December 1, 2000
What happened to the NPDB & Campbell Anti Anti-Trust Bill
The opening to the public of the NPDB is till a possibility but the House champion of the measure Rep. Tom Billey Jr. (R-Va.) is retiring. As of now no one has stepped forward to take his leadership position on this bill.
The bill sponsored by Congressman Campbell to allow physicians to be exempt from antitrust laws passed the House by an overwhelming vote (276-136). It then went to the Senate where it is essentially dead. Campbell could get no Republican or Democratic Senator to sponsor the bill. Why is that, you may ask. The Democrats did not want to help since Campbell was running against Diane Feinstein for the California Senate. The Senate Republican leader, Senator Lott, believes that the passage of the bill would lead to more law suits and more labor unions. The Republicans are also not happy with the AMA for their stand in favor of the Democratic Patient’s Bill of Rights. The Allied Health Practitioners are also against it. They believe they will be left out of any bargaining demands. The good news is that many state legislatures are considering proposal to allow some joint bargaining. California, thanks to the CMA, is one that is still considering it, but not very strongly.
JCAHO has stated in its recent newsletter that HR standards do not apply to volunteers but do apply to contract personnel. The institution may both review and adopt that contractor's policies or have their own and require the contractee to conform to theirs. The verified information required, depending on the relevancy, is education, licensure, evidence of one’s knowledge, experience and competence, evaluation, health, criminal background checks, and references. Either the contracted organization or individual or an audit of information may supply verification by the contracted organization. Audits must include an attestation of the accuracy of the information. When a JCAHO institution contracts for staff they must also define the requirements and review the practices of the contracted organization for compliance with the requirements. If the contractors are not doing the necessary things the organization can do their own checks.
Documentation authentication time is up to the individual institutions or state law. Whatever the institution decides must be complied with. If the timeframe is in hours the signature and date must include the time of the signature to ensure compliance.
Operative reports summaries must be written immediately post operative and prior to the patient going to the next level of care, the post anesthesia care unit.
The top ten hospital accreditation problems are HR.5, competence assessment; TX.3.5, Care; IM.7.7, Patient Data; PE.1.7.1, Assessment; HR.4.3, Staff Education; IM.22.214.171.124, Patient Data; PE.1.7, Assessment; IC.4, Infection Control; LD.126.96.36.199, Leadership, and PE.1.3 Assessment.
No credentialing nor privileging are required for organ harvest teams coming to a hospital if the Organ Procurement Organizations (OPO) and the hospital have a memo of understanding that the OPO will only send qualified, trained individuals.
Happy news. The JCAHO will begin conducting surveys during the evening, night and weekend shifts for full surveys. Those organizations surveyed about this were overwhelming in favor. They must be smoking good stuff.
The survey for compliance of restraint and seclusion standards for one hour face to face meetings by physicians or other licensed independent practitioner with the proper authority in the medical and surgical floors for behavioral problems or in behavioral health floors or institutions began September 1, 2000. One needs evidence of performance via medical records, restraint logs, policies and procedures, staff interviews and patient interviews. This rule includes side rails and gerichairs when they restrict a patient’s movement. One must consider and document what may happen if the restrain is used versus what may happen if it is not used and is it the least restrictive means.
As mentioned in my July and October 2000 newsletters, JCAHO has changed some of their criteria. The ones that affect the medical staff the most are (1) what needs to be the policy if a patient undergoing conscious sedation inadvertently slips deeper into moderate or deep sedation; (2) Fair hearing procedures for AHPs; (3) When a physician only covers the institution by telemedicine you do not need full credentialing, but do need a policy; (4) Reappointment information must contain specific Performance Improvement information about each specific practitioner as compared to peer data and (5) how to have effective peer review policy. Please go to the JCAHO web site for detail on these standards, www.JCAHO.org.
Another new rule to start on 1/1/01 is documentation what to do in the event of a disaster. The EC.1.6 requires a hazard vulnerability analysis identifying special procedures in response to different disasters. You must look at and document what could happen such as power failures and what precautions to take. The plan must include a description of how, when and by whom the plan is activated. It does not state if a JCAHO inspection is considered a disaster.
Another national consulting firm has just come out with a new impaired physician policy. The policy preamble states that (1) the impaired physician is not entitled to a fair hearing and (2) the hospital CEO plays a significant part of the process with the medical staff leadership. "This is because an impaired physician is a hospital concern, not merely a medical staff problem." This consultant, who works for hospitals, believes the CEO should be the point person. I agree that both the hospital and medical staff need to be involved but I believe that the Chief of Staff should be the lead and give reports to the CEO. A different way, but one that keeps control in the hands of physicians and not administrators. For my views please see the article on disruptive physicians at
Copying of Credentials File
Physicians who wish to copy information such as licenses from their own files should be allowed to do so except for those items such as confidential letters of reference. Each hospital medical staff should have a policy stating their copying policy. The physician should be allowed access to all information in their files except for the letters of reference and be allowed to place rebuttal statements in the file.
URAC Credentialing Changes
The URAC, which credentials managed care organizations, has gone to a three-year cycle and removed the requirement for primary verification of hospital privileges. They have also gone on some standards from "must" to "should." Sounds like they want the business over the NCQA.
The Election Re: Health and Pot
The People’s Republic of Massachusetts suffered a setback when the voters went against Question 5 that would have mandated a 17-person committee implement a system to guarantee comprehensive health coverage for all residents by July 2002. It also mandated that HMO’s administrative costs and executive salaries not exceed 10% of the revenues. Lastly, it would have banned the entry into the state by for profit health care plans. I have no idea what "comprehensive health coverage nor how this was to be financed" mean. I also do not believe that any business can be mandated into what their overhead may be.
The Massachusetts Secretary of State smarting from the defeat of Question 5 wants legislation to curtail political spending by non-profit HMOs. This would occur by allowing consumers to withhold premium amounts if they did not agree with the HMO’s political stance. These organizations spent about $5 million to defeat Question 5. The Secretary also used public funds to promote Question 5, but doesn’t comment on that. Harvard Pilgrim stated its contribution was $1.1 million or $1.10 per member. The HMOs stated that if Question 5 passed, premiums would have been raised several hundred dollars per year per consumer.
The state employers and HMOs are now working together to do in a stepwise approach to covering the uninsured.
California passed Proposition 36 that allows first and second time drug users to be placed in rehabilitation instead of or in conjunction with jail time.
In California we have Proposition 215 that allows marijuana use with physician recommendation. Colorado voted to also allow patient use of marijuana use for certain diseases. These patients would be in a state database. As in California there was no provision for distribution. The Colorado Feds stated that they will continue to classify marijuana possession as a crime, but small amounts will probably not be prosecuted. Nevada has also gone with marijuana use for certain conditions by passing a state constitutional amendment by a 65-35%vote. Alaska went the other way by voting down a drug which would not only have legalized the drug but would have given amnesty to those previously convicted of marijuana crimes. In the most interesting election to me, the citizens of Mendocino County, California voted to allow county residents to grow 25 marijuana plants each. I have a feeling we have not heard the last from this county.
There are now to be blinded tests regarding the efficacy of marijuana. The UC San Diego and San Mateo County will each fund studies. The researchers are limited to the only legally grown marijuana in the United States. Every year or two the government grows 1 ˝ acres at the University of Mississippi.
The US Supreme Court has agreed to hear whether "medical necessity" is a legitimate defense in those states that have passed laws allowing the defense.
In an article in the AMNews there is a discussion as to what constitutes a "clean claim". The article talks about how some insurance companies in states where clean claims are not defined are making physicians jump through multiple hoops. California does not have a definition of clean claims, except that any claim not stated "not clean" is deemed clean after 30 days. This is the basis for physicians being able to get interest at 10% per annum from insurance companies and IPAs.
OSHA has had for the past 18 years a voluntary facility inspection where qualified institutions are removed from the routine scheduled inspection in exchange for approval of the facility. OSHA also agreed that if you voluntarily comply there will be no penalty levy for noncompliance. This is for institutions and companies that have comprehensive safety and health programs. Only three hospitals have taken advantage of this program. Blake Medical Center in Bradenton, Florida just finished the voluntary inspection. Minor faults were found. No penalties were assessed. Blake had reduced their lost-time claim injuries by 65% and workers’ compensation costs were decreased by 50%. One national consulting company cautions about going into the program too quickly. They were concerned about the money it would cost to fix any violations. They state this could be up to tens of thousands of dollars. The consulting company does not balance that money against the savings mentioned above plus the fines that could be levied by an OSHA inspection. One would and should correct any problems that will decrease the hospital insurance and payout costs dramatically as well as aiding employees.
On the other side of the coin nursing homes are going to feel the pinch of the new rules. They believe it will cost about $30,000 per facility in the first year. Since patient lifting is the most common cause of injury in the nursing home, they will have to purchase assist equipment.
The new OSHA rules covering repetitive stress in all general industry including hospitals and medical offices have been published. Compliance is to be by October 2001. The rules require at a minimum all businesses, with minimal exceptions, to (1) inform all employees about repetitive stress disorders and all muscular skeletal diseases (MSD) of upper and lower extremities and back, the causes and reporting mechanisms; (2) a problem that is related to an action triggers implementation of a full ergonomic program with participation of the workers. Employers must provide access to healthcare for these injured workers and provide the workers with a minimum of 90% of their pay for 90 days if the workers are unable to work. If the workers are placed on light duty, they must receive 100% of their former pay. The rules would require changing the height of assembly lines and offer new keyboards or furniture to provide support for key entry workers. The regulation is being challenged. Congress is waiting on the Florida vote since Bush would likely permit congressional efforts to prevent enforcement of the rules. The OSHA site is
Ergonomic programs mean to evaluate each station and make the appropriate changes. This may include lowering all typing stations and purchasing wrist rests for all computer users. Yes, it will be very expensive, but so are the injuries. Please see November 15, 2000 Legislation News on this site. The Congress may not have the votes to stop the implementation.
Here we go again. A CDC researcher in the November 10 Morbidity and Mortality Weekly Report states that we could save money and anxiety by not performing annual Pap smears, especially "if there is only low grade abnormalities which MIGHT have gone away if we’d left the women alone." She states " there are problems with annual screening that can result in potential harmful treatment and stress." ACOG suggests annual Pap tests. The ACS guidelines are for annual exams until there are three negative exams and then less frequently.
In a story in USA Today the new seismic standards for California hospitals to be in compliance by 2030 will be $20 billion. By 1/1/2001 hospitals must tell the state how vulnerable their buildings are to an earthquake. On 1/1/02 plans need to be turned into the state for repairing the hospitals. By 2008, all hospitals will need to be able to withstand a "large earthquake." By 2030, hospitals have to insure all facilities will be operational after an earthquake. The money necessary to get there is equal to all the money spent in California on capitol expenditures combined in the past decade.
Where is the new money to come from? Many if not most of the hospitals will not be able to raise the money necessary via bonds. With healthcare at its present level, there can be no guarantee of paying the bonds off. The legislature may re-visit the problem.
The University of California Irvine is expected to receive a $235 million grant to demolish its main hospital and reconstruct it to conform to the 2008 seismic regulations.
In another good use for the healthcare dollar the Department of Justice has collected a record breaking $1.5 billion in civil fraud recoveries with whistleblower suits leading the way with $1.2 billion. Be careful out there.
Besides Fraud and Abuse there is also EMTALA where hospitals and physicians may be fined. In May, June and July 2000, 14 hospitals and one physician paid fines totaling $341,000. Included in these fines were $25,000 from Kaiser Richmond, $61,000 from Kaiser South Sacramento and Suburban Medical Center in Paramount. The one physician was from Fort Lauderdale, Florida. He was fined $15,000 and was excluded from Medicare and Medicaid for one year. He admitted no wrongdoing in the settlement.
