42 CFR 405.205 - Coverage of a non-experimental/investigational (Category B) device. | Title 42 - Public Health | Code of Federal Regulations

§ 405.205

Coverage of a non-experimental/investigational (Category B) device.

(a) For any device that meets the requirements of the exception at § 411.15(o) of this chapter, the following procedures apply:

(1) The FDA notifies CMS, when it notifies the sponsor, that the device is categorized by FDA as non-experimental/investigational (Category B).

(2) CMS uses the categorization of the device as a factor in making Medicare coverage decisions.

(b) If the FDA becomes aware that a categorized device no longer meets the requirements of the exception at § 411.15(o) of this chapter, the FDA notifies the sponsor and CMS and the procedures described in paragraph (a)(2) of this section apply.

Title 42 published on 2012-10-01

The following are only the Rules published in the Federal Register after the published date of Title 42.

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

2013-03-18; vol. 78 # 52 - Monday, March 18, 2013

78 FR 16614 - Medicare Program; Medicare Hospital Insurance (Part A) and Medicare Supplementary Medical Insurance (Part B)

GPO FDSys XML | Text

Additional Documents

type	regulations.gov
FR Doc.	2013-06159
RIN
	CMS-1455-NR

DEPARTMENT OF HEALTH AND HUMAN SERVICES, Centers for Medicare & Medicaid Services

Notice of CMS ruling.

The CMS ruling announced in this notice is effective on March 13, 2013.

42 CFR Parts 405, 411, 412, 419, 424, and 489

Summary

This notice announces a CMS Ruling that establishes a policy that revises the current policy on Part B billing following the denial of a Part A inpatient hospital claim by a Medicare review contractor on the basis that the inpatient admission was determined not reasonable and necessary. This revised policy is intended as an interim measure until CMS can finalize a policy to address the issues raised by the Administrative Law Judge and Medicare Appeals Council decisions going forward. To that end, elsewhere in this issue of the Federal Register , we published a proposed rule entitled, “Medicare Program; Part B Inpatient Billing in Hospitals,” to propose a permanent policy that would apply on a prospective basis.

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].

It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.

United States Code

U.S.C. : Title 42 - THE PUBLIC HEALTH AND WELFARE

42 USC § 290dd–2 - Confidentiality of records

42 USC § 290dd–3 to 290ee–3 - Omitted

§ 1395 - Prohibition against any Federal interference

Statutes at Large

Title 42 published on 2012-10-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 42 CFR 405 after this date.

2013-03-18; vol. 78 # 52 - Monday, March 18, 2013

78 FR 16614 - Medicare Program; Medicare Hospital Insurance (Part A) and Medicare Supplementary Medical Insurance (Part B)

GPO FDSys XML | Text

Additional Documents

type	regulations.gov
FR Doc.	2013-06159
RIN
	CMS-1455-NR

DEPARTMENT OF HEALTH AND HUMAN SERVICES, Centers for Medicare & Medicaid Services

Notice of CMS ruling.

The CMS ruling announced in this notice is effective on March 13, 2013.

42 CFR Parts 405, 411, 412, 419, 424, and 489

Summary

This notice announces a CMS Ruling that establishes a policy that revises the current policy on Part B billing following the denial of a Part A inpatient hospital claim by a Medicare review contractor on the basis that the inpatient admission was determined not reasonable and necessary. This revised policy is intended as an interim measure until CMS can finalize a policy to address the issues raised by the Administrative Law Judge and Medicare Appeals Council decisions going forward. To that end, elsewhere in this issue of the Federal Register , we published a proposed rule entitled, “Medicare Program; Part B Inpatient Billing in Hospitals,” to propose a permanent policy that would apply on a prospective basis.

42 CFR 405.205 - Coverage of a non-experimental/investigational (Category B) device.

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