Friday, August 1, 2014

New ICD-10 Compliance Date - Final Rule

Centers for Medicare and Medicaid Services has announced a final rule establishing October 1, 2015, as the new ICD-10 compliance date.


The final rule, scheduled to be published in the Federal Register on August 4, implements Section 212 of the Protecting Access to Medicare Act (PAMA) of 2014 which became law on April 1 delaying the ICD-10 implementation deadline from October 1, 2014 to October 1, 2015.


The final rule not only establishes October 1, 2015, as the new ICD-10 compliance date but also requires the continued use of ICD-9-CM through September 30, 2015.

The one-year delay in the ICD-10 code switchover will take a financial toll on the healthcare industry, according to CMS, which estimates the cost to HIPAA covered entities will be $1.1 billion to $6.8 billion. However, the final rule from CMS concludes that a one-year delay--as opposed to a longer delay--will be the “least costly and most fiscally responsible way to implement the requirements of section 212 of PAMA." Because a delay of longer than one year would slow or even stop progress towards ICD-10 implementation, the final rule establishes the “shortest delay permitted by law, which is one year.”


Medicare, Medicaid, and Children's Health Insurance Programs: Extended Temporary Moratoria on Enrollment of Ambulance Suppliers and Home Health Agencies in Designated Geographic Locations

Action

Extension of temporary moratoria.

Summary

This document announces the extension of temporary moratoria on the enrollment of new ambulance suppliers and home health agencies (HHAs) in specific locations within designated metropolitan areas in Florida, Illinois, Michigan, Texas, Pennsylvania, and New Jersey to prevent and combat fraud, waste, and abuse.

Dates

Effective Date: July 29, 2014.

For Further Information Contact

August Nemec, (410) 786-0612.
News media representatives must contact CMS' Public Affairs Office at (202) 690-6145 or email them at press@cms.hhs.gov.

Supplementary Information

I. Background

A. CMS' Imposition of Temporary Enrollment Moratoria

Section 6401(a) of the Affordable Care Act added a new section 1866(j)(7) to the Social Security Act (the Act) to provide the Secretary with authority to impose a temporary moratorium on the enrollment of new Medicare, Medicaid or CHIP providers and suppliers, including categories of providers and suppliers, if the Secretary determines a moratorium is necessary to prevent or combat fraud, waste, or abuse under these programs. For a more detailed explanation of these authorities, please see the July 31, 2013 notice (78 FR 46339) or February 4, 2014 extension and establishment of a temporary moratoria document (hereinafter referred to as the February 4, 2014 moratoria document) (79 FR 6475).
Based on this authority and our regulations at § 424.570, we have implemented two phases of the moratoria to date. In the notice issued on July 31, 2013 (78 FR 46339), we imposed moratoria on the enrollment of home health agencies in Miami-Dade County, Florida and Cook County, Illinois and surrounding counties and on the enrollment of ground ambulance suppliers in the Harris County, Texas area and surrounding counties. Then, in the document published on February 4, 2014 (79 FR 6475), we imposed moratoria on the enrollment of home health agencies in Broward County, Florida, Dallas County, Texas and Wayne County, Michigan and surrounding counties and on the enrollment of ground ambulance suppliers in Philadelphia, PA and surrounding counties.

B. Determination of the Need for Extending a Moratorium

In extending these enrollment moratoria, CMS considered both qualitative and quantitative factors suggesting a high risk of fraud, waste, or abuse. CMS relied on law enforcement's longstanding experience with ongoing and emerging fraud trends and activities through civil, criminal, and administrative investigations and prosecutions. CMS' determination of a high risk of fraud, waste, or abuse in these provider and supplier types within these geographic locations was then confirmed by CMS' data analysis, which relied on factors the agency identified as strong indicators of risk. (For a more detailed explanation of this determination process and of these authorities, see the July 31, 2013 notice (78 FR 46339) or February 4, 2014 moratoria document (79 FR 6475)).
1. CONSULTATION WITH LAW ENFORCEMENT
In consultation with the HHS-OIG and the Department of Justice (DOJ), CMS identified two provider and supplier types in nine geographic locations that warrant a temporary enrollment moratorium. For a more detailed discussion of this consultation process, see the July 31, 2013 notice (78 FR 46339) or February 4, 2014 moratoria document (79 FR 6475).
2. BENEFICIARY ACCESS TO CARE
Beneficiary access to care in Medicare, Medicaid, and CHIP is of critical importance to CMS and its state partners, and CMS carefully evaluated access for the target moratorium locations. Prior to imposing and extending these moratoria, CMS consulted with the appropriate State Medicaid Agencies and with the appropriate State Department of Emergency Medical Services to determine if the moratoria would create an access to care issue for Medicaid and CHIP beneficiaries in the targeted locations and surrounding counties. All of CMS' state partners were supportive of CMS analysis and proposals, and together with CMS, determined that these moratoria will not create access to care issues for Medicaid or CHIP beneficiaries. CMS also reviewed Medicare data for these areas and found there are no current problems with access to HHAs or ground ambulance suppliers.
3. LIFTING A TEMPORARY MORATORIUM
In accordance with § 424.570(b), a temporary enrollment moratorium imposed by CMS will remain in effect for 6 months. (For a more detailed explanation of how CMS can lift a temporary moratorium, see the July 31, 2013 notice (78 FR 46339) or February 4, 2014 moratoria document (79 FR 6475).) If CMS deems it necessary, the moratorium may be extended in 6-month increments. CMS will evaluate whether to extend or lift the moratorium before any subsequent moratorium periods. If one or more of the moratoria announced in this document are extended or lifted, CMS will publish a document to that effect in theFederal Register.
Once a moratorium is lifted, the provider or supplier types that were unable to enroll because of the moratorium will be designated to CMS' high screening level under § 424.518(c)(3)(iii) and § 455.450(e)(2) for 6 months from the date the moratorium was lifted.

II. Extension of Home Health and Ambulance Moratoria—Geographic Locations

As noted earlier, we previously imposed moratoria on the enrollment of new HHAs in Broward county, Miami-Dade and Monroe and their surrounding counties in Florida, the Illinois counties of Cook, DuPage, Kane, Lake, McHenry, and Will, the Michigan counties of Macomb, Monroe, Oakland Washtenaw, and Wayne and the Texas counties of Brazoria, Chambers, Collin, Fort Bend, Galveston, Dallas, Harris, Liberty, Denton, Ellis, Kauffman, Montgomery, Rockwall, Tarrant, and Waller. Further, we previously imposed moratoria on the enrollment of new ground ambulance suppliers in the Texas Counties of Brazoria, Chambers, Fort Bend, Galveston, Harris, Liberty, Montgomery, and Waller and the Pennsylvania counties of Bucks, Delaware, Montgomery; and Philadelphia and the New Jersey counties of Burlington, Camden, and Gloucester. These moratoria became effective upon publication in theFederal Registerof a notice on July 31, 2013 (78 FR 46340)and a moratoria document on February 4, 2014 (79 FR 6475).
In accordance with § 424.570(b), CMS may deem it necessary to extend previously-imposed moratoria in 6-month increments. Under its authority at § 424.570(b), CMS is extending the temporary moratoria on the Medicare enrollment of HHAs and ground ambulance suppliers in the geographic locations discussed herein. Under regulations at § 455.470 and § 457.990, these moratoria also apply to the enrollment of HHAs and ground ambulance suppliers in Medicaid and CHIP. Under § 424.570(b), CMS is required to publish a document in theFederal Registerannouncing any extension of a moratorium, and this extension of moratoria document fulfills that requirement.
CMS consulted with both the HHS-OIG and DOJ regarding the extension of the moratoria on new HHAs and ground ambulance suppliers in all of the moratoria counties, and both HHS-OIG and DOJ agree that a significant potential for fraud, waste, and abuse continues to exist in these geographic areas. The circumstances warranting the imposition of the moratoria have not yet abated, and CMS has determined that the moratoria are still needed as we monitor the indicators and continue with administrative actions such as payment suspensions and revocations of provider/supplier numbers. (For more information regarding the monitored indicators, see section I.B. of the February 4, 2014 moratoria document (79 FR 6475).)
Based upon CMS' consultation with the relevant State Medicaid Agencies, CMS has concluded that extending these moratoria will not create an access to care issue for Medicaid or CHIP beneficiaries in the affected counties at this time. CMS also reviewed Medicare data for these areas and found there are no current problems with access to HHAs or ground ambulance suppliers. Nevertheless, the agency will continue to monitor these locations to ensure that no access to care issues arise in the future.
Based upon our consultation with law enforcement and consideration of the factors and activities described previously, CMS has determined that the temporary enrollment moratoria should be extended for an additional 6 months.

III. Summary of the Moratoria Locations

CMS is executing its authority under sections 1866(j)(7), 1902(kk)(4), and 2107(e)(1)(D) of the Act to extend these moratoria in the following counties for these providers and suppliers:
Table 1—HHA Moratoria
StateCity/metro areaCounties
FLFort LauderdaleBroward.
FLMiamiMonroe.
Dade.
ILChicagoCook.
DuPage.
Kane.
Lake.
McHenry.
Will.
MIDetroitMacomb.
Monroe.
Oakland.
Washtenaw.
Wayne.
TXDallasCollin.
Dallas.
Denton.
Ellis.
Kaufman.
Rockwall.
Tarrant.
TXHoustonBrazoria.
Chambers.
Fort Bend.
Galveston.
Harris.
Liberty.
Montgomery.
Waller.
Table 2—Part B Ambulance Moratoria
StateCity/metro areaCounties
PA/NJPhiladelphiaBucks.
Burlington (NJ).
Camden (NJ).
Delaware.
Gloucester (NJ).
Montgomery.
Philadelphia.
TXHoustonBrazoria.
Chambers.
Fort Bend.
Galveston.
Harris.
Liberty.
Montgomery.
Waller.

IV. Collection of Information Requirements

This document does not impose information collection and recordkeeping requirements. Consequently, it need not be reviewed by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. 35).

V. Regulatory Impact Statement

CMS has examined the impact of this document as required by Executive Order 12866 on Regulatory Planning and Review (September 30, 1993), Executive Order 13563 on Improving Regulation and Regulatory Review (January 18, 2011), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96-354), section 1102(b) of the Social Security Act, section 202 of the Unfunded Mandates Reform Act of 1995 (March 22, 1995; Pub. L. 104-4), Executive Order 13132 on Federalism (August 4, 1999) and the Congressional Review Act (5 U.S.C. 804(2)).
Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). A regulatory impact analysis (RIA) must be prepared for major regulatory actions with economically significant effects ($100 million or more in any 1 year). This document will prevent the enrollment of new home health providers and ambulance suppliers in Medicare, and new home health providers and ambulance suppliers in Medicaid and CHIP. Though savings may accrue by denying enrollments, the monetary amount cannot be quantified. After the imposition of the moratoria on July 30, 2013, 231 HHAs and 7 ambulance companies in all geographic areas affected by the moratoria had their applications denied. We have found the number of applications that are denied after 60 days declines dramatically, as most providers and suppliers will not submit applications during the moratoria period. Therefore, this document does not reach the economic threshold and thus is not considered a major action.
The RFA requires agencies to analyze options for regulatory relief of small entities. For purposes of the RFA, small entities include small businesses, nonprofit organizations, and small governmental jurisdictions. Most hospitals and most other providers and suppliers are small entities, either by nonprofit status or by having revenues of $7.0 million to $35.5 million in any one year. Individuals and states are not included in the definition of a small entity. CMS is not preparing an analysis for the RFA because it has determined, and the Secretary certifies, that this document will not have a significanteconomic impact on a substantial number of small entities.
In addition, section 1102(b) of the Act requires us to prepare a regulatory impact analysis if an action may have a significant impact on the operations of a substantial number of small rural hospitals. This analysis must conform to the provisions of section 604 of the RFA. For purposes of section 1102(b) of the Act, CMS defines a small rural hospital as a hospital that is located outside of a Metropolitan Statistical Area for Medicare payment regulations and has fewer than 100 beds. CMS is not preparing an analysis for section 1102(b) of the Act because it has determined, and the Secretary certifies, that this document will not have a significant impact on the operations of a substantial number of small rural hospitals.
Section 202 of the Unfunded Mandates Reform Act of 1995 also requires that agencies assess anticipated costs and benefits before issuing any regulatory action whose mandates require spending in any 1 year of $100 million in 1995 dollars, updated annually for inflation. In 2014, that threshold is approximately $141 million. This document will have no consequential effect on state, local, or tribal governments or on the private sector.
Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a proposed regulatory action (and subsequent final action) that imposes substantial direct requirement costs on state and local governments, preempts state law, or otherwise has Federalism implications. Since this document does not impose any costs on state or local governments, the requirements of Executive Order 13132 are not applicable.
In accordance with the provisions of Executive Order 12866, the Office of Management and Budget reviewed this document.

Authority

Sections 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh) and 44 U.S.C. Chapter 35; Sec. 1103 of the Social Security Act (42 U.S.C. 1302).
Dated: July 2, 2014.
Marilyn Tavenner,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2014-18174 Filed 7-29-14; 4:15 pm]
BILLING CODE 4120-01-P


Study Finds Pediatric Telemedicine Improves Patient Outcomes

Study Finds Pediatric Telemedicine Improves Patient Outcomes   Study Pediatric Telemedicine Following a comprehensive study of 1,000 pediatric telemedicine consultations available throughout Latin America, researchers at Children’s Hospital of Pittsburgh discovered physicians there were highly satisfied with the services and believed they had improved patient outcomes.
The study, covered in Healthcare IT News, showcased Children’s multi-center experience in telemedicine at three hospitals in Colombia and one in Mexico from July 2011 to June 2013.
Children’s physicians provided 1,040 consultations for 476 patients, with a real-time intervention taking place in 23% of those encounters. In 6% of the tele-consultations, a different diagnosis was suggested based on the interpretation of cardiac or imaging studies.
Relevant patient data was provided in a secure database and telemedicine hardware was used for real-time consultations.
We’re told that a CICU physician from Children’s participated in all encounters.
Based on anonymous surveys of physicians participating at the international centers, 96% of respondents reported being satisfied or highly satisfied with the telemedicine service, while 58% rated the promptness and time dedicated by the tele-intensivists as very high. Physicians reported that they sometimes changed their clinical practice in relation to the telemedicine encounters, with changes in surgical management noted most frequently.
“Now we know that the physicians we assist internationally consider this technology to be useful for patient outcomes and education. We will continue to expand access to the world’s best healthcare for children around the world,” said lead investigator Ricardo A. Muñoz, M.D.

The study is available for review here.