(Re: Y2K Physician Readiness,
Negotiated Rulemaking for Labs, New
Coverage Process,
6th Scope of Work, Lead Screening,
Acquisition of PINs,
Managed Care Provider Protection,
and Other Matters )
From the
Practicing Physicians Advisory Council
(PPAC)
For June 14,
1999
Members of the Council:
Marie G. Kuffner, MD, Chair
Anesthesiologist
Los Angeles, CA
Jerold M. Aronson, MD
Pediatrician
Narberth, Pennsylvania
Richard A. Bronfman, MD
Podiatric Physician
Little Rock, Arkansas
Wayne R. Carlsen, DO
Geriatrician
Athens, Ohio
Mary T. Herald, MD
Internist
Westfield, New Jersey
Sandral Hullett, MD
Family Practitioner
Eutaw, Alabama
Stephen A. Imbeau, MD
Internal Medicine/Allergist
Florence, South
Carolina
Jerilynn S. Kaibel, DC
Chiropractor
San Bernardino, CA
Derrick L. Latos, MD
Nephrologist
Wheeling, West Virginia
Dale Lervick, OD
Optometrist
Lakewood, Colorado
Sandra B. Reed, MD
Obstetrician/Gynecologist
Thomasville, Georgia
Susan Schooley, MD
Family Practitioner
Detroit, Michigan
Maisie Tam, MD
Dermatologist
Burlington, Massachusetts
Victor Vela, MD
Family Practice
San Antonio, Texas
Kenneth M. Viste, Jr., MD
Neurologist
Oshkosh, Wisconsin
HCFA Staff at the March 15 Meeting:
Aron Primack, MD
Executive Director
Practicing Physicians Advisory
Council
Medical Officer
Center for Health Plans and Providers
David C. Clark, RPH
Director
Office of Professional Relations
Center for Health Plans and Providers
Bernice Catherine Harper, LLD
Office of Professional Relations
Center
for Health Plans and Providers
John P. Lanigan
Office of Professional Relations
Center for Health
Plans and Providers
Grant Bagley, MD
Director
Coverage and Analysis Group,
Office of
Clinical Standards and Quality
Robert Berenson, MD
Director
Center for Health Plans and Providers
Rick Fenton
Deputy Director
Family and Children’s Health Program Group
Center for Medicaid and State Operations
William Gould
Senior Health Insurance Specialist
Office of Financial
Management
Thomas Gustafson, PhD
Director
Plans and Provider Purchasing
Center
for Health Plans and Providers
Steven Jencks, MD
Director
Quality Improvement Group
Office of
Clinical Standards and Quality
Robert Loyal
Technical Advisor
Division of Provider Supplier
Enrollment
Office of Financial Management
Gerald Wright
UPIN Project Officer
Division of Provider Supplier
Enrollment
Office of Financial Management
________________________________
Ted Cron, Consultant Writer-Editor
======================================================
Public
Witness:
Herman Abromowitz, MD, American Medical Association
The 29th meeting of the Practicing Physicians Advisory Council (PPAC) took place on Monday, June 14, 1999, in the Multipurpose/Auditorium of the HCFA Administration Building in Baltimore, MD.
Dr. Kuffner called the meeting to order at 8:30 AM. The first staff witness was Dr. Robert Berenson, who referred to the May 6th letter from Eric Anderson of the AMA in regard to the re-chartering and the future of PPAC and other matters. Dr. Berenson suggested...
Impact of the BBA: The Council responded, noting that (1) the BBA impact on fee-for-service beneficiaries and physicians was different from the impact on those in managed care, and (2) the discussion has been almost exclusively on Medicare, although the BBA impacts on Medicaid populations (especially children) can be equally devastating. Dr. Berenson agreed, adding that all BBA issues were now on the table.
The Council indicated strong willingness to assist HCFA in reviewing and responding to the CPT panel’s report; it was recommended that the Panel’s Report be put on the agenda of PPAC’s September meeting. The Chair also suggested that, in light of Dr. Berenson’s remarks, that the September meeting be switched from Monday to Friday to enable senior HCFA personnel to attend.
The Chair then welcomed William Gould, who described HCFA’s far-reaching, nationwide, physician education effort on Y2K: e.g., a 20-person outreach team from HCFA headquarters, 50 persons from the regional offices, 22 national conferences, 40 “learning sessions,” etc. Mr. Gould said physicians need to understand that “Y2K really is...a business continuity issue,” involving communications between providers and “the contractor systems and the payer systems,” including HCFA’s billing and reimbursement systems.
A “Freeze” That Is Not Frozen: HCFA is confident that its “25 internal mission-critical systems” and “all 75 of our contractor systems are compliant,” Mr. Gould reported, adding that HCFA will install fee schedule updates for the skilled nursing, home health, and Part A programs on October 1 and will provide Year 2000 updates for physicians on January 17. He also explained that the misnamed “freeze” is really a pause in HCFA’s system to make adjustments but is not a freeze on payments or other business transactions.
Mr. Gould reviewed the aid (and requirements) being given to States but noted that HCFA cannot provide assistance to physicians. However, HCFA recently sent physicians a letter about Y2K, and Mr. Gould urged physicians to take seriously their legal liability with regard to the problem. He suggested that all physicians consult HCFA’s Website for tips, dial its toll-free number (1-800-958-HCFA), and pursue a five-step process of becoming aware of the problem, assessing what has to be done, renovating the system as needed, testing the system, and finally setting up a contingency plan...just in case.
States Are “Silent” Partners: Council reaction was mixed, applauding HCFA’s efforts but observing that very little of it seemed to be reaching the practicing physicians. Of those attending the June 14th meeting, a large number indicated they had never received HCFA’s letter. Other Members observed that State Medicaid agencies are “notoriously silent” to Y2K inquiries from Medicaid providers. Mr. Gould noted that HCFA is in a “partnership” with the States and is precluded from initiating a release of negative results from its 35-State survey. The Council, therefore, recommended that if, after a “60-day waiting period,” a particular State plan does not make public the results of the HCFA survey of State Y2K compliance efforts, HCFA should be free to make that State’s results public.
The Council also recommended that HCFA gather into one Web super-site the data on compliance among equipment manufacturers, labs, and others; but Mr. Gould reminded the Council that FDA has a substantial Web super-site listing some 14,000 or so manufacturers and their level of Y2K compliance. In any case, the Council recommended that HCFA devise a way to inform Medicare beneficiaries of potential Y2K problems with home health equipment.
Herman Abromowitz, MD, a Trustee of the American Medical Association, was the meeting’s only scheduled public witness. Dr. Abromowitz reviewed the Y2K issues facing physicians and urged HCFA to expand its physician education efforts and alert patients, in a timely and non-hysterical manner, to the Y2K issues that involve life-saving medical equipment and drugs. Council Members were concerned that home health care patients were not being warned of possible Y2K problems in their equipment. Dr. Abromowitz said this is a role for their attending physicians—provided the information is available to them—but neither he nor the Council felt this was being accomplished.
CPT Report Scheduled for September, Also: Although the CPT Editorial Panel report and HCFA’s proposed documentation guidelines were not on the agenda, Dr. Abromowitz went on to note that the Panel had produced an alternative set of “patient-centered and clinically relevant guidelines that can be used consistently and accurately by physicians and health plan providers.” However, because the subject had not been listed in the Federal Register notice for the June 14 meeting, Dr. Kuffner suggested that further discussion be postponed and the matter be added to the agenda for the September meeting. Dr. Primack urged Members to consult the HCFA Website for the full text of the proposed E&M Guidelines, as preparation for the discussion at the September meeting.
The Chair next welcomed Dr. Grant Bagley, who reviewed for the Council the progress thus far in the use of negotiated rulemaking to develop uniform laboratory coverage policies for laboratory tests, as mandated by the BBA. Dr. Bagley described the lengthy and complex process of chartering an 18-person advisory committee that represented all interested parties: physicians, laboratories, insurance carriers, consumers, etc.
The committee dealt with many difficult issues: e.g., when do you use a metabolic panel? how should claims be processed? what is the “date of service”? what should be done about “point-of-care” testing? and what about such controversial matters as “chemo-sensitivity testing,” “extreme drug-resistance testing for oncology patients,”and cutting-edge technologies like triponents ? Despite the complexity of the task, the advisory committee did get “most of the high-volume tests out of the way,” Dr Bagley said.
The Rule Over a Year Away: The January deadline was missed, said Dr. Bagley, but a “proposed rule will be out later this year,” followed by a 60- or 90-day comment period. A final uniform rule on lab tests for Medicare Parts A & B, dealing with most of the key issues, will be published possibly early next year and take effect a year after that. The Council requested that the comment period not end before PPAC’s September meeting, so that Members may contribute to the NPRM record. Dr. Bagley indicated that the NPRM may not in any case be published by September, since HCFA’s draft is still being vetted in the HHS Departmental review process and then must go back to the advisory committee for its sign-off. The Council then recommended that the NRM rule be placed on its December agenda.
Dr. Bagley also noted that the advisory committee felt the final rule ought not to go into the Code of Federal Regulations because “that was not a very flexible mechanism...because, after all, you change codes. You're going to change ICD-9 codes. We're going to have to continually update and work on these policies. So,” Dr. Bagley said, “the policies will go into the coverage issues manual, which is easier to change as we update policies. But once...there, [they] will be national, uniform policies.”
After a short, mid-morning break, Dr. Bagley returned to the witness table to discuss HCFA’s new approach to decision-making with regard to coverage policies. He noted that HCFA had published a proposed rule in January 1989 but could never get all interested parties to agree on a final rule; hence, none was ever published. The operative approach was for HCFA to “pay for something ...when it is...‘medically necessary,’” a determination made by individual physicians and reviewed by carrier medical directors, an approach that has allowed a great deal of local decision-making latitude across the country. Now, after 10 years of experience and with help from other PHS and HHS agencies, the stage is set for the agency to move ahead with a final rule. Dr. Bagley said that, under the proposed rule (still in the concept stage), HCFA will look at such things as “the peer-reviewed literature...authoritative studies...technology assessments ...randomized trials...medical evidence [indicating] clinical benefit...and risks and benefits,” when determining what is to be covered for payment.
A Simple Letter Can Start It: Anybody can start the process of coverage decision-making, as the FR notice indicates, by sending HCFA an ordinary letter with some kind of supporting medical evidence. The simplicity of this informal opening process should have great appeal to ordinary physicians and beneficiaries, as well as to manufacturers and special interests. If HCFA accepts the letter’s premise, then “we will deal with it within 90 days,” said Dr. Bagley. In response to Member questions, Dr. Bagley...
Meanwhile, the accumulation of good medical evidence can be very time-consuming for review by the advisory committee panels; hence, the proposed coverage process will still be a long time in development and efficacy.
The AMA Recommends Separation: The AMA’s Dr. Abromowitz returned to the witness table to make several additional points, including the plea that HCFA’s “coverage policy process be separated from its fraud and abuse and program integrity activities.” Dr. Abromowitz also urged PPAC to oppose HCFA’s attempt to permit managed care plans to hide their own decision-making process within a HCFA-sanctioned “black box,” away from patient and physician scrutiny. Dr. Kuffner noted that the latter issue was not on the day’s agenda but that the concept of separation might well be included in the September agenda. She then recessed the meeting for lunch.
The Chair welcomed Dr. Steven Jencks to the witness table to provide an update on quality improvement activities. Dr. Jencks indicated that nothing new was taking place, other than “a new emphasis on PRO partnerships for success in the 6th Scope.” Dr. Jencks described several PRO-provider/PRO-consumer partnerships and gave examples from Georgia, Arizona, and Michigan. Council Members indicated general approval of the direction HCFA is taking in the 6th Scope of Work: i.e., focusing again on quality of care rather than on fraud and abuse.
The next HCFA staff witness was Mr. Rick Fenton, who came to alert the Council to HCFA’s response to the January 1999 GAO Lead Screening Report, which indicated that high-risk, Medicaid-eligible children were not being adequately screened for high blood lead levels. (The Chair noted that this was possibly the first strictly Medicaid issue to be on a PPAC agenda.) Three of every four children with elevated blood levels are covered by Medicaid and should be screened twice a year under Early and Periodic Screening, Diagnosis, and Treatment (EPSDT) up to the age of 2...but too many are not.
The fault seems to lie with managed care plans (some HMOs actually employ physician screening disincentives), State Medicaid agencies (too few make lead screening and data collecting priority activities), and providers of child health care (physicians are daunted by poor reimbursement policies, confusing test procedures, and inadequate pharmaceuticals). HCFA has joined with the Centers for Disease Control and Prevention (CDC) and the Health Resources and Services Administration (HRSA) to gather data and devise a plan of action, which would include more public and physician education.
Kinks Remain in the System: The Council approved of Mr. Fenton’s approach, but noted that there is still a discrepancy between HCFA’s guidelines and those developed by CDC and the American Academy of Pediatrics. Also, the agency has not ironed out the kinks in its data collection system in order to ensure standard, consistent, and timely reporting of prevalence data by zip-code-plus-four, for example. (A full statement on the issue was prepared and presented by Member Dr. Jerold Aronson.)
A stronger argument was made by those Members who decried the low value given lead screening (and other preventive health measures) by HCFA, whether by statute or regulation, making it impossible for many physicians, especially those serving inner-city children, to do the work and get reimbursed for it. The Council reviewed the problems in Detroit, Alabama, and California (where a Medicaid increase was just enacted; but, the Council noted, most of the increase stops at the level of the managed care organization and little of it reaches down to physicians).
More Trickle-Down Funds Are Needed: The Council agreed that additional funding was necessary to accomplish lead screening goals, but that the funds should not to be included in the capitation rate, because experience indicates that the additional money will not “trickle down” to the physicians on the line.
The Chair welcomed Mr. Robert Loyal, who noted that HCFA is striving to make the process for securing a PIN more “user-friendly” to physicians and institutions. After soliciting opinions from health care professions and institutions at a HCFA “town meeting,” Mr. Loyal said the agency is looking at...
A New Regulation for “855": In addition to working on a project to revise and streamline the Form 855, HCFA will, in the near future, publish a proposed regulation covering the enrollment and revalidation of providers, said Mr. Loyal. The regulation will “relate to establishing and maintaining Medicare Provider billing privileges.” The new rule will also clarify HCFA’s requirements for a provider’s “initial enrollment and ...subsequent revalidation...on some periodic basis,” such as once every 3 years, which Mr. Loyal noted, is the approach used “with...durable medical equipment suppliers.” Group practices will apply as a group, but each member, will have to apply individually, also.
The proposed “user-friendly” application is now 17 pages long and takes (“conservatively”) about 3 hours to complete. Another innovation is PECOS (provider enrollment and chain ownership system), planned for implementation in FY2000; this system will gather from carriers and intermediaries the validated data being collected via the 855.
Why Not a Signed Release?: The Council offered a number of suggestions, such as HCFA sending a provider a printout of the information on record and having the provider sign off or make the appropriate changes. Some Members also noted that the 18-month “turnaround time” for the initial enrollment means that new physicians, especially recent graduates, must try to earn a living for a year and a half without access to the Medicare patient population. Because certain contractors have been slow and unresponsive, the Council suggested that Mr. Loyal set up an ombudsman system for physicians caught in such a bind. The Council also strongly recommended that HCFA do a pilot test of the new PIN application and revalidation system.
Mr. Loyal is interested in receiving the specifics regarding any applications as described above, in order to determine the nature of the problem an fix it.
“From a Simple Way...to 17 Pages”: The Chair recalled that the reason behind this new system was the allegedly flagrant fraud and abuse a few years ago by some durable medical equipment suppliers whose only real business was printing stationery and filing false claims. The issue was not physicians. “All of a sudden,” said Dr. Kuffner, “we go from a simple way to...apply for a Medicare number to...a 17-page form which isn't user-friendly,...all of this in an effort to prove...that the doctor really is a physician, alive and licensed.”
The Council argued that a physician’s false statement to HCFA about a criminal record would have to be checked with the State licensing board anyway. In that case, the Council wondered why HCFA didn’t merely ask every physician to sign a one-page release form authorizing a State board to verify his or her existence and good character. However, Mr. Loyal responded that the proposed regulation “will require the collection of information uniformly across the nation, provide the government— through its contractors—with the ability to deny enrollment where individuals fail to provide certain information essential to the enrollment process or who provide false information as part of the enrollment process.”
Very Few “Horror Stories”: The UPIN Project Officer, Mr. Gerald Wright, then joined Mr. Loyal at the witness table in order to respond in more detail to Member concerns. Mr. Wright said that the “horror stories” of enrollment delays and revalidation confusion are rare exceptions and not the rule for his program. He went on to explain that “the major issue is that we have spent 25 years allowing our contractors to collect this information. We're now trying to standardize that information.” But, Mr. Wright admitted, some physicians “do not have that information readily available and that causes some delays.”
Mr. Wright also noted that a physician could use the new form 855 to apply to other health care programs as well (VA, CHAMPUS, etc.), but he or she must follow the application processes of those agencies. In any case, the new 855 will not be in effect until next year.
The Chair next welcomed Dr. Thomas Gustafson to the witness table to report on protections for providers—especially chiropractors—in managed care plans. Dr. Gustafson recalled that HCFA released a report on April 12, 1999, regarding manual manipulation of the spine to correct a subluxation. Unfortunately the report was based on 1991 data. The Office of the Inspector General (IG) is now preparing a new report, building on a report they issued in January but with new survey data that will give a more accurate picture of the delivery of this service as well as the status of chiropractors in Medicare+Choice.
Dr. Gustafson, reported that HCFA expects to issue an “operational policy letter” to managed care plans in the Fall that will emphasize the need to make manual manipulation of the spine to correct a sublation, which is part of the regular Medicare benefit package, available to Medicare beneficiaries enrolled in managed care plans.
Who Delivers Manual Manipulation Services?: The Council asked if non-physicians, such as physical therapists, can legally provide and bill for "manipulation of the spine to correct a subluxation." Dr. Gustafson noted that the agency had recently concluded that managed care plans must make physicians, which include but are not limited to chiropractors, available to deliver this service. However, he was not sure if that clarification had been disseminated to all managed care plans. Dr. Gustafson also noted that some observers were concerned about the possibility that provision by managed care plans for the delivery of manual manipulation of the spine to correct a subluxation was, some standard, not adequate.
The Council emphasized that failure to make this service available would be contrary to the law, which says that all Part B services must be made available to Medicare beneficiaries enrolled in HMOs. Dr. Gustafson replied that, while the law required plans to deliver the subluxation-correcting service, the law does not require the plans to contract with any particular class or group of providers for any particular service. Dr. Gustafson added that HCFA is considering how to ensure plan marketing materials make clear what types of providers are available through the plan.
A “Final-Final” Rule Is on the Way: HCFA is operating under an “interim final rule” in the managed care arena, in order to keep pace with fast-moving events in the field, said Dr. Gustafson. A second “final-final” rule (now in a 475-page draft) will be published in the Fall. Among other issues, this rule will respond to comments relating to two provisions of the law, one of which prohibits discrimination by a managed care plan against any recognized provider of health services, while the other assures plans of the freedom to contract with or hire whomever they wish. (In any case, a provider has to already be a contractor to have a standing to appeal.)
Members countered that a provider who may have suffered plan discrimination has no way of appealing the plan’s action; they noted that such negative actions by the plans are often shrouded under the cloak of “proprietary data.” Dr. Gustafson indicated he was not clear if that was the case or not. The Chair suggested and the Members agreed that provider protections under managed care ought to be added to the September agenda. Members asked Dr. Gustafson to list a few questions (“three to five”) that he and his staff would especially like PPAC to ponder in September.
As to last year’s exodus of plans from the Medicare program, Dr. Gustafson said there were many reasons, but Medicare regulations seemed to play a comparatively small role in those decisions. This year, he thought that plans continued to be more concerned with Medicare’s payment rates than with the Medicare+Choice regulations.
Final Comments
In the remaining minutes before adjournment, Council Members reviewed the day’s agenda and their reactions to it. They generally affirmed...
The Chair promised to e-mail a consolidation of these comments to Mr. Loyal.
The 29th meeting of the Practicing Physicians Advisory Council was adjourned by the Chair at 4:10 PM. The next meeting will be in Washington, D.C., on ________, September __, 1999.
Marie G. Kuffner, MD
Chair
Practicing Physicians Advisory
Council
The Honorable Donna F. Shalala, PhD
Secretary
Department of Health and
Human Services
200 Independence Avenue, SW
Washington, DC 20201
Dear Secretary Shalala:
I am pleased to submit to you Report Number Twenty-Nine of the Practicing
Physicians Advisory Council (PPAC). This Report summarizes the deliberations
held on June 14th in the HCFA headquarters in Baltimore. It was a very
productive meeting in which HCFA staff and Council Members raised a number of
substantive issues important to practicing physicians, as the enclosed Report
will indicate. The success of this meeting was due in no small measure to the
seriousness with which the Members of the Council approach their task and with
the excellent cooperation and forthcoming presentations by the HCFA
staff.
It was generally agreed that the
Council’s effectiveness would be greatly enhanced, if its meetings could somehow
take advantage of HCFA leadership meetings. Similarly, we felt that a
representative from your Immediate Office of the Secretary would also facilitate
the discussion as well.
Marie G. Kuffner, MD
Chair
Practicing Physicians Advisory Council
Enclosed: PPAC Report Number Twenty-Nine
Attachments
Last Updated September 15, 1999
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