CMS Seeks Comments: Attending Physician’s Certification of Medical Necessity for Home Oxygen (Reinstatement of a previously approved ICR)

Tomorrow’s Federal Register will contain a notice from CMS attached here on reinstatement of a previously approved Information Collection Request (ICR).  Under the Paperwork Reduction Act, CMS is not allowed to collect information from ten or more people/organizations without OMB’s approval.

The text of the CMS notice — which includes contact information at CMS for more information — is reprinted below:

Type of Information Collection Request: Reinstatement of a previously approved collection;

Title: Attending Physician’s Certification of Medical Necessity for Home Oxygen Therapy and Supporting Documentation Requirements;

Use: Under Section 1862(a)(1)(A) of the Social Security Act (the Act), 42 U.S.C. §1395y(a), the Secretary may only pay for items and services that are “reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.” In order to assure this, CMS and its contractors develop Medical policies that specify the circumstances under which an item or service can be covered. The certificate of medical necessity (CMN) provides a mechanism for suppliers of Durable Medical Equipment, defined in 42 U.S.C. §1395x (n), and Medical Equipment and Supplies defined in 42 U.S.C. §1395j(5), to demonstrate that the item being provided meets the criteria for Medicare coverage. Section 1833(e), 42 U.S.C. §1395l(e), provides that no payment can be made to any provider of services, or other person, unless that person has furnished the information necessary for Medicare or its contractor to determine the amounts due to be paid. Certain individuals can use a CMN to furnish this information, rather than having to produce large quantities of medical records for every claim they submit for payment. Under Section 1834(j)(2) of the Act, 42 U.S.C. §1395m(j)(2), suppliers of DME items are prohibited from providing medical information to physicians when a CMN is being completed to document medical necessity. The physician who orders the item is responsible for providing the information necessary to demonstrate that the item provided is reasonable and necessary and the supplier shall also list on the CMN the fee schedule amount and the suppliers charge for the medical equipment or supplies being furnished prior to distribution of such certificate to the physician. Any supplier of medical equipment who knowingly and willfully distributes a CMN in violation of this restriction is subject to penalties, including civil money penalties (42 U.S.C. §1395m (j)(2)(A)(iii)). Under Section 42 Code of Federal Regulations §410.38 and §424.5, Medicare has the legal authority to collect sufficient information to determine payment for oxygen, and oxygen equipment. Oxygen and oxygen equipment is by far the largest single total charge of all items paid under durable medical equipment coverage authority. Detailed criteria concerning coverage of home oxygen therapy are found in Medicare Carriers Manual Chapter II-Coverage Issues Appendix, Section 60-4. For Medicare to consider any item for coverage and payment, the information submitted by the supplier (e.g., claims and CMNs), including documentation in the patient’s medical records must corroborate that the patient meets Medicare coverage criteria. The patient’s medical records may include: physician’s office records; hospital records; nursing home records; home health agency records; records from other healthcare professionals or test reports. This documentation must be available to the DME MACs upon request. Form Number: CMS-484 (OCN: 0938-0534); Frequency: Occasionally; Affected Public: Private Sector: Business or other for-profits, Not-forprofits; Number of Respondents: 8,880; Total Annual Responses: 1,541,359; Total Annual Hours: 308,271. (For policy questions regarding this collection contact Doris Jackson at 410-786-4459. For all other issues call 410-786-1326.)