Answers to common regulatory questions
Answers to common regulatory questions
How to conquer the fine print of coverage, regs
[Editor’s Note: In keeping with President Clinton’s pledge to make the Medicare program more accountable and user-friendly, HCFA recently published a notice in the Federal Register (Dec. 18, 1996), p. 66,676, addressing questions on how to track Medicare coverage decisions, regulations, and other parts of the Medicare payment regulatory process. In this article, we summarize that text, pull key excerpts, and place the information in a question-and-answer format for quick reading.]
Question: Patients, vendors, and other interested parties frequently ask us if Medicare is paying for a particular service or technology. How do we track these coverage decisions in a timely manner, and how do we get the most up-to-date information?
Answer: "We receive numerous inquiries from the general public about whether specific items or services are covered under Medicare," HCFA’s notice in the Dec. 18, 1996, Federal Register points out. Many providers, carriers, and intermediaries subscribe to copies of the Medicare Coverage Issues Manual, which identifies many of those medical items, services, technologies, and treatment procedures that can be paid for under Medicare.
"On Aug. 21, 1989, we published a notice in the Federal Register that contained all the Medicare covered decisions issued in the manual to date."
In that notice, HCFA indicated that future revisions would be published on an as-needed basis, but not regularly. "We publish revisions as a result of technological changes, medical practice changes, responses to inquiries we receive seeking clarifications, or the resolution of coverage issues under Medicare," the notice says. If no Coverage Issues Manual revisions were published during a particular quarter, a notice is published citing that fact.
Question: The addenda are printed in fine print and are hard to follow. How do we use coverage addenda?
Answer: The Dec. 18, 1996, Federal Register offers the most recent addenda available on covered Medicare services. "To aid the reader, we have organized and divided this current listing into six addenda," the notice states. The first four relate to specific coverage decisions. Here is how these addenda are classified, and how you can use them:
• Changes in the Coverage Issues Manual. These are found in Addendum I. These updates, when added to material from the original one published Aug. 21, 1989, constitute a complete manual as of the end of 1996. (If you need the original manual, contact the NTIS at the address listed on p. 44.)
• Which Federal Registers you need for particular addenda. Addendum II in the notice lists previous Federal Register documents that contain a listing of all previously published HCFA Medicare and Medicaid manuals and memoranda.
• Transmittal number and topic. Addendum III lists for each Medicare manual or program memorandum a HCFA transmittal number unique to that instruction, and its subject matter.
• Current quarter coverage revisions. Addendum IV lists all revisions for the current quarter. "For the revisions, we give a brief synopsis of [each] as they appear on the transmittal, the manual section number, and the title of the section," the notice explains. "We present a complete copy of the revised material, no matter how minor the revision, and identify the revisions by printing in italics the text that was changed."
Question: How do I use the addenda to track major regulations or substantive interpretations of regulations?
Answer: Addendum V is one place to go, especially if you don’t have access to or interest in electronic versions of the Federal Register. Addendum V lists all substantive and interpretive Medicare and Medicaid regulations and general notices published in the Federal Register for the last quarter of the year.
"For each item, we list the date published, the Federal Register citation, the parts of the Code of Federal Regulations (CFR) that have changed (if applicable), the agency file code number, the title of the regulation, the ending date of the comment period (if applicable), and the effective date (if applicable.)"
Question: Where do I find major regulations regarding certain coverage decisions for investigational devices regulated by the Food and Drug Administration (FDA)?
Answer: On Sept. 19, 1995, HCFA announced that certain devices with an "investigational device exemption" approved by the FDA and certain services related to those devices also may be covered.
Addendum VI includes listings of the FDA-approved investigational device exemption numbers that have been approved in the past quarter. The listings are organized according to category A and category B, and identified by the investigational device exemption number.
All future investigational device exemption categorizations and the numbers assigned to them will be published quarterly in this fashion.
Subscribe Now for Access
You have reached your article limit for the month. We hope you found our articles both enjoyable and insightful. For information on new subscriptions, product trials, alternative billing arrangements or group and site discounts please call 800-688-2421. We look forward to having you as a long-term member of the Relias Media community.