterone therapy may supplement PDE5 inhibitor therapy.

Documentation Required

Document Failure or Contraindication of Nonsurgical Treatment

Implantable semi-rigid or inflatable penile prostheses require documented physiologic ED and proof that nonsurgical methods were ineffective or contraindicated. Submit progress notes confirming treatment failure or contraindication before requesting the implant.

Document the relevant organic disease or condition supporting physiologic ED, as applicable.
Required implant criteria also include normal prolactin and thyroid hormone levels, normal serum testosterone, and absence of active substance abuse, drug-induced impotence, and untreated depression or psychiatric illness.

Step Therapy

Consider Hormonal and PDE5 Therapy First

When testosterone is low but FSH, LH, and prolactin are normal, consider testosterone supplementation with PDE5 inhibitor therapy before proceeding to a prosthesis.

If repeat testosterone remains low, consider FSH, LH, and prolactin.
Obtain endocrine consultation if FSH, LH, or prolactin is abnormal.

Documentation Required

History and Physical Evaluation

Complete a comprehensive history and physical examination before treatment, including medical history, sexual history, and psychosocial evaluation.

Identify and address underlying causes and relevant comorbidities when possible.
Include documentation of organic disease, prior injuries or surgeries, neurologic disease, vascular disease, Peyronie’s disease, renal failure, and other conditions contributing to ED.

Documentation Required

Required Laboratory Workup

Submit the required laboratory workup with results obtained within the preceding 12 months, unless an expressly exempt clinical indication applies.

Blood glucose and/or HbA1c within diabetes control range
Complete blood count, creatinine, hepatic panel, lipid profile, and prostate-specific antigen
Serum testosterone collected before 10:00 a.m.
If testosterone is abnormally low, repeat testing to confirm; if still below normal, consider FSH, LH, and prolactin, with endocrine consultation for abnormal results.
The laboratory tests are not required for acute ischemic priapism lasting more than 36 hours, prior ischemic priapism lasting more than 24 hours with failed medical therapy, or Peyronie’s disease with ED refractory to oral and/or injectable ED therapy.

Documentation Required

Medical Management and Treatment Failure

Before requesting treatment, submit progress notes showing that coexisting medical issues are appropriately managed and reasonably controlled, and that ED is refractory to medical therapies or that those therapies are contraindicated.

Document failure or contraindication of oral, injectable, transdermal, and external-device treatments as applicable.
For implantable prostheses, document the required physiologic ED and other clinical coverage criteria.

Documentation Required

Psychological Assessment When Acceptance Is a Concern

Obtain a psychological assessment before offering an implantable device when there is concern about the member’s acceptance of the device.

Include the assessment in the clinical documentation submitted with the PA request.

Documentation Required

Assess Alternative Treatment After Conservative-Therapy Failure

When injectable medications, oral and transdermal medications, and external devices are ineffective, submit a complete assessment addressing the need for alternative treatment, including an implantable device or surgical revascularization.

Document the treatment history, outcomes, contraindications, and rationale for the proposed alternative.

Documentation Required

Surgeon Attestation and Informed Consent

For an ED surgery request, the surgeon performing the procedure must provide a letter attesting that the member meets the applicable clinical coverage criteria and that informed consent was obtained.

The letter must state that risks and complications were discussed, including the surgeon’s own complication rates.
The treating professional may choose between an inflatable and rigid prosthesis.

Note

Optional Diagnostic Workup

Optional diagnostic studies may be submitted as supporting clinical documentation but are not required for coverage.

Biothesiometry
Nocturnal penile tumescence testing to exclude psychogenic causes, if indicated
Pharmacological response testing using vasoactive drugs such as papaverine HCl, phentolamine mesylate, or prostaglandin E1
For qualifying revascularization cases: dynamic infusion cavernosometry and cavernosography; duplex Doppler/ultrasound with intracorporeal papaverine when appropriate; and pudendal arteriography.

Denial Risk

Implant Criteria Not Met

Expect denial risk when physiologic ED and all implantable-prosthesis criteria are not documented. Coverage requires every applicable criterion, including failed or contraindicated nonsurgical treatment and the required laboratory and organic-disease documentation.

Absence of active alcohol or substance abuse, drug-induced impotence, and untreated depression or psychiatric illness
Normal prolactin, thyroid hormone, and serum testosterone levels
A qualifying history of organic disease or other similar dysfunction accepted at MassHealth review

Denial Risk

Revascularization Criteria Not Met

Penile revascularization for vasculogenic ED is covered only when all required criteria are documented; requests lacking any criterion face denial.

Member is under 55 years old.
Focal arterial inflow blockage is demonstrated by duplex Doppler ultrasonography or arteriography.
Normal corporeal venous function; no active smoking; no diabetes or systemic vascular occlusive disease.
ED is directly caused by blunt-trauma arterial injury to the pelvis and/or perineum.

Denial Risk

Experimental or Investigational Treatment

Do not request coverage for treatments identified as experimental, investigational, or non-covered under the guideline; such requests face denial.

Examples include acupuncture, acoustical wave therapy, botulinum toxin, endovascular treatment, epalrestat, extracorporeal shock wave therapy, gene therapy, pelvic-floor muscle training for post-prostatectomy ED, percutaneous perineal electrostimulation, stem-cell therapy, and tacrolimus.
Exogenous testosterone replacement therapy and topical creams or gels containing vasodilators are also non-covered.

Denial Risk

Uncovered Indication for External Penile Pumps

External penile pumps are not covered for excluded indications, including prevention of ED following prostatectomy. Ensure the requested indication matches the covered guideline criteria.

External penile pumps are listed as non-covered for indications other than the covered indication.

Documentation Required

Incomplete Submission

An incomplete submission may delay or prevent authorization. Clinical information and supporting documentation must be submitted by the MassHealth-enrolled qualified health professional performing the procedure; for a penile implant, this is the professional performing the surgery.

Include the required history and physical, laboratory results, treatment-failure or contraindication documentation, and any applicable surgeon attestation.
Submit through POSC or, if an approved waiver applies, use the PA-1 form with all supporting documentation.

DefinitionDynamic infusion cavernosometry and cavernosography, used to document vascular or venous function in selected erectile dysfunction evaluations.