Response to Recommendations from November 2011 CFSAC meeting

Response to Recommendations from November 2011 CFSAC meeting

Post #203 Shortlink: http://wp.me/pKrrB-2ur

The response from the Assistant Secretary for Health to Recommendations from the November 2011 CFSAC meeting is now available on the CFSAC website at: http://1.usa.gov/OghDXF

http://www.hhs.gov/advcomcfs/asst-sect-letter2012.pdf

or open here  asst-sect-letter2012

Text:

DEPARTMENT OF HEALTH & HUMAN SERVICES Office of the Secretary

Office of the Assistant Secretary for Health Washington, D.C. 20201
AUG -3 2012
Gailen Marshall Jr., MD, PhD

Chair, Chronic Fatigue Syndrome Advisory Committee
Professor and Chair Professor of Medicine and Pediatrics
The University of Mississippi Medical Center 2300
North State Street, N416 Jackson, MS 39216-4505

Dear Dr. Marshall:

I have received the recommendations developed by the Chronic Fatigue Syndrome Advisory Committee (CFSAC) during its November 8-9, 2011, meeting. The advice and counsel provided by CFSAC serves as a valuable resource in the Department of Health and Human Services’ (HHS) efforts to properly address the issues and concerns pertaining to chronic fatigue syndrome.

Since the meeting the Department has carefully considered your recommendations. Dr. Nancy Lee, the Designated Federal Officer for CFSAC, has worked collaboratively with the ex officio representatives to the committee to provide responses to the recommendations developed at the meeting. The enclosed document contains information about activities currently undertaken by HHS to work with public health experts and members of the chronic fatigue syndrome community to increase knowledge and provide a better understanding of this debilitating health condition.

I have shared the committee’s recommendations with Secretary Kathleen Sebelius.

The Department is committed to addressing this condition. I commend you and your committee members for the important work you do.

Sincerely yours,
/s/Howard K. Koh
Howard K. Koh, M.D., M.P.H. Assistant Secretary for Health

Enclosure

cc: Dr. Christopher R. Snell
U.S. Public Health Service

RESPONSES TO RECOMMENDATIONS FROM THE CHRONIC FATIGUE SYNDROME ADVISORY COMMITTEE (CFSAC)

REF: November 8-9, 2011 CFSAC Meeting

Recommendation 1: This recommendation addresses the process by which CFSAC transmits recommendations to the Secretary and the Secretary communicates back to CFSAC whether or not a recommendation was acted upon. CFSAC recommends that this process be transparent and clearly articulated to include regular feedback on the status of the Committee’s recommendations. This communication could originate directly from the Office of the Secretary or be transmitted via the relevant agency or agencies.

Procedures are in place to ensure that recommendations made by federal advisory committees are properly handled. The CFSAC charter stipulates that the Committee provides advice and recommendations to the Secretary, through the Assistant Secretary for Health (ASH). Initially, the CFSAC recommendations are sent to the ASH for review. After reviewing the recommendations, the ASH forwards them to appropriate officials within the Office of the Secretary and the Operating and/or Staff Divisions that may be impacted by the Committee’s recommendations. A letter is sent to acknowledge receipt of the recommendations. A response may be prepared to accompany the letter which describes any actions that the Department may take in response to the recommendations made by the Committee. All pertinent information about the recommendations is provided to the designated Federal officer (DFO). The DFO then provides the information to the Chair and the Committee.

Recommendation 2: CFSAC recommends to the Secretary that the NIH or other appropriate agency issue a Request for Application (RFA) for clinical trials research on chronic fatigue syndrome/myalgic encephalomyelitis (ME/CFS).

The National Institutes of Health (NIH) funds research on myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS); investigators are encouraged to submit proposals for ME/CFS research, including clinical trials, through two funding announcements that are currently open for submission of applications. The next deadline for receipt of applications is October 24, 2012. In fiscal year 2011, NIH funded two applications for clinical trials on ME/CFS. NIH has received few applications proposing ME/CFS research, and even fewer applications proposing ME/CFS clinical trials. It is unclear whether the paucity of ME/CFS clinical trial applications reflects the current status of the field or an acknowledgement that clinical trials are difficult to design for a complex and multi-faceted illness. Clinical trials are challenging to design and conduct for all diseases, with basic requirements of a well-defined patient population, valid measurement instruments, appropriate safeguards for subjects, and generalizability of the clinical trial outcomes to the larger affected patient population. NIH is taking action to stimulate ME/CFS research across NIH through the regular monthly meetings of the Trans-NIH ME/CFS Working Group (WG). The WG discusses the current status of ongoing research on ME/CFS and proposes methods to increase the number and quality of research applications submitted to NIH ranging from preclinical research to clinical trials. In addition, the WG is focusing on the recommendations from the April 2011 State of the Knowledge Workshop on ME/CFS to develop priorities. The outcome from these planning sessions will suggest a range of activities and research.

Recommendation 3: CFSAC would like to encourage and support the creation of the DHHS Interagency Working Group on Chronic Fatigue Syndrome and ask this group to work together to pool resources that would put into place the “Centers of Excellence” concept that has been recommended repeatedly by this advisory committee. Specifically, CFSAC encourages utilizing HHS agency programs and demonstration projects, available through the various agencies, to develop and coordinate an effort supporting innovative platforms that facilitate evaluation and treatment, research, and public and provider education. These could take the form of appropriately staffed physical locations, or be virtual networks comprising groups of qualified individuals who interact through a variety of electronic media. Outreach and availability to underserved populations, including people who do not have access to expert care, should be a priority in this effort.

HHS leadership has identified the need for a Department-wide plan to address ME/CFS. The Department established the HHS Ad Hoc Workgroup on ME/CFS to develop a plan and to identify opportunities for interagency collaboration. The HHS ME/CFS plan will highlight recently initiated programs and future agency-specific and cross-agency activities. In developing the report, the Ad Hoc Workgroup will consider recommendations made by CFSAC. After completion, the ME/CFS plan will be posted on the CFSAC website. The DFO, Nancy C. Lee, M.D. is responsible for providing leadership and coordination for development of the HHS ME/CFS report.

Recommendation 4: This multi-part recommendation pertains to classification of CFS in ICD classification systems:

a) CFSAC considers CFS to be a multi-system disease and rejects any proposal to classify ME/CFS as a psychiatric condition in the U.S. disease classification systems.

b) CFSAC rejects the current classification of ME/CFS in Chapter 18 of ICD-9-CM under R53.82, chronic fatigue unspecified, chronic fatigue syndrome, not otherwise specified.

c) CFSAC continues to recommend that ME/CFS should be classified in ICD-IO-CM in Chapter 6 under Diseases of the Nervous System at G93.3 in line with ICD-IO, the World Health Organization, and ICD-I-CA [sic], the Canadian Clinical Modification and in accordance with CFSAC’s recommendations of August 2005 and May 2011. CFSAC rejects CDC’s National Center for Health Statistics (NCHS) Option 2 and recommends that ME/CFS remain in the same code and the same subcode as myalgic encephalomyelitis because CFS includes both viral and non-viral triggers.

d) CFSAC recommends that an “excludes one”* be added to G93.3 for chronic fatigue, R53.82, and neurasthenia, F48.8. CFSAC recommends that these changes be made in ICD-10-CM prior to its rollout in 2013.**

[*Ed: Should read "Excludes 1". For definitions for “Excludes1″ and “Excludes2″ see Post #118]

[**Ed: On August 3, HHS announced Final Rule to delay compliance date for ICD-10-CM/PCS to October 1, 2014.]

Development and implementation of the guidelines for the lCD-10 fall within HHS under the purview of the Centers for Disease Control and Prevention (CDC) and the Centers for Medicare and Medicaid Services. Use of the revised codes will provide robust and specific data that will improve patient care and enable the international comparability of health care data. On February 16, 2012, the Department issued a press release announcing that HHS would initiate a process to postpone the date that certain health care entities must comply with the ICD-10.

A proposal to change the classification of ME/CFS in ICD-10-CM was presented at the September 2011 Coordination and Maintenance (C & M) Committee/CDC/NCHS; a subsequent proposal was received on January 12, 2012 and will be presented at the September 19, 2012 C & M meeting for additional discussion.

+++
Related posts

Notice of Meeting of the ICD-9-CM Coordination and Maintenance Committee

Coding CFS in ICD-10-CM: CFSAC and the Coalition4ME/CFS initiative

Extracts: ICD-9-CM Coordination and Maintenance Committee Meeting Summary document (CFS coding)

Extracts: ICD-9-CM Coordination and Maintenance Committee Meeting September 14, 2011 (Coding of CFS in ICD-10-CM)

CFSAC announces dates of Spring meeting

CFSAC announces dates of Spring meeting

Post #160 Shortlink: http://wp.me/pKrrB-240

Chronic Fatigue Syndrome Advisory Committee (CFSAC)

http://www.hhs.gov/advcomcfs/index.html

The Chronic Fatigue Syndrome Advisory Committee (CFSAC) provides advice and recommendations to the Secretary of Health and Human Services via the Assistant Secretary for Health of the U.S. Department of Health and Human Services on issues related to chronic fatigue syndrome (CFS). These include:

• factors affecting access and care for persons with CFS;
• the science and definition of CFS; and
• broader public health, clinical, research and educational issues related to CFS.

Administrative and management support for CFSAC activities is provided by the Office of the Assistant Secretary for Health (OASH). However, staffing will continue to be provided primarily from the Office on Women’s Health, which is part of OASH.

Dr. Nancy C. Lee, Deputy Assistant Secretary for Health – Women’s Health, is the Designated Federal Officer for CFSAC.

Chronic Fatigue Syndrome Advisory Committee (CFSAC) Spring Meeting

http://www.hhs.gov/advcomcfs/advcomcfs-cfsacmeeting.html

The Chronic Fatigue Syndrome Advisory Committee (CFSAC), 2012 spring meeting will be held on Wednesday, June 13, 2012 from 9:00 a.m. until 5:00 p.m. EST and Thursday, June 14, 2012 from 9:00 a.m. until 5:00 p.m. EST.

The meeting will be held at the U.S. Department of Health and Human Services, Hubert Humphrey Building, 200 Independence Avenue, S.W., Room 800, Washington, D.C. 20201. For directions please visit
http://www.hhs.gov/about/hhhmap.html .

The meeting will be webcast live and available by audio (listening-only). Additional information and the CFSAC agenda will be posted to the CFSAC website by June 4, 2012.

Update: May 24, 2012

Above notice now reads:

The meeting will provide a live video stream and be available by audio (listening only). Additional information and the CFSAC agenda will be posted to the CFSAC website by June 4, 2012. Instructions for public testimony will be provided at a later date in a Federal Register Notice. We are not accepting requests or testimony at this time.

 

Related material

Most recent CFSAC postings:

CFSAC November 8-9, 2011 meeting: Minutes and Recommendations to HHS posted (January 14, 2012)

CFSAC November 2011 meeting: videos, presentations and Day One Agenda item (December 27, 2011)

International Classification of Diseases – Clinical Modification (ICD-CM): Presentation by Donna Pickett, RHIA, MPH, National Center for Health Statistics (NCHS)

Reminder: Comment period on ICD-10-CM proposed delay ends May 17

Reminder: Comment period on ICD-10-CM proposed delay ends May 17

Post #159 Shortlink: http://wp.me/pKrrB-23H

On April 9, the US Department of Health and Human Services issued a proposed rule calling for a one year delay in the ICD-10-CM/PCS compliance deadline.

The proposed rule would postpone the compliance date by which providers and industry have to adopt ICD-10-CM by one year, from October 1, 2013 to October 1, 2014. 

The proposed rule was published in the Federal Register on April 17, followed by a 30 day period during which CMS will take comments.

Comments should be submitted to HHS no later than 5:00 pm ET on May 17, 2012.

 

Proposed Rule

The Proposed Rule documentation can be found on this page in PDF and HTML formats:

http://www.regulations.gov/#!documentDetail;D=CMS-2012-0043-0001

Administrative Simplification: Adoption of a Standard for a Unique Health Plan Identifier; Addition to the National Provider Identifier Requirements; and a Change to the Compliance Date for ICD-10-CM and ICD-10-PCS Medical Data Code Sets

Document ID: CMS-2012-0043-0001 Document Type: Proposed Rule
Docket ID: CMS-2012-0043 RIN:

More information on the proposed rule is available from this CMS fact sheet

HHS PROPOSES ONE-YEAR DELAY OF ICD-10 COMPLIANCE DATE (CMS-0040-P)

Submitting comment

Submitting comment by post:

Centers for Medicare & Medicaid Services
Department of Health and Human Services
Attention: CMS–0040–P
P.O. Box 8013
Baltimore, MD 21244–8013

Submitting comment online:

Go to the Federal Regulations website, here:

http://www.regulations.gov/#!documentDetail;D=CMS-2012-0043-0001

Hit the Submit a Comment button, top right of web page

http://www.regulations.gov/#!submitComment;D=CMS-2012-0043-0001

For delivery by hand see the Alternate Ways to Comment pop up, top right of Submit a Comment page.

Related material

Press release: April 9, 2012

Summary Proposal Rule

This proposed rule would implement section 1104 of the Patient Protection and Affordable Care Act (hereinafter referred to as the Affordable Care Act) by establishing new requirements for administrative transactions that would improve the utility of the existing Health Insurance Portability and Accountability Act of 1996 (HIPAA) transactions and reduce administrative burden and costs. It proposes the adoption of the standard for a national unique health plan identifier (HPID) and requirements or provisions for the implementation of the HPID. This rule also proposes the adoption of a data element that will serve as an other entity identifier (OEID), an identifier for entities that are not health plans, health care providers, or “individuals,” that need to be identified in standard transactions. This proposed rule would also specify the circumstances under which an organization covered health care provider must require certain noncovered individual health care providers who are prescribers to obtain and disclose an NPI. Finally, this rule proposes to change the compliance date for the International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM) for diagnosis coding, including the Official ICD-10-CM Guidelines for Coding and Reporting, and the International Classification of Diseases, 10th Revision, Procedure Coding System (ICD-10-PCS) for inpatient hospital procedure coding, including the Official ICD-10-PCS Guidelines for Coding and Reporting, from October 1, 2013 to October 1, 2014. 

HHS proposes one year delay for ICD-10-CM compliance

HHS proposes one year delay for ICD-10-CM compliance

Post #156 Shortlink: http://wp.me/pKrrB-22q

Yesterday, April 9, the US Department of Health and Human Services issued a proposed rule calling for a one year delay in the ICD-10-CM/PCS compliance deadline.

According to a Centers for Medicare and Medicaid Services (CMS) press release, the proposed rule would postpone the compliance date by which providers and industry have to adopt ICD-10-CM by one year, from October 1, 2013 to October 1, 2014. 

Official publication of the proposed rule is expected to be published in the Federal Register on April 17, followed by a 30 day period during which CMS will take comments.

Full proposal document (pre-publication PDF version)

      http://www.ofr.gov/OFRUpload/OFRData/2012-08718_PI.pdf

or at:

https://s3.amazonaws.com/public-inspection.federalregister.gov/2012-08718.pdf

This document is scheduled to be published in the
Federal Register on 04/17/2012 and available online at
http://federalregister.gov/a/2012-08718 , and on FDsys.gov

Press release issued April 9, 2012:

http://www.hhs.gov/news/press/2012pres/04/20120409a.html

Details for: NEW HEALTH CARE LAW PROVISIONS CUT RED TAPE, SAVE UP TO $4.6 BILLION

For Immediate Release: Monday, April 09, 2012
Contact: CMS Office of Public Affairs
202-690-6145

NEW HEALTH CARE LAW PROVISIONS CUT RED TAPE, SAVE UP TO $4.6 BILLION

Department of Health and Human Services (HHS) Secretary Kathleen Sebelius today announced a proposed rule that would establish a unique health plan identifier under the Health Insurance Portability and Accountability Act of 1996 (HIPAA). The proposed rule would implement several administrative simplification provisions of the Affordable Care Act.

The proposed changes would save health care providers and health plans up to $4.6 billion over the next ten years, according to estimates released by the HHS today. The estimates were included in a proposed rule that cuts red tape and simplifies administrative processes for doctors, hospitals and health insurance plans.

“The new health care law is cutting red tape, making our health care system more efficient and saving money,” Secretary Sebelius said. “These important simplifications will mean doctors can spend less time filling out forms and more time seeing patients.”

Currently, when health plans and entities like third party administrators bill providers, they are identified using a wide range of different identifiers that do not have a standard length or format. As a result, health care providers run into a number of time-consuming problems, such as misrouting of transactions, rejection of transactions due to insurance identification errors, and difficulty determining patient eligibility.

The rule simplifies the administrative process for providers by proposing that health plans have a unique identifier of a standard length and format to facilitate routine use in computer systems. This will allow provider offices to automate and simplify their processes, particularly when processing bills and other transactions.

The proposed rule also delays required compliance by one year– from Oct. 1, 2013, to Oct. 1, 2014– for new codes used to classify diseases and health problems. These codes, known as the International Classification of Diseases, 10th Edition diagnosis and procedure codes, or ICD-10, will include new procedures and diagnoses and improve the quality of information available for quality improvement and payment purposes.

Many provider groups have expressed serious concerns about their ability to meet the Oct. 1, 2013, compliance date. The proposed change in the compliance date for ICD-10 would give providers and other covered entities more time to prepare and fully test their systems to ensure a smooth and coordinated transition to these new code sets.

The proposed rule announced today is the third in a series of administrative simplification rules in the new health care law. HHS released the first in July of 2011 and the second in January of 2012, and plans to announce more in the coming months.

More information on the proposed rule is available on fact sheets at

http://www.cms.gov/apps/media/fact_sheets.asp

The proposed rule may be viewed at www.ofr.gov/inspection.aspx . Comments are due 30 days after publication in the Federal Register.

Media coverage:

MedPage Today

HHS Announces ICD-10 Delay

Joyce Frieden, News Editor, MedPage Today | April 09, 2012

 

ICD10 Watch

Breaking News: HHS proposes 1-year delay in ICD-10 implementation deadline

Carl Natale | April 09, 2012

 

Healthcare Finance News

HHS proposes one-year ICD-10 delay

Tom Sullivan, Government Health IT | April 10, 2012

Follow

Get every new post delivered to your Inbox.

Join 136 other followers

%d bloggers like this: