Medical Device Daily Washington Editor
Most of the attention drawn by the June 30 announcement by the Centers for Medicare & Medicaid Services of it's proposed fee schedule for 2009 had to do with the showdown over fee-for-service providers under Part B (Medical Device Daily, July 1, 2008), but a little noticed provision for reimbursement for telehealth consultations was also part of the proposal.
According to the fact sheet accompanying the press release, telehealth was reimbursed prior to 2006, but the advisory panel for relative value updates of the American Medical Association (AMA; Washington) "deleted the codes for follow-up inpatient consultations and advised practitioners to bill for these services using the codes for subsequent hospital care," according to the fact sheet. Perhaps as an unintended consequence, the codes recommended by AMA correlated to a wider range of services than follow-up consultations, "including some services that may be inappropriate for delivery through telehealth," so CMS left them out for 2007.
However, the agency has proposed to restore some codes for consultation between the patient's attending physician and a consulting physician who is not available for face-to-face discussions.
Some private payers, such as Duke University Medical Center (Durham, North Carolina) also provide for telehealth between patient and doctor, but the Medicare program is not yet that far along with telehealth.
Contract manufacturing a sore spot
The device industry has its share of regulatory burdens, but the use of a contract manufacturer sometimes adds to the headaches in unexpected ways, as the June 27 warning letter to Oncology Tech (OT; San Antonio) clearly demonstrates.
The maker of brass blocks known as Mod 1 modulators, which are used to modulate radiation intensity during radiotherapy, was cited for a dozen deviations from the quality systems regulations, including failure of company management to "ensure that an adequate and effective quality system has been fully implemented and maintained." However, the bulk of the rest of the citations mentions the firm's contractor.
The second citation states that OT had no standard operating procedures (SOPs) for design controls, "including the design transfer of the device specifications to your contract manufacturer, and verification of their production process specifications and control of design changes."
Communication practices seem to be the source of the third citation, which states that OT "does not have a design and development plan that defines the specific design activities and responsibilities that are to be performed between" OT and its contract manufacturer, which was not named in the warning letter.
FDA also cited OT for a change of material for the Mod 1, a finding the agency derived from a visit to the company's web site. According to the warning letter, the site indicates that OT changed the material from "high-quality 360 brass" to "6061 aircraft-grade aluminum" without validating the change. The agency also said that OT had "no record of design changes" in connection with this change of material, although the letter did not say whether the contracting company had such records.
Among the other citations was that OT did not maintain records of the validation of software used receive encrypted patient data and decrypt and re-encrypt that data.
The lack of familiarity with contract operations also fed a citation that stated that OT had not "established written procedures or signed a contract agreement that delineates the specific responsibilities and manufacturing operations to be performed by your firm and your contract manufacturer."
At press time, the company had not returned a call for comment.
Vietnam signs drug and device safety deal
Secretary of Health and Human Services Michael Leavitt recently inked a memorandum of understanding (MOU) with the Socialist Republic of Vietnam designed to enhance the safety of drugs and medical devices traded between the two nations.
The agreement, signed June 24, is one of the pieces of a strategic plan adopted by HHS last year with the aim of taking some of the onus for the safety of a wide range of products off the U.S. Customs Service and putting it on the producers of those products in the lands where they work. Leavitt met with Vietnamese officials in Hanoi just two months earlier to put the final touches on the agreement, which went into force immediately.
"Trade between our two nations has grown exponentially in recent years and our societies are better off as a result and our cooperation in health is stronger than ever," said HHS deputy secretary Tevi Troy. He described the MOU as "an important step forward for the health of the American and Vietnamese people."
The MOU requires that the two governments "will exchange information on their respective regulatory systems, such as details on laws and regulations [and] guidance documents." The exchange will also boost the flow of information on "potential or emerging issues of product safety (food-borne illnesses, food contamination, etc.)."
Various agencies at HHS will also conduct workshops and training programs on safety issues as well as on best practices for clinical trials. The agreement is in force for three years and "is subject to revision and renewal, contingent upon the approval of both nations."