President Clinton has signed into law federal legislation aimed at preventing needle stick injuries. There is already similar legislation in 17 states including California. There is currently a shortage of the new needles and the expense of purchase is high. Hopefully as the new needles become more plentiful the price will come down.
FDA & HCFA HCV Rules
The FDA an HCFA are proposing two rules regarding Hepatitis C Virus (HCV). The HCFA rule requires hospitals that use transfusions to prepare and follow written procedures when they obtain and transfuse potentially contaminated blood. The FDA rule goes to blood banks and requires quarantine of prior collections from a questionable donor, do donor testing, and notify prior transfusion recipients. The rule would also require the record retention period be 10 years.
Hospital Nursing Ratios
The state has mandated that hospitals have specified nursing to patient ratios. The problem is no one has yet determined what these ratios should be. To no one’s surprise the CNA is calling for low ratios and the hospitals are for higher ones. The hospitals state they want to avoid "one size fits all" ratios. The health department is to draft the ratios by 2002.
Legality of Giving Drug Samples to Patients
There is no law against giving away sample medications to patients. The only potential legal issue is documentation of the drug, dosage and amount in the patient’s chart. There is currently an ethical question about the samples. Some have suggested that be using the samples of new costly drugs, a physician would be more apt to prescribe these instead of cheaper drugs. One company has recently been giving physicians generic samples for their patients. The only true legal issues are (1) the samples must not be sold and (2) if someone other than a physician dispenses the drug. If a nurse, nurse practitioner, or physician assistant dispenses they must follow the State law regarding their scope of practice.
President Clinton will issue in the next two weeks final rules on medical privacy that have the force of law. The rules will place the burden on insurance companies, HMOs, physicians and hospitals as well as all other medical providers to not only have privacy rules but also have their contractees i.e. lawyers, accountants and consultants protect the medical privacy of all consumers of health care. The health care community will need to rewrite the contracts with their business partners to guarantee the medical information is kept private. The rules will leave out a new federal cause of legal action for damages for breach of the disclosure of confidential information. The new rules gives a federal right to all patients to inspect, copy and ask to make corrections of information they think is inaccurate or incomplete in their medical records.
HMO Appeal Procedures
President Clinton in his third major health care order in several weeks issued regulations for procedures of appeal for 130 million private sector employees. The rules that go into effect 1/1/02 exempted some small businesses, government workers and church related organizations. Currently insurers are given 90 days to respond. The rules break medicine into three groups. The first is pre-approved. If procedures are in this group there must be an answer in 15 days. If the answer is "no" and the patient challenges, the response must be in 30 days. The second group is payment for services already rendered. Here the plan must give an answer in 30 days and the plan has an additional 60 days after an appeal to answer. The last group is urgent cases as perceived by the patient’s physician. The plan has 72 hours to tell whether or not they will pay. If the insurers do not comply consumers may file for an injunction in Federal court. There may not be any fees or charges for filing an appeal with the insurer. The Department of Labor estimates a cost of $103 million for startup costs in 2001 and an additional $379 million per year beginning in 2002. I wonder who will pay for this and how many employers will drop health insurance because of the new rules.
New Jersey Wellness Plan
New Jersey now requires HMOs and health plans to provide free comprehensive annual physicals. The plan covers people over 20 years old and include standard tests to detect diabetes, cancer, heart disease, anemia and glaucoma. Also a physician or NP is to counsel patients on breast or testicular self-examination, smoking cessation, weight control, and back exercises. The cost may not now be more than a $220 average and is pegged to inflation.
DISCLAIMER: Although this article is updated periodically, it reflects the author's point of view at the time of publication. Nothing in this article constitutes legal advice. Readers should consult with their own legal counsel before acting on any of the information presented.