2-8-08: In a whistleblower case, involving the False Claims Act, the whistleblower, a former Merck sales manager is awarded $68 million, seven year later.
Merck will pay $671 million after allegations it overcharged Medicaid and paid kickbacks to doctors. According to prosecutors, Merck cheated Medicaid out of millions of dollars in discounts over eight years by routinely overbilling the government for its most popular medicines, the arthritis drug Vioxx (rofecoxib) and the cholesterol drug Zocor (simvastatin).
According to prosecutors, Merck had about 15 different programs used by its sales representatives to give doctors and other health professionals 'illegal kickbacks,' disguised as fees for training or consultation, to induce them to prescribe Merck drugs.
Merck issued a statement denying that the settlement constitutes an admission by Merck of any liability or wrongdoing and that it believes its pricing and sales and marketing policies and practices were consistent with all applicable regulations and contracts during the relevant time. (American Health Lawyers Association, Health Law Daily, 2-8-08).
Billing Claims - Incorrect payments to providers - UnitedHealth settles billing claims for $12 million in 36 states and is to implement a three year process improvement
"On 9-6-07, UnitedHealth Group agreed to pay $12 million to settle claims by
36 states and the District of Columbia over billing practices at the company's
According to AP (8-12-07): Americans are living longer than ever, but not as long as people in 41 other countries, according to "international numbers provided by the Census Bureau and domestic numbers from the National Center for Health Statistics." One significant factor, according to researchers, "is that 45 million Americans lack health insurance, while Canada and many European countries have universal healthcare." Dr. Christopher Murray, head of the Institute for Health Metrics and Evaluation at the University of Washington, "said improved access to health insurance could increase life expectancy." However, "he predicted, the U.S. won't move up in the world rankings as long as the healthcare debate is limited to insurance." Murray suggests policymakers should also "focus on ways to reduce cancer, heart disease and lung disease" and he "advocates stepped-up efforts to reduce tobacco use, control blood pressure, reduce cholesterol and regulate blood sugar."
A federal court in
Plaintiff brought claims pursuant to 42 U.S.C. § 1981, the New York Human Rights Law, New York Executive Law §§ 290, et seq. (NYSHRL), the Sherman Antitrust Act, 15 U.S.C. §§ 1, et seq., and New York General Business Law § 340 (NYGBL), as well as common law claims for interference with prospective economic advantage and prima facie tort.
While it “is well-established that the Sherman Antitrust Act does not apply
to concerted action among officers or employees of the same enterprise acting as
such,” the court found that "'member physicians of an independent practice
association [are] legally capable of conspiring among themselves' for purposes
of the Sherman Antitrust Act." See Capital Imaging Assocs., P.C. v.
Iasis Healthcare, Franklin, Tenn., which owns or operates 14 hospitals in
five states said it is cooperating with a subpoena from the HHS inspector
general's office seeking records dating back to 1999 on contractual arrangements
between physicians and the system's hospitals. The arrangements include leases,
medical directorships and recruitment agreements. In January HHS offered
new guidance to hospitals about their contractual arrangements with
Is this for Fraud and Abuse Investigation?
Four hip- and knee-replacement manufacturers received subpoenas from the U.S. attorney's office in Newark, N.J., for documents related to any consulting and service contracts between the companies and orthopedic surgeons who use or are considering using the companies' orthopedic implants. The companies are: Biomet, Johnson & Johnson's DePuy Orthopedics, Smith & Nephew, and Stryker Corp. (Modern Healthcare's Daily Dose, 3-31-05)
Mandate for Electronic Prescribing
The guarantee widespread adoption of e-prescribing in the future includes improved patient care, increased profitability for health plans, and a new Medicare mandate requiring it.
Health Information Technology Benefits
Grants are being awarded to help determine how best to use health information technologies to improve patient safety by reducing medication errors; increasing the use of shared health information between providers, laboratories, pharmacies and patients; helping to insure safer patient transitions between health care settings, including hospitals, doctors' offices, and nursing homes; and reducing duplicative and unnecessary testing. Health information technology has the potential to produce savings of up to 10 percent of the country's total annual spending on health care. (HHS news 101-13-04)
Resources from the Government Current Status and Future Focus
Fiscal Year 2005 Work Plan
The Office Inspector General (OIG) Fiscal Year 2005 Work Plan is available
online. The Work Plan sets forth various projects to be addressed during
the fiscal year by the Office of Audit Services, Office of Evaluation and
Inspections, Office of Investigations, and Office of Counsel to the Inspector
Red Book Available
The 2004 Cost-Saver Handbook, commonly called the Red Book is available
online. The Red Book The Red Book is a compendium of significant Office of
Inspector General (OIG) cost-saving recommendations that have not been fully
implemented. The OIG claims that full implementation of the
recommendations in the 2004 edition of the Red Book could produce substantial
savings to the Department. Each recommendation includes a summary of the
current law, the reason that action is needed, the estimated savings that would
result from taking the recommended action, and the status of actions taken and
the type of action needed (legislative, regulatory, or procedural) is indicated.
Side Note of interest: Flu Vaccination - Prosecute Price Gauging
HHS Secretary urges States to prosecute for flu vaccination price gauging. With the loss of half of our nation's flu vaccine due to manufacturing issues in England some are trying to make a quick profit from this public health challenge. (HHS Press Release 10-14-04)
Antitrust Complaint - Evanston Northwestern Healthcare Corporation and Highland Park Hospital
The Federal Trade Commission (FTC) filed its first antiturt challenge to
ahopsital merger in six years against
Evanston Northwestern Healthcare Corporation (ENH) alleging that ENH's merger
with Highland Park Hospital resulted in anticompetitive price increases and that
a physician group affiliated with the merged hospitals engaged in price fixing
in violation of the FTC Act. The FTC's complaint asserts that the merger
violated the Clayton Act, based on an analysis conducted under the Horizontal
Merger Guidelines and on the actual competitive effects - in the form of higher
prices actually charged by ENH after the merger. The FTC seeks a remedy to
restore competition to the benefit of consumers seeking competitively-priced
Per Crain's (2-11-04): ENH said it will fight the FTC challenge because it does not have dominant market share.
say health insurers are likely to make coverage decisions based on genetic
test results. |
of people surveyed believe genetic testing should be made widely available. |
say employers are likely to reject job applicants based on test results. |
say they would get their children tested if tests were widely available. |
say they would get tested if tests were widely available. |
Electronic eligibility checking is among a set of eight
standard transactions targeted by the "administrative simplification"
section under the Health Insurance Portability and Accountability Act (HIPAA).
Per Modern Healthcare 10/22/03:
“A woman in Pakistan doing cut-rate clerical work for UCSF Medical
Center, San Francisco, threatened to post patients' confidential files
on the Internet unless she was paid more money. The violation of medical privacy -- apparently the first of its kind -- highlights the danger of "offshoring" work that involves sensitive materials, an increasing trend among budget-conscious
three different subcontractors was used. UCSF and its original contractor say they had no knowledge that the work eventually would find its way abroad.”
A class-action lawsuit was brought on behalf of military
personnel whose personal information was stolen in a burglary at a TriCare
contractor. The lawsuit was based on
Per OIG 10-30-03:
The Office of Inspector General (OIG) of the Department of Health and
Human Services (HHS) protects the integrity of HHS programs from fraud, waste
and abuse through its nationwide network of auditors, investigators and
analysts. In FY 2002, OIG saved taxpayers a record $21 billion, excluded 3,448
people and companies from Medicare/Medicaid reimbursement, secured 517 criminal
convictions and 236 civil actions.
2002 Fraud and Abuse Collections by Federal Government
The federal government won or negotiated for healthcare
fraud collections in 2002 more than $1.8 billion in judgments, settlements and
administrative penalties and collected $1.6 billion of that amount.
The Justice Department filed 361 criminal indictments and HHS' inspector
general's office filed 221 civil actions in 2002, according to a joint annual
report by the agencies. The inspector general's office collected $150.2 million
in improper payments, issued 20 advisory opinions and excluded 3,448 individuals
or organizations from participating in federal healthcare programs. Between 1997
and 2002, the fraud and abuse program collected $4.3 billion in healthcare fraud
recoveries and returned $4.1 billion to the Medicare Trust Fund. (Modern
Per OIG (10-7-03):
Efforts to combat fraud were consolidated and strengthened under Public
Law 104-191, the Health Insurance Portability and Accountability Act of 1996 (HIPAA).
The Act established a comprehensive program to combat fraud committed against
all health plans, both public and private. The legislation required the
establishment of a national Health Care Fraud and Abuse Control Program (HCFAC),
under the joint direction of the Attorney General and the Secretary of the
Department of Health and Human Services (HHS) acting through the Department's
Inspector General (HHS/OIG). The HCFAC program is designed to coordinate
Federal, State and local law enforcement activities with respect to health care
fraud and abuse. The Act requires HHS and DOJ detail in an Annual Report the
amounts deposited and appropriated to the Medicare Trust Fund, and the source of
OIG Committed to Investigating Fraud
Investigating fraud committed
against Medicare and Medicaid will be a significant focus of the DHHS OIG in
fiscal year 2004, the agency said in its Work Plan for Fiscal Year 2004.
This includes investigations for services not rendered, making claims
that manipulate payment codes in effort to inflate reimbursement amounts, and
making other false claims to obtain program funds in 2004.
Also, OIG anticipates publishing several new safe harbors for the
Anti-Kickback Statute in 2004.
See OIG Work Plan at:
A nursing home in Baton Rouge, La., will pay the biggest
civil settlement by a single nursing home for "failure of care" to
resolve allegations that the home billed Medicare and Medicaid for services that
were not rendered or were provided "in a grossly deficient manner"
from 2000 to 2002. The settlement of
$750,000 is so high partly because of its failure to fulfill a previous plan of
correction. The settlement protects
General Health System from civil but not criminal charges.
General Health System no longer owns the nursing home.
The system's flagship is 436-bed
This is an area of increasing interest to
Office Inspector General (OIG)
has some Corporate Integrity Agreements CIAs) on its website at:
For Advisory Opinions FAQ see: http://oig.hhs.gov/fraud/advisoryopinions/aofaq.html
An Illinois couple sued the Federal Drug Administration (FDA) and is seeking class action status in the first legal challenge to a new law that prevents states and consumers to legally import lower-cost prescription drugs from Canada. The lawsuit claims that the new U.S. Medicare law violates the Andrews' privacy by denying them freedom to make their own medical decisions. It also asserts the law disproportionately effects seniors who don't live in northern border states and can't easily drive into Canada to buy cheaper medicine. Illinois Governor Rod Blagojevich claims such a program would save $91 million from the $340 million Illinois spends on prescription drugs for state workers and retirees. Economists claim that if the lawsuit is to prevail that Canadians will suffer the consequences of reduced supply or higher costs by the US drug companies not wanting to lose profits in US market.
A senior Food and
Drug Administration official said the agency won't sue cities and states that
set up plans to bring in the unapproved prescription drugs from
The importation of price-controlled drugs from
Dr. Mark McLaughlin visited Russia to see how surgeons worked there when he was a neurosurgery resident in Pittsburgh in 1997. He found a healthcare system with antiquated technology (Russian neurosurgeons rarely used microscopes when performing delicate brain surgery), poor pay with top surgeons earning just $200 a month, not much prestige being a surgeon as it was more like a manual laborer. He also found surgeons struggling to save lives. He brought an internationally renown surgeon to St. Petersburg to teach new techniques and brought some of the Russian surgeons to America. He says: "These doctors remind me of why I went into medicine. They inspire me to be as good as I can be." (Parade October 26, 2003)
Evanston Northwestern Healthcare was reviewed by the Office Inspector General (OIG) at the request of the the Centers for Medicare and Medicaid Services to determine the lever of provider compliance with national Medicare Outpatient cardiac rehabilitation policies. The review disclosed that the hospital did not designate a physician to directly supervise the services provided by its cardiac rehabilitation program. Various recommendations were made including that the hospital implement controls to endure that medical record documentation is maintained to support Medicare outpatient cardiac rehabilitation services.
9-23-03: Per Crain's Chicago Business: Vista Health indicated it will seek state permission to close one of its two hospitals, 231 bed Provena St. Therese Medical Center in Waukegan, IL. This comes after Vista had learned that Federal Trade Commission (FTC) staff would urge the FTC not to challenge the merger that created Vista Health. In March the FTC announced it was investigating Vista Health as part of an antitrust review of completed hospital mergers. The venture lost more than $17 million on revenue of $154.8 million in 2002. The consolidation of St. Therese with 142 bed Victory Memorial Hospital in Waukegan is expected to take about two years to complete.
7/17/03: In one of the largest health care fraud settlements in U.S., Abbott Laboratories will pay $622 million to resolve federal probe for fraud. A CIA was entered into with the Office of Inspector General of the Department of Health and Human Services.
Per Chicago Tribune, May 15, 2003, Section 2, page 1 and 2, "Illinois Probes Cancer Treatment Centers' Billing" by Bruce Japsen: A whistleblower lawsuit filed under seal in 1999 was brought by a former employee of the Cancer Treatment Centers of America. Cancer Treatment Centers of America and two top executives are named in the complaint, the founder and CEO and the COO. This is a Zion, Illinois based company and Illinois authorities are investigating whether this company over-billed government and private insurers for oncology services and medical care. The allegations include: patients were enticed to choose Cancer Treatment facilities by free airline tickets for travel to its facilities; billed for services not rendered by the doctors, did not document and billed when doctors were not present.
The Cancer Treatment Centers of America network covers four states and billings exceeded $100 million annually between 1997 and 2000 of which $40 million was for Medicare health insurance and $6 million for Medicaid.
The whistleblower who filed the complaint under seal handled physician billings until she was fired in May 2000 and had worked in Zion from 1997 to 2000. The U.S. Justice Department declined to intervene in the case and the seal was lifted in March, 2002.
2-3-03: For new proposed law, believed to be the first of its kind by its supporters - Holding Doctors Accountable for Quality of Care - see Class 5 - New News.
for compliance with HIPAA Electronic
Health Care Transactions and Code Set standards:|
Apply for one year extension by October 15, 2002
Submit compliance plan by October 16, 2003
Rule compliance deadline |
Health Insurance Portability and Accountability Act of 1996 (HIPAA)
Health Insurance Portability and Accountability Act of 1996 (HIPAA)
10/16/02: Per HHS Secretary Tommy Thompson,
Deadline Passed -- TO FILE EXTENSION ELECTRONICALLY: http://www.cms.hhs.gov/hipaa/hipaa2/ASCAForm.asp
How can you make the process of complying with HIPAA requirements easy? The following steps may help, per AMedNews.com (7-22-02):
|Familiarize yourself with HIPAA basics.|
|Designate a privacy official and define the job responsibilities - include a backup privacy official to step in as needed, such as when the privacy official is on vacation|
|Develop your HIPAA documentation strategy with legal advice - the attorney - clientconfidentiality privilege may be useful to encourage frank conversations and prevent documents frombeing taken out of context.|
|Develop a HIPAA privacy budget and a "time and task" chart - create a chart listing who is responsible for what task, how much time and money it will take to complete it and the date by which the task must be finished - complying with the privacy regulations will take time and money.|
|Understand how patient information flows in and out of your practice -privacy official should interview every staff member in the office to find out who has access to what patient information and how the information flows through the office then create a log listing what patient information is disclosed to whom and why..|
|Draft your notice of privacy practices. - this is one of the most critical documents that the practice will create as it says how the practice protects private information. The notice must be posted in the office, and on the practice's Web site, if it has one. All patients who come in for a visit after April 2003 must read and sign the document, which must be kept on file. If the patient refuses to sign the document, the practice must document that the patient refused to sign it.|
|Draft your HIPAA privacy policies and procedures -this document has to be comprehensive and may be a 60 to 100 page book outlining the practice's privacy policies and procedures.|
|Develop and implement a training program for all employees - such as workshops, videos, computer programs and books. Simply giving your employees a book to read about the HIPAA regulations probably won't be enough.|
|Test your personnel and reassess your training program.|
|Get signed documents from patients. Keep track of which patients signed privacy notification documents.|
|Identify business associates, develop a business associates contract and start getting signed contracts. Business associates are defined as third parties that "perform a service or function on behalf of your practice that involves the use of disclosure of patient information." All business associates are required to sign a contract agreeing to comply with the practice's privacy regulations.|
|Assess your HIPAA compliance and implementation status - do one final check to make sure that your practice is in compliance and that nothing has been missed.|
NOW, CELEBRATE all of your and your staff's hard work.
2-18-03: The Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) uses a nationwide network of auditors, investigators and analysts to detect fraud, waste and abuse . In FY 2002, OIG claims that it saved taxpayers a record $21 billion, excluded 3,448 people and companies from Medicare/Medicaid reimbursement, secured 517 criminal convictions and 236 civil actions.
12-18-02: Per Chicago Tribune (12-18-02), "U.S. Sues Hospitals on Medicare Billing," with subtitle "Northwestern, Loyola are Cited": the federal government has sued Northwestern Memorial Hospital, Loyola University Medical Center and 25 other hospitals around the country accusing them of overcharging Medicare multi-millions of dollars. The U.S. Justice Department claims the hospitals improperly charged Medicare for procedures involving experimental cardiac devices that had not been approved by the Food and Drug Administration. Under the federal False Claims Act, private citizens are permitted to file suits on behalf of the government and share in any recovery. the allegations were first brought to the government's attention via several civil suits filed in 1994 in federal court in Seattle by a whistleblower, Kevin Cosens, a former medical device salesman from Seattle. Already, the U.S. has reached settlements with 31 hospitals for about $42 million and the government is finalizing settlements with two other hospitals. Whistleblowers can get 15 to 25% of settlements. Cosens and his attorney have already reaped more than $9 million as their share of the settlements.
Defenses or tools to use in settlement strategies for the hospitals may include: the now-contested technology very quickly became the accepted standard of care and Medicare routinely pays for all of these devices today, in 1995 Medicare clarified its policy for payments for procedures involving these same investigational devices to specifically permit billing Medicare, the hospital did not bill Medicare for the devices only the procedures to implant them, the government may have paid more if the new devices had not been used, these devices made it possible for patients to avoid major surgery with longer recovery rate and larger costs to the government per patient.
10-2-02 Per Modern Healthcare (9-30-02): The number of whistleblower lawsuits filed under the False Claims Act has declined from a peak of 535 in 1997 to 300 in 2001. Recoveries remain high and have reached $850 million to date this year.
The DHHS OIG last week released its fiscal year 2003 work plan setting forth its planned activities over the next year. Fraud and abuse are among the items on Inspector General's (IG) agenda in FY 2003. The IG will also study financial arrangements between physicians and ambulatory surgical centers and evaluate the conditions under which physicians bill "incident-to" services and supplies. Also, the IG indicated revised guidance for compliance plans for the hospital industry would be forthcoming. See workplan at: http://oig.hhs.gov/publications/docs/workplan/2003/Work%20Plan%202003.pdf
Modern Healthcare (7-25-02): From 1997 to 2001, Massachusetts General Hospital Anesthesia Associates, an anesthesiology group practice affiliated with 855-bed Massachusetts General Hospital in Boston, allegedly double-billed Medicaid for anesthesiology services and failed to report the overbilling. The 130-doctor group will pay $1.5 million to the state's Medicaid program to resolve allegations of billing fraud. The group is part of the larger Massachusetts General Physicians Organization, a 1,600-member doctors group affiliated with Massachusetts General. "This truly was a computer billing error," the organization's CFO, Jim Heffernan, said and that the state Medicaid program uses a different system and that our billing submissions were incorrect and there was no intent to defraud. The settlement includes $1.2 million in returned payments and about $300,000 in penalties and reimbursement of investigation costs. The group agreed to a three-year billing compliance program, including conducting a quarterly review of claims.
Per Modern Healthcare (7-2-02): To date, at least 50 hospitals nationwide have negotiated settlements to resolve similar allegations involving upcoding pneumonia (billing Medicare for a more serious form of pneumonia than was actually treated) - paying a settlement total of more than $48 million. As part of a national federal investigation based on a 7-year-old whistleblower lawsuit, recently, three hospitals settled allegations of pneumonia upcoding for a collective $3.7 million. Saint Anthony's Health Center, Alton, Illinois, 296-bed, part of BJC HealthCare, St. Louis, is the largest of the three settlements, and it will pay $2 million to resolve upcoding allegations; Cumberland Medical Center, Crossville, Tennessee, 144-bed, will pay $1.43 million, and General Hospital, Brownsville, Pennsylvania, 115-bed, will pay $225,000.
For an interesting analysis of how the Office of Inspector General (OIG) analyzes if a hospital offering free transportation services to certain patients for extended courses of treatment is a violation of the fraud and abuse anti-kickback statutes see Advisory Opinion 00-7 at:
This is an advisory opinion applicable only to the given specific situation, however this opinion gives a good overview of how the anti-kickback statute is interpreted and applied by the OIG. Examples of abusive situations involving free transportation that are a violation are listed in the Advisory Opinion, such as:
"Psychiatric facilities offering out-of-state patients free round-trip airline tickets to Florida in order to receive services at their facilities; Van drivers soliciting, and offering free transportation services to, Medicaid patients for health care providers who compensate the drivers on a per patient or per service basis; Unscrupulous health care providers offering residents of nursing facilities and other congregate care facilities free transportation services to and from their offices for services that are frequently of questionable necessity; Hospitals offering patients free limousine services; and Hospitals offering patients free ambulance services without making individual determinations of financial need."
Alleged Unnecessary Procedures to Boost Income - Kickbacks and Death Study of Edgewater Hospital in Chicago
6-29-02: According to Chicago Tribune, "Edgewater Doctor's Sentence is 12 Years," a Chicago cardiologist was sentenced to 12 1/2 years in federal prison and forfeit $2 million in profits and pay an additional $14.4 million in restitution for performing unnecessary heart procedures that resulted in the deaths of two patients. Edgewater Hospital closed in December with millions of dollars in losses. The cardiologist pleaded guilty in February to racketeering after he admitted he performed 750 unnecessary cardiac catheterizations and many other unneeded medical tests as part of a scheme to boost Edgewater's profits. Most of the unnecessary procedures were paid for by Medicare. Three other doctors and a hospital administrator have pleaded guilty and are serving prison sentences ranging from 35 months to 61/2 years. The management company which formerly ran the hospital has pleaded not guilty and awaits trial in August. Prosecutors allege the cardiologist and others at the hospital kicked back money to physicians for admitted hundreds of patient to Edgewater who did not need hospitalization. Prosecutors claimed many of those who were admitted were substance abusers, homeless people and senior citizens who were given cash, food, and cigarettes and coached to lie about symptoms.
12/3/01: According to Crain's Chicago Business, a former executive at Edgewater Medical Center was sentenced to 61/2 years in prison in connection with alleged Medicare fraud and a physician was sentenced to 52 months in prison for his part in the alleged scheme to perform and bill for unnecessary medical procedures.
5/18/01: According to Chicago Tribune (May 18, 2001), page 1 and 28, "Fraud Ring Alleged at Chicago Hospital", a 58 count indictment was made against three physicians, a hospital administrator and a hospital management company involving a situation in which allegedly un-indicted "patient recruiters" recruited patients from homeless shelters throughout Chicago to go to Edgewater Medical Center to receive medical and detoxification treatment in return for cash, food and cigarettes. The indictment alleges that Medicare, Medicaid, and private companies paid more than $1 million for unneeded medical care performed at the 160 bed facility. Counts in the various indictments include: healthcare fraud, paying kickbacks for referrals, mail fraud, wire fraud, racketeering, racketeering conspiracy. One of the physicians is claimed to have allegedly received a lucrative contract to provide anesthesia services at the hospital in return for referring patients and to have allegedly received more than $290,000 in payments in exchange for patient admissions. Another doctor is allegedly claimed to have received monthly payments to pay for sending patients to be admitted to the hospital.
Per Modern Healthcare (6-18-02): Tenet Healthcare Corp., Santa Barbara, Calif., announced this morning that it would pay $55.75 million to settle civil allegations relating to clinical laboratory billing violations and fraud at two of its hospitals. Tenet denies wrongdoing in the settlements. The for-profit chain of 115 hospitals agreed to pay $17 million to resolve issues relating to clinical laboratory unbundling fraud at 139 current or former Tenet hospitals. Tenet also will pay $29 million to settle allegations that its 360-bed Palmetto General Hospital, Hialeah, Fla., defrauded Medicare by filing fraudulent cost reports through its home health agency. Tenet will also pay $9.75 million to settle cost-reporting fraud allegations at its 244-bed Brotman Medical Center, Culver City, Calif.
Per Modern Healthcare (5/24/02): The former owner of a
behavioral health facilit, Campus Hospital of Cleveland, was sentenced for paying
kickbacks for patient referrals from 1995 through 1998 to one year in prison
and ordered to pay $600,000 in restitution . This person pleaded guilty to
participating in a conspiracy to pay $600,000 in “referral fees” to
“patient recruiters” for referring out-of-state Medicare patients to Campus
for substance-abuse treatment. The hospital’s former COO and two other
defendants also pleaded guilty to the scheme and were sentenced in March. The
hospital paid in the range of $600 to $1,000 per referral and received $3,500 by
Medicare for each case. The former COO was ordered to serve four months in
prison followed by home detention and must pay $600,000 in restitution; a
nationally known lecturer and author of 14 books on substance-abuse treatment
also pleaded guilty was sentenced to four months’ home confinement and $30,000
4/02: The federal government collected over $1.3 billion in 2001 as a result of judgments, settlements, and administrative impositions in healthcare fraud cases and proceedings, according to an annual report by DHHS and the Department of Justice (DOJ). Federal prosecutors filed 445 criminal indictments in health care fraud cases in 2001. A total of 465 defendants were convicted for health care fraud-related crimes in 2001. There were also 1,746 civil matters pending, and 188 civil cases filed in 2001. HHS excluded 3,756 individuals and entities from participating in the Medicare and Medicaid programs, or other federally sponsored health care programs, most as a result of convictions for crimes relating to Medicare or Medicaid, for patient abuse or neglect, or as a result of licensure revocations. This record number of exclusion actions is the result of successful collaboration with state Medicaid Fraud Control Units (MFCUs) and state licensure boards.
4-12-02: The United States Attorney's Office for the District of Columbia and the Department of Justice announced that PacifiCare Health Systems will pay the United States $87.3 million to settle allegations that it and its predecessor companies violated the False Claims Act with respect to claims submitted to the Office of Personnel Management. The predecessor firms were FHP International and TakeCare Corporation. This is the largest civil settlement involving contracts with OPM to provide benefits to federal employees under the Federal Health Benefits Program (FEHBP). Today's settlement resolves allegations by the United States that PacifiCare, through its subsidiary health maintenance organization plans, submitted inflated claims for insurance payments based on rates that were not developed in accordance with OPM regulations and rating instructions.
8/13/01: An Order was filed in the United States District Court
for the District of Columbia August 7, 2001, approving the settlement in the
Columbia/HCA Healthcare Corp. case in which HCA will pay $745 million, plus
interest. The amounts for the various qui tam relators (6 relators
specified) was listed as well in the court Order.
10/8/01 According to a report by Taxpayers Against Fraud, a Washington, D.C., public interest group: For every dollar the government spent fighting health care fraud using the FCA between fiscal years 1997 and 2000, it recovered $8.
Health-related fraud cases accounted for 41% of the nearly $7 billion the government recovered under the FCA since its amendment, and according to the report, the Medicare error rate, which measures improper payments due to estimated fraud, waste and abuse, fell to 7% in 2000 from 14% in 1996. (This information is from AMNews 10/15/01)
DHHS OIG Declines to Impose Sanctions on Ambulatory Surgical Center Joint Venture
12/3/01: In Advisory Opinion No. 01-21, issued on November 16, 2001, and posted on
November 26, 2001, the OIG concluded that it would not impose sanctions in connection with a
medical center's proposal to acquire an ownership interest in an operating ambulatory surgical center currently owned by a group of
gastroenterologists. While the OIG found that the proposed arrangement did not qualify for safe harbor protection, it concluded that the safeguards putin place by the parties made the risk of abuse sufficiently low.
On October 5, 2000, the Committee on the Budget, U.S. House of Representatives, Waste, Fraud and Abuse Task Force Release Final Summaries, See Task Force on Healthcare that starts off by quoting Uwe E. Reinhardt, professor of political economy at Princeton University, stating in The Wall Street Journal (January 21, 2000) that "[T]he statutes and rules governing Medicare... now run the risk of becoming themselves a form of waste, fraud and abuse." The following lists the Task Force's major finding on fraud measurement techniques in the Medicare Program:
|The volume of Medicare regulations is excessive;|
|Regulation affects the way doctors practice medicine;|
|The cost of regulation is unknown;|
|Medicare suffers billions of dollars in improper payments;|
|The current measure of improper Medicare payments is limited; and|
|There is no measurement of improper payments in Medicaid.|
The Task Force highlighted "two wasteful, burdensome regulations that do not even comply with the law" stated that "Considering Medicare is subject to more than 130,000 pages of regulations and supporting documents, further investigation is warranted."
See: http://www.house.gov/budget and select "Task Force on Healthcare."
12-14-00: According to a press release on December 14, 2000, entitled "Attorney General Announces Largest Department of Justice Fraud Settlement in History", under a civil settlement, HCA will pay $745 million, plus interest, for its alleged false billing practices and it will pay $95 million in criminal fines. According to this press release: ""In addition to these fines and damages, HCA - formerly known as Columbia/HCA - has also signed a Corporate Integrity Agreement with the Department of Health and Human Services. The agreement will assure that the violations that led to this investigation in the first place are not repeated. It will also require HCA to self-report misconduct to the Department of Health and Human Services and cooperate in the ongoing investigations into the conduct of individuals. Today's civil settlement resolves claims that the company engaged in fraudulent billing practices, including overbilling the government, charging for services that were not performed and claiming funds for non-reimbursable costs. It is a settlement that not only recoups the funds for the American taxpayer - but penalizes the company as well. It's a simple message: If you overbill the U.S. taxpayer, then we are going to make you pay it back, and then some."
For press release see: http://www.usdoj.gov/opa/pr/2000/December/697ag.htm
Tenet Healthcare Pays $29 Million Settlement To DOJ
On 7-17-02 the Department of Justice (DOJ) announced it has reached a
settlement with a subsidiary of Tenet Healthcare Corporation, Lifemark
Hospitals of Florida, to resolve allegations that Lifemark, Tenet, and other affiliated companies violated the False Claims Act by submitting false claims to the Medicare Program for home healthcare services based on false, fraudulent, and misleading statements or omissions regarding the patient's medical condition, history, and/or eligibility for Medicare. Also, the government alleged that some claims submitted to the Medicare Program were for services: (1) never rendered, (2) provided by unskilled, unlicensed, or uncertified personnel, (3) based on insufficient, forged, or missing documentation, and/or (4) never ordered by a physician. The case was investigated by the United States Department of Health and Human Services, Office of Inspector General, and the Federal Bureau of Investigation, and was handled by the United States Attorney's Office for the Southern District of Florida and the Civil Division of the Department of Justice.
Minn. frees anesthetists of physician
Minnesota with about 1,100 nurse anesthetists, is the fourth state to allow nurse anesthetists to work without physician supervision. Gov. Jesse Ventura notified the Centers for Medicare and Medicaid Services that Minnesota would exercise its right to opt out of the supervision requirement. Minnesota joins Idaho, Iowa and Nebraska in opting out. Anesthesiologists have vehemently opposed allowing nurse anesthetists to provide anesthesia without physician supervision, and the battle has been particularly fierce in Minnesota. In January, a federal appeals court reinstated a $1.3 billion False Claims Act lawsuit in which the Minnesota Association of Nurse Anesthetists charged area anesthesiologists with defrauding Medicare of as much as $100 million by billing for procedures as “personally performed” when nurses did the majority of the work. Source: Modern Healthcare (4-23-02)
From HHS press release 2-21-02: the portion of Medicare fee-for-service
payments that do not comply with Medicare laws and regulations, was 6.3 percent
in fiscal year 2001, compared with 6.8 percent in fiscal year 2000.
Secretary Tommy G. Thompson said "We are also working to make our
procedures and rules more understandable through our regulatory reform efforts,
which will help physicians and other providers avoid unintended
errors." For fiscal year 2001, medical reviewers examined the medical
records behind 6,594 claims filed on behalf of 600 beneficiaries
nationwide. These were selected randomly by OIG from the total 34 million
beneficiaries enrolled in fee-for-service Medicare. About 931 million
fee-for-service Medicare claims
were filed in 2001. According to this press release, improper payments include:
"Medically unnecessary" services -- Usually cases in
reviewers determined that the beneficiary's condition did not warrant
inpatient hospital care, but did warrant a lower level of care (43.2 percent of improper payments in 2001);
Documentation deficiencies -- Instances where medical records were
insufficient to support the claims, or nonexistent (42.9 percent); or
Miscoding -- Services found to be coded for a higher level of care
than was supported by the medical records (17 percent).
By projecting the findings of the review, the fiscal year 2001 rate would
represent an estimated $12.1 billion in improper payments out of the total $191.8 billion in fee-for-service Medicare payments -- compared with $11.9 billion in fiscal year 2000, out of the total $173.6 billion in payments that year. The improper payment rate does not measure fraud, although some overpayments could be the result of fraud. The audit process does not attempt to determine the exact cause of the error.
See the OIG Improper Fiscal Year 2001 Medicare Fee-for-Service Payments report at:
According to Chicago Tribune (January 16, 2001), Section 3, page 2: "Rush to Disclose Pays Off For Rush," by voluntarily disclosing, the maximum amount is double damages as compared to whistle-blower cases where damages typically are triple. See the 7th Circuit 1999 case of Mathers vs. Bank of Farmington that held that cases publicly disclosed to government investigators before a whistle-blower's action cannot result in a claim for the whistle blower. This case may trigger health facilities to come forward on their own.
According to Chicago Tribune (January 10, 2001), Section 3, page 2: "Rush to Pay U.S. $800,000 for over-billing on Clinic's Work". According to this article, Rush-Presbyterian-St. Luke's Medical Center agreed to pay for over-billing Medicare and Medicaid for services provided by its transplant clinic. The hospital voluntarily notified the U.S. attorney's office in Chicago in May, 1999 that the federal programs were billed for physician services even though attending doctors were not present for certain outpatient procedures for a period of six years ending in May, 1999.
Four months after Rush's disclosure to federal authorities, in September, 1999, a Rush nurse alleged identical fraud allegations in a federal civil action brought under the False Claims Act against the hospital. Last August, the nurse's claims were dismissed. Because the hospital came forward with the irregularities, the hospital avoided a much costlier settlement from claims filed by the nurse whistleblower.
The Department of Heath and Human Services ("DHHS") Office of Inspector General ("OIG") issued its "Open Letter to Health Care Providers" in March 2000, the OIG concluded that companies that self-disclosed improper billing to the government obtained more favorable settlement agreements and corporate integrity agreements ("CIAs") than companies that failed to self-disclose.
One of the most effective ways to challenge an overpayment determination or a calculation of penalties appears to be by challenging the statistical sampling conducted in the Medicare program by proving the failure by those authorized by HCFA to conduct the sampling studies correctly.
DHHS OIG Declines to Impose Sanctions on Ambulatory Surgical Center Joint Venture - ophthalmologists
10/22/01: In Advisory Opinion No. 01-17 (issued on Oct. 10, 2001, and posted on
Oct. 17, 2001), the DHHS OIG determined that it would not impose sanctions on an existing ambulatory surgical center joint venture between a hospital-affiliated entity and an entity owned indirectly by five ophthalmologists, together with the execution of three related ancillary agreements. The OIG was primarily concerned that the Hospital could potentially direct or influence referrals to the surgical center in violation of the Anti-Kickback Statute. However, the Hospital certified that it would (1) refrain from taking any actions to encourage
Hospital-affiliated physicians to refer patients to the surgical center, (2)
not allow compensation paid to physicians to be directly or indirectly
related to the value or volume of referrals to the surgical center, and (3) annually inform physicians of the foregoing measures. Based on these safeguards the OIG concluded that the potential risk for fraud and abuse was sufficiently low and declined to impose sanctions.
See: 2001 Advisory Opinion No. 01-17, at:
U.S. Court In District Of Columbia Holds Lithotripsy Furnished "Under
Arrangement" Is Not An Inpatient Or Outpatient Hospital Service Under Stark II And Therefore Not A Designated Health Service
7-12-02: In the first successful challenge to regulations promulgated under the Stark II law, the U.S. District Court for the District of Columbia granted summary judgment to plaintiffs, the American Lithotripsy Society and the Urology Society of America, finding that the Stark statute, which was designed to prevent the overutilization of certain medical services, did not encompass lithotripsy, a procedure not susceptible to overutilization. After examining Stark II's text, structure, purpose, and legislative history, the court found the disputed category-inpatient and outpatient hospital services-to be unambiguous, even though undefined. In the case American Lithotripsy Society v. Thompson, No. 01-01812, the court held that certain regulations promulgated by the Centers for Medicare & Medicaid Services (CMS) violated the Administrative Procedure Act, 5 U.S.C. Sect. 706(2)(A) and the Regulatory Flexibility Act, 5 U.S.C. Sect. 601 et seq. The regulations mandated that, because lithotripsy is a service performed "under arrangement," it is an inpatient or outpatient hospital service subject to Stark II prohibitions; however the court found that the category did not encompass lithotripsy.
See court's opinion through the American Lithotripsy
Society's web page, at http://www.lithotripsy.org/alsvshhs2.html
The Health Care Financing Administration ("HCFA") published a notice in
the April 4 Federal Register, 66 Fed. Reg. 17813, extending the deadline of the public comment period to June 4, 2001 on the Stark II Phase I Final Rule.
Previously: Health and Human Services (HHS) has released a final regulation to be effective January 4, 2002 aiming to help with self referral related issues. This final regulation, among other things, generally permits physicians to refer to entities with which they have a compensation relationship, as long as the compensation paid to the physician is no more than would be paid to someone who provided the same services but was not in a position to generate business for the entity. The final regulation also clarifies some of the exceptions to the self-referral prohibition and offers guidance on how to structure financial arrangements to comply with the exceptions.
See the new rule, "Physicians' Referrals to Health Care Entities With Which They Have Financial Relationships," in the January 4 Federal
Register, 66 Fed. Reg. 905, at http://www.access.gpo.gov/su_docs/fedreg/a010104c.html
Note: On February 2, 2001, the Health Care Financing Administration (HCFA) published a notice temporarily delaying for sixty days the effective date of section 424.22 regarding physician certification and plan of treatment requirements for home health services which would have become effective February 5, 2001 and now will become effective April 6, 2001 to give President Bush's administration officials time to review the rule. See Federal Register, 66 Fed. Reg. 8771 or go to: http://www.access.gpo.gov/su_docs/fedreg/a010202c.html
On 9/25/00 the Department of Health and Human Services' Office of Inspector General ("OIG") issued
The final physician guidance is available on the Office of Inspector General Web site at: http://www.dhhs.gov/progorg/oig/new.html For additional help, call OIG Public Affairs at ( 202)619-1343.
This final guidance is a "roadmap" to help physicians in
individual and small group practices design voluntary compliance programs that best fits the needs of that
individual practice. Inspector General June Gibbs Brown claims that "The
guidance itself provides great flexibility as to how a physician practice could
implement compliance efforts in a manner that fits with the practice's existing operations and
Inspector General Brown further stated that, "We are encouraging physician practices to adopt the active application of compliance principles in their practice, rather than implement rigid, costly, formal procedures. Our goal in issuing this final guidance was to show physician practices that compliance can become a part of the practice culture without the practice having to expend substantial monetary or time resources."
The following is from an e-mail sent by the HHS-OIG-Media in regards to this
final guidance: "Under the law, physicians are not subject to civil, administrative or criminal penalties for innocent errors, or even negligence. The
Government's primary enforcement tool, the civil False Claims Act, covers only
offenses that are committed with actual knowledge of the falsity of the claim, reckless disregard or deliberate ignorance of
the truth or falsity of a claim. The False Claims Act does not cover mistakes, errors or negligence. The OIG is very mindful of the
difference between innocent errors ("erroneous claims") and reckless
or intentional conduct ("fraudulent claims").
A voluntary compliance program can help physicians identify both erroneous and fraudulent claims and help ensure that submitted claims are true and accurate. It can also help the practice by speeding up and optimizing proper payment of claims, minimizing billing mistakes and avoiding conflicts with the self-referral and anti-kickback statutes.
Unlike other guidance previously issued by the OIG, the final physician guidance does not suggest that physician practices implement all seven standard components of a full scale compliance program. While the seven components provide a solid basis upon which a physician practice can create a compliance program, the OIG acknowledges that full implementation of all components may not be feasible for smaller physician practices. Instead, the guidance emphasizes a step by step approach for those practices to follow in developing and implementing a voluntary compliance program. As a first step, physician practices can begin by identifying risk areas which, based on a practice's specific history with billing problems and other compliance issues, might benefit from closer scrutiny and corrective/educational measures.
The step by step approach is as follows: 1) conducting internal monitoring and auditing through the performance of periodic audits; 2) implementing compliance and practice standards through the development of written standards and procedures; 3) designating a compliance officer or contact(s) to monitor compliance efforts and enforce practice standards; 4) conducting appropriate training and education on practice standards and procedures; 5) responding appropriately to detected violations through the investigation of allegations and the disclosure of incidents to appropriate Government entities; 6) developing open lines of communication, such as discussions at staff meetings regarding erroneous or fraudulent conduct issues and community bulletin boards, to keep practice employees updated regarding compliance activities; and 7) enforcing disciplinary standards through well-publicized guidelines.
The final guidance identifies four specific compliance risk areas for physicians: 1) proper coding and billing; 2) ensuring that services are reasonable and necessary; 3) proper documentation; and 4) avoiding improper inducements, kickbacks and self-referrals. These risk areas reflect areas in which the OIG has focused its investigations and audits related to physician practices.
The final guidance also provides direction to larger practices in developing compliance programs by recommending that they use both the physician guidance and previously issued guidance, such as the Third-Party Medical Billing Company Compliance Program Guidance or the Clinical Laboratory Compliance Program Guidance, to create a compliance program that meets the needs of the larger practice.
The final guidance includes several appendices outlining additional risk areas about which various physicians expressed interest, as well as information about criminal, civil and administrative statutes related to the Federal health care programs. There is also information about the OIG's provider self-disclosure protocol and Internet resources that may be useful to physician practices."
11-15-02: Per Crain's Chicago Business: The parties have entered into a settlement agreement and terms not made public other than Blue Cross Blue Shield of Illinois agreed to dismiss its antitrust lawsuit against Advocate health Care based on the negotiated settlement. (For more details see class 7).
10-28-02: Blue Cross and Blue Shield of Illinois filed an antitrust case against Advocate Health Care in Illinois as Advocate's contracts with Blue Cross are up for renewal at the end of this year and negotiations for renewal have stalled. Advocate took out a full page advertisement in today's Chicago Tribune as "An open letter to employers who carry Blue Cross and Blue Shield health insurance" stating that "Advocate Health Care, our 10 hospitals, doctors and all 24, 500 employees ...we serve more patients than any other health care provider in the area - touching two million lives every year." Advocate states that "We have offered to negotiate all contract issues through an independent, impartial mediator selected by a third party, but Blue Cross has rejected that offer." [See Class 7 for more on Provider Contracts]
More Antitrust Issues
5/14/02: Per Modern Healthcare: Two Denver-area physician groups settled Federal Trade Commission (FTC) charges alleging a wide range of anticompetitive activity, including price fixing and orchestrated boycotts. The FTC complaints name 41-member Physician Integrated Services of Denver, 45-member Aurora Associated Primary Care Physicians and a consultant who negotiated with payers on behalf of both groups. The settlement does not impose monetary penalties but restricts how the groups deal with insurance companies in contract negotiations.
5/21/02: Per Modern Healthcare: U.S. Justice Department said it would not stand by an agreement with the Federal Trade Commission to divide antitrust duties by industry, citing the objections of Sen. Ernest Hollings (D-S.C.) and concerns over budgetary cuts if the agreement were to continue.
1/29/02: According to Crain's Chicago Business, "Waukegan Hospitals Write Their Own Rate Rx" by Sarah A. Klein, with sub-caption "But Push to Up Insurers Fees Draws Attention of Feds," the newly formed venture Vista Health, combining Provena St Therese Medical Center and Victory Memorial Hosptial is under investigation by the Federal Trade Commission (FTC) for alleged federal antitrust laws violation in seeking rate increases from insurers.
8/01: An opinion issued by the Department of Justice Antitrust Division cleared a proposal by a group of doctors in El Paso, Texas to form a joint venture. According to the Department of Justice opinion, the Rio Grande Eye Associates (REGA) is an Independent Practice Association established as a professional association under Texas law. RGEA's network of eight ophthalmologists will provide ophthalmologic services at reduced prices to managed care plans and other third-party purchasers of ophthalmologic services in the El Paso, Texas area. RGEA will also provide utilization review and quality assurance services. RGEA will be a non-exclusive physician network and its member ophthalmologists will be free to compete with RGEA, both individually and through other provider networks. RGEA will implement a 20% fee withholding arrangement whereby RGEA's providers will recoup some or all of the fees withheld only if the members of RGEA, as a group, meet pre-established cost containment and quality utilization goals. The joint venture will include less than 30 percent of the ophthalmologists in the El Paso area.
7/17/00: According to Modern Healthcare: Two Florida hospital systems will pay fines totaling almost $500,000 for sharing sensitive pricing and managed-care information in violation of a 1994 antitrust settlement. A lawsuit brought by the U.S. Justice Department and the state of Florida was filed in May, 1994 in U.S. District Court in Tampa, Florida. This lawsuit claimed that a merger of the 258 bed Mease Hospital in Dunedin, Florida and 100 bed Mease Countryside Hospital, Safety Harbor, