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The Centers for Medicare and Medicaid Services (CMS), formerly the Health Care Financing Administration, has proposed changes to the outpatient prospective payment system (OPPS) that will take effect Jan. 1. Those changes were published in the Federal Register. (For information on accessing the Federal Register, see "Source and resources," at the end of this article.)
Here are the highlights:
• Reprocessing of single-use devices.
Currently, Medicare won’t pay for single-use devices that have been reprocessed. However, CMS is proposing a change to line up with current policy from the Food and Drug Administration (FDA), CMS will consider reprocessed single-use devices eligible for pass-through payments if the devices meet the FDA’s regulatory criteria, says Eric Zimmerman, Esq., attorney with McDermott, Will, and Emery in Washington, DC. (For information on how to get the new guidance from the FDA, see "Source and resources," at the end of this article.)
• Beneficiary coinsurance adjustments.
CMS is proposed to amend the regulations for provider-based entities, which doesn’t apply to freestanding centers, Zimmerman says. The requirement is for hospitals to make the beneficiary aware that, by virtue of receiving services, there will be a facility payment in addition to the physician’s professional fee, he says. Hospitals are required to disclosure this information before services are rendered and to estimate what the additional charge will be, Zimmerman says.
• Outlier payment.
Under current policy, Medicare determines outlier payment adjustment in aggregate fashion for all outpatient services, Zimmerman says. "What they’re proposing is to calculate them based on each individual outpatient service," he says.
• Provider-based status rules.
CMS has taking some of its guidance that has been published in Q&A format on it’s web site and put it into a regulation, which makes it more reliable, Zimmerman says. In addition, CMS is putting into regulation some of the legislation in the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000 (BIPA). In addition, the provider-based status rules include some new changes — a reporting requirement and EMTALA requirement:
Currently, CMS requires that a main provider, which creates or acquires an entity that it wants to claim as provider-based, must report it to CMS if the entity is off-campus or the costs of that entity in the main provider’s cost report would increase the total costs by at least 5%. The main provider also must furnish all information that CMS needs to determine whether the entity is provider-based. "This requirement has been criticized as redundant of the requirement that a main provider obtain a provider-based status determination for an entity before billing its services that way or including its costs on its cost report," according to McDermott, Will, and Emery’s Sept. 10, 2001, Health Law Update.
CMS has proposed deletion of this reporting requirement. "CMS would, however, retain the additional requirement that a provider report any material change in relationship between it and any provider-based facility, such as a change in ownership or entry into a new or different management contract, that could affect the provider-based status of the entity," according to the Update.
— Emergency Medical Treatment and Active Labor Act (EMTALA).
"Perhaps one of the most troubling and vexing aspects of the original provider-based status rules is the manner in which CMS applied the requirements of EMTALA to off-campus provider-based entities," the Update says. CMS has announced that it intends to re-examine its regulations and reconsider the appropriateness of applying EMTALA to off-campus locations, according to the Update. CMS intends to publish a proposed rule to address these concerns shortly, it says.
For more information on proposed changes to the outpatient prospective payment system, contact:
• Eric Zimmerman, Esq., Attorney, McDermott, Will, and Emery, 600 13th St. N.W., Washington, DC 20005. Telephone: (202) 756-8148. Fax: (202) 756-8087. E-mail: firstname.lastname@example.org.
The proposed rule in the Aug. 24, 2001, Federal Register is available free on line at the web site: www.access.gpo.gov/su_docs/aces/aces140.html. Also, many libraries have copies. To order a copy, specify the date, and enclose a check or money order for $9 made out to the Superintendent of Documents, or enclose your Visa or MasterCard number and the expiration date. Send your request to: New Orders, Superintendent of Documents, P.O. Box 371954, Pittsburgh, PA 15250-7954. Credit card orders also can be placed by calling (202) 512-1800 or faxing the request to (202) 512-2250.
The Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health has released a documents about reprocessing of devices labeled for single use. This document offers labeling guidance can be found on the web: www.fda.gov/cdrh/comp/guidance/1392.pdf. This document provides guidance to hospitals and third-party reprocessors about their responsibility. Hospital and third-party reprocessors are subject to all of the same regulations as manufacturers of the original devices. The document includes definitions and labeling requirements.