December 2002 News Archives:
December
30, 2002 Security Rule Delayed for Fine-Tuning The Federal
Register of Friday, December 27, made no mention of the final security
rule nor the transactions modifications which were due to be published
on that date. As of the 28th, the security rule had not been submitted
to the Office of Management and Budget, the White House panel that
reviews federal regulations for budgetary impact. OMB review generally
takes a minimum of two weeks, longer on massive rulemakings like
the security piece of HIPAA.
Modern Physician reports that the final security rule could be
delayed more than a couple of weeks in part because of the holidays
and also because HHS has called in additional staff to fine-tune
the language, according to Robert Tennant, Washington representative
for the Englewood, Colo.-based Medical Group Management Association.
"I would be absolutely shocked to see (the rule) in January,"
Tennant says.
Read
more.
December
27, 2002 OCR to Automate Privacy Complaint Submittals Comments
are being requested on a proposed project of the Office for Civil
Rights (OCR) to automate its forms for discrimination and medical
privacy complaints. Effective April 14, 2003, OCR has jurisdiction
over certain health plans, health clearinghouses and healthcare
providers with respect to enforcement of the standards for privacy
of individually identifiable health information rule issued pursuant
to HIPAA. OCR wants to develop an automated complaint submittal
process for individuals to file written complaints with OCR when
they believe that on or after April 14, 2003, their right to the
privacy of protected health information has been violated. OCR estimates
that there will be approximately 21,710 complaints concerning medical
privacy (16,283 burden hours annually).
Send comments, which should be received within 60 days of this
notice, via email to Geerie.Jones@HHS.gov
or mail to:
OS Reports Clearance Office,
Room 503H, Humphrey Building,
200 Independence Avenue SW
Washington, DC 20201
December
27, 2002 New Workgroup to Assess Impact of Information Security
Requirements on Healthcare Under the auspices of URAC (also
known as the American Accreditation HealthCare Commission) and the
National Institute of Standards and Technology (NIST), the Security
Healthcare Certification and Accreditation Workgroup will bring
together members of the public and private sectors to develop a
uniform approach to the identification and implementation of best
practices in healthcare information security. The Workgroup intends
to serve as a resource for the healthcare community by developing
white papers, drafting crosswalks, and participating in educational
programs. Ultimately, the Workgroup hopes to promulgate a common
set of healthcare security standards that will cover security policies,
procedures, controls, and auditing practices.
The Workgroup will have its next meeting on January 10, 2003 at
NIST in Gaithersburg, MD, where the Workgroup will facilitate a
healthcare sector review of the recently released draft NIST Special
Publication 800-37, Guidelines for the Security Certification and
Accreditation of Federal Information Technology Systems.
Read more.
December
26, 2002 NCQA Releases Privacy Certification for BAs Draft
Standards The National Committee for Quality Assurance (NCQA)
released on December 16 draft standards for its new Privacy Certification
for Business Associates (PCBA) program. The program will certify
that business associates have processes in place for handling protected
health information (PHI) that are in compliance with HIPAA. Proposed
program requirements relate to: privacy protections for oral, written,
and electronic PHI; processes and practices for the storage, use,
and disclosure of PHI; employee training in PHI protections; consumer
access to PHI; and contracting between covered entities and their
business associates.
Read
more.
December
26, 2002 X12N Draft Guides Review Period Extended According
to the WEDI SNIP X12N Insurance Subcommittee, most of the draft
X12N implementation guides currently available for public review
were posted without meeting one of the process requirements. As
a result, these implementation guides will not be brought forward
for a publication vote at the February 2003 X12 trimester meeting
in Denver, as previously expected. Instead, X12N will finalize the
necessary changes at the February meeting, then by April 2003, revised
drafts will be made available for another public review period.
It is expected that the impacted guides will then be moved forward
for a publication vote at the June 2003 X12 trimester meeting.
The affected implementation guides, some of which are missing
Appendix D, commonly referred to as the Change Log, are:
- 834, Benefit Enrollment and Maintenance (004050X125)
- 820, Payroll Deducted and Other Group Premium Payment for Insurance
Products (004050X137)
- 270/271, Health Care Eligibility/Benefit Inquiry and Information
Response (004050X138)
- 276/277, Health Care Claim Status Request and Response (004050X139)
- 278/278, Health Care Services Request for Review and Response
(004050X140)
- 837, Health Care Claim: Institutional (004050X141)
- 837, Health Care Claim: Dental (004050X142)
- 837, Health Care Claim: Professional (004050X143)
- 277, Health Care Claim Acknowledgment (004040X167)
The current online conferences for these guides will be kept open
and comments received during this period may be considered in the
development of the next draft. The deadline for comments has been
extended by one week for all implementation guides to January 8,
2003 except for the X167 Health Care Claim Acknowledgement.
The end date for the X167 guide public review will remain January
13, 2003.
Review
the Draft X12N Implementation Guides.
December
19, 2002 HHS Readying More HIPAA Rules HHS officials,
Jared Adair, director of the newly formed Office of HIPAA Standards,
and Karen Trudel, deputy director, told Health Data Management in
a recent interview that HHS expects to publish the proposed claims
attachment rule by mid-2003. The department expects in early spring
2003 to publish the final provider and proposed payer identifier
rules.
Anticipated rules publication schedules cited by Adair and Trudel
are slightly less ambitious than the semiannual regulatory agenda
recently published in the Federal Register. According to the agenda,
the provider and payer identifier rules are set for publication
in February, with the claims attachments rule following in March.
There was no mention of the final security rule or the transactions
modifications due out on Dec. 27. HHS has started work on a proposed
HIPAA enforcement rule and could publish it during 2003, although
no timetable is set.
Read
more.
December
18, 2002 NCVHS Urges HHS to Help Industry with HIPAA Implementation
The National Committee on Vital and Health Statistics (NCVHS) sent
a letter Nov. 25 to HHS, asking for more education, outreach, and
technical assistance to the health care industry regarding HIPAA
administrative simplification. As part of its responsibilities under
HIPAA, NCVHS monitors the implementation of the HIPAA Administrative
Simplification provisions. NCVHS' Subcommittee on Privacy and Confidentiality
held several hearings this Fall to learn about the implementation
activities of covered entities.
Despite finding widespread support for the goals of HIPAA and the
Privacy Rule, the committee found "there is an extremely high
level of confusion, misunderstanding, frustration, anxiety, fear,
and anger as the April 14, 2003 compliance date nears."
NCVHS makes the following recommendations:
- OCR and CMS need to improve coordination on education, outreach,
and technical assistance.
- OCR should establish covered entity teams to assist the various
industries and professions with their unique compliance issues.
- OCR should enhance its web site and improve its FAQ response
process, posting answers to questions within 30 days.
- OCR should assist in the coordination and publication of state
preemption analyses, and should publish an analysis of other federal
laws that may overlap with the Privacy Rule (e.g., Gramm-Leach-Bliley,
FERPA).
- OCR should sponsor train-the-trainer programs for the private
sector.
- OCR should prepare a simple, one-page handout explaining the
basics of the Privacy Rule for providers to distribute to their
patients.
- OCR should communicate clearly and specifically with providers
and other covered entities about its enforcement plan and penalty
assessments.
- OCR should draft and make widely available guidance such as
model forms and templates, including state-specific, industry-specific,
and profession-specific forms, as well as standardized gap assessment
guides, simple checklists, a HIPAA practice management handbook,
and time-lines to assist covered entities.
- Congress and the state Medicaid agencies should make adjustments
to Medicaid reimbursement rates to recognize the costs of complying
with HIPAA.
- Congress should fund the $42.5 million for technical assistance
authorized under the Administrative Simplification Compliance
Act (ASCA), and that some of that funding should be allocated
to Privacy Rule implementation and NCVHS' recommendations.
- Congress should fund HIPAA compliance grants for the states.
- Congress should provide tax incentives or other mechanisms for
HIPAA compliance for providers lacking the resources to comply.
December
17, 2002 Agenda Confirms Security Rule Publication Date
The semiannual regulatory agenda describing regulatory actions federal
agencies are developing appeared in the Federal Register last week.
The agenda published Dec. 9 confirms HHS' affirmation that the security
rule remains on schedule for publication this month, giving the
projected date for the Security Standards Final Rule as 12/00/02.
Other items on the agenda:
- Modifications to Standards for Electronic Transactions (on
two related proposed rules), Final Action 12/02
- Standard Unique Health Care Provider Identifier, Final Action
02/03
- National Standard for Identifiers of Health Plans, Proposed
Rule 02/03
- Claims Attachments Standards, Proposed Rule 03/03
December
13, 2002 Despite Rumors, HHS Maintains Security Rule Still
Coming Dec. 27 Despite recent rumors that the Final Security
Rule will not be published on December 27 as previously indicated,
Health Data Management reports that the final HIPAA data security
rule remains on schedule for publication on that date. Health Data
Management quotes Karen Trudel, deputy director of the new Office
of HIPAA Standards in the Centers for Medicare and Medicaid Services
(CMS).
Reportedly, HHS officials wish to have further review of certain
aspects of the rule and it is still in the clearance process. HHS
and CMS have had to wade through several thousand comments on the
proposed rule, then ensure the final rule was compatible with the
two HIPAA final privacy rules.
A final rule making modifications to the transactions and code
sets rule also is scheduled for a Dec. 27 publication in the Federal
Register. The final rule will combine two previously proposed rules
making modifications, Trudel says.
Read
more.
December
13, 2002 New Healthcare Industry Preemption Analysis Resource
for States & Territories The Confidentiality Coalition,
a 130-member organization representing the health care industry
and a part of the Healthcare Leadership Council, announced their
sponsorship of a state preemption analysis resource for HIPAA privacy
rules. The group recognized the need for an industrywide analysis
for covered entities, business associates and other impacted by
the rules and all 54 states and jurisdictions. The analysis will
cover:
- Providers, including institutional and professional;
- Hospitals, clinical labs, long term care and SNFs, clinics,
pharmacy, medical groups, physicians, pharmacists, nurses, lab
technicians, podiatrists, certified nurse midwives, doctors of
osteopathy, nurse practitioners, speech therapists, physical therapists,
occupational therapists, physician assistants;
- Health plans;
- Third party administrators and utilization review organizations;
- Business associates and other downstream users: PBMs, device
manufacturers, eHealth entities, underwriters;
- Researchers; and
- Hospitals, medical colleges, teaching hospitals, pharmaceutical
and biotech, medical technology companies.
The analysis is expected to be made available online as soon as
February 2003. The tool will allow users to select the states and
types of entities covered under the analysis and to subscribe just
to the information pertinent to their organization. Updates will
be provided annually.
Read
more (PDF).
December
9, 2002 CMS Filed Its ASCA Extension; As Enforcer, Now Offers
Online HIPAA Complaint Form The Centers for Medicare and Medicaid
Services (CMS), charged with enforcing the HIPAA electronic transactions
and code set standards, has posted on its site an Online Complaint
Submission Form. The form allows complaints to be submitted about
covered entities' non-compliance with the HIPAA transaction standards.
Complaints can also be submitted on a paper-based form available
by download from the site. CMS' form is not to be used to file complaints
regarding the privacy of health information, as HHS' Office for
Civil Rights (OCR) will enforce the HIPAA privacy standards.
Modern Physician reports CMS officials say the more than 1 million
covered entities that missed the October 15 deadline to apply for
the ASCA extension will not be actively pursued, but that enforcement
will be "complaint driven." In the event a complaint is
filed against a covered entity, that entity will either have to
demonstrate compliance or be prepared to submit a corrective action
plan. Fines for noncompliance can be as high as $100 per offense,
with a maximum of $25,000 per year.
One of the over 500,000 groups that applied for a one-year extension
was CMS, according to Modern Physician. CMS applied for an extension
back in August to give them "the time to space out the implementation"
because of the "enormous complexity" of ensuring compliance
for both CMS and its numerous private subcontractors overseeing
Medicare payments in each state.
View
CMS' Complaint Submission Form.
Read
Modern Physician's article, "CMS: HIPAA scofflaws will not
be hunted."
Read
Modern Physician's article, "Even CMS applied for a HIPAA extension."
December
5, 2002 OCR Releases Guidance on Final Modified Privacy Rule
Yesterday, the Department of Health & Human Services' (HHS) Office
of Civil Rights (OCR) released guidance on the final modified Privacy
Rule that explains key elements of HIPAA Privacy Rule requirements.
HHS published the Privacy Rule on December 28, 2000, and adopted
modifications of the Rule on August 14, 2002. The guidance is meant
to communicate as clearly as possible the privacy policies contained
in the Privacy Rule.
For a particular segment in the Privacy Rule, the guidance will
provide a brief explanation of the segment and how the Rule works,
followed by Frequently Asked Questions (FAQ) about that
provision. The guidance does not address all of the relevant provisions
in the Rule, although OCR anticipates adding segments in the future
as it develops guidance on more Privacy Rule standards. OCR will
also be adding to the FAQs on an ongoing basis as new questions
arise.
The Privacy Rule Standards addressed are:
- Incidental Uses and Disclosures
- Minimum Necessary
- Personal Representatives
- Business Associates
- Uses and Disclosures for Treatment, Payment, and Health Care
Operations
- Marketing
- Public Health
- Research
- Workers Compensation Laws
- Notice
- Government Access
- Miscellaneous FAQs
Read the
entire Guidance document (382K PDF).
December
5, 2002 JCAHO Releases Its Business Associate Agreement
The Joint Commission on Accreditation of Healthcare Organizations
(JCAHO) has released its business associate (BA) agreement for accredited
organizations to use in order to release protected health information
to the JCAHO during the survey process. Under the regulation accreditors
are considered "business associates" of covered entities
and are required to have BA agreements to ensure that the business
associate will safeguard patients' personal health information (PHI).
Read
more.
December
2, 2002 Revised Summaries of More State Health Privacy Laws
Released Last week, the Health Privacy Project released the
final batch of revised summaries of the health privacy statutes
of the remaining six states: Maine, North Carolina, Ohio, Tennessee,
West Virginia and Wisconsin. These updated summaries reflect changes
in state health privacy statutes that have been made since the original
report, "The State of Health Privacy: An Uneven Terrain,"
was published in 1999. The 1999 version of the report will be available
until the full 2002 updated edition is available, which will be
posted on the Health Privacy
Project's web site later this month.
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