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TO:
Hillary Rodham Clinton
FROM:
Jennifer Klein
DATE:
7/7/95
RE:
Remarks for the Reinventing Health Care Regulation Event
If you have a chance to take a look, here is a draft of your remarks for Tuesday's
regulatory review event. Your remarks lay out the problem and put the regulatory reform
efforts in the larger context of the current debate about Medicare and Medicaid. Steve
Gleason will talk about the impact of these changes (especially the elimination of the
physician attestation form) on health care providers. (Apparently, the staff at Mercy Hospital
actually cheered when they found out they will no longer have to fill out the form!) The
Vice President will talk about how this fits in with his Reinventing Government Initiative.
I have included some fairly political comments on page 2. Melanne agreed with this
approach, but I wanted to be sure you feel comfortable with it.
P.S. Thanks for meeting my parents! They (not surprisingly) thought you're wonderful.
FIRST LADY HILLARY RODHAM CLINTON
REINVENTING HEALTH CARE REGULATION EVENT
THE WHITE HOUSE
JULY 11, 1995
[Acknowledgments: Vice President Gore, Secretary Shalala (who
could not be here today), HCFA Administrator Bruce Vladeck, Dr.
Steve Gleason and the National Health Policy Council.]
Thank you all for joining us today. And thank you again for
all of the work you did last year on health care reform and
continue to do.
Last year, you taught all Americans that while we have the
highest quality health care system in the world, that system is
too complicated. And that while we boast some of the most
talented and dedicated health professionals and advanced research
institutions, those professionals and institutions are
overburdened by paperwork, red tape and needless regulation.
As part of our reform efforts last year, we looked for ways
to streamline regulations and simplify the health care system.
At the same time, Vice President Gore's Reinventing Government
Initiative began eliminating unnecessary regulatory burdens in
all areas of government. Today's meeting represents the perfect
marriage of those two efforts. One step in an ongoing effort to
free doctors, hospitals and other health care providers to do
what they were trained to do. One step to maintain and enhance
quality in our health care system -- not by micromanaging but by
measuring results.
Hospitals today hire four new administrators for every new
doctor -- four to one -- simply to handle the avalanche of
insurance forms and paperwork. Doctors' offices spend 80 hours a
month on administration That's time not spent with a child who
needs a check-up; time not spent diagnosing a patient with
bronchitis. I will never forget talking to a nurse last year who
summed it up for me. She said she had gone into nursing to care
for people. If she had wanted to be an accountant she would have
studied accounting and worked for an accounting firm. Instead,
after training to be a nurse, she spent nearly 50 percent of her
time filling out forms.
Even worse, many of you have made, or watched the
institutions where you work make, difficult choices to hire more
bookkeepers and clerical people while laying off nurses and
medical technicians. That is an unacceptable choice that no
physician, hospital or nursing home should have to face.
We can make a significant start on simplifying the health
care system by improving how the Federal health programs do
business. In recent months the health care debate has centered
around the need to reform Medicare and Medicaid and to get
spending under control. Everyone agrees that Medicare and
Medicaid can be improved. And everyone agrees that Federal
health spending is growing too fast. Over the next five years
alone, almost 40 percent of the growth in Federal spending will
come from the rise in Federal health care costs. They are
growing faster than GDP. Faster than overall inflation. Faster
than almost all other items of government spending.
But, as the President has been saying, there is a right way
and a wrong to slow the growth in Medicare and Medicaid spending
and to address the problems in these programs. The Republican
proposal to take deep Medicare cuts to pay for tax breaks for the
wealthiest Americans is the wrong way. Their Medicaid block
grant proposal -- under which children and elderly and disabled
Americans would lose coverage -- is the wrong way.
Instead, we need to remember that Medicare and Medicaid have
lifted millions of Americans out of poverty and have helped
millions more manage to pay for desperately needed health care
services. The right way is to improve and strengthen these
programs and make them more efficient. That's why the President
proposed a budget that reaches balance in ten years but that has
half of the Medicare and one-third of the Medicaid savings in the
Republican plan. That's why the President's budget takes only
the Part A cuts needed to strengthen the Medicare Trust Fund
rather than playing on fears about the insolvency of the Fund to
slash Medicare spending to pay for other priorities. And that's
why the President's budget takes the first steps toward health
care reform.
But even as this debate continues, there are changes that we
can make in Federal health care programs right now. Changes that
will improve these programs -- and improve your ability to work
with these programs -- bit by bit, piece by piece. We can
simplify the system and regulate the right way, without
compromising quality.
In the past two and a half years we've made progress.
[Insert examples.] The reforms that the Vice President will
outline today are part of an ongoing process. I hope that we can
build off of the work we've done so far and leave here with the
promise and the challenge of continuing a working relationship
that involves the White House, HHS in Washington, its regional
offices, those of you working in communities across the country,
and those of you who represent health care professionals
nationwide. With your help, we can continue to identify
unnecessary and burdensome regulations and work together to
simplify and improve our health care system.
[Introduce Steve Gleason.]
###
JUL-07-1995
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"I am determined to see reform of our regulatory
system, so that it costs less, meddles less, and puts
more responsibility in the hands of the people
themselves."
President Bill Clinton -- February 21. 1995
"We can improve the relationship between regulators
and the people they regulate to achieve our national
goal of a robust economy that also protects public
health and safety.
Vice President Al Gore -- February 21,1995
OVERVIEW
Introduction
The Clinton Administration has made reforming the Federal government's regulatory process a
top priority. Consistent with this commitment, President Clinton and Vice President Gore asked
Health and Human Services Secretary Donna Shalala to assist in meeting this priority by carefully
examining the regulatory requirements of the Health Care Financing Administration (HCFA).
As part of the Vice President's reinventing government initiative, HCFA has reviewed its
regulations to determine which requirements could be reduced or eliminated without
compromising Medicare and Medicaid beneficiaries' access to quality health care. This report
contains recommendations resulting from the review of HCFA's regulations.
Agency Overview
The Health Care Financing Administration (HCFA) has a major responsibility for health care
financing and quality oversight of health care providers. HCFA operates the Medicare program,
serving nearly 37 million beneficiaries, and in partnership with State governments, the Medicaid
program, which serves another 36 million beneficiaries.
HCFA ensures that program beneficiaries are aware of the services for which they are eligible and
that those services are accessible, meet acceptable standards of quality, and are delivered in an
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In March, 1994, HCFA published a regulation that replaced the requirement for physicians to
provide hospitals annually with a signed acknowledgment concerning penalties for
misrepresenting certain information with a one-time signing requirement at the time a
physician is initially granted hospital admitting privileges. Almost 24,000 hours of physician
time will be saved. One major medical association characterized this change as one that will
alleviate the "hassle factor" for physicians and an rimportant step toward restoring mutual trust
between the Federal Government and the medical profession.
HCFA is totally redesigning its system to pay claims for Medicare services. The development
of the Medicare Transaction System (MTS) will increase control of program expenditures, and
improve services to beneficiaries and providers. Final contracts for the analysis, design,
development, testing, and implementation of the MTS were awarded January and March 1994.
Presently providers must cope with 9 different claims processing systems operated by 72
insurance companies at 57 sites. This integrated, national system will replace the diverse
existing systems and significantly simplify administrative operations for beneficiaries,
providers, and the Medicare program.
HCFA has re-invented the evaluation of Medicare contractors. The newly restructured
Medicare contractor performance evaluation establishes Medicare beneficiaries and medical
care providers as integral partners in the evaluation process. It allows for greater flexibility in
evaluating Medicare contractor operations and performance. The new evaluation began
October 1, 1994.
The nursing home monitoring and enforcement rule, effective July 1, 1995, strikes the critical
balance between strengthening quality standards in nursing homes to meet the health and
quality of life needs of residents, and providing flexibility to apply remedies that fit specific
problems at nursing facilities. Overall, the rule (1) links enforcement remedies to deficiencies;
Dreft
(2) motivates facilities to remain in compliance with Federal requirements that promote the
quality of care and quality of life in nursing homes; (3) promotes survey and enforcement
language
consistency; and, (4) avoids unnecessary burden on facilities through the use of an informal
dispute resolution process.
As has been the case throughout the development of this regulation, the Department of Health
and Human Services will consult extensively with interested parties in the implementation of
the enforcement regulation. An extensive monitoring system will provide data to evaluate the
implementation process and the impact of the regulatory change. The structure of the
enforcement process permits time to observe the regulations in action before major penalties
are assessed. Adjustments to the process, policies, and procedures will be made if data
indicates that they are needed.
Obtaining Medicaid home and community-based services waivers was simplified in a rule
published July 25, 1994. The final rule enables States to offer a wide variety of home and
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efficient manner. HCFA also ensures that health care providers of services meet approved
standards, and that program funds are used efficiently.
Regulatory Reform Principles
Regulatory reform can only be accomplished by keeping in touch with the needs of customers.
For HCFA, this means knowing what beneficiaries want and need and knowing how we can work
with our partners to fulfill and even exceed the expectations of our customers, our beneficiaries.
To help with the regulatory review process, HCFA relied on three basic principles that help define
the Agency's new and improved customer service mission.
Communicate not dictate -- The number one tenet of this principle is to communicate --
through listening and consulting, thereby increasing our understanding of what our customers
need, what they like and dislike about our programs, and how we can serve them better overall.
This principle says that HCFA will consult with our partners and beneficiaries about how our
programs and policies should improve, instead of dictating such changes to them as has been
done too often in the past. When changes are a result of legislative initiatives, HCFA will
consult with partners and stakeholders on the full range of implementation issues that need to
be addressed.
Educate rather than inundate -- Top rate customer service also means making sure that
customers understand our programs and policies. Providing reams and reams of information is
not enough -- and probably not effective. The "new" HCFA is committed to educating instead
of inundating. This principle ensures that HCFA will educate our customers by developing
effective educational techniques and disseminating information about how our programs
operate rather than inundating them with information that is difficult to understand and doesn't
speak to their needs.
Innovate more than regulate -- HCFA's new and improved mission of customer service is
driven by innovation more than regulation. This means that HCFA will rely upon innovation
in program operations and administration more than regulation to foster improved customer
service capabilities. For example, by streamlining Medicare claims processing and
information exchange, the Medicare Transaction System will make electronic interaction with
Medicare easier for providers and beneficiaries and will enable Medicare contractors to devote
more time to customer service activities.
Accomplishments
During the Clinton Administration, HCFA's regulatory improvements include:
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community-based services as cost-effective alternatives to more expensive institutional care.
Without this regulatory movement, joint State and Federal efforts to expand opportunities to
provide cost-effective alternatives to institutional care would have been frustrated. The
regulatory provisions were worked out in collaboration with the States (through the National
Governor's Association).
Regulatory Reform Initiatives
The following proposals are the major HCFA initiatives that have evolved from our commitment
to the regulatory reform process. In some cases, recommendations reflect actions based on
collaborative efforts, including public consultation with industry groups, beneficiary
organizations, and State associations and agencies. All of these projects were designed to cut
unnecessary red tape and burdensome regulations. Most importantly, they demonstrate HCFA's
customer-focus and responsiveness to the changing needs of all its customers and partners.
1. Physician Attestation: Eliminate the physician form required to certify the accuracy of all
diagnosis and procedures before submission for payment by Medicare.
2. Clinical Laboratory Improvement Amendments: Reduce burden and improve the CLIA
system by rewarding good performance by laboratories, creating incentives for manufacturers to
develop more reliable testing equipment, allowing private organizations that meet certain
standards to accredit laboratories, and using proficiency testing as an outcome measure to monitor
laboratory performance.
3. Outcome Performance Measures: Change current regulations that focus solely on
requirements for measuring processes, rather than outcomes of care. Changes involve:
Home Health Agency Conditions of Participation
Medicare Hospital Conditions of Participation
ESRD Facility Conditions of Coverage
Rules for ESRD Facilities - A Pilot for Good Performers
Elimination of Personnel Requirements for Excellent ESRD Facilities
4. The HCFA-1500 Form: Mandate participating Federal Employee Health Benefit Pian carriers
use the HCFA-1500 form for physicians' and other practitioners' claims. The HCFA-1500 is used
by physicians and others to submit claims for reimbursement of health care services under
Medicare.
5. Annual Preadmission Screening and Annual Resident Review: Eliminate the requirement
that mentally ill and mentally retarded nursing home residents are assessed annually. The
preadmission screening for these residents is retained.
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6. Nurse Aide Training and Competency Evaluations: Permit States to approve nurse aide
training and competency evaluation programs offered in nursing homes.
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HCFA INITIATIVES
1. Physician Attestation
Background: Since the Medicare hospital inpatient prospective payment system (PPS) was
implemented by HCFA in 1984, HCFA regulations have required physicians to sign an
"attestation form" for each Medicare patient discharged from a hospital. The form certifies the
accuracy of the diagnoses and procedures for each patient. This information is used to ensure that
the correct coding is on the claim, the correct diagnosis-related group (DRG) can be assigned, and
the proper Medicare payment can be made.
Feedback from physicians, hospitals, and intermediaries have told us that obtaining the physician's
signature is burdensome and results in billing delays that hurt hospital cash flow and hinders
service to the beneficiary. Peer Review Organization (PRO) review of attestations has resulted in
fewer that a 0.01% denial rate of sampled claims. In addition, the improvement in hospital record
keeping and coding sophistication make the hospitals the appropriate focus for combating fraud
and abuse.
Proposed Solution: Eliminate the form requirement and instead hold hospitals responsible for
the accuracy of their diagnoses and procedures. With improved technology and software coding
capabilities, hospitals are more equipped than ever to combat billing fraud and abuse, the form's
original purpose. This change, which can be implemented by regulation, will have the following
benefits:
Impact:
Reduces paperwork burden and "hassle" on physicians and hospitals.
Decreases administrative costs for hospitals.
11 million forms will be eliminated.
Almost 200,000 hours of physician time will be saved.
Hospitals will have improved cash flow and reduced labor costs by approximately $22,500 per
hospital per year.
Implementation and Timeline: HCFA will publish this final regulation September 1, 1995.
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2. Clinical Laboratory Improvement Amendments
Background: The Clinical Laboratories Improvement Amendments (CLIA) of 1988 established
baseline quality standards that ensure the accuracy, reliability, and timeliness of laboratory testing.
These requirements are based on the complexity of the test performed, rather than where the test is
performed. Compliance with the standards is determined through on-site inspection.
HCFA and the Centers for Disease Control and Prevention, which share responsibility for the
CLIA program, continually review ways to reduce the burden and improve the entire CLIA
system. A flexible survey system that employs data analysis to target good performers and allow
for self-attestation and off-site review has already been initiated for certain laboratories. HCFA
has reduced information requirements and eliminated unnecessary paperwork and has taken steps
to reduce personnel requirements. HCFA also revised and streamlined the inspection process.
Additional burden reductions are being undertaken that will virtually eliminate oversight for
certain laboratories, establish performance standards in place of process requirements, and use
information and education as a substitute for sanctions.
Proposed Solutions:
1. Waive the routine 2-year survey of users of "black box" technology, conducting surveys only
if there are indications of problems or complaints. ("Black box" technology refers to simple
and easy to use test systems that have demonstrated accuracy and precision through scientific
studies.) We will develop and implement criteria for accurate and precise "black box"
technology that will be followed to determine if the technology qualifies for waiver of the
routine 2-year survey. A small number of surveys will be conducted to validate the criteria for
determining "black box" technology and assure quality.
Impact:
-
Creates incentives for manufacturers to develop more reliable testing equipment by
stimulating demand for accurate and precise technological testing systems.
Reduces paperwork and costs for providers, especially for physician office laboratories, as
well as costs of program management.
Implementation and Timeline: Proposed rules will be published September 1995.
2. Clarify and expand the waiver criteria and streamline the waiver process so that CLIA
regulations can be waived for more tests. CLIA requirements will be waived for tests
approved for home by the FDA -- that is, tests that do not require trained personnel.
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Impact:
-
Decreases burden, especially for physician office laboratories because of less regulatory
oversight.
-
Increases access to greater variety of tests. Physician office laboratories may expand the
range of tests they perform without an increase in costs/burden.
-
Creates incentives for manufacturers to develop more test systems that meet the clarified
waiver criteria and criteria for approval for home use.
-
Eliminates inspection fees for many of the 60,000 physician office and other small
laboratories not now waived who decide to perform only tests from the expanded waiver
category.
-
Many additional laboratories will face lower inspection fees because, while they will
continue to perform non-waived tests, many more tests will fall into the expanded waiver
category.
Implementation and Timeline: Proposed regulations will be published in September 1995.
3. Use performance standards and require less frequent on-site inspections (surveys) of excellent
performers. Approve private accrediting organizations for deemed status when their
accreditation standards are as stringent as CLIA. Exempt laboratories from CLIA
requirements when the State where they are located has requirements equal to or more
stringent than CLIA's.
Impact:
- Reduces inspection burdens.
- Rewards good performers with fewer inspections. This is a positive incentive to improve
performance.
- Approving organizations for deemed status offers laboratories oversight by peers.
-
Approving States for CLIA exemption allows expanded role for States with strong
licensure programs.
Implementation and Timeline: To date, notices to approve four accrediting organizations
(College of American Pathologists, Joint Commission on Accreditation of Healthcare
Organizations, Commission on Office Laboratory Accreditation, and the American Society of
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Histocompatibility and Immunogenetics) and the State of Washington have been published.
Notices for two additional accrediting organizations and one additional State are pending.
Final rules to eliminate redundancies or unnecessary requirements for federal review and
approval will be published in March 1996.
4. Use proficiency testing (PT) "failures" for education and as an outcome indicator in laboratory
quality. (PT is testing samples of known values to assess the accuracy of a laboratory's
results.) Sanctions (for example, loss of Medicare payment or loss of approval to do testing)
are imposed only in cases of immediate jeopardy or when the laboratory has refused to correct
the problem or has had repeated failures on proficiency testing.
Impact:
-
Less intrusive than traditional regulation and oversight.
-
Allows use of proficiency testing as an outcome measure to monitor laboratory
performance, and provide laboratories with feedback on test quality and an incentive to
improve performance.
-
Minimizes the fear of sanctions in 60,000 non-waived laboratories.
Implementation and Timeline: A proposed rule will be published in
March 1996.
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3. Outcome Performance Measures
Background: Medicare, as a purchaser of health care, requires hospitals, home health agencies
(HHAs), and End-Stage Renal Disease (ESRD) facilities to meet health and safety requirements
to participate in the Medicare program. Historically, these requirements measure "process"
(procedural and administrative systems as proxies for quality health care) rather than "outcomes"
(evaluations of actual patient care) and the adequacy of quality management programs.
HCFA is committed to changing current regulations that focus solely on requirements for
measuring processes. The Agency realizes that not focusing on outcome measures results in
several inherent problems. First, regulatory requirements vary by type of facility and provider
even when the services provided in each facility are the same, creating inequities and inappropriate
incentives. Second, without outcome measures, there is very little information available for
consumers onlthe quality of care at a given facility. Third, by law, HHAs must be surveyed
yearly--even though historical data show that this frequency is excessive for many HHAs and does
not improve care.
HCFA is revising regulations for hospitals, home health agencies, and End-Stage Renal Disease
facilities, that would address these issues and eliminate unnecessary process requirements and
focus on the outcomes of care.
Proposed Solution: Eliminate unnecessary process requirements and instead develop outcome-
based performance standards; collect and analyze patient care data needed for continuous quality
improvement and performance evaluation; increase consistency of requirements across providers;
and ask the customer to provide input on what the outcome measures should be, and to evaluate
the services they received. We are seeking legislation to give us flexible survey cycles.
Impact:
Eliminating unnecessary process requirements for compliance will reduce compliance and
survey burdens and make it possible to focus on actual patient care.
Educating the consumer will produce a strong, non-regulatory force to improve quality of care.
Powerful data will be available to regulators and providers.
Produces savings because providers are free to achieve high quality outcomes in the most cost-
effective manner.
Outcome Performance Measures Initiatives
HCFA is currently involved in the following new initiatives that focus on the concept of
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"Outcomes Performance Measures" and the consensual approach to developing regulations.
Home Health Agency Conditions of Participation:
HCFA is developing revisions to the Medicare Home Health Agency (HHA) conditions of
participation. The purpose of the revision is to place greater emphasis on patient outcomes while
reducing the current emphasis on process requirements (e.g., elaborate professional qualifications
and other "paperwork" requirements) and enhancing an HHA's flexibility in meeting patient needs.
The Agency has actively involved home health beneficiaries, providers, physicians, professional
organizations (American Association of Retired Persons, National Association for Home Care,
American Federation of Home Health Agencies, American Medical Association, Visiting Nurses
Association of America, American Academy of Home Care Physicians), States (State Survey and
Medicaid Agencies), and intermediaries in order to receive input on developing revisions to the
conditions of participation. A work group of HCFA staff and representatives of Medicare
beneficiaries, home health providers, physicians, and State Survey Agencies will develop a
Standard Core Assessment Instrument for use in home health care. The use of this tool is central
to HCFA's efforts to place the emphasis of survey and enforcement on patient outcomes.
Implementation and Timeline: HCFA will publish a proposed rule in September 1996.
Hospital Conditions of Participation:
HCFA is revising the current hospital conditions of participation to center on the patient, support a
cross-functional approach to patient care, and focus on quality. In developing these revisions,
HCFA has worked closely with organizations representing hospitals, practitioners, patients, and
States and has already distributed informal pre-regulatory drafts to approximately 70 outside
groups for comment.
Implementation and Timeline: HCFA will publish a proposed rule in
January 1996.
End Stage Renal Disease (ESRD) Conditions of Coverage:
HCFA's ESRD Conditions of Coverage (COC) have not been comprehensively revised since their
original implementation in the late 1970's. The current COC are primarily focused on process-
oriented requirements, and do not provide adequate support for a modern survey system based on
an outcome-oriented approach. Under the current regulation, facilities have a substantial
paperwork burden. As a result, revised regulations must be issued to increase facility flexibility
and to bring the ESRD COC up to current standards of practice in the ESRD community. The
revised COC will address the outcome-oriented, patient-centered standards process where
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appropriate, reflect innovations in the dialysis and transplant community, and address new issues
such as adequacy of dialysis to ensure that the Medicare beneficiary is receiving the most
progressive quality of care possible. Thus, HCFA's emphasis will be on the total patient
experience with dialysis, including patient functional well-being and continuous quality
improvement (CQI). The revised regulations will include development of performance
expectations for the facility that result in quality, comprehensive care for the dialysis patient.
Implementation and Timeline: HCFA will publish a proposed rule in
March 1996.
Rules for ESRD Facilities - A Pilot for Good Performers:
HCFA is conducting a pilot project to apply a different, less prescriptive set of rules to excellent
ESRD facilities. Under the pilot project, an ESRD facility's performance will be measured using
only three key patient care outcome indicators. First, these indicators will be used in place of the
current certification standards, which are largely structure and process requirements. Second, the
pilot project will focus on helping facility staff's use outcome measures in an ongoing way to
improve the care provided to dialysis patients. Third, facilities that document sustained
achievement in the outcome indicators over six consecutive months will be awarded a HCFA
certificate of excellence.
The indicators measure the quality of hemodialysis in three areas critical to the health of the
patient: adequate dialysis, control of anemia, and adequate water supply. They will be used by the
facilities to monitor the condition of each dialysis patient and to achieve improvement in the
patient's health status. For the pilot project, excellence will be identified through a process
focused on the quality indicators. The process will look at whether facilities have an internal
quality monitoring and monitoring system, whether the results of such monitoring are
documented, and whether results are sustained. The facilities that qualify in this pilot will have
established certain internal quality control mechanisms in order to participate. Routine surveys of
these facilities will be waived. Surveys will be conducted in response to complaints about the
quality of care or if the data indicate a potential serious problem.
Information about project results will be packaged in brochures and newsletters so that ESRD
patients and non-participating ESRD facilities will be aware of the results. In this competitive
industry, a successful project will stimulate many other providers to seek recognition as
"EXCELLENT" facilities.
ESRD facilities will be notified of their eligibility to participate and participation will be
voluntary. The pilot will be limited to facilities in the States of Colorado, Idaho, Montana, and
Washington.
Implementation and Timeline: Planning for this pilot is underway. Regulations to permit this
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pilot will be published in November 1995.
Elimination of Personnel Requirements:
HCFA is conducting a pilot project that will evaluate the impact of the elimination of Medicare
personnel requirements for ESRD facilities. Currently, the Medicare conditions for coverage for
ESRD facilities include fairly detailed specifications for several types of personnel employed in
furnishing ESRD services to Medicare beneficiaries. For example, the medical director of the
facility must be a physician, board eligible in internal medicine; the nurse in charge must have 12
months of clinical experience, with 6 months experience with ESRD patients; the social worker
must be master level educated, etc. Over the years, HCFA has received comments from the
industry both in favor of elimination of the personnel requirements and in favor of strengthening
them. Those in favor of relaxing the requirements commonly cite the difficulty rural facilities can
face in recruitment of personnel with the requisite experience. They believe that the job does not
require the level of experience and education prescribed in order to perform adequately. Those in
favor of maintaining personnel requirements cite the medical condition of ESRD patients as
justification for the skills level requirements. They express concern that if the personnel
requirements are weakened or eliminated that ESRD facilities, most of which are proprietary
entities, would hire less experienced and more inexpensive personnel to provide care that is of
inferior quality.
The pilot project would be conducted in concert with another proposed project establishing new
rules for historically good ESRD performers (see above) being conducted by HCFA's Seattle
Regional Office. HCFA will collect information regarding the skills level of all personnel
employed by those facilities participating in the project. Facilities would be informed that as part
of the project, Medicare would not apply any of the personnel requirements contained in the
conditions for coverage. At the end of the two-year project period, HCFA will recollect
information regarding the education and experience level of all the facility's staff and evaluate the
impact of the changes on predetermined measures of quality of care.
Implementation and Time line: Planning for this pilot is underway. Regulations to permit this
pilot will be published in November 1995.
Reinventing Health Care Regulations DRAFT July 7, 1995 (5:21pm)
13
JUL-07-1995 18:18 FROM ADMINISTRATOR'S OFFICE
TO
94561715 P.15
The HCFA-1500 Form
Background: The HCFA-1500 form is currently used by physicians, other practitioners, and
DME suppliers to submit claims for Medicare reimbursement of health care services. HCFA-1500
is also used by many other insurers for claims submission. Although many Federal programs
require the use of the HCFA-1500, use of the form is not required by the Federal Health Benefit
plan (FEHBP) In addition, instructions for the form vary across programs.
Proposed Solution: The Office of Personnel Management (OPM) will require participating
FEHBP carriers to use the HCFA-1500 form for physicians' and other practitioners' claims.
Impact: Physicians will be able to use one form to submit claims for services provided to many
patients.
Implementation and Time frame: OPM will phase in the use of the HCFA-1500 over four years,
beginning January 1996.
14
DRAFT July 7, 1995 (5:21pm)
Reinventing Health Care Regulations
JUL-07-1995 18:18 FROM ADMINISTRATOR'S OFFICE
TO
94561715 P.16
5
S. Preadmission Screening and Annual Resident Review (PASARR) of Mentally III and
Mentally Retarded Residents
Background: Nursing homes under Medicare and Medicaid are currently required by law to
conduct an initial assessment of each resident within 14 days of admission, with a reassessment
whenever a significant change in condition occurs but in any event at least once a year. In
addition, there is a statutory requirement that for persons with serious mental illness or mental
retardation entering a nursing home the State is required to conduct: (1) a preadmission screening
to assure that the individual is being appropriately placed in a nursing home, and (2) an annual
reassessment to assure that the patient continues to be appropriately diagnosed and treated.
Proposed Solution: Legislation would be proposed to eliminate the duplicate annual assessment.
Resident assessments and reassessments required under the general nursing home requirements are
entirely adequate to assure that residents continuing needs are properly assessed and met.
Preadmission screening, which appropriately deters inappropriate admissions, would continue.
Impact: By eliminating the redundant annual PASARR reassessment, costly duplication of effort
by States would be reduced and nursing facilities would be relieved intrusive annual inspections.
Implementation and Timeline: Legislation will be proposed.
Reinventing Health Care Regulations DRAFT July 7, 1995 (5:21pm)
15
JUL-07-1995 18:19 FROM ADMINISTRATOR'S OFFICE
TO
94561715
P.17
6
Z.
Nurse Aide Training and Competency Evaluations
Background: To assure quality of care in nursing homes, current law prohibits nursing homes
from using nurse aides that have not successfully completed a training or competency evaluation
program. The statute requires the Secretary to establish requirements for the approval of nurse
aide training and competency programs. The law further forces States to prohibit, for a period of
two years, nurse aide training and competency evaluation programs operated by or in nursing
homes that were subject to an extended survey or partial extended survey or certain other
sanctions. (Extended or partial extended surveys are conducted as more intensive follow-up
investigations after a routine survey has demonstrated that a facility is furnishing substandard
care.)
When a facility's program has been disapproved, the facility may not even be the site of an aide
program conducted by others during the time that the two-year penalty is imposed. The
prohibition on approval of nurse aide training and competency evaluation programs causes a
special problem for rural nursing homes where a community college or other training facility may
be inaccessible to nurse aides. Rural facilities can face a serious shortage of trained and competent
staff due to the expense and inconvenience of sending prospective aides to remote locations.
Alternative training programs may not be available.
Proposed Solution: Specify that a State could choose to approve a nurse aide training and
competency evaluation program offered in (but not by) a nursing home subject to an extended or
partial extended survey or certain other sanctions if the State determines that there is no other
nurse aide training and competency evaluation program offered within a viable distance. States
would be required to provide ongoing oversight of these programs in the interest of patient health
and safety.
Impact: This proposal would safeguard the availability of nursing homes which might otherwise
stop participation in the Medicare and Medicaid programs as a result of losing a training programs'
approval. It would also make it easier for nurse aides to obtain the training they need to provide
quality services to our beneficiaries.
Implementation and Timeline: Legislation will be proposed.
16
DRAFT July 7, 1995 (5:21pm)
Reinventing Health Care Regulations
JUL-07-1995 18:19 FROM ADMINISTRATOR'S OFFICE
TO
94561715 P.18
Conclusion
Under President Clinton's leadership, HCFA has made communication, cooperation, and
partnership the guiding principles of the regulatory process, replacing the adversarial environment
that often existed in the past. At a time when the American health care system is undergoing
dramatic changes, HCFA is committed to "putting the federal government's customers -- the
American people -- first". We are pleased to report that the initiatives described in this report
represent just the beginning phases of HCFA's ongoing support of the National Performance
Review efforts.
Reinventing Health Care Regulations DRAFT July 7, 1995 (5:21pm)
17
TOTAL P.18
Doug Farbrother
632-0150 X 114
First Lady's Remarks
ReGo 2 - HCFA Reform
FAX632-0390
July 11, 1995
(draft as of 07/03/95 9:39 AM- 750 words)
Thank you ladies and gentlemen. Thank you for joining Vice President
Gore and me to unveil the reinvention of the Health Care Financing
Administration.
(Acknowledgments from advance.)
While health care has a special place in my heart, when it come to
reinventing government, there is nothing unique about health care. The
same principles apply:
We have to take a lesson from America's best run companies and put the
customers first. We need to focus on the results that the American
People want, and forget about following the rules just for the sake of
following the rules.
We have to cut out the red tape and the paper work that costs an
enormous amount of time and money - red tape that sends a constant
message to federal workers and to Americans everywhere that
Washington knows best, and that Washington doesn't trust you. We
have to stop treating full-grown Americans like children.
We have to trust the people who are working on the front lines of
use these--
American health care. As a general rule, they have more than enough
common sense, they are creative and innovative, and they want to take
learned what we
care of their patients - otherwise they wouldn't have suffered through
years and years of medical training.
And when it comes to regulation, we have to change to a system that is
Idere's cure in hearm reform
based on partnership, rather than adversarial enforcement and
punishment. In other words, the we ought to base our systems on the
what's
assumption that most doctors and hospitals want to help you - they
wrongearm
want to make you well again - and only a very, very few are out to
the care system
flimflam you or to bilk the government. We can certainly design our
systems to catch the few flimflam artists without punishing the vast
majority of honest Americans.
Vice President Al Gore and his team - a group of dedicated federal
workers who call themselves the National Performance Review - have
been putting these principles to work for nearly two years.
They are changing the way that the government buys things - no more
$600 hammers - no more government specifications for ashtrays or
chocolate chip cookies. Tomorrow's government uses common sense
and commercial items.
They're changing the way that the government is managed - no more
industrial-age hierarchy with huge corporate headquarters and layer upon
layer of wasteful micro-management. Tomorrow's government uses
common sense and information-age teamwork.
They are changing the way government regulates - whether it's to clean
up the environment, or to keep workers safe and healthy, or any of the
dozens of other high goals that Americans have chosen to pursue
through government. No more mile-high stacks of incomprehensible
rules - no more bureaucracy and red tape - no more nasty attitude of
Washington-versus-America Tomorrow's government uses common
sense and partnership to achieve its regulatory goals.
The Clinton-Gore administration is creating tomorrow's government the
right way. We're making it work better and cost less.
But, there is a wrong way to do it, too. The wrong way is to forget all about
making it work better, and just hack away at the cost. People who don't
seem to care whether government starts working better are missing a basic
point about America.
In America, the government is not some force at work against the people.
The government is for the people - and by the people. Government is the
people of America working together to solve some of their biggest national
problems.
But if government does not work well - if it does not solve the problems it
sets out to solve - problems like crime or poverty, disease or ignorance,
threats to our security or to our economy - then Americans loose faith in
government. And when we do that we are loosing confidence in our own
ability to take effective action together.
That is a crisis of confidence we face today. Thirty years ago, when asked if
government could be trusted to do the right thing, 75% of Americans said
yes. Today, it's less than 20%.
We have to restore our faith in government. We have to restore our faith in
ourselves. That's why we have to make government work better - not just
cost less.
And now, to tell you how one more part of government - the Health Care
Financing Administration - is going to be working better and costing less,
here is the man who has been down in the trenches fixing it, Vice President
Al Gore.
07/07/95
00:38 FAX 515 222 7257
MERCY WEST ADMIN
001
HOSPITAL
MERCY
MEDICAL
CENTER
Sixth & University Des Moines. lows 50314
FAX TRANSMITTAL
DATE:
7/7
TO:
Patrick Marris
(202)632-0390-
VP office
To: Jennifer Kline
-456.2878
FROM:
L12 Shannahan
Dr.Gleann
MEDICAL RECORD SERVICES
(515)
(Telephone Number)
(515)
248-8813
(Fax Number)
NUMBER OF PAGES (including transmittal sheet) :
COMMENTS: This is the Form: Mercy had 11,127 Medicare
discharges cy 1994. 555 Bed hosp.
I'll call you soon
CONFIDENTIALITY NOTICE: The documents accompanying this fax
transmission contain confidential information belonging to the
sender which is legal privileged. The information is intended for
the use of the individual or entity named above. If you are not
the intended recipient, you are hereby notified that any
disclosure, copying, distribution or the taking of any action in
reliance on or regarding the contents of this faxed information is
strictly prohibited. If you have received this fax in error,
please notify the sender immediately so that we may arrange to
secure its return. Thank you
07/07/95
00:38 FAX 515 222 7257
MERCY WEST ADMIN
002
MERCY
HOSPITAL MEDICAL CENTER
MERCY HOSP. MED. CENTER
400 University Ave. Des Moines. Town 50374
PHYSICIAN ATTESTATION STATEMENT
PAGE: 1
DATE 06/15/95
NAME
ACCT 0005818035150 MED REC NO 005049085
ADM/VST DATE 05/30/95 DIS/DEPART DATE
ROOM/BED
DATE OF BIRTH 10/22/04 AGE 90 SEX F LOS 017 DSCH DISP
ATTENDING PHYSICIAN
MDC 007 DISEASES AND DISORDERS OF THE HEPATOBILIARY SSTEM AND PANCREAS
DRC 193 BIL PROC W CC, EX ONLY CHOLCYST W/WD CDE
OUTLIER STATUS
CHARGES 20823.64
REIMB
11750.37
ADMITTING DIAGNOSIS
574.51 CHOLEDOCHLITH NOS 1.1 OBST
PRINCIPAL DIAGNOSIS
1.
574.51
CHOLEDOCHLITH NOS W OBST
SECONDARY DIAGNOSES
2.
285.1
POST OF ANEMIA
3. 997.4
POST OF ILEUS
4.
576.1
CHOLANGITIS
5.
714.0
RHEUMATOID ARTHRITIS
6.
401.9
HYPERTENSION NOS
PROCEDURES
DATE
:-
51.41
CDE FOR CALCULUS REMOV
06/02/95
2.
51.10
ERCP
05/31/95
3.
38.93
VENOUS CATHETER NEC
05/30/95
4.
87.53
INTRAQPER CHOLANGIOGRAM
06/02/95
1 CERTIFY THAT THE NARRATIVE DESCRIPTIONS OF THE PRINCIPAL AND SECONDARY
DIAGNOSES AND THE MAJOR PROCEDURES PERFORMED ARE ACCURATE AND COMPLETE
TO THE BEST OF MY KNOWLEDGE.
ATTENDING PHYSICIAN
DATE
Here is draft release for Tuesday HCFA event.
As this has to be cleared by several offices--White House Press, Vice President, First Lady,
HHS, HCFA and OIRA--I would appreciate your short edits by Noon, Monday, July 10 so I can
get to work on the final product.
This release and the HCFA booklet will be handed out to the press at the event and be available
for the later briefings.
Thanks for your help.
Mike Rusself
Mike Russell, NPR Press
202-632-0150, ext. 153
632-0390
fax
DRAFT
THE WHITE HOUSE
OFFICE OF THE PRESS SECRETARY
FOR IMMEDIATE RELEASE
Contact: 202-632-0150
Tuesday, July 11, 1995
VICE PRESIDENT, FIRST LADY ANNOUNCE REFORM OF HEALTH CARE RULES
Less Paperwork, More Time For Patient Care Will Result From Reinvented Regulations
Vice President Al Gore and First Lady Hillary Rodham Clinton today unveiled a series of
health care regulatory reforms within the Health Care Financing Administration (HCFA), an
agency of the U.S. Department of Health and Human Services. The changes include cutting
burdensome paperwork requirements--giving health care providers more precious time for
6.705
patients--and the removal of roadblocks to innovation and cost-cutting.
Highlights of the HCFA reforms include:
Nursing home regulation to focus on quality of care rather than
enforcement of process standards. Will allow flexibility to apply
remedies that fit specific problems at nursing facilities.
Physicians Medicare "attestation" form to be eliminated. Result is
elimination of 11 million forms and savings of 200,000 hours of
physician time. Will cut labor costs $22, 500 per hospital per year.
Streamlining of lengthy laboratory equipment certification and
standard
inspection process while maintaining accuracy and reliability
standards. Creation of incentives for manufacturers to develop more
reliable equipment.
Refocus, Medicare providers toward actual patient care by changing
unnecessary process requirements to outcome-based performance
standards. Produces savings as providers are free to achieve high
quality outcomes in most cost-effective manner.
Removal of barriers to HMOs in rural areas. Will improve access to
care for Medicare-beneficiaries.
Vice President Gore said: "When it comes to reinventing government. health care--although
a more personal issue--isn't that different from other national problems. We need to focus on
first class care rather than forcing our doctors and caregivers to worry more about staying within
the lines of regulation. They shouldn't be forced to look over their shoulders but instead be
allowed to use the best of innovation and inspiration to provide quality health care."
2.
"We have to change to a system that is based on partnership, rather than enforcement and
punishment," said Mrs. Clinton. "We ought to base our system on the assumption that most
doctors and hospitals want to help--they want to make you well again--and only a very, very few
are out to bilk the government. This reinvention of regulations is a major step in our goal of
giving Americans the very best health care system."
Donna E. Shalala, Secretary of the Department of Health and Human Services, said: "I'm
expecting Melissa to come up with a quote here that will get me in all the top papers across the
country."
(insert short quote)
"This is where my quote should go," said Bruce C. Vladeck, Jr., HCFA Administrator.
(insert short quote)
The Health Care Financing Administration operates the Medicare program, oversees state-
federal Medicaid plans, and is responsible for the quality of health care provided by 60, 000
hospitals, nursing homes, home health agencies and other facilities. HCFA also oversees the
quality of 152,000 testing laboratories in the U.S. and the federal licensing of health maintenance
organizations (HMOs).
TENTATIVE SCHEDULE FOR PHYSICIANS (Gleason folks)
Tuesday, July 11
NOTE: You should come to the Pennsylvania Avenue entrance to the
Old Executive Office Building at the corner of Pennsylvania and
17th Street (this building is right next to the White House).
Please try to arrive by 9:00 . am to allow for your security
clearance.
9:30am - 10:45am
Budget/Issues Briefing
Room 450, Old Executive Office Building
(This will include a substantive
briefing on Medicare and Medicaid)
11:00am - 11:45am
Special Event
The White House
Political mtg
with 1st Lady
11:45am - 12:30pm
Lunch (on your own) (many local sandwich
shops near the Old Executive Office
Building)
12:45pm - 2:00pm
Healthcare Regulatory Reform Event with
the Vice President and First Lady
Room 450, Old Executive Office Building
2:00pm - 3:30 pm
Potential press interviews for
individual physicians (for those who are
able to stay during this time period, we
will try to arrange press interviews
with your home state press).
ADDITIONAL NOTE:
We apologize for changes in the schedule
which have moved the length of the meetings
into the afternoon. We hope this will not
inconvenience anyone's scheduled travel
plans.
JUL-06-1995 14:36 FROM ADMINISTRATOR'S OFFICE
TO
94567431 P.01
HEALTH CARE FINANCING ADMINISTRATION
John Moralis
7203 Claudia Cooley
John Morrell
3/11/44
to
call Yarwood Bruil
350
5-7316
ADDRESSEE:
FROM: Jennifer Boulanger
Bob Knisely
366-9777
OFFICE OF THE ADMINISTRATOR
Jennifer Klein 455-2599
200 INDEPENDENCE AVE., S.W.
Nancy Ann Min
ROOM 314G
WASHINGTON, DC 20201
Molly Poag
395-9128
Allison Eyat
PHONE: 202-690-6726
PHONE:
FAX : 202-690-6262
Doug Far brother
TOTAL PAGES:
ADDRESSEE'S FAX MACHINE NUMBER:
DATE:
REMARKS:
July 6, 1995
MEMORANDUM TO PHYSICIAN ORGANIZATIONS
FROM:
MARILYN YAGER, SPECIAL ASSISTANT TO THE PRESIDENT
OFFICE OF PUBLIC LIAISON
202/456-6683
RE:
INVITATION TO JOIN THE VICE PRESIDENT AND FIRST LADY
FOR A HEALTH CARE REGULATORY REFORM EVENT.
We wish to invite your organization to join Vice
President Al Gore and First Lady Hillary Clinton for
the official release of our Health Care Regulatory
Reform recommendations on Tuesday, July 11.
As part of the discussions the First Lady had with many
of your organizations during the health care reform
deliberations, and more recently as part of the Vice
President's reinventing government initiative, HCFA has
reviewed its regulations to determine which
requirements could be reduced or eliminated. Although
we view this process as an ongoing effort, the report
to be released on July 11 will contain recommendations
resulting from the initial phase of the regulatory
reform review.
Please join us for this event on Tuesday, July 11, at
12:45 pm in Room 450 of the Old Executive Office
Building. Due to space limitations each organization
will be limited to five seats. Attendees should arrive
by 12:30 pm using the Pennsylvania Avenue entrance to
the Old Executive Office Building at the corner of
Pennsylvania and 17th Street.
Please fax (202/456-6218 or 202/456-6682) the full
legal names of the individuals representing your
organization, their social security numbers, and birth
dates by Monday morning at 12:00 noon. Should you have
any questions please contact me or my assistant Dani
Rose.
In addition, there will be a private meeting with the
First Lady and the most senior representative from each
physician organization (preferably the President or
Executive Director) at 12:00 noon in Room 472, prior to
the event on July 11. Please let me know who is the
one person representing your organizations at this
meeting.
JUL-06-1995 14:36 FROM ADMINISTRATOR'S OFFICE
TO
94567431
P.02
"I am determined to see reform of
our regulatory system, so that it
costs less, meddles less, and puts
more responsibility in the hands of
the people themselves."
President Bill Clinton -- February 21, 1995
"We can improve the relationship
between regulators and the people
they regulate to achieve our national
goal of a robust economy that also
protects public health and safety."
Vice President Al Gore -- February 21,1995
OVERVIEW
Introduction
The Clinton Administration has made reforming the Federal government's
regulatory process, while maintaining Medicare and Medicaid beneficiaries'
access to quality care, a top priority. Consistent with this commitment, President
Clinton and Vice President Gore asked Health and Human Services Secretary
Donna Shalala to assist in meeting this priority by carefully examining the
regulatory requirements of the Health Care Financing Administration (HCFA).
As part of the Vice President's reinventing government initiative, HCFA has
reviewed its regulations to determine which requirements could be reduced or
eliminated without compromising Medicare and Medicaid beneficiaries' access to
quality health care. This report contains recommendations resulting from the
review of HCFA's regulations.
Reinventing Health Care Regulations DRAFT July 6, 1995 (2:23pm)
1
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Agency Overview
The Health Care Financing Administration (HCFA) has major responsibility for
health care financing and quality oversight of health care providers. In particular:
HCFA operates the Medicare program, serving nearly 37 million
beneficiaries.
HCFA and State governments in partnership operate the Medicaid program,
which serves another 36 million beneficiaries.
HCFA oversees the quality of care provided to Medicare and Medicaid
patients in hospitals, nursing homes, home health agencies, hospices and other
facilities. Some 60,000 providers are surveyed each year under HCFA
auspices.
HCFA also administers the Clinical Laboratories Improvement Act (CLIA)
and, together with the Centers for Disease Control, oversees the quality of
laboratory testing for the entire Nation. Approximately 152,000 laboratories,
which perform billions of tests each year, are subject to this Act.
Under Title XIII of the Public Health Service Act, HCFA provides Federal
qualification of health maintenance organizations (HMOs). At present, 52 to
54 percent of the HMOs in the country have Federal qualifications.
HCFA provides Federal oversight of State regulation of Medigap insurance,
the insurance that supplements Medicare benefits.
HCFA works with a number of partners in administering its programs:
HCFA contracts with 73 fiscal intermediaries and carriers to assist in
operating the Medicare program by providing claims payment, medical
review, and provider and beneficiary services. Fifty-three Peer Review
Organizations engage in quality improvement for Medicare professional
services.
HCFA works with the governments of all of the States, the District of
Columbia, and territories in running the Medicaid program.
State survey agencies, under contract to HCFA, inspect CLIA laboratories and
providers participating in Medicare and Medicaid.
2
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HCFA contracts with 18 End-Stage Renal Disease Networks which oversee
the quality of, and access to, dialysis services provided to beneficiaries
qualified for Medicare because of their End-Stage Renal Disease (kidney
failure).
HCFA contracts directly with 195 managed care organizations providing
Medicare Part A and B services directly to 2.8 million beneficiaries.
HCFA, with its 10 regional offices, ensures that program beneficiaries are aware
of the services for which they are eligible and that those services are accessible,
meet acceptable standards of quality, and are delivered in an efficient manner.
HCFA also ensures that health care providers of services meet approved
standards, and that program funds are used efficiently, without fraud or abuse.
HCFA Mission and Goals
In February 1994, HCFA prepared a detailed Strategic Plan, which it is now
implementing, that sets forth our mission statement, vision statement, goals and
objectives, and the specific strategies we will pursue to reach them. HCFA's
Strategic Plan, with its customer service focus, has become the Agency's
blueprint for the future.
HCFA's mission statement, which clearly expresses the Agency's conviction that
HCFA exists to serve its beneficiaries, is:
"We Assure Health Care Security for Beneficiaries"
To HCFA health care security means access to affordable and quality health care
services; protection of the rights and dignity of beneficiaries; and, provision of
clear and useful information to beneficiaries and providers to assist them in
making health care decisions.
Building on the mission, HCFA defined its vision of HCFA's future role as:
We Guarantee Equal Access to the Best Health Care"
The vision reflects our commitment that all individuals will be given an
unconditional assurance of having the same opportunity to have their health care
needs met, regardless of location, income, or other circumstances; and, the quality
of health care they receive is the best that can be provided.
Reinventing Health Care Regulations DRAFT July 6, 1995 (2:23pm)
3
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Regulatory Reform Principles
Regulatory reform can only be accomplished by keeping in touch with the needs
of customers. For HCFA, this means knowing what beneficiaries want and need
and knowing how we can work with our partners to fulfill and even exceed the
expectations of our customers, our beneficiaries.
To help with the regulatory review process, HCFA relied on three basic principles
which help define the Agency's new and improved customer service mission.
Communicate not dictate -- The number one tenet of this principle is to
communicate -- through listening and consulting, thereby increasing our
understanding of what our customers need, what they like and dislike about
our programs, and how we can serve them better overall. This principle says
that HCFA will consult with our partners and beneficiaries about how our
programs and policies should improve, instead of dictating such changes to
them as has been done too often in the past. When changes are a result of
legislative initiatives, HCFA will consult with partners and stakeholders on
the range of implementation issues that need to be addressed.
Educate rather than inundate -- Top rate customer service also means making
sure that customers understand our programs and policies. Providing reams
and reams of information is not enough -- and probably not effective. The
"new" HCFA is committed to educating instead of inundating. This principle
ensures that HCFA will educate our customers by developing effective
educational techniques and disseminating information about how our
programs operate rather than inundating them with information that is difficult
to understand and doesn't speak to their needs.
Innovate more than regulate -- HCFA's new and improved mission of
customer service is driven by innovation more than regulation. This means
that HCFA will rely upon innovation in program operations and
administration more than regulation to foster improved customer service
capabilities. For example, by streamlining Medicare claims processing and
information exchange, the Medicare Transaction System will make electronic
interaction with Medicare easier for providers and beneficiaries and will
enable Medicare contractors to devote more time to customer service
activities.
4
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Accomplishments
HCFA's recent regulatory improvements include:
In March, 1994, HCFA published a regulation that replaced the requirement
for physicians to provide hospitals annually with a signed acknowledgment
concerning penalties for misrepresenting certain information with a one-time
signing requirement at the time a physician is initially granted hospital
admitting privileges. One major medical association characterized this change
as one that will alleviate the "hassle factor" for physicians and an important
step toward restoring mutual trust between the Federal Government and the
medical profession.
HCFA is totally redesigning its system to pay claims for Medicare services.
The development of the Medicare Transaction System (MTS) will increase
control of program expenditures, and improve services to beneficiaries and
providers. Final contracts for the analysis, design, development, testing, and
implementation of the MTS were awarded January and March 1994.
Presently providers must cope with 10 different claims processing systems
operated by 77 insurance companies at 57 sites. HCFA has awarded a
contract for the analysis, design, development, testing, and implementation of
the MTS. This integrated, national system will replace the diverse existing
systems and significantly simplify administrative operations for beneficiaries,
providers, and the Medicare program.
HCFA has re-invented the evaluation of Medicare contractors. The newly
restructured Medicare contractor performance evaluation establishes Medicare
beneficiaries and medical care providers as integral partners in the evaluation
process. It allows for greater flexibility in evaluating Medicare contractor
operations and performance. The new evaluation began October 1, 1994.
Medicare and Medicaid inspections of most health care facilities (for example,
nursing homes, hospitals, hospices, and ESRD facilities) are done using a
flexible survey cycle. The frequency of a survey for any provider is a function
of their past, and believed current, performance. Providers with poor
compliance histories and/or current consumer complaints are surveyed more
frequently than providers with good performance records.
Obtaining Medicaid home and community-based services waivers was
simplified in a rule published July 25, 1994. The final rule enables States to
Reinventing Health Care Regulations DRAFT July 6, 1995 (2:23pm)
5
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offer a wide variety of home and community-based services as cost-effective
alternatives to more expensive institutional care. Without this regulatory
movement, joint State and Federal efforts to expand opportunities to provede
cost-effective alternatives to insititutional care would have been frustrated.
The regulatory provisions were worked out in collaboration with the States
(through the National Governor's Association).
Regulatory Reform Recommendations
The following proposals are the major HCFA initiatives that have evolved from
our commitment to the regulatory reform process. In some cases
recommendations reflect actions based on collaborative efforts, including public
consultation with industry groups, beneficiary organizations, and State
associations and agencies. All of these projects were designed to cut unnecessary
red tape and burdensome regulations. Most importantly, they demonstrate
HCFA's customer-focus and responsiveness to the changing needs of all its
customers and partners.
shartities
1. Nursing Home Regulation Enforcement: The monitoring and enforcing
requirements for nursing homes participating in Medicare and Medicaid were
revised and became effective July 1, 1995.
1
2. Physician Attestation: Eliminate the physician form required to certify the
accuracy of all diagnosis and procedures before submission for payment by
Medicare.
L
3. Clinical Laboratories Improvement Amendments: Make a series of
significant changes that reduce burden and improve the entire CLIA system by
recognizing technological advances, creating incentives for manufacturers,
increasing access to a variety of tests, rewarding good performance, allowing
private organizations that meet certain standards to accredit laboratories and
permitting states to be exempted from CLIA requirements..
4. Outcome Performance Measures: Change current regulations that focus
3
solely on requirements for measuring processes, rather than outcomes of care.
Changes involve:
Home Health Agency Conditions of Participation
Medicare Hospital Conditions of Participation
ESRD Facility Conditions of Coverage
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Rules for ESRD Facilities - A Pilot for Good Performers
Elimination of Personnel Requirements for Excellent ESRD Facilities
5. Waive 50/50 Requirement For Medicare Managed Care Plans: Change the
X
current law that requires that all managed care plans providing service to
Medicare beneficiaries have a commercial enrollment of at least 50 percent of
total enrollment.
6. The HCFA-1500 Form: All participating Federal Employee Health Benefit
4
Plan carriers will use the HCFA-1500 form for physicians' and other
practitioners' claims. The HCFA-1500 is used by physicians and others to submit
claims for reimbursement of health care services under Medicare.
5
7. Annual Preadmission Screening and Annual Resident Review: Eliminate
the requirement that mentally ill and mentally retarded nursing home residents are
assessed annually. The preadmission screening for these residents is retained.
6
8. Nurse Aide Training and Competency Evaluations: Permits States to
approve nurse aide training and competency evaluation programs offered in
nursing homes.
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HCFA INITIATIVES
1. Nursing Home Regulation Enforcement
Background: HCFA revised both the requirements nursing homes must meet to
participate in Medicare and Medicaid and the rules for monitoring and enforcing
requirements. The improved participation rules focus on resident quality of care
and quality of life using outcome-based performance measures, where possible.
These rules have improved conditions in nursing homes. For example, the use of
physical restraints has been reduced 50 percent since 1987. More improvements
in care and quality of life are possible.
Solution: The monitoring and enforcement rule, effective July 1, 1995, strikes the
critical balance between strengthening quality standards in nursing homes to meet
the health and quality of life needs of residents, and providing flexibility to apply
remedies that fit specific problems at nursing facilities. Overall, the rule (1) links
enforcement remedies to deficiencies; (2) motivates facilities to remain in
compliance with Federal requirements that promote the quality of care and quality
of life in nursing homes; (3) promotes survey and enforcement consistency; and,
(4) avoids unnecessary burden on facilities through the use of an informal dispute
resolution process.
Impact:
16,700 nursing homes are impacted by this rule.
System is outcomes-oriented, not process oriented. Surveyors will focus on
the direct care given to the resident, not on administrative processes.
"Poor performers" are treated differently than "good performers." Facilities
with good records are given the opportunity to correct their deficiencies and
avoid remedies, while "poor performing" facilities (for example, those with a
history of noncompliance, egregious deficiencies, or failure to implement a
continuous quality improvement program), or those found to have an
"immediate jeopardy," will be assessed immediate remedies, including civil
money penalties.
"Yo-Yo compliance" is discouraged. Facilities that routinely come into
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compliance only long enough to be recertified, but that do not sustain
compliance, can be sanctioned quickly.
More remedies are available. This regulation recognizes that a single
enforcement response is not appropriate for all deficiencies, and provides
alternatives to existing remedies which are now only termination or denial of
payment for new admissions.
Remedies will fit specific problems. The regulation provides the flexibility to
apply a remedy that fits the scope and severity, or level of "harm" that exists
in each case.
An informal dispute resolution is set forth in regulation. Providers are given
an opportunity to dispute survey findings to the State or HCFA regional
office. However, this informal review will not delay enforcement actions.
Implementation and Timeline: HCFA published a final enforcement rule
November 10, 1994. It was effective July 1, 1995.
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2. Physician Attestation
Background: Since the Medicare hospital inpatient prospective payment system
(PPS) was implemented by HCFA in 1984, HCFA regulations have required
physicians to sign an "attestation form" for each Medicare patient discharged
from a hospital. The form certifies the accuracy of the diagnoses and procedures
for each patient. This information is used to ensure that the correct coding is on
the claim, the correct diagnosis-related group (DRG) can be assigned, and the
proper Medicare payment can be made.
Feedback from physicians, hospitals, and intermediaries have told us that
obtaining the physician's signature is burdensome and results in billing delays
that hurt hospital cash flow and hinders service to the beneficiary. Peer Review
Organization (PRO) review of attestations has resulted in fewer that a 0.01%
denial rate of sampled claims. In addition, the improvement in hospital record
keeping and coding sophistication make the hospitals the appropriate focus for
combating fraud and abuse.
Proposed Solution: Eliminate the form requirement and instead hold hospitals
responsible for the accuracy of their diagnoses and procedures. With improved
technology and software coding capabilities, hospitals are more equipped than
ever to combat billing fraud and abuse, the form's original purpose. This change,
whichican be implemented by regulation, will have the following benefits:
Impact:
Reduces paperwork burden and "hassle" on physicians and hospitals.
Decreases administrative costs for hospitals.
11 million forms will be eliminated.
Almost 200,000 hours of physician time will be saved.
Hospitals will have improved cash flow and reduced labor costs by
approximately $22,500 per hospital per year.
Implementation and Timeline: HCFA will publish this final regulation
September 1, 1995.
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3. Clinical Laboratory Improvement Amendments
Background: The Clinical Laboratories Improvement Amendments (CLIA) of
1988 established baseline quality standards that ensure the accuracy, reliability,
and timeliness of laboratory testing. These requirements are based on the
complexity of the test performed, rather than where the test is performed.
Compliance with the standards is determined through on-site inspection.
HCFA and the Centers for Disease Control and Prevention, which share
responsibility for the CLIA program, continually review ways to reduce the
burden and improve the entire CLIA system. A flexible survey system that
employs data analysis to target good performers and allow for self-attestation and
off-site review has already been initiated for certain laboratories. HCFA has
reduced information requirements and eliminated unnecessary paperwork and has
taken steps to reduce personnel requirements. HCFA also revised and streamlined
the inspection process. Additional burden reductions are being undertaken that
will virtually eliminate oversight for certain laboratories, establish performance
standards in place of process requirements, and use information and education as
a substitute for sanctions.
Proposed Solutions:
1. Waive the routine 2-year survey of users of "black box" technology,
conducting surveys only if there are indications of problems or complaints.
("Black box" technology refers to simple and easy to use test systems that
have demonstrated accuracy and precision through scientific studies.) We will
develop and implement criteria for accurate and precise "black box"
technology that will be followed to determine if the technology qualifies for
waiver of the routine 2-year survey. A small number of surveys will be
conducted to validate the criteria for determining "black box" technology and
assure quality.
Impact:
-
Creates incentives for manufacturers to develop more reliable testing
equipment by stimulating demand for accurate and precise technological
testing systems.
Reduces paperwork and costs for providers, especially for physician office
laboratories, as well as costs of program management.
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Implementation and Timeline: Proposed rules will be published September
1995.
2. Clarify and expand the waiver criteria and streamline the waiver process so
that CLIA regulations can be waived for more tests. CLIA requirements will
be waived for tests approved for home by the FDA -- that is, tests that do not
require trained personnel.
Impact:
-
Decreases burden, especially for physician office laboratories because of
less regulatory oversight.
-
Increases access to greater variety of tests. Physician office laboratories
may expand the range of tests they perform without an increase in
costs/burden.
-
Creates incentives for manufacturers to develop more test systems that
meet the clarified waiver criteria and criteria for approval for home use.
-
Eliminates inspection fees for many of the 60,000 physician office and
other small laboratories not now waived who decide to perform only tests
from the expanded waiver category.
-
Many additional laboratories will face lower inspection fees because,
while they will continue to perform non-waived tests, many more tests
will fall into the expanded waiver category.
Implementation and Timeline: Proposed regulations will be published in
September 1995.
3. Use performance standards and require less frequent on-site inspections
(surveys) of excellent performers. Approve private accrediting organizations
for deemed status when their accreditation standards are as stringent as CLIA.
Exempt laboratories from CLIA requirements when the State where they are
located has requirements equal to or more stringent than CLIA's.
Impact:
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-
Reduces inspection burdens.
-
Rewards good performers with fewer inspections. This is a positive
incentive to improve performance.
-
Approving organizations for deemed status offers laboratories oversight by
peers.
-
Approving States for CLIA exemption allows expanded role for States
with strong licensure programs.
Implementation and Timeline: To date, notices to approve four accrediting
organizations (College of American Pathologists, Joint Commission on
Accreditation of Healthcare Organizations, Commission on Office Laboratory
Accreditation, and the American Society of Histocompatability and
Immunogenetics) and the State of Washington have been published. Notices
for two additional accrediting organizations and one additional State are
pending. Final rules to eliminate redundancies or unnecessary requirements
for federal review and approval will be published in March 1996.
4. Use proficiency testing (PT) "failures" for education and as an outcome
indicator in laboratory quality. (PT is testing samples of known values to
assess the accuracy of a laboratory's results.) Sanctions (for example, loss of
Medicare payment or loss of approval to do testing) are imposed only in cases
of immediate jeopardy or when the laboratory has refused to correct the
problem or has had repeated failures on proficiency testing.
Impact:
-
Less intrusive than traditional regulation and oversight.
-
Allows use of proficiency testing as an outcome measure to monitor
laboratory performance, and provide laboratories with feedback on test
quality and an incentive to improve performance.
-
Minimizes the fear of sanctions in 60,000 non-waived laboratories.
Implementation and Timeline: A proposed rule will be published in March
1996.
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4. Outcome Performance Measures
Background: Medicare, as a purchaser of health care, requires hospitals, Home
Health Agencies (HHAs), and End-Stage Renal Disease (ESRD) facilities to meet
health and safety requirements to participate in the Medicare program.
Historically, these requirements measure "process" (procedural and administrative
systems as proxies for quality health care) rather than "outcomes" (evaluations of
actual patient care) and the adequacy of quality management programs.
HCFA is committed to changing current regulations that focus solely on
requirements for measuring processes. The Agency realizes that not focusing on
outcome measures results in several inherent problems. First, regulatory
requirements vary by type of facility and provider even when the services
provided in each facility are the same, creating inequities and inappropriate
incentives. Second, without outcome measures, there is very little information
available for consumers on the quality of care at a given facility. Third, by law,
HHAs must be surveyed yearly-even though historical data show that this
frequency is excessive for many HHAs and does not improve care.
HCFA is revising regulations for hospitals, home health agencies, and end stage
renal disease facilities, that would address these issues and eliminate unnecessary
process requirements and focus on the outcomes of care.
Proposed Solution: Eliminate unnecessary process requirements and instead
develop outcome-based performance standards; collect and analyze patient care
data needed for continuous quality improvement and performance evaluation;
increase consistency of requirements across providers; and ask the customer to
provide input on what the outcome measures should be, and to evaluate the
services they received. We are seeking legislation to give us flexible survey
cycles.
Impact:
Eliminating unnecessary process requirements for compliance will reduce
compliance and survey burdens and make it possible to focus on actual patient
care.
Educating the consumer will produce a strong, non-regulatory force to
improve quality of care.
Powerful data will be available to regulators and providers.
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Produces savings because providers are free to achieve high quality outcomes
in the most cost-effective manner.
Outcome Performance Measures Initiatives
HCFA is currently involved in the following new initiatives that focus on the
concept of "Outcomes Performance Measures" and the consensual approach to
developing regulations.
Home Health Agency Conditions of Participation:
HCFA is developing revisions to the Medicare Home Health Agency (HHA)
conditions of participation. The purpose of the revision is to place greater
emphasis on patient outcomes while reducing the current emphasis on process
requirements (e.g., elaborate professional qualifications and other "paperwork"
requirements) and enhancing an HHA's flexibility in meeting patient needs. The
Agency has actively involved home health beneficiaries, providers, physicians,
professional organizations (American Association of Retired Persons, National
Association for Home Care, American Federation of Home Health Agencies,
American Medical Association, Visiting Nurses Association of America,
American Academy of Home Care Physicians), States (State Survey and
Medicaid Agencies), and intermediaries in order to receive input on developing
revisions to the conditions of participation. A work group of HCFA staff and
representatives of Medicare beneficiaries, home health providers, physicians, and
State Survey Agencies will develop a Standard Core Assessment Instrument for
use in home health care. The use of this tool is central to HCFA's efforts to place
the emphasis of survey and enforcement on patient outcomes.
Implementation and Timeline: HCFA will publish a proposed rule in
September, 1996.
Hospital Conditions of Participation:
HCFA is revising the current hospital conditions of participation to center on the
patient, support a cross-functional approach to patient care, and focus on quality.
In developing these revisions, HCFA has worked closely with organizations
representing hospitals, practitioners, patients, and States and has already
distributed informal pre-regulatory drafts to approximately 70 outside groups for
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comment.
Implementation and Timeline: HCFA will publish a proposed rule in January,
1996.
End Stage Renal Disease (ESRD) Conditions of Coverage:
HCFA's ESRD Conditions of Coverage (COC) have not been comprehensively
revised since their original implementation in the late 1970's. The current COC
are primarily focused on process-oriented requirements, and do not provide
adequate support for a modern survey system based on an outcome-oriented
approach. Under the current regulation, facilities have a substantial paperwork
burden. As a result, revised regulations must be issued to increase facility
flexibility and to bring the ESRD COC up to current standards of practice in the
ESRD community. The revised COC will address the outcome-oriented, patient-
centered standards process where appropriate, reflect innovations in the dialysis
and transplant community, and address new issues such as adequacy of dialysis to
ensure that the Medicare beneficiary is receiving the most progressive quality of
care possible. Thus, HCFA's emphasis will be on the total patient experience
with dialysis, including patient functional well-being and continuous quality
improvement (CQI). The revised regulations will include development of
performance expectations for the facility that result in quality, comprehensive
care for the dialysis patient.
Implementation and Timeline: HCFA will publish a proposed rule in March,
1996
Rules for ESRD Facilities - A Pilot for Good Performers:
HCFA is conducting a pilot project to apply a different, less prescriptive set of
rules to excellent ESRD facilities. Under the pilot project, an ESRD facility's
performance will be measured using only three key patient care outcome
indicators. First, these indicators will be used in place of the current certification
standards, which are largely structure and process requirements. Second, the pilot
project will focus on helping facility staff's use outcome measures in an ongoing
way to improve the care provided to dialysis patients. Third, facilities that
document sustained achievement in the outcome indicators over six consecutive
months will be awarded a HCFA certificate of excellence.
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The indicators measure the quality of hemodialysis in three areas critical to the
health of the patient: adequate dialysis, control of anemia, and adequate water
supply. They will be used by the facilities to monitor the condition of each
dialysis patient and to achieve improvement in the patient's health status. For the
pilot project, excellence will be identified through a process focused on the
quality indicators. The process will look at whether facilities have an internal
quality monitoring and monitoring system, whether the results of such monitoring
are documented, and whether results are sustained. The facilities that qualify in
this pilot will have established certain internal quality control mechanisms in
order to participate.
Information about project results will be packaged in brochures and newsletters so
that ESRD patients and non-participating ESRD facilities will be aware of the
results. In this competitive industry, a successful project will stimulate many
other providers to seek recognition as "EXCELLENT" facilities.
ESRD facilities will be notified of their eligibility to participate and participation
will be voluntary. The pilot will be limited to facilities in the States of Colorado,
Idaho, Montana, and
Washington.
Implementation and Timeline: Planning for this pilot is underway.
Elimination of Personnel Requirements:
HCFA is conducting a pilot project that will evaluate the impact of the
elimination of Medicare personnel requirements for ESRD facilities. Currently,
the Medicare conditions for coverage for ESRD facilities include fairly detailed
specifications for several types of personnel employed in furnishing ESRD
services to Medicare beneficiaries. For example, the medical director of the
facility must be a physician, board eligible in internal medicine; the nurse in
charge must have 12 months of clinical experience, with 6 months experience
with ESRD patients; the social worker must be master level educated, etc. Over
the years, HCFA has received comments from the industry both in favor of
elimination of the personnel requirements and in favor of strengthening them.
Those in favor of relaxing the requirements commonly cite the difficulty rural
facilities can face in recruitment of personnel with the requisite experience. They
believe that the job does not require the level of experience and education
prescribed in order to perform adequately. Those in favor of maintaining
personnel requirements cite the medical condition of ESRD patients as
justification for the skills level requirements. They express concern that if the
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personnel requirements are weakened or eliminated that ESRD facilities, most of
which are proprietary entities, would hire less experienced and more inexpensive
personnel to provide care that is of inferior quality.
The pilot project would be conducted in concert with another proposed project
establishing new rules for historically good ESRD performers (see above) being
conducted by HCFA's Seattle Regional Office. HCFA will collect information
regarding the skills level of all personnel employed by those facilities
participating in the project. Facilities would be informed that as part of the
project, Medicare would not apply any of the personnel requirements contained in
the conditions for coverage. At the end of the two-year project period, HCFA
will recollect information regarding the education and experience level of all the
facility's staff and evaluate the impact of the changes on predetermined measures
of quality of care.
Implementation and Time line: Planning for this pilot is underway.
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5. 50/50 Waiver for Medicare Managed Care
Background: Current law requires that all managed care plans providing
services to Medicare beneficiaries have a commercial enrollment of at least 50
percent of total enrollment. The 50/50 requirement is intended to be a proxy of
quality. It has the unintended consequence of making it less likely that managed
care plans will contract to provide care in rural areas.
Proposed Solution: Under this legislative proposal, managed care plans that
either are seeking Medicaid contracts under a State Medicaid managed care
initiative, or are planning to operate as Medicare contractors in a predominantly
rural area, would be eligible for a waiver of the 50/50 rule if they met certain
quality-based requirements. These requirements would include a positive track
record as a Medicare contractor, minimum commercial enrollment and the
provision of encounter data on enrollees. This proposal is necessary to increase
access to quality managed health care for Medicaid and Medicare beneficiaries
who reside in rural areas.
Impact: This proposal would remove a barrier to HMOs located in rural areas. It
will also improve access to care for Medicare and Medicaid beneficiaries.
Implementation and Timeline: The statute must be amended to make this
change. Legislation will be proposed.
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6. The HCFA-1500 Form
Background: The HCFA-1500 form is currently used by physicians, other
practitioners, and DME suppliers to submit claims for Medicare reimbursement of
health care services. HCFA-1500 is also used by many other insurers for claims
submission. Although many Federal programs require the use of the HCFA-1500,
use of the form is not required by the Federal Health Benefit plan (FEHBP). In
addition, instructions for the form vary across programs.
Proposed Solution: The Office of Personnel Management (OPM) will require
participating carriers to notify physicians that they accept the HCFA-1500 form
for claims filed under FEHBP.
Impact: Physicians will be able to use one form to submit claims for services
provided to many patients.
Implementation and Time frame: OPM will use the HCFA-1500 beginning
January, 1996.
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7. Preadmission Screening and Annual Resident Review (PASARR) of
Mentally III and Mentally Retarded Residents
Background: Nursing homes under Mediacare and Medicaid are currently
required by law to conduct an initial assessment of each resident within 14 days of
admission, with a reassessment whenever a significant change in condition occurs
but in any event at least once a year. In addition, there is a statutory requirement
that for persons with serious mental illness or mental retardation entering a
nursing home the State is required to conduct: (1) a preadmission screening to
assure that the individual is being appropriately placed in a nursing home, and (2)
an annual reassessment to assure that the patient continues to be appropriately
diagnosed and treated.
Proposed Solution: Legislation would be proposed to eliminate the duplicate
annual assessment. Resident assessments and reassessments required under the
general nursing home requirements are entirely adequate to assure that residents
continuing needs are properly assessed and met. Preadmission screening, which
appropriately deters inappropriate admissions, would continue.
Impact: By eliminating the redundant annual PASARR reassessment, costly
duplication of effort by States would be reduced and nursing facilities would be
relieved intrusive annual inspections.
Implementation and Timeline: Legislation will be proposed.
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8. Nurse Aide Training and Competency Evaluations
Background: To assure quality of care in nursing homes, current law prohibits nursing
homes from using nurse aides that have not successfully completed a training or
competency evaluation program. The statute requires the Secretary to establish
requirements for the approval of nurse aide training and competency programs. The law
further forces States to prohibit, for a period of two years, nurse aide training and
competency evaluation programs operated by or in nursing homes that were subject to an
extended survey or partial extended survey or certain other sanctions. (Extended or
partial extended surveys are conducted as more intensive follow-up investigations after a
routine survey has demonstrated that a facility is furnishing substandard care.)
When a facility's program has been disapproved, the facility may not even be the site of
an aide program conducted by others during the time that the two-year penalty is
imposed. The prohibition on approval of nurse aide training and competency evaluation
programs causes a special problem for rural nursing homes where a community college
or other training facility may be inaccessible to nurse aides. Rural facilities can face a
serious shortage of trained and competent staff due to the expense and inconvenience of
sending prospective aides to remote locations. Alternative training programs may not be
available.
Proposed Solution: Specify that a State could choose to approve a nurse aide training
and competency evaluation program offered in (but not by) a nursing home subject to an
extended or partial extended survey or certain other sanctions if the State determines that
there is no other nurse aide training and competency evaluation program offered within a
viable distance. States would be required to provide ongoing oversight of these
programs in the interest of patient health and safety.
Impact: This proposal would safeguard the availability of nursing homes which might
otherwise stop participation in the Medicare and Medicaid programs as a result of losing
a training programs' approval. It would also make it easier for nurse aides to obtain the
training they need to provide quality services to our beneficiaries.
Implementation and Timeline: The statute must be amended to make this change.
Proposed legislation is under development.
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Conclusion
Under President Clinton's leadership, HCFA has made communication,
cooperation, and partnership the guiding principles of the regulatory process,
replacing the adversarial environment that often existed in the past. At a time
when the American health care system is undergoing dramatic changes, HCFA is
committed to "putting the federal government's customers -- the American
people -- first". We are pleased to report that the initiatives described in this
report represent just the beginning phases of HCFA's ongoing support of the
National Performance Review efforts.
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EXECUTIVE OFFICE OF THE PRESIDENT
30-Jun-1995 02:32pm
TO:
(See Below)
FROM:
Allison H. Eydt
Office of Mgmt and Budget, OIRA
SUBJECT: Stark I Revised Preamble Language
HHS faxed me materials addressed to you reflecting revised
preamble language for the Stark I regulation. These materials are
a follow-up to your Stark conversations with Administrator Vladeck
last Friday.
The preamble language continues to argue that HCFA does not have
administrative discretion to create a shared office laboratory
exception. In particular, the preamble states, "We believe that
this provision (section 1877 (b) (4)) says and means 'no potential
for abuse.' The statute does not say that HCFA can create new
exceptions whenever it determines that there are potential abuses,
but that these are outweighed by policy concerns such as the
flexibility an exception will give to the provider community or to
patients."
I continue to question HCFA's rigid interpretation. Such an
interpretation renders the flexibility provided the Secretary to
offer exceptions under section 1877 (b) (4) (when the exception
"does not pose a risk of program or patient abuse") as useless and
undeserving of delicate underlying Congressional negotiations.
Instead of an administrative exception, HCFA states, "we believe
that it is up to Congress to draw the line on what it would
consider to be an acceptable amount of risk and any criteria
necessary to minimize that risk." HCFA then offers a detailed
legislative exception that is comparable to the existing in-office
ancillary services exception. The proposed exception includes two
other important features, however. It is limited to a laboratory
that "is shared by five or fewer physicians ("shared laboratory
physicians")" and "the profits of the shared laboratory cannot be
shared based directly on the volume or value of referrals.' These
additional provisions are designed to discourage flagrant
overutilization.
I believe that this exception has great potential and appeal,
particularly if HCFA would adopt it administratively. Supporting
this, John Morrall came up with an interesting economic
perspective. One could argue that HCFA legally can adopt this
provision administratively because it may REDUCE NET PROGRAM
ABUSES resulting from existing legislative Stark provisions.
Assuming that physicians do not shut down laboratory operations
all together or refer out, in the absence of such a provision,
physicians may have the incentive to spin off into single
physician office labs where the referral/profit relationship is
guaranteed to be one-for-one. Five physician office laboratories
operating under these incentives logically would create more
overutilization and program abuse than one laboratory of five
physicians that "cannot share profits based directly on the volume
or value of referrals. Therefore, it would be fiscally
irresponsible for HCFA to ignore this administrative opportunity
to mitigate the net impact of program abuses resulting from
existing legislated exceptions.
I shared this analysis with RMO staff. They find it interesting,
but not entirely compelling in the absence of strong empirical
evidence.
HCFA is waiting for feedback from you. Despite, the RMO staff's
skepticism, I recommend that we share this argument with HCFA, and
continue to press for adoption of an administrative exception
(perhaps one identical to their legislative proposal.)
In case you are interested, more ideas pertaining to volume
threshholds are coming.
Distribution:
TO: Sally Katzen
CC: Phyllis E. Kaiser-Dark
CC: James B. MacRae Jr.
CC: John F. Morrall, III
CC: Daniel J. Chenok
CC: Joseph F. Lackey, Jr.
CC: Mary W. Poag
CC: Jennifer L. Klein
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EXECUTIVE OFFICE OF THE PRESIDENT
OFFICE OF MANAGEMENT AND BUDGET
WASHINGTON. O.C. 20603
OFFICE OF INFORMATION AND REGULATORY APFAIRS
FAX TRANSMITTAL
FAX: (202) 395-6974
DATE: 6/29/95
TO:
Jeriklein.
FROM:
Allicon Eydt
RECIPIENT'S FAX NO:
TOTAL NUMBER OF PAGES (INCLUDING 6-2878 TRANSMITTAL SHEET): : lepgs
RECIPIENT'S TELEPHONE NO:
COMMENTS:
You may want to use this for the
roll out
oresen push
for the exception in therwle,
not legislat on
Casi t you have questions
NOTE: IF YOU DO NOT RECEIVE ALL OF THE PAGES; PLEASE CALL AS
SOON AS POSSIBLE.
SENT BY:Xcrox Telecopier 7020 : 6-28-95 ; 6:58PM ;
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Health Care Financing Administration
The Administrator
Washington, D.C. 20201
June 23, 1995
NOTE TO SALLY KATZEN, OMB
SUBJECT: Revised Preamble Language for Stark I Regulation
As we agreed, HCFA has drafted some language for the Preamble to the Stark regulation
that lays out fully the reasons why a shared laboratory exception cannot be established
through regulations. It also contains specific legislarive recommendations for establishing
a shared laboratory exception
The attached language was, as you can see, drafted by OGC. The language was drafted
for the Federal Register, not OMB, so it contains all the reasons why we are not
establishing a shared laboratory exception -- including references to intent and legislative
history that would not bind us if we were able successfully to craft an exception under
current law.
We're certainly willing to modify the language to delete any offending sections, but we
believe generally that the final rule should contain as comprehensive a defense of the
position it takes as it is possible to draft
Please call if you want to discuss this or FAX a mark-up.
Thank you.
Bn Bruce C. Vladeck
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MEMORANDUM
TO
:
Tom Hoyer
BPD
FROM
:
Myra K. Erhardt
Attorney
SUBJECT: Revision of the preamble for BPD-674-FC to reflect
HCFA's policy on shared labs
AB you requested, we have revised as follows the section of
the preamble for BPD-674-FC which discusses shared laboratories:
1.
The response on E16 should be revised as follows:
Response: we received a large number of comments
addressing the shared laboratory issue and many
detailed suggestions for designing an exception for
shared laboratories. However, our legal authority to
create an exception for shared laboratories is
extremely limited.
The statute contains a long list of exceptions to
the broad general prohibition on referrals. Many, if
not all, of these exceptions, appear to reflect
Congress' weighing and balancing of the need it
perceived to curtail abusive financial arrangements
while not interfering excessively in the effective
delivery of health care services. Congress constructed
these exceptions to reflect practical decisions it made
after talking at length to the health care community.
For example, Congress chose to exempt from the
prohibition any physician who has an ownership or
investment interest in an entity that provides services
in a rural area or in a hospital in Puerto R1CC. We
are aware of no evidence to support the assumption that
all such arrangements are immune from abuse; however
Congress, for policy reasons, chose to provide a
blanket exception for all of these relationships.
Similarly, Congress chose to except most in-office
ancillary services provided by a solo practitioner or
group practice physician in his or her own offices.
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Page 2 Tom, Hoyer
The legislative history for $ 1877 does not indicate
that Congress excepted these services because it
believed they were immune from abuse. In fact, there
are studies showing that physicians can and do over-
utilize and overcharge for services they provide in
their own offices. Congress apparently provided this
exception because it did not wish to intrude into the
internal operations of an individual practice.
Congress demonstrated its awareness of the shared
laboratory issue by considering a shared laboratory
exception as part of its OBRA ' 93 amendments to 5 1877.
Congress specifically chose not to create a blanket
exception in the law for all shared laboratories or for
any particular category of shared laboratories. The
legislative history makes it clear that Congress
considered a limited shared laboratory exception but
chose not to enact 1C. The conference report for OBRA
'93 describes the House Energy and Commerce Committee's
proposal for a shared laboratory exception, but
specifically points out that this provision was not
included in the conference agreement (H.R. Rep. No.
213, 103d Cong., lst Sess. 809-810 (1993)) In
addition, Congress very deliberately established
certain standards in S 1877 (h) (4) as those necessary
for an association of physicians-to qualify as a group
practice in order to share a laboratory under the in-
office ancillary services exception. Congress retained
these standards in OBRA '93 and in fact added further
requirements.
Although we understand that there may be practical
reasons for a shared laboratory exception, we do not
believe that the statute gives HCFA the authority to
engage in the same type of balancing which Congress
undertock in enacting (and amending) I 1877. HCFA does
not have the authority to radically revise or alter any
of the provisions in S 1877. For example, HCFA does
not have the authority to expand the in-office
exception to include shared laboratories. HCFA instead
has only the independent authority under 1 1877 (b) (4)
to create exceptions for additional financial
relationships, but only when it determines that an
exception "does not pose a risk of program or patient
abuse."
We believe that this provision says and means "no
potential for abuse." The statute does not say that
HCFA can create new exceptions whenever it determines
that there are potential abuses, but that these are
outweighed by policy concerns such as the flexibility
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Page Э - Tom, Hoyer
an exception will give to the provider community or to
patients. The legislative history for the original
salf-referral prohibition reveals that Congress
considered giving the Secretary the authority to create
additional case-by-case exceptions with respect to
ownership or investment interests. The Secretary could
provide an individual exception if an entity
demonstrated to the Secretary's satisfaction that the
items and services provided by the entity would
otherwise be unavailable LO patients in the area, the
items and services provided by the entity would be more
convenient to patients based upon travel time, or the
items or services provided by the entity would be
supplied at substantially lower cost. This authority
was never enacted. H. Conf. Rep. 386, 10lst Cong., 1st
Sess. 847-848 (1989).
We believe that the "does not pose a risk of
program or patient abuse" standard is a very difficult
one to meet and must be based on evidence that the
exception could not be used to circumvent the purposes
of the law. However, by its very nature, a shared
laboratory facility will be one in which the physician-
owners will share in the profits; each additional
referral will likely increase the income of the
facility and the share of each investor.
Commenters advocating a shared laboratory
exception have suggested a variety of standards that a
shared laboratory would have to meet. A number of
commenters suggested that a shared laboratory exception
should, among other things, limit the size of the
laboratory, its location, or the number of physicians
who can invest in it. However, we are aware of no
evidence that the size or location of any shared
investment either increases or decreases the incentive
for investors to make referrals to it. We also have no
evidence that any of the other criteria suggested by
the commenters would prevent abuse.
Even assuming we have the latitude to interpret
"does not pose a risk of program or patient abuse" to
mean only a significant or meaningful amount of risk,
any attempts we might make to draw a line between
acceptable and unacceptable amounts of risk would be
purely arbitrary. Should anyone be aware of data that
demonstrates that certain criteria will prevent or
greatly reduce the potential abuse of patients or of
the Medicare program, we would be very interested in
receiving it.
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Page 4 - Tom Hoyer
In light of the many practical concerns commenters
have raised about shared laboratories, we believe that
Congress should "weigh and balance" the issue and
consider again whether to establish a shared laboratory
exception. We believe that it 18 up to Congress to
draw the line on what it would consider to be an
acceptable amount of risk and any criteria necessary to
minimize that risk. We have the following suggestions
on how Congress might wish to design a shared
laboratory exception for small laboratory facilities
which serve a limited number of physicians who are all
located in one building. Our suggestions are based not
on assumptions about what criteria would prevent the
risk of abuse. Instead, we have attempted to design an
exception which addresses many of the specific problems
raised by the commenters, and is comparable in many
ways to the in-office ancillary services exception.
The exception would apply to shared laboratory services that
are furnished:
(1) by a laboratory chat-
(a) is shared by five or fewer physicians ("shared
laboratory physicians") 1 and
(b) is located in the same building in which all the
shared laboratory physicians furnish physician
services unrelated to the furnishing of laboratory
services;
(2) personally by a shared laboratory physician or by an
individual who is directly supervised by a shared
laboratory physician; and
(3) to & patient of a shared laboratory physician who
received physician services unrelated to the laboratory
services in the building in which the shared laboratory
is located.
The shared laboratory cannot require that the shared
laboratory physicians maintain a volume of referrals to the
laboratory. The profits of the shared laboratory cannot be
shared based directly on the volume or value of referrals.
1. On page E19, lines 15-16 should read: "In any case, as
explained above, we do not believe that we have the authority to
establish a separate exception for shared laboratories."
Please let us know if we may be of further assistance.
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EXECUTIVE OFFICE OF THE PRESIDENT
06-Jul-1995 12:26pm
TO:
(See Below)
FROM:
Daniel J. Chenok
Office of Mgmt and Budget, OIRA
SUBJECT: HCFA Roll-Out Meeting and CLIA/Starke issue
Hope you're having a great time!
On the whole, yesterday's HCFA Roll-out event meeting was
productive and HCFA agreed to make most of the changes that we
advocated. This note summarizes the status of the CLIA exceptions
that remain outstanding (shared facilities and testing); the
changes that HCFA agreed to in the book; and the event logistics
FYI. Please try and at least read the CLIA/STARK section ASAP.
Thanks.
CLIA/STARKE
This is the only issue that you may need to make a policy
call on today. Bruce Vladek would like to speak with you about
whether to include the shared facilities exception as part of the
roll-out. His inclination is to leave it out at this time, since
the sticing remains whether to propose the policy in regulation or
through statute. We still believe and strongly recommend that
this exception be achieved through regulation, and that we not let
event timing dictate an agreement that may need further
discussion. Vladek seemed willing to listen, but his attorneys
have deemed that sufficient flexibility does not exist to allow a
regulatory fix.
Jennifer Klein with the DPC would like to include this
issue, but will defer to our judgment to leave it out if
necessary. Elaine Kamarck wanted to know if we could at least
include a placeholder. One possibility that Allison and I
discussed would be to announce the policy as framed in HCFA's
legislative proposal that we all agree on, excepting shared labs
with 5 or fewer doctors; and to explicitly indicate that the
Administration is exploring the most effective and responsible
avenue for implementation, legislative or regulatory.
Note that the Health RMO position remains unresolved. RMO
staff oppose an exception, while Nancy-Ann appears more
sympathetic. Jen Klein is calling her for a more dfeinitive
position before you call Bruce.
CHANGES TO THE BOOK/ROLL-OUT
1. HCFA is adding a new initiative to the book, a legislative
proposal to allow nurse aide training in rural areas by
"substandard" facilities. Current rules do not allow in-house
training by some facilities, which means no training in many rural
areas since other sources are not available. This legislative
proposal to give relief in rural areas builds on prior regulatory
changes made in the nursing home enforcement rule.
2. HCFA will discuss exploration of a legislative proposal on
exempting "black box" technologies from CLIA oversight as a more
effective counter to current Congressional proposals. We will see
what language they come back with, and try to ensure that it is
sufficiently strong (Elaine pushed this as well).
3. HCFA agreed to expand the end-stage renal disease pilot under
"performance measures" to indicate that this is a model that they
will expand to other areas as a way to reward good performers. At
our urging, they will also add a quid pro quo of more flexible
enforcement and regulatory relief, in addition to simply providing
"certificates of excellence".
4. HCFA will add realistic time frames in this Administration for
most proposals, and will add estimates of burden reduction where
appropriate.
5. On physician attestation, HCFA will announce a final rule
without proposal as we have advocated, by this September.
EVENT LOGISTICS
As of now, the event will be called "Reinventing Health
Care Regulation", and will be in Room 450 OEOB at 12:30 on
Tuesday. Various doctor's, nursing home, and consumer groups will
attend, as will congressional staff and perhaps Dingell, Stark and
Mikulski among others.
Congressional staff and labor unions will receive oral
briefings prior to the event. Just before, Vladek and the First
Lady will meet with the doctors' groups.
The First Lady will open the event, and introduce Dr. Steve
Gleason who will discuss the wondrous burden reduction of
physician attestation reform. The VP will then put this in the
context of other regulatory events, followed by (potentially)
remarks from the President.
You and Vladek are then expected to attend a briefing in
the press room. You can also expect a call from Ron Faunier (sp?)
from AP on Monday night, who will prepare the wire story for
Tuesday release.
Distribution:
TO: Sally Katzen
CC: Allison H. Eydt
CC: John F. Morrall, III
CC: James B. MacRae Jr.
CC: Mary W. Poag
CC: Jennifer L. Klein
CC: Phyllis E. Kaiser-Dark
Health Care
Event LIVEA Reg. Reform
Order:
First Lady - Gleason - FL - VPOTUS
Health care imp. to us. while health care reform, VPS Reinv.
Gov. working at same time.
Need simplicity / reduce burdens
FL & steve set up problem
REGO P HCR
Do altestation
perfect marriage
Last climinated year paper
Get acknowledgements from Bruce's OFFICE
FL briefing -- - talk to Brenda
Finish remarks
Waxman
Pryor
Wyden
Bruce to do briefing
Stark
Janet to talk to Debbie Chang
Dingers
Minursni
Press
George Anders - -
10 minute w/ VP 1 Bruce :- ask Lorraine to sign off
Ron Fournier - - to be called for AP - - Bruce would
need to be available - - Sally would get call
Robert A. KNISELY
202-366-3640 or 703-757-0293
107/04/95
O
14:59
1/3
RUSH TO: Jennifer Klein, DPC [v: 456-2599]
FAX: 456-2878
FROM: Robert A. KNISELY
PAGES (INCLUDING THIS COVER): 3
Jennifer Boulanger, Molly Poag, Jennifer Klein: here's my first
chop at the HCFA paper. See you on Wednesday afternoon.
KNiZ
Tuesday, July 4, 1995
Robert A. KNISELY
202-366-3640 or 703-757-0293
107/04/95
15:00
2/3
From the Desk of Robert A. Knisely
To: Jenuifer Boulanger, HCPA re: Reliventing HFCA Regulations
First, I want you to know that I can see you've done a heck of a lot of work in these 18 pages so
far. We're not home yet, but I can tell It's possible to bc donc before the 11th, and possible
without spending all weekend NEXT weekend on final edits and policy dust ups.
Congratulations!
I hope you found a copy of the FDA Reinventing Regulations report. Easier to follow.
I think that the audience is largely specialist, but occasionally generalist (we'd like to think so,
anyway). Therefore, a quick look for really specialized language (le. "deemed status") would be
worthwhile. If we explain it once we're home free. I've made a quick start, which we can discuss
tomorrow afternoon.
Needless to say, we will need dates and form for all "deliverables," even deliverables to the
Federal Register. That is, we must say that we will have an NPRM published in the Federal
Register by September 30, 1995 (or whatever). The dates can become a sticking point. Please
start picking some dates, and not too far in the future.
Also, please be aggressive in your use of the APA. You can expect some "cover" from OIRA
here. Can we do any final rules? Perhaps the removal of physicians' attestation? Can we avoid
the use of the ANPRM anywhere, since no one will think we're serious?
I am hoping that the promised "BACKGROUND" section will include a good list of previous
accomplishments of this Administration. We should have a separate section OIL these, even 11
asked
some of the material is repeated later.
While we haven't done Executive Summarles for the previous reports, an introductory
paragraph is still needed -- I hopc that's in Background as well.
You may have a little too much about reinventing HCFA; we'll see what others say.
Most of the rest of my comments are querulous, or "puppy to small dog" changes:
I like to sprinkle Americans and America throughout; I won't give patriotism away without a
fight!
We need to look carefully al the order in which you list Impacts, for maximum advantage.
Page 1: Medigap is unexplained. Do you mean insurance carriers?
Page 2: Don't we need to say health care providers once? Gotta say kidney along with renal,
oncc.
The paragraph starting "HCFA," could be recast as goals, except that it's placed before goals.
Page 4: I think that "innovate more than regulate" requires more explanation. Don't you need to
Deputy Director, Burcau of Transportation Statistics
Ronm 2104, U. S. Department nf Transportation, 400 Seventh Street SW, Washington, DC 20590
Date: 07/04/1995
Voice: 202-366-DATA, Fax: 202-366-3640 (backup fax: 703-757-0293), & Internet: [email protected]
Time: 2:59 PM
Robert A. KNISELY
202-366-3640 or 703-757-0293
007/04/95
15:00
3/3
From the Desk of Robert A. Knisely
reduce as well as revise Nursing Home Regulation's requirements? Don't youwant to "eliminate
1
the requirement that physicians certify" rather than ellminate the form? Need some better
language than "series of significant changes."
Page 5: HCFA 1500: Can you say that participating carriers must accept the HCFA 1500 w/o
addenda? And you gotta say HOW you'll modify the annual requirement for RRRMIMRR.
Page 6: Needs some examples here. I can't tell what in fact you propose to do.
Page 8: HCFA and CDCP "have taken significant actions" -- share them with us, here and (I
hope) in the Adminstration Accomplishments section.
Page 9: What states have more stringent requirements than CLIA?
Page 11: Re: process requirements for surveying HHAs annually; are you proposing legislation
to make this every two years?
Page 14: Can you get your Good Performers from this pilot effort to help my mentoring others?
By getting their good works written up? By being good "benchmarks"? Both EPA and OSHA
are doing exciting things with their outstanding performers.
Page 15: Is waiving the 50% commercial requirement for managed care only a problem in rural
areas? Don't center citles provide the same challenge?
Page 16: Must commit to getting some sort of result out of OPM by a date certain.
Page 17: I don't understand this. Are there two levels of review now, one "semi official?" I'd like
to hear this one again. On its face, I don't like it.
Page 18: Can you talk a little about how these changes Ht into a larger, more long term effort at
re-regulation or reinvention at HCFA? That would be great!
See you tomorrow afternoon!
Deputy Director, Burcau of Transportation Statistics
Room 2104, U. S. Department nf Transportation, 400 Seventh Street SW, Washington, DC 20590
Date: 07/04/1995
Voice: 202-366-DATA, Fax: 202-366-3640 (backup fax: 703-757-0293), & Internet: [email protected]
Time: 2:59 PM
ahca
American Health eAssociation
1201 L Street, NW, Washington, DC 20005-4014
FAX: 202-842-3860
Writer's Telephone: 202/898-2828
June 9, 1995
Ms. Jennifer Klein
Special Assistant to the
President for Domestic Policy
2nd Floor, West Wing
The White House
Washington, DC 20500
Dear Ms. Klein: Jennifer:
Attached please find the letter which I sent to Bruce Vladeck. I wanted to convey my
thanks for assisting us in ensuring that these issues that are critical to the industry are
successfully resolved. To that end, I would ask that at the very least, the PASARR and
Nurse Aide Training issues be included in the Vice President's regulatory relief package.
We will shortly be contacting you to discuss appropriate next steps that we need to take
to ensure that this happens.
I believe that by including these two key provisions in the regulatory relief efforts, we
will not only resolve key problematic concerns but will also show the over 16,000 long
term care providers, the commitment by the Administration to provide regulatory relief to
the provider community.
Likewise, I also believe that it is crucial that both the White House and the long term care
industry continue to coordinate efforts and work together to oppose any and all attempts
by Congress to block-grant Medicaid funds to the states. Although AHCA has already
shared with you the efforts that we have undertaken in this regard, I would urge you to
continue to keep us apprised of the efforts by the White House. Please do not hesitate to
contact us and include us in your efforts.
The American Health Care Association is a federation of 51 affiliated associations, representing 11,000 non-profit and for-profit
nursing facility, residential care and subacute providers nationally.
Ms. Jennifer Klein
June 9, 1995
Page Two
Again, thank you for your assistance and we look forward to working with you on both
these and other activities.
Sincerely,
Paul
Paul R. Willging, Ph.D.
Executive Vice President
G:\reg\je\9585
AHCA 6/7
PASSAR
agreement on annual PASSAR - Do in reg. review
need to look at initial more
Need
6
look at duplication of residency assessment
joint
proposal.
leginative
functions
OR have
loss of auth. to provide training in rural Facilities
maybe IF you can attribute substandard care to
we
personel, would do limits on training
some
deemed status
fight between AHA and JCAHD
2 components of care
clinical + ADL
payment rate ought to be the same whether
indiv. IS in hospital, institution, home
Willing to do a demonstration on 3. day subacute
e.g. bed soves
work group to come up w/ demo to be
implemented early next year. ORD
Barbhra Cooper to head It up.
Going by San.1
[Lewin study]
DATE:
TIME:
THE WHITE HOUSE
WASHINGTON
FAX COVER SHEET
TO:
Steve Gleason
Bob Waters
PHONE: (__)
202-857-6395
FAX:
(
)
515-222-7257
247-4259
FROM: J.Klein
PHONE: (202) 456- 2599
PAGES FOLLOWING COVER SHEET:
JUN-30-1995 18:51 FROM ADMINISTRATOR'S OFFICE
TO
94562878 P.01
6/30/95
FAX TO:
Elaine Kamark
Bob Knisely
Doug Farbrother
Jennifer Klein
Sally Katzen
Molly Poag
Allison Eydt
Attached is HCFA's first draft of the Reinventing HCFA Regulations document. We are looking
for the perfect quotation from President Clinton to open the report. The introduction section is
being drafted and we will have that Wednesday. In addition, we will be adding additional material
in the "HCFA Initiatives" section (mostly the "timeline" information).
Please give me your comments, as soon as you can. My number is 690-8502. Thank you.
Jennifer Boulanger
CC:
Claudia Cooley
Jackie White