CLA-2 RR:CR:TE 965916 ttd

Mr. Tom Miesen
Gloria-Med America, Inc.
1813 E. John Sims Parkway, Suite 3
Niceville, FL 32578

RE: Modification of New York Ruling Letter E82160, dated June 10, 1999; Classification of Medical Graduated Compression Panty Hose

Dear Mr. Miesen:

This letter concerns New York Ruling Letter (NY) E82160, issued to you on June 10, 1999, regarding the tariff classification of medical compression panty hose under the Harmonized Tariff Schedule of the United States Annotated (HTSUSA). After review of that ruling, Customs has determined that the classification for two out of the three styles considered has changed from subheading 6115.12.2000, HTSUSA, as other panty hose to subheading 6115.12.1000, HTSUSA, as surgical panty hose with graduated compression for orthopedic treatment. For the reasons that follow, this ruling modifies, in part, NY E82160.

Pursuant to section 625(c)(1) Tariff Act of 1930 (19 U.S.C. 1625(c)(1)) as amended by section 623 of Title VI (Customs Modernization) of the North American Free Trade Agreement Implementation Act (Pub. L. 103-82, 107 Stat. 2057, 2186), notice of the proposed modification of NY E82160 was published on January 8, 2003, in the Customs Bulletin, Volume 37, Number 2. As explained in the notice, the period within which to submit comments on this proposal was until February 7, 2003. No comments were received in response to this notice.

FACTS:

The articles under consideration are two styles of compression panty hose, identified in NY E82160 as Style Lady Gloria 24 and Style Soft 151. Style Lady Gloria 24 is comprised of 76 percent polyamide and 24 percent elastane fabric, with a decitex of 226 and supplies graduated compression ranging from 20-30 mm Hg.1 Style Soft 151 is comprised of 68 percent polyamide and 32 percent elastane fabric, with a decitex of 486 and supplies compression in the range of 20-30 mm Hg.

In NY E82160, we classified Style Lady Gloria 24 and Style Soft 151 in subheading 6115.12.2000, HTSUSA, which provides for "Panty hose, tights, stockings, socks and other hosiery including stockings for varicose veins, and footwear without applied soles, knitted or crocheted: Panty hose and tights: Of synthetic fibers, measuring per single yarn 67 decitex or more: Other." We note that at the time NY E82160 was issued we considered the following:

It is Customs position that surgical compression hosiery, because of their construction and application of use, are more than simple compression stockings to treat varicose veins. The hosiery is made of heavy gauge, opaque, elasticized knit fabric, and is designed to supply compression in the range of 30-40 mm mercury to 50-60 mercury. They are prescribed by physicians for the treatment of venous diseases and other serious conditions such as reversible and irreversible lymphedema and severe post-thrombotic treatment.

ISSUE:

What is the proper classification of the subject graduated compression panty hose under the HTSUSA?

LAW AND ANALYSIS:

Classification of goods under the HTSUSA is governed by the General Rules of Interpretation (GRI). GRI 1 provides that classification shall be determined according to the terms of the headings and any relative section or chapter notes. Merchandise that cannot be classified in accordance with GRI 1 is to be classified in accordance with subsequent GRI taken in order. The Harmonized Commodity Description and Coding System Explanatory Notes (EN), constitute the official interpretation of the Harmonized System at the international level. While neither legally binding nor dispositive, the EN provide a commentary on the scope of each heading of the HTSUS and are generally indicative of the proper interpretation of these headings.

Heading 6115, HTSUSA, provides for "Panty hose, tights, stockings, socks and other hosiery, including stockings for varicose veins, and footwear without applied soles, knitted or crocheted."

In HQ 963517 and HQ 963518, both dated January 2, 2002, Customs classified stockings with graduated compression ranging 20-30 mm Hg as surgical stockings for orthopedic treatment. To reach our decision, we considered a study evaluating the effects of duration of use of class I (20-30 mm Hg) graduated compression hosiery. See Robert Weiss, Neil Sadick, Mitchel Goldman, & Margaret Weiss, Post-Sclerotherapy Compression: Controlled Comparative Study of Duration of Compression and its Effects on Clinical Outcome DERMATOL SURG, 35: 105-108 (1999). This study essentially persuaded our office that compression greater than 20 mm Hg is presently considered necessary for reduction of venous insufficiency.2 We noted certain statements made in the study, including " . . . in terms of controlling objective and subjective parameters of venous insufficiency no difference was found between class I (20-30 mm Hg) and class II (30-40 mm Hg) compression stockings." Based on our review, we found that the study suggested that sclerotherapy results overall can be significantly improved by class I compression and should be part of the post-operative sclerotherapy protocol. In citing other studies, the study concluded that class I (20-30 mm Hg) compression may be recommended over class II since patient compliance is much higher and symptom improvement is identical. See Jungbeck C, Thulin I, Darenheim C, Norgen L. Graduated Compression Treatment in Patients with Chronic Venous Insufficiency; A Study Comparing Low and Medium Grade Compression Stockings. PHLEBOLOGIE, 12:142-5 (1997).

Moreover, during our review of HQ 963517 and HQ 963518, this office examined several letters from vascular surgeons and dermatologists familiar with the beneficial effects of compression on the venous system. The letters indicated consensus within the medical community that surgical stockings with graduated compression of 20-30 mm Hg are principally used for orthopedic purposes and are primarily prescribed by physicians to prevent or correct bodily deformities and the consequences associated with venous disease. The letters established that it is widely recognized that 20 mm Hg of compression is considered necessary for the treatment of venous disease. We noted in HQ 963517 and HQ 963518 that the physicians stated that they recommend using surgical supports with graduated compression of 20 to 30 mm Hg for several reasons: to prevent telangiectatic matting following sclerotherapy, to prevent thrombus formation and phlebitic reactions following sclerotherapy, to reduce post-operative edema, to prevent venous ulcerations, to prevent venous dermatitis and as treatment protocol for post-operative invasive vascular procedures.

In HQ 963517 and HQ 963518, Customs determined that physicians generally recommend graduated compression therapy as a treatment for venous insufficiency. We further recognized that graduated compression hosiery is generally available in three classes of compression; class I specifically covers a compression range of 20-30 mm Hg. We found that physicians generally prescribe compression stockings and that doctors indicated that patients generally find the hosiery uncomfortable and do not wear them unless directed by a doctor. Moreover, letters from medical authorities and conversations with medical professionals confirmed that certified and well-trained personnel must measure various parts of the foot and leg of a patient in order to obtain a proper fit for the stockings. We also found that pharmacies and medical supply companies prefer that a patient have a prescription that prescribes the amount of compression and noted that stockings obtained by prescription are often covered by insurance. We observed that graduated compression stockings are significantly more expensive than support hosiery of the types generally found in retail stores, noting that panty hose with 20-30 mm Hg compression typically sell for approximately $75.00 to $100.00 and similar thigh-high stockings typically sell for $60.00 to $95.00 per pair.

Accordingly, in HQ 963517 and HQ 963518, we concluded that surgical panty hose and stockings with graduated compression ranging from 20-30 mm Hg should be considered surgical hosiery with graduated compression for orthopedic treatment when prescribed by a physician and/or specially fitted to the patient.

As the subject styles of panty hose both have a graduated compression range of 20-30 mm Hg and are prescribed by a physician, Customs finds that the instant graduated compression hosiery is within the scope of subheading 6115.12.1000, HTSUSA, providing for surgical panty hose with graduated compression for orthopedic treatment.

HOLDING:

Based on the foregoing, Style Lady Gloria 24 and Style Soft 151 are classified under subheading 6115.12.1000, HTSUSA, which provides for "Panty hose, tights, stockings, socks and other hosiery, including stockings for varicose veins, and footwear without applied soles, knitted or crocheted: Panty hose and tights: Of synthetic fibers, measuring per single yarn 67 decitex or more: Surgical panty hose with graduated compression for orthopedic treatment." The general column one rate of duty is "Free."

NY E82160 is hereby MODIFIED, in part. In accordance with 19 U.S.C. ยง1625(c), this ruling will become effective 60 days after its publication in the Customs Bulletin.

Sincerely,

Myles B. Harmon, Director
Commercial Rulings Division
1 Compression is measured by how much pressure is required to elevate a column of Mercury (Hg) a certain distance, as measured in millimeters (mm).
2 The partial failure of leg veins to carry blood up towards the heart results in venous disorders, which vary in severity from mild varicosity to deep vein thrombosis and thromboembolism. The use of graduated compression stockings is one of the methods used in the prevention and treatment of these disorders. The stockings are constructed so that the maximum pressure is exerted at the ankle and gradually decreasing up the leg, thus achieving a milking effect that helps blood rise toward the heart.
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