SECRETARY'S ADVISORY COMMITTEE ON REGULATORY REFORM REGIONAL HEARING #3
MEETING MINUTES/SUMMARY 

April 17, 2002
Ramada Plaza Suites & Conference Center
Philadelphia Room
Pittsburgh, Pennsylvania

Dr. Wood, the Committee chair, encouraged the day’s speakers to provide their ideas for solutions, not just descriptions of problems.

Ms. Brand, director of the Office of Rural Health Policy, said rural areas, defined for some purposes as areas with fewer than 50,000 people, have one-fifth of the nation’s population. Rural residents are disproportionately elderly. Fewer health care providers are available to them, the hospitals they use are smaller, and they are more likely to be uninsured than urban and suburban dwellers. The Office of Rural Health Policy was created in 1987, and it often deals with the "unintended consequences" of national policy decisions. A recent Rural Task Force in the Department of Health and Human Services (HHS) found that small-town mayors and administrators had trouble figuring out where to access the HHS bureaucracy, and the department is working to create clearer rural liaisons. Current initiatives include a "flex" grant program for critical-access hospitals, a capital program to refurbish hospitals, payment increases for community health centers and core service providers, tele-health and distance learning programs, and pilot grants to small hospitals.

Mr. Hoyer said the government has been coming to terms with rural health needs gradually over the last 30 years. When Medicare was enacted as a national program, it was intended to be the same everywhere with cost-based reimbursement. The introduction of prospective payment for hospitals in 1983 did not particularly suit rural areas. By the late 1990s, legislation began to address rural needs specifically, with attention to critical-access hospitals, rural payment, and tele-medicine. In an effort to work better with rural providers, regional offices of the Centers for Medicare and Medicaid Services (CMS) now have rural health coordinators, and Administrator Tom Scully has begun an "open-door" process to vet issues. Current issues include payment, the burden of regulation on small facilities, use of Minimum Data Set (MDS) data, rules governing the use of physician assistants and nurse anesthetists, storage of medical records, uniform surveys for critical-access hospitals, and special rules for entities that are both hospitals and home health agencies.

Mr. Trysla talked about CMS Administrator Tom Scully’s open-door meetings. Current issues include the burden of Emergency Medical Treatment and Active Labor Act (EMTALA) regulations on small facilities, cost reports, how "sole providers" are affected when "like" providers exist within 35 miles, the ability of rural hospitals to get provider numbers for their weekend contract physicians, staff status as independent contractors vs. employees, and the 855B process. CMS’s open-door initiative is an effort to compensate for the fact that rural hospitals do not have the resources to hire consultants and lobbyists to influence and interpret CMS regulations.

9:38 A.M. The committee joined the Rural issues conference call in proGRess

Issues discussed included survey rules on waiting rooms; the role of "allied health professionals" (physician assistants and nurse practitioners); difficulties rural hospitals face in getting provider numbers for their temporary and locum tenens doctors; tele-medicine; operating hours for rural clinics; secondary payer forms; and advance beneficiary notices (ABNs).

10:05 a.m. Break

Mr. Harman, a hospital administrator, said West Virginia hospitals are in financial trouble, with rising costs and inadequate reimbursement for care such as delivering babies. Proposed home health cuts will hit rural providers hard. Rural areas have high rates of uninsured people relying on charity care, as well as high rates of disease. His recommendations include releasing regulations in a coordinated fashion, factoring the cost of implementation into payments, limiting data collection for the Outcome and Assessment Information Set (OASIS) to payment-related items, eliminating redundant consent requirements in the Health Insurance Portability and Accountability Act (HIPAA) regulations, giving providers a HIPAA exemption for "incidental" disclosures of information, and relaxing HIPAA’s business associate requirements. Other recommendations include providing more J-1 visas for foreign doctors to serve rural areas, increasing payment for critical ambulance services (and switching to a cost-based system), and tort reform for malpractice cases.

Tim Size, Rural Wisconsin Cooperative
Sauk City, Wisconsin

Mr. Size, executive director of the cooperative, talked about Secretary Tommy Thompson’s efforts as Governor of Wisconsin to simplify regulations for rural areas. He recommended institutionalizing the rural task force and open-door process within CMS to allow rural providers to comment on new legislation and regulations; disaggregating all health data to study the particular needs of rural areas; doing a rural impact analysis on all new regulations; more research on best practices for rural areas; and fundamentally changing the prospective payment system in rural areas to reflect labor market costs and the higher rates of cost-shifting across payers.

Dr. Wayne Myers
Maine

Dr. Myers, a pediatrician and former director of the Office of Rural Health Policy, said simple laboratory tests like a blood count should not require a diagnosis code, so that doctors don’t have to second guess their real diagnosis in order to get paid. This is particularly difficult as different fiscal intermediaries, labs and hospitals all have different diagnosis requirements. Rural hospitals rely heavily on foreign doctors under the J-1 visa program, and they could better use nurse practitioners for ambulatory care. More rural health policy research is needed to identify provider models that work well there. Congress often punts rural issues to the Secretary of HHS, and it’s difficult for rural providers to navigate multiple layers of the agency to get their needs heard. The Office for Rural Health Policy should be given standing to work out all waivers and exceptions of regulations for rural areas.

Dr. Mona Counts, Primary Care Center of Mt. Morris
Mt. Morris, Pennsylvania

Dr. Counts, a nurse practitioner, said nurse practitioners need to be recognized as providers under Medicare Part A for hospice and home health work. There should be a universal application for credentialing, rather than the current system where nurse practitioners must re-apply in different states for billing purposes. Rural organizations need outreach and technical assistance to help them write grants and secure funding from already available programs.

Raymond Bahl, Apprise Counselor
Pennsylvania

Mr. Bahl talked about Apprise, a volunteer program that helps seniors get information on Medicare, Medicaid, Medigap, long-tem care, and Medicare+Choice (M+C) options, as well as how to navigate the appeals process and the paperwork. The lack of a Medicare prescription drug benefit is the main problem seniors are talking about. They wonder why drugs are cheaper in Canada and why only some seniors qualify for drug company discounts. Medigap providers are not clearly explaining the difference between "issue age" and "attained age" in the contracts. The Medicare summary of benefits notice is confusing when it says "THIS IS NOT A BILL," but you may be responsible for the charges.

The committee and the panel discussed tele-medicine and inter-state barriers that arise; HIPAA business associate requirements; beneficiaries who are not helped by means-tested programs; the evolution of rural advocacy in federal health policymaking; and community-based care delivery models.

Paul Smith, a former durable medical equipment provider, said carrier audits drove him out of business, but that the U.S. Attorney declined to prosecute him for Medicare fraud after years of scrutiny. Carriers are arrogant, condescending and confrontational, he said, and they base recoupment on an extrapolation from a small audit sample. Mr. Smith is running for Congress.

Phyllis Fredland, a home health agency executive director from Pittsburgh, said the OASIS home health assessment tool and HIPAA requirements greatly increase her costs. OASIS duplicates other work and contributes to nurses’ frustration with the profession. She recommended requiring only the payment-related questions and increasing home health payments, especially for resource-intensive patients. Carriers often ask for additional documentation, which creates high printing costs. They should be required to get the information electronically and to examine the OASIS record first before sending a request, since what they want is often in the record.

Dr. Robert Urban, a rural family practice physician and president of the American Association of Physicians and Surgeons, said government has encroached on physician autonomy in many ways. Greater use of medical savings accounts could restore that autonomy, but the regulations currently governing the accounts are unnecessarily restrictive and appear designed to make them fail as a viable insurance product.

Dr. James Pendleton, a retired psychiatrist from Philadelphia, also recommended a market-based approach to health care with greater use of medical savings accounts. They would promote wise spending and allow patients to know prices ahead of time. He recommended that CMS form a medical savings account task force.

Kay Bishirjian, with the American Dietetic Association, said that dieticians should be included in the National Health Service Corps to work in conjunction with physicians in rural areas to treat chronic diseases such as diabetes.

Dr. Dean Cross, a cardiologist from rural New York, said American health care is in a crisis. Low Medicare fees and new requirements to submit claims electronically are hurting small, cash-strapped doctors’ offices. Different sources within CMS often give different answers to the same question. Medicare should pay doctors more and reward appropriate care. Small offices should be exempt from electronic claims requirements.

Mr. Tirone, director of federal relations, said JCAHO is a not-for-profit accrediting agency for hospitals, home care, health care networks and nursing homes. Forty-five states allow "deeming" for at least some providers, whereby JCAHO accreditation satisfies state requirements. Areas of difficulty include survey and sampling, data extraction, coordination of data requirements between government and private groups and the very slow process for updating regulatory requirements. He recommended CMS approval of the proposed 2000 Life Safety Code, expanded deeming, better data sharing, and revision of the data validation process. HHS regulations are often written in very detailed form, which makes it difficult for JCAHO to adapt to changing circumstances; the agency needs either a quicker update process or more broadly written regulations.

Mr. Webber, vice president of external affairs, described NCQA’s work accrediting health maintenance organizations, preferred provider organizations, provider networks, behavioral health programs, and disease management programs. NCQA’s work is recognized by 24 states as meeting or exceeding state requirements. Health plans with business in multiple regions face conflicting requirements and multiple reviews. He recommended less frequent surveys for good performers, prominently displaying good ratings to incentivize good performance, using evidence-based performance standards, allowing adequate lead time on new requirements, standardizing requirements across government and private programs, expanding the use of deeming to meet government requirements, and changing the M+C survey cycle from two to three years to bring it in line with NCQA and make joint surveys possible.

Ken Segel, Pittsburgh Regional Health Care Initiative

Mr. Segel, director, described the work of the initiative, which began in the late 1980s and includes 40 area hospitals and hundreds of clinicians. The initiative’s goal is to work for "perfect" patient outcomes by solving problems at the point that care is delivered. The science of improving complex adaptive systems requires that reformers have few goals, let parts of a system learn from one another, and provide robust support for localized learning. The initiative is generating risk-adjusted outcomes measurements. It bases its review on information that physicians find useful, which generates better data. Some areas of work have been on medication errors and infections acquired in healthcare settings. One burden providers face is the wasteful need to recall and re-issue medications when a patient is discharged from the hospital to rehab. People often assume that regulations constrain more than they actually do.

Q&A

The committee and the panel discussed coordinating care across providers, the evolution of managed care, and possible changes to the regulation development process.

1:15 p.m. multiple reviewS, panel two

Mr. Eckenrode, senior vice president of the center’s insurance division, said multiple governmental and non-governmental entities scrutinize his health system, making complex and repetitive demands. They all want the same or similar information on their own timelines, which creates a burden for the hospital staff. More coordination is needed.

Elizabeth Concordia, University of Pittsburgh Medical Center

Ms. Concordia, president and CEO of two of the center’s hospitals, recommended a standard insurance form and uniform claims submission guidelines; using "Smart Card" technology to free up the staff from transcribing information from one form to another at discharge; reforming the Medicare appeals process; eliminating cost reports for skilled nursing facilities, since payment is not contingent on them; and having fewer and better-coordinated surveys that share already assembled information. The medical center would welcome the opportunity to pilot test a reform demonstration.

Dr. Daniel Martich, University of Pittsburgh Medical Center

Dr. Martich, an associate professor and medical records director, described the evolution of the physician’s progress note, which is now tied up with billing concerns and other legal obligations. Frequently changing guidelines and audits by the Office of Inspector General (OIG) generate much anxiety among doctors and take away from patient care. He recommended standardizing medical notes, using pick lists and electronic records, adopting a "chart it once" rule to eliminate duplicate note writing, and documenting by exception (reporting only the unusual results).

The group recommends eliminating or simplifying cost reports, improving consistency of rules across CMS regions, getting better guidance to providers, streamlining the Evaluation and Management (E&M) documentation guidelines, and coordinating regulations across agencies. The medical center is willing to pilot test these changes.

Q&A

The committee and the panel discussed the latitude that HHS has in conducting demonstration projects, use of Smart Cards to share patient information, the business relationship between accrediting agencies and those they evaluate, opportunities to coordinate surveys across agencies, oversight of accrediting agencies, coordination of regulations as patients move between different types of providers, and prospects for the use of deeming to accredit long-term care providers.

2:15 P.M. Adjourn for day, site visits

Meeting summary prepared by John McCoy, Health Policy Analyst Mathematica Policy Research, Inc.