CLA-2 RR:CR:TE 963517 SS
Port Director
U. S. Customs Service
700 Doug Davis Drive
Atlanta, GA 30354
RE: Decision on Application for Further Review of Protest 1704-99-100314; Classification of Graduated Compression Panty Hose and Stockings; Classification of Anti-Embolism Stockings
Dear Port Director:
This is in response to the Application for Further Review of Protest Number 1704-99-100314 filed by the importer, MediUSA L.P., contesting the classification of graduated compression panty hose and stockings and anti-embolism stockings which you forwarded to our office for review on November 22, 1999. The Protestant disagrees with the decision of the port to liquidate the subject merchandise under subheadings 6115.12.2000 and 6115.93.9020, HTSUSA, as other panty hose or stockings. The Protestant claims that the merchandise was properly classified as entered under subheadings 6115.12.1000 and 6115.93.3000, HTSUSA, as surgical panty hose or stockings with graduated compression for orthopedic treatment.
The Application for Further Review of Protest was timely filed and is proper pursuant to Part 174 of the Customs Regulations (19 CFR 174).
FACTS:
There are two classes of merchandise under protest. The first class is graduated compression panty hose and stockings. The hosiery is designed to supply graduated compression ranging from 20-30 mm Hg. They are knit from 71–75 percent nylon and 25-29 percent spandex. The importer describes the hosiery as being made of a heavyweight fabric and having the appearance of traditional medical stockings. The hosiery is available in multiple sizes and styles. The products are packaged and sold by prescription as part of a line of hosiery with graduated compression which ranges from 20 to 50 mm Hg. The hosiery is sold through medical supply houses and similar places by professionals skilled in fitting these stockings.
The second class of merchandise is described by the importer as anti-embolism stockings. These stockings have a compression of 18 mm Hg. The compression supplied is not graduated. The importer claims that the stockings are designed to be worn by recumbent patients in the hospital in order to reduce the risk of developing an embolism. The stockings are not prescribed by a doctor. There was no evidence submitted that a patient must be measured by specially trained personnel in order to ensure a proper fit.
The port reclassified the articles as other panty hose and stockings based on the belief that articles with less than 30 mm Hg of compression did not supply sufficient compression for orthopedic treatment and that the anti-embolism stockings were not prescribed by a physician.
ISSUE:
I. What is the proper classification of graduated compression panty hose and stockings under the HTSUSA?
II. What is the proper classification of the anti-embolism stockings 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.
It is undisputed that these products are classified under heading 6115, HTSUSA, as “panty hose, tights, stockings, socks and other hosiery, including stockings for varicose veins, and footwear without applied soles, knitted or crocheted.” The products are of synthetic fibers and it is assumed for the purposes of this ruling that the yarns measure 67 decitex or more. The only issue in this case is whether the items are considered surgical panty hose or stockings with graduated compression for orthopedic treatment within the scope of subheadings 6115.12.1000 and 6115.93.3000, HTSUSA.
I. Graduated Compression Panty Hose and Stockings
Under the Tariff Schedules of the United States (TSUS), surgical support stockings were classified as orthopedic appliances. In Treasury Decision (T.D.) 76-133, Customs offered the following description of surgical stockings:
For tariff classification purposes, a surgical stocking is a leg and foot covering which is made from a heavy gauge, opaque, elasticized fabric with either a one or two-way stretch, and which is worn as a remedial support of the leg. It is designed for use in post-surgical support and in the treatment of thrombophlebitis, varicosities, edema, and other physical ailments, and is sold either singly or in pairs. It is not the type of merchandise commonly known as support hose which can be purchased in a variety of retail stores. Surgical stockings are usually obtained at the direction of a physician at certain medical supply outlets which have personnel specially trained to measure and fit the merchandise to the legs of each individual patient.
The graduated compression panty hose and stockings at issue meet this general description of surgical stockings.
