In this ongoing series, we’ll discuss what steps you need to take and what you need to know to add a successful subspecialty service to your practice. Photodynamic therapy (PDT) is a safe and effective treatment modality for many dermatological conditions. Presently, this therapy is approved solely for the treatment of actinic keratoses. Nonetheless, both neoplastic and non-neoplastic diseases — including superficial basal cell carcinomas, Bowen’s disease, squamous cell carcinoma, condyloma acuminatum, and verruca vulgaris — have all responded to PDT in clinical studies. Additionally, inflammatory conditions such as acne, localized scleroderma, hidradenitis, and leishmaniasis can be treated with PDT. Cosmetic conditions including hirsutism, sebaceous hyperplasia, and photoaging are also generally considered to improve with PDT.1 Adding PDT to your clinic provides patients an additional treatment regimen. for a variety of conditions. This article outlines the fundamentals of incorporating PDT into one’s practice or starting a career with an emphasis on PDT.
Photodynamic Therapy at a Glance
PDT consists of the application of a topical photosensitizer followed by exposure to light. Mechanistically, PDT relies on light-induced energy transfer from photosensitizers, which generate free radicals in the presence of oxygen, leading to barrier dysfunction and ultimately cell death. Effective photodynamic therapy relies on two important principles: 1) Photosensitizer uptake is limited to the cells comprising the target lesion, and 2) the chosen light source is able to sufficiently penetrate the entire depth of the target lesion. The use of light-induced treatments dates back to 1904, at which time von Tappeiner and Jesionek treated cutaneous tumors with lamp light following the application of a 5% eiosin dye. Since that time, photosensitizers have evolved; hematoporphyrins became popular in 1937, but were limited by their tendency to invoke non-specific phototoxicity. Eventually, more purified compounds with higher selectivity for damaged tissue became available. Today, topical 5-aminolevulinic acid (ALA), an intermediate in heme biosynthesis, has become the photosensitizer of choice due to its high selectivity for skin tumors and exceptional quantum yield. (Quantum yield refers to the ability of a compound to induce photodynamic effects, so those compounds with the highest quantum yields become photoactive at the lowest concentrations.) ALA light absorption is maximized at wavelengths between 400 nm and 420 nm, while skin penetration increases with longer wavelengths, up to 1100 nm. A blue light with a wavelength of approximately 630 nm is preferred for photodynamic therapy because of its capability to both efficiently penetrate the skin and be absorbed by ALA. Alternatively, red light can be used in some cases. Some practitioners prefer an alternative photosensitizer such as methyl aminolevulinate (MAL), a lipophyllic precursor to ALA, which may result in increased cell penetration. Currently, ALA in combination with blue light, and MAL in conjunction with red light are the only FDA-approved photodynamic treatment regimens. PDT treatment regimens vary depending on the condition being treated. For example, a typical treatment regimen for actinic keratoses consists of three to five monthly treatments, while acne may improve with three once-weekly sessions. Patients and physicians may prefer PDT for the treatment of AKs, because this therapy results in similar efficacy to other treatments with less cracking and irritation to the skin. In one large clinical trial, at 12-week follow-up, 72% of patients achieved complete clearance of AKs following one or two treatments with ALA and blue light. Additionally, 88% of patients cleared at least 75% of their lesions.2 Another trial comparing cryotherapy to MAL-PDT showed the complete remission rate with MAL-PDT is superior (91%) to cryotherapy (68%) 3 weeks post treatment.3 In addition, cosmetic outcomes were superior with PDT. Further supporting evidence for PDT suggests the rates of squamous cell carcinoma may be decreased in immunologically suppressed organ transplant recipients who receive routine PDT therapy.4 To increase the efficacy of treatments for hypertrophic lesions, patients can be treated with cryotherapy prior to undergoing PDT, as is commonly done when patients receive other field-directed therapies such as imiquimod or flououracil. Additionally, patients with multiple lesions are often treated with PDT in combination with pulsed dye laser therapy, as this combination leads to decreased irritation and improved lesional clearance. PDT is an effective treatment for acne, and patients with treatment-resistant disease might be offered this treatment when isotretinoin is contraindicated or intolerable. Physicians and patients may prefer this modality over isotretinoin because it involves less paperwork, is not contraindicated in females of child-bearing age, and does not require blood tests. Similar to isotretinon, PDT is effective in treating acne because of its ability to suppress the sebaceous glands. Studies in which inflammatory acne is pretreated with ALA for 3 hours prior to exposure to red light have demonstrated similar long-term clearance rates to that of oral isotretinoin.5 Unfortunately, insurance providers currently do not reimburse for PDT used for acne because this is not an FDA-approved indication. Economically, patients with mild acne should utilize topical therapies and oral antibiotics before considering PDT.
Training Required
Although at present neither photodynamic fellowships nor formal accreditation are available in the United States, there are multiple avenues for a physician to learn and incorporate PDT into practice. An excellent place to learn PDT is by attending training courses during regional and national conferences, such as the American Academy of Dermatology.6 Another potential route is spending time during residency with an attending who focuses on PDT, either at your home institution or through an away elective. Practicing physicians interested in incorporating this treatment modality into offices would benefit from spending time with a dermatologist currently utilizing PDT. Contacting a local photodynamic equipment supplier is a good place to start, as these representatives could refer you to physicians within your area who utilize this therapy.
Clinical Operations
The process of PDT starts with physicians prescribing PDT to patients most likely to benefit. Once prescribed, an experienced nursing staff can typically manage treatments, though a physician must also be on site. When patients arrive at the office, their skin may be scrubbed with acetone or debrided with EKG tape or microdermabrasion to maximize photosensitizer uptake. Next, patients receive pretreatment with topical ALA or MAL, which requires between 30 minutes to 3 hours of incubation time, depending on the location being treated. In addition, photosensitizers are often occluded with plastic wrap — eg, Saran wrap — to increase penetration. Following appropriate pre-treatment, patients are exposed to blue light for approximately 16 minutes. Typically, including incubation time, patients might spend between 2 and 4 hours at the office per treatment. Though the procedure is safe, many patients do experience mild side effects including pain, acute inflammatory skin reactions and skin tanning. Patients can be offered NSAIDs or acetaminophen for pain control. In addition, pain can be minimized with high-speed ventilation and continuous water spritzing during treatments. Following treatments, patients must be cautioned to absolutely avoid sunlight exposure because of the risk of phototoxicity for up to 36 hours post-treatment. A well-trained nursing staff is essential in operating an efficient PDT practice, but apart from general nursing degrees, no special certificates or degrees are required to work in the PDT setting. Training occurs on the job, where nurses learn to apply the ALA solution, position patients appropriately, and initiate the indicated treatment protocols. Nurses should also be able to educate patients about PDT, recognize side effects, and communicate any necessary information with physicians. Physicians are the primary educators for nursing personnel and should expect to spend 1 or more months training nurses before they are comfortable independently administering therapy. During every third treatment, a patient should be seen by a physician in order to assess clinical progress and augment treatment protocols as necessary. While PDT training requires an investment of time in the initial stages, once properly trained, nurses can improve overall clinic efficiency.
The Right Tools
The costs associated with adding PDT to an existing practice consist of leasing or purchasing a blue light ($7,000) or red lighting ($12,000), purchasing topical ALA or MAL, and equipping a treatment room for PDT administration. Some physicians may opt to supplement PDT with pulsed dye laser therapy if available. While this is not essential, the combination increases treatment efficacy and decreases irritation. PDT can be carried out in a typical outpatient treatment room measuring at least 9 feet by 10 feet.
Reimbursement Issues
Presently, non-hyperkeratotic AKs, superficial basal cell carcinoma, and Bowen’s disease are approved indications for third-party reimbursement. However, to be reimbursed for superficial basal cell carcinoma or Bowen’s disease, insurance companies require evidence of failure, intolerance or contraindication for standard medical/surgical care. The most common CPT and HCPCS codes utilized for PDT are 96567 (photodynamic therapy by external application of light to destroy premalignant and/or malignant lesions of the skin and adjacent mucosa by activation of photosensitive drug), J7308 (aminolevulinic acid HCL for topical administration), and J7309 (methyl aminolevulinate [MAL] for topical administration). Common ICD-9 codes utilized are 173.0-173.9 (other malignant neoplasm of skin), 232.0-232.9 (carcinoma in situ of skin and Bowen’s disease), and 702.0 (actinic keratosis). Reimbursement rates depend on diagnosis, coding, insurance company and area of practice. Additional coding is applicable when treatment is augmented with pulsed dye laser therapy.
Issues to Consider
Adding PDT to your dermatological practice provides an additional treatment modality for a variety of conditions. But before adding this service to your practice, there are some important issues to consider. One consideration is that blue lights can be expensive and some physicians may have difficulty justifying the capital investment in this equipment without knowing how much revenue the purchase may generate. For this reason, initially leasing a blue light may be a preferable to purchasing. An additional limitation to PDT is the paucity of reimbursable indications. Some patients may not choose to utilize this therapy because of the associated out-of-pocket expenses.
Conclusion
Current practitioners are optimistic that if research continues to support the efficacy of PDT, more conditions will eventually qualify for third-party reimbursement. With PDT as a safe and effective method to treat a variety of conditions, adding this service to your practice will provide patients an additional dimension of dermatologic treatment. Patients will welcome an additional treatment option for a number of common conditions. Furthermore, providing patients more choices allows them greater flexibility in determining which therapy is most beneficial for their needs. Mr. Hagele is with the Center for Dermatology Research, Department of Dermatology at Wake Forest University School of Medicine, Winston-Salem, NC. Dr. Dabade is with the Center for Dermatology Research, Department of Dermatology, Wake Forest University School of Medicine, Winston-Salem, NC. Dr. Feldman is with the Center for Dermatology Research, and the Departments of Dermatology, Pathology and Public Health Services, Wake Forest University School of Medicine, Winston-Salem, NC. Dr. Clemons is with Tri-Cities Skin & Cancer, Johnson City, TN. Disclosures: The Center for Dermatology Research, with which Dr. Dabade, Dr. Feldman and Mr. Hagele are affiliated, is supported by an educational grant from Galderma Laboratories, L.P. Dr. Feldman has received research, speaking and/or consulting support from Galderma, Abbott Labs, Warner Chilcott, Aventis Pharmaceuticals, 3M, Connetics, Roche, Amgen, Biogen, GSK/Steifel and Genentech. Dr. Clemons has received speaking support from DUSA Pharmaceutical and is a DUSA pharmaceutical stockholder.
In this ongoing series, we’ll discuss what steps you need to take and what you need to know to add a successful subspecialty service to your practice. Photodynamic therapy (PDT) is a safe and effective treatment modality for many dermatological conditions. Presently, this therapy is approved solely for the treatment of actinic keratoses. Nonetheless, both neoplastic and non-neoplastic diseases — including superficial basal cell carcinomas, Bowen’s disease, squamous cell carcinoma, condyloma acuminatum, and verruca vulgaris — have all responded to PDT in clinical studies. Additionally, inflammatory conditions such as acne, localized scleroderma, hidradenitis, and leishmaniasis can be treated with PDT. Cosmetic conditions including hirsutism, sebaceous hyperplasia, and photoaging are also generally considered to improve with PDT.1 Adding PDT to your clinic provides patients an additional treatment regimen. for a variety of conditions. This article outlines the fundamentals of incorporating PDT into one’s practice or starting a career with an emphasis on PDT.
Photodynamic Therapy at a Glance
PDT consists of the application of a topical photosensitizer followed by exposure to light. Mechanistically, PDT relies on light-induced energy transfer from photosensitizers, which generate free radicals in the presence of oxygen, leading to barrier dysfunction and ultimately cell death. Effective photodynamic therapy relies on two important principles: 1) Photosensitizer uptake is limited to the cells comprising the target lesion, and 2) the chosen light source is able to sufficiently penetrate the entire depth of the target lesion. The use of light-induced treatments dates back to 1904, at which time von Tappeiner and Jesionek treated cutaneous tumors with lamp light following the application of a 5% eiosin dye. Since that time, photosensitizers have evolved; hematoporphyrins became popular in 1937, but were limited by their tendency to invoke non-specific phototoxicity. Eventually, more purified compounds with higher selectivity for damaged tissue became available. Today, topical 5-aminolevulinic acid (ALA), an intermediate in heme biosynthesis, has become the photosensitizer of choice due to its high selectivity for skin tumors and exceptional quantum yield. (Quantum yield refers to the ability of a compound to induce photodynamic effects, so those compounds with the highest quantum yields become photoactive at the lowest concentrations.) ALA light absorption is maximized at wavelengths between 400 nm and 420 nm, while skin penetration increases with longer wavelengths, up to 1100 nm. A blue light with a wavelength of approximately 630 nm is preferred for photodynamic therapy because of its capability to both efficiently penetrate the skin and be absorbed by ALA. Alternatively, red light can be used in some cases. Some practitioners prefer an alternative photosensitizer such as methyl aminolevulinate (MAL), a lipophyllic precursor to ALA, which may result in increased cell penetration. Currently, ALA in combination with blue light, and MAL in conjunction with red light are the only FDA-approved photodynamic treatment regimens. PDT treatment regimens vary depending on the condition being treated. For example, a typical treatment regimen for actinic keratoses consists of three to five monthly treatments, while acne may improve with three once-weekly sessions. Patients and physicians may prefer PDT for the treatment of AKs, because this therapy results in similar efficacy to other treatments with less cracking and irritation to the skin. In one large clinical trial, at 12-week follow-up, 72% of patients achieved complete clearance of AKs following one or two treatments with ALA and blue light. Additionally, 88% of patients cleared at least 75% of their lesions.2 Another trial comparing cryotherapy to MAL-PDT showed the complete remission rate with MAL-PDT is superior (91%) to cryotherapy (68%) 3 weeks post treatment.3 In addition, cosmetic outcomes were superior with PDT. Further supporting evidence for PDT suggests the rates of squamous cell carcinoma may be decreased in immunologically suppressed organ transplant recipients who receive routine PDT therapy.4 To increase the efficacy of treatments for hypertrophic lesions, patients can be treated with cryotherapy prior to undergoing PDT, as is commonly done when patients receive other field-directed therapies such as imiquimod or flououracil. Additionally, patients with multiple lesions are often treated with PDT in combination with pulsed dye laser therapy, as this combination leads to decreased irritation and improved lesional clearance. PDT is an effective treatment for acne, and patients with treatment-resistant disease might be offered this treatment when isotretinoin is contraindicated or intolerable. Physicians and patients may prefer this modality over isotretinoin because it involves less paperwork, is not contraindicated in females of child-bearing age, and does not require blood tests. Similar to isotretinon, PDT is effective in treating acne because of its ability to suppress the sebaceous glands. Studies in which inflammatory acne is pretreated with ALA for 3 hours prior to exposure to red light have demonstrated similar long-term clearance rates to that of oral isotretinoin.5 Unfortunately, insurance providers currently do not reimburse for PDT used for acne because this is not an FDA-approved indication. Economically, patients with mild acne should utilize topical therapies and oral antibiotics before considering PDT.
Training Required
Although at present neither photodynamic fellowships nor formal accreditation are available in the United States, there are multiple avenues for a physician to learn and incorporate PDT into practice. An excellent place to learn PDT is by attending training courses during regional and national conferences, such as the American Academy of Dermatology.6 Another potential route is spending time during residency with an attending who focuses on PDT, either at your home institution or through an away elective. Practicing physicians interested in incorporating this treatment modality into offices would benefit from spending time with a dermatologist currently utilizing PDT. Contacting a local photodynamic equipment supplier is a good place to start, as these representatives could refer you to physicians within your area who utilize this therapy.
Clinical Operations
The process of PDT starts with physicians prescribing PDT to patients most likely to benefit. Once prescribed, an experienced nursing staff can typically manage treatments, though a physician must also be on site. When patients arrive at the office, their skin may be scrubbed with acetone or debrided with EKG tape or microdermabrasion to maximize photosensitizer uptake. Next, patients receive pretreatment with topical ALA or MAL, which requires between 30 minutes to 3 hours of incubation time, depending on the location being treated. In addition, photosensitizers are often occluded with plastic wrap — eg, Saran wrap — to increase penetration. Following appropriate pre-treatment, patients are exposed to blue light for approximately 16 minutes. Typically, including incubation time, patients might spend between 2 and 4 hours at the office per treatment. Though the procedure is safe, many patients do experience mild side effects including pain, acute inflammatory skin reactions and skin tanning. Patients can be offered NSAIDs or acetaminophen for pain control. In addition, pain can be minimized with high-speed ventilation and continuous water spritzing during treatments. Following treatments, patients must be cautioned to absolutely avoid sunlight exposure because of the risk of phototoxicity for up to 36 hours post-treatment. A well-trained nursing staff is essential in operating an efficient PDT practice, but apart from general nursing degrees, no special certificates or degrees are required to work in the PDT setting. Training occurs on the job, where nurses learn to apply the ALA solution, position patients appropriately, and initiate the indicated treatment protocols. Nurses should also be able to educate patients about PDT, recognize side effects, and communicate any necessary information with physicians. Physicians are the primary educators for nursing personnel and should expect to spend 1 or more months training nurses before they are comfortable independently administering therapy. During every third treatment, a patient should be seen by a physician in order to assess clinical progress and augment treatment protocols as necessary. While PDT training requires an investment of time in the initial stages, once properly trained, nurses can improve overall clinic efficiency.
The Right Tools
The costs associated with adding PDT to an existing practice consist of leasing or purchasing a blue light ($7,000) or red lighting ($12,000), purchasing topical ALA or MAL, and equipping a treatment room for PDT administration. Some physicians may opt to supplement PDT with pulsed dye laser therapy if available. While this is not essential, the combination increases treatment efficacy and decreases irritation. PDT can be carried out in a typical outpatient treatment room measuring at least 9 feet by 10 feet.
Reimbursement Issues
Presently, non-hyperkeratotic AKs, superficial basal cell carcinoma, and Bowen’s disease are approved indications for third-party reimbursement. However, to be reimbursed for superficial basal cell carcinoma or Bowen’s disease, insurance companies require evidence of failure, intolerance or contraindication for standard medical/surgical care. The most common CPT and HCPCS codes utilized for PDT are 96567 (photodynamic therapy by external application of light to destroy premalignant and/or malignant lesions of the skin and adjacent mucosa by activation of photosensitive drug), J7308 (aminolevulinic acid HCL for topical administration), and J7309 (methyl aminolevulinate [MAL] for topical administration). Common ICD-9 codes utilized are 173.0-173.9 (other malignant neoplasm of skin), 232.0-232.9 (carcinoma in situ of skin and Bowen’s disease), and 702.0 (actinic keratosis). Reimbursement rates depend on diagnosis, coding, insurance company and area of practice. Additional coding is applicable when treatment is augmented with pulsed dye laser therapy.
Issues to Consider
Adding PDT to your dermatological practice provides an additional treatment modality for a variety of conditions. But before adding this service to your practice, there are some important issues to consider. One consideration is that blue lights can be expensive and some physicians may have difficulty justifying the capital investment in this equipment without knowing how much revenue the purchase may generate. For this reason, initially leasing a blue light may be a preferable to purchasing. An additional limitation to PDT is the paucity of reimbursable indications. Some patients may not choose to utilize this therapy because of the associated out-of-pocket expenses.
Conclusion
Current practitioners are optimistic that if research continues to support the efficacy of PDT, more conditions will eventually qualify for third-party reimbursement. With PDT as a safe and effective method to treat a variety of conditions, adding this service to your practice will provide patients an additional dimension of dermatologic treatment. Patients will welcome an additional treatment option for a number of common conditions. Furthermore, providing patients more choices allows them greater flexibility in determining which therapy is most beneficial for their needs. Mr. Hagele is with the Center for Dermatology Research, Department of Dermatology at Wake Forest University School of Medicine, Winston-Salem, NC. Dr. Dabade is with the Center for Dermatology Research, Department of Dermatology, Wake Forest University School of Medicine, Winston-Salem, NC. Dr. Feldman is with the Center for Dermatology Research, and the Departments of Dermatology, Pathology and Public Health Services, Wake Forest University School of Medicine, Winston-Salem, NC. Dr. Clemons is with Tri-Cities Skin & Cancer, Johnson City, TN. Disclosures: The Center for Dermatology Research, with which Dr. Dabade, Dr. Feldman and Mr. Hagele are affiliated, is supported by an educational grant from Galderma Laboratories, L.P. Dr. Feldman has received research, speaking and/or consulting support from Galderma, Abbott Labs, Warner Chilcott, Aventis Pharmaceuticals, 3M, Connetics, Roche, Amgen, Biogen, GSK/Steifel and Genentech. Dr. Clemons has received speaking support from DUSA Pharmaceutical and is a DUSA pharmaceutical stockholder.
In this ongoing series, we’ll discuss what steps you need to take and what you need to know to add a successful subspecialty service to your practice. Photodynamic therapy (PDT) is a safe and effective treatment modality for many dermatological conditions. Presently, this therapy is approved solely for the treatment of actinic keratoses. Nonetheless, both neoplastic and non-neoplastic diseases — including superficial basal cell carcinomas, Bowen’s disease, squamous cell carcinoma, condyloma acuminatum, and verruca vulgaris — have all responded to PDT in clinical studies. Additionally, inflammatory conditions such as acne, localized scleroderma, hidradenitis, and leishmaniasis can be treated with PDT. Cosmetic conditions including hirsutism, sebaceous hyperplasia, and photoaging are also generally considered to improve with PDT.1 Adding PDT to your clinic provides patients an additional treatment regimen. for a variety of conditions. This article outlines the fundamentals of incorporating PDT into one’s practice or starting a career with an emphasis on PDT.
Photodynamic Therapy at a Glance
PDT consists of the application of a topical photosensitizer followed by exposure to light. Mechanistically, PDT relies on light-induced energy transfer from photosensitizers, which generate free radicals in the presence of oxygen, leading to barrier dysfunction and ultimately cell death. Effective photodynamic therapy relies on two important principles: 1) Photosensitizer uptake is limited to the cells comprising the target lesion, and 2) the chosen light source is able to sufficiently penetrate the entire depth of the target lesion. The use of light-induced treatments dates back to 1904, at which time von Tappeiner and Jesionek treated cutaneous tumors with lamp light following the application of a 5% eiosin dye. Since that time, photosensitizers have evolved; hematoporphyrins became popular in 1937, but were limited by their tendency to invoke non-specific phototoxicity. Eventually, more purified compounds with higher selectivity for damaged tissue became available. Today, topical 5-aminolevulinic acid (ALA), an intermediate in heme biosynthesis, has become the photosensitizer of choice due to its high selectivity for skin tumors and exceptional quantum yield. (Quantum yield refers to the ability of a compound to induce photodynamic effects, so those compounds with the highest quantum yields become photoactive at the lowest concentrations.) ALA light absorption is maximized at wavelengths between 400 nm and 420 nm, while skin penetration increases with longer wavelengths, up to 1100 nm. A blue light with a wavelength of approximately 630 nm is preferred for photodynamic therapy because of its capability to both efficiently penetrate the skin and be absorbed by ALA. Alternatively, red light can be used in some cases. Some practitioners prefer an alternative photosensitizer such as methyl aminolevulinate (MAL), a lipophyllic precursor to ALA, which may result in increased cell penetration. Currently, ALA in combination with blue light, and MAL in conjunction with red light are the only FDA-approved photodynamic treatment regimens. PDT treatment regimens vary depending on the condition being treated. For example, a typical treatment regimen for actinic keratoses consists of three to five monthly treatments, while acne may improve with three once-weekly sessions. Patients and physicians may prefer PDT for the treatment of AKs, because this therapy results in similar efficacy to other treatments with less cracking and irritation to the skin. In one large clinical trial, at 12-week follow-up, 72% of patients achieved complete clearance of AKs following one or two treatments with ALA and blue light. Additionally, 88% of patients cleared at least 75% of their lesions.2 Another trial comparing cryotherapy to MAL-PDT showed the complete remission rate with MAL-PDT is superior (91%) to cryotherapy (68%) 3 weeks post treatment.3 In addition, cosmetic outcomes were superior with PDT. Further supporting evidence for PDT suggests the rates of squamous cell carcinoma may be decreased in immunologically suppressed organ transplant recipients who receive routine PDT therapy.4 To increase the efficacy of treatments for hypertrophic lesions, patients can be treated with cryotherapy prior to undergoing PDT, as is commonly done when patients receive other field-directed therapies such as imiquimod or flououracil. Additionally, patients with multiple lesions are often treated with PDT in combination with pulsed dye laser therapy, as this combination leads to decreased irritation and improved lesional clearance. PDT is an effective treatment for acne, and patients with treatment-resistant disease might be offered this treatment when isotretinoin is contraindicated or intolerable. Physicians and patients may prefer this modality over isotretinoin because it involves less paperwork, is not contraindicated in females of child-bearing age, and does not require blood tests. Similar to isotretinon, PDT is effective in treating acne because of its ability to suppress the sebaceous glands. Studies in which inflammatory acne is pretreated with ALA for 3 hours prior to exposure to red light have demonstrated similar long-term clearance rates to that of oral isotretinoin.5 Unfortunately, insurance providers currently do not reimburse for PDT used for acne because this is not an FDA-approved indication. Economically, patients with mild acne should utilize topical therapies and oral antibiotics before considering PDT.
Training Required
Although at present neither photodynamic fellowships nor formal accreditation are available in the United States, there are multiple avenues for a physician to learn and incorporate PDT into practice. An excellent place to learn PDT is by attending training courses during regional and national conferences, such as the American Academy of Dermatology.6 Another potential route is spending time during residency with an attending who focuses on PDT, either at your home institution or through an away elective. Practicing physicians interested in incorporating this treatment modality into offices would benefit from spending time with a dermatologist currently utilizing PDT. Contacting a local photodynamic equipment supplier is a good place to start, as these representatives could refer you to physicians within your area who utilize this therapy.
Clinical Operations
The process of PDT starts with physicians prescribing PDT to patients most likely to benefit. Once prescribed, an experienced nursing staff can typically manage treatments, though a physician must also be on site. When patients arrive at the office, their skin may be scrubbed with acetone or debrided with EKG tape or microdermabrasion to maximize photosensitizer uptake. Next, patients receive pretreatment with topical ALA or MAL, which requires between 30 minutes to 3 hours of incubation time, depending on the location being treated. In addition, photosensitizers are often occluded with plastic wrap — eg, Saran wrap — to increase penetration. Following appropriate pre-treatment, patients are exposed to blue light for approximately 16 minutes. Typically, including incubation time, patients might spend between 2 and 4 hours at the office per treatment. Though the procedure is safe, many patients do experience mild side effects including pain, acute inflammatory skin reactions and skin tanning. Patients can be offered NSAIDs or acetaminophen for pain control. In addition, pain can be minimized with high-speed ventilation and continuous water spritzing during treatments. Following treatments, patients must be cautioned to absolutely avoid sunlight exposure because of the risk of phototoxicity for up to 36 hours post-treatment. A well-trained nursing staff is essential in operating an efficient PDT practice, but apart from general nursing degrees, no special certificates or degrees are required to work in the PDT setting. Training occurs on the job, where nurses learn to apply the ALA solution, position patients appropriately, and initiate the indicated treatment protocols. Nurses should also be able to educate patients about PDT, recognize side effects, and communicate any necessary information with physicians. Physicians are the primary educators for nursing personnel and should expect to spend 1 or more months training nurses before they are comfortable independently administering therapy. During every third treatment, a patient should be seen by a physician in order to assess clinical progress and augment treatment protocols as necessary. While PDT training requires an investment of time in the initial stages, once properly trained, nurses can improve overall clinic efficiency.
The Right Tools
The costs associated with adding PDT to an existing practice consist of leasing or purchasing a blue light ($7,000) or red lighting ($12,000), purchasing topical ALA or MAL, and equipping a treatment room for PDT administration. Some physicians may opt to supplement PDT with pulsed dye laser therapy if available. While this is not essential, the combination increases treatment efficacy and decreases irritation. PDT can be carried out in a typical outpatient treatment room measuring at least 9 feet by 10 feet.
Reimbursement Issues
Presently, non-hyperkeratotic AKs, superficial basal cell carcinoma, and Bowen’s disease are approved indications for third-party reimbursement. However, to be reimbursed for superficial basal cell carcinoma or Bowen’s disease, insurance companies require evidence of failure, intolerance or contraindication for standard medical/surgical care. The most common CPT and HCPCS codes utilized for PDT are 96567 (photodynamic therapy by external application of light to destroy premalignant and/or malignant lesions of the skin and adjacent mucosa by activation of photosensitive drug), J7308 (aminolevulinic acid HCL for topical administration), and J7309 (methyl aminolevulinate [MAL] for topical administration). Common ICD-9 codes utilized are 173.0-173.9 (other malignant neoplasm of skin), 232.0-232.9 (carcinoma in situ of skin and Bowen’s disease), and 702.0 (actinic keratosis). Reimbursement rates depend on diagnosis, coding, insurance company and area of practice. Additional coding is applicable when treatment is augmented with pulsed dye laser therapy.
Issues to Consider
Adding PDT to your dermatological practice provides an additional treatment modality for a variety of conditions. But before adding this service to your practice, there are some important issues to consider. One consideration is that blue lights can be expensive and some physicians may have difficulty justifying the capital investment in this equipment without knowing how much revenue the purchase may generate. For this reason, initially leasing a blue light may be a preferable to purchasing. An additional limitation to PDT is the paucity of reimbursable indications. Some patients may not choose to utilize this therapy because of the associated out-of-pocket expenses.
Conclusion
Current practitioners are optimistic that if research continues to support the efficacy of PDT, more conditions will eventually qualify for third-party reimbursement. With PDT as a safe and effective method to treat a variety of conditions, adding this service to your practice will provide patients an additional dimension of dermatologic treatment. Patients will welcome an additional treatment option for a number of common conditions. Furthermore, providing patients more choices allows them greater flexibility in determining which therapy is most beneficial for their needs. Mr. Hagele is with the Center for Dermatology Research, Department of Dermatology at Wake Forest University School of Medicine, Winston-Salem, NC. Dr. Dabade is with the Center for Dermatology Research, Department of Dermatology, Wake Forest University School of Medicine, Winston-Salem, NC. Dr. Feldman is with the Center for Dermatology Research, and the Departments of Dermatology, Pathology and Public Health Services, Wake Forest University School of Medicine, Winston-Salem, NC. Dr. Clemons is with Tri-Cities Skin & Cancer, Johnson City, TN. Disclosures: The Center for Dermatology Research, with which Dr. Dabade, Dr. Feldman and Mr. Hagele are affiliated, is supported by an educational grant from Galderma Laboratories, L.P. Dr. Feldman has received research, speaking and/or consulting support from Galderma, Abbott Labs, Warner Chilcott, Aventis Pharmaceuticals, 3M, Connetics, Roche, Amgen, Biogen, GSK/Steifel and Genentech. Dr. Clemons has received speaking support from DUSA Pharmaceutical and is a DUSA pharmaceutical stockholder.