With the inception of the HTSUSA, heading 6115, HTSUSA, provided for stockings for varicose veins while heading 9021, HTSUSA, provided for orthopedic appliances. In 1991, Customs distinguished between orthopedic appliances and stockings for varicose veins. Customs held that stockings which supplied a compression range of 30-40 mm Hg, 40-50 mm Hg, or 50-60 mm Hg were classifiable as orthopedic appliances of heading 9021, HTSUSA. See Headquarters Ruling Letter (HQ) 088272, dated March 1, 1992, and HQ 086146, dated March 14, 1991. The articles were available by prescription only through medical and surgical supply outlets and a patient had to be measured and fitted by trained personnel to ensure a proper fit. In describing the stockings as more than simply compression stockings for the treatment of varicose veins, Customs relied on the fact that they were prescribed by a physician for the treatment of serious venous diseases and other serious conditions such as reversible and irreversible lymphedema and severe post-thrombotic treatment. While acknowledging the articles could be used for patients with varicose veins, Customs found that they were also used in large numbers for patients with post-operative swelling, including orthopedic patients. Customs concluded that the articles acted to prevent the consequences of venous disease in that they prevented significant swelling and could be determined to prevent deformity in regard to venous ulcerations and dermatitis.
In 1992, the HTSUSA was amended to transfer surgical stockings and panty hose with graduated compression out of heading 9021, HTSUSA, to heading 6115, HTSUSA. Special subheadings were created to specifically provide for surgical compression panty hose and stockings for orthopedic purposes. For a detailed history of the transfer from heading 9021, HTSUSA, to heading 6115, HTSUSA, see HQ 959399, dated December 16, 1996. Since that time, Customs has consistently limited the classification of surgical compression panty hose and stockings to items which have a minimum compression of 30 mm Hg. HQ 959399, dated December 16, 1996; NY B87014, dated August 6, 1997; NY B81996, dated February 24, 1997; NY E82160, dated June 10, 1999; NY E82592; dated June 11, 1999; NY E82593, dated June 11, 1999; NY E82594, dated June 11, 1999; NY E82595, dated June 11, 1999; NY E82596, dated June 11, 1999; and NY F80388, dated December 28, 1999. These rulings also indicate that Customs has generally required that the articles be prescribed by a physician.
Protestant contends that earlier changes in the language of the surgical stockings provision broadened the subheading to include stockings merely for the treatment of varicose veins. Specifically, Protestant argues that the deletion of the phase “other than stockings merely for the treatment of varicose veins” brought stockings merely for the treatment of varicose veins within the ambit of the surgical stockings provision. We disagree. Customs has previously addressed this argument and explained that tariff classification history and International Trade Commission practice justify separate classification. HQ 959399, dated December 16, 1996.
Protestant next contends that numerous medical studies support the effectiveness of stockings with compression under 30 mm Hg. Although Protestant was unable to supply copies of the cited studies, this office is aware of a study which evaluates 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). Most importantly, the study persuades this office that compression greater than 20 mm Hg is presently considered necessary for reduction of venous insufficiency. The study makes certain important statements 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.” The study also suggests 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 concludes 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).
This office also reviewed several letters from vascular surgeons and dermatologists familiar with the beneficial effects of compression on the venous. The letters indicated agreement 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 also establish that it is widely recognized that 20 mm Hg of compression is considered necessary for the treatment of venous disease. The physicians state that they recommend using surgical supports with graduated compression of 20 to 30 mm Hg 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.
The letters from the medical authorities and conversations with medical professionals confirm that a patient must be measured by certified and well-trained personnel in order to obtain a proper fit for the stockings. The doctors indicate that patients generally find the hosiery uncomfortable and do not wear them unless directed by a physician. Lastly, the letters advise that surgical stockings are significantly more expensive than support hosiery of the types generally found in retail stores.
Research by this office indicates that physicians recommend graduated compression therapy as a treatment for venous insufficiency. Graduated compression hosiery is generally available in three classes of compression; class I specifically covers a compression range of 20-30 mm Hg. Compression stockings are generally prescribed by a physician. The pharmacy or medical supply staff will take measurements of various parts of the foot and leg in order to fit the stocking and prefer that a patient have a prescription which prescribes the amount of compression. Stockings obtained by prescription are often covered by insurance. Graduated compression stockings are significantly more expensive than support hosiery of the types generally found in retail stores. Panty hose with 20-30 mm Hg compression typically sell for approximately $75.00 to $100.00. Similar thigh-high stockings typically sell for $60.00 to $95.00 per pair.
Customs finds that surgical panty hose and stockings with graduated compression ranging from 20-30 mm Hg should be considered surgical panty hosiery with graduated compression for orthopedic treatment when they are primarily prescribed by a physician and are specially fitted to the patient by certified well-trained personnel.
The following information was obtained from MediUSA’s website:
Mediven compression stockings are designed to help push stretched or damaged veins back into place, helping the valves close properly so your veins can carry blood throughout your body with near normal efficiency. “Graduated compression” means the compression is stronger at the bottom of the leg-at the ankles and calves - and steadily decreases in pressure toward the top of the leg. This feature helps counteract the effects of gravity and reduces swelling in the feet and ankles.
Medical compression stockings must be prescribed by a physician and individually fitted for maximum effectiveness and comfort. Once your doctor prescribes the compression strength and type, they can recommend an authorized fitter to measure and fit you with the right size. The correct fit and appropriate compression strength is very important to ensure that you have the best chance possible to fight vein disease.
http://www.mediusa.com/compTherapy.html
Compression stockings should only be worn after consulting with your doctor and with your physician’s prescription.
Your authorized Mediven retailer is trained as a professional fitter. You must have your measurements taken by a fitter before purchasing Mediven prescription stockings. Your precise measurements will be taken at a fitting including your waist, hips, thighs, calves, ankles and feet. Fittings usually take place at a medical supply store.
http://www.mediusa.com/right.html
Customs believes the instant graduated compression hosiery is within the scope of the subheadings providing for surgical panty hose and stockings with graduated compression for orthopedic treatment.
To the extent that this ruling conflicts with previous rulings on surgical stockings supplying compression in the range of 20-30 mm Hg, please be advised that those rulings are under review to determine whether they should be the subject of a proposed notice of modification.
Anti-Embolism Stockings
The anti-embolism stockings only provide 18 mm Hg of compression. This falls below the minimum 20-30 mm Hg standard established above. Protestant argues that non-ambulatory patients needs are met by a lesser degree of compression. However, no evidence has been presented to persuade this office that 18 mm Hg of compression should be considered the minimum amount of compression necessary for treating venous disease for non-ambulatory patients. Furthermore, the anti-embolism stockings are distinguishable from the stockings discussed previously in that they are available without prescription and do not require specialized fitting. Additionally, the terms of the subheading clearly require the stockings to provide graduated compression. The instant stocking supply equalized compression, not graduated compression.
Protestant’s own website indicates that the instant stockings are distinctly different from surgical stockings with graduated compression for orthopedic treatment. Hospital stockings, such as the anti-embolism stockings, which offer mild equalized compression for bedridden patients are commonly used on patients recuperating after various surgeries. The stockings are worn by non-ambulatory patients to prevent blood clots during the healing process. They are specifically designed for patients who are lying down in bed. While lying down, blood pressure is equalized along the leg. These hospital stockings are not made to treat vein disease for patients who are on their feet. Only medically prescribed graduated compression stockings provide the correct type of therapy for the daily treatment of vein disease. The hospital stockings are ineffective for the treatment of vein disease because they cannot support the vein walls for upright patients and merely prevent blood clots for bedridden patients. Customs finds this class of merchandise to be distinguishable from surgical stocking with graduated compression for orthopedic treatment. Accordingly, the anti-embolism stockings are beyond the scope of the subheading providing for surgical stockings with graduated compression for orthopedic treatment and are classifiable as other stockings.
HOLDING:
Based on the foregoing, the graduated compression panty hose are classifiable under subheading 6115.12.1000, HTSUSA, which is the provision for surgical panty hose with graduated compression for orthopedic treatment. The applicable rate of duty was1.2 percent ad valorem in1998 and “Free” in 1999.
The graduated compression stockings are classifiable under subheading 6115.93.3000, HTSUSA, which is the provision for surgical stockings with graduated compression for orthopedic treatment. The applicable rate of duty was 2.3 percent ad valorem in 1998 and “Free” in 1999.
The anti-embolism stockings are classifiable under subheading 6115.93.9020, HTSUSA, which is the provision for other stockings not containing lace or net. The applicable rate of duty was 15.1 percent ad valorem in 1998 and 15 percent ad valorem in 1999. The textile category code is 632.
The protest should be ALLOWED in part and DENIED in part. In accordance with Section 3A(11)(b) of Customs Directive 099 3550-065, dated August 4, 1993, Subject: Revised Protest Directive, you are to mail this decision, together with the Customs Form 19, to the protestant no later than 60 days from the date of this letter. Any reliquidation of the entry or entries in accordance with the decision must be accomplished prior to mailing the decision.
Sixty days from the date of the decision, the Office of Regulations and Rulings will make the decision available to Customs personnel, and to the public on the Customs Home Page on the World Wide Web at www.customs.gov, by means of the Freedom of Information Act, and other methods of public distribution.
Sincerely,
John Durant, Director
Commercial Rulings Division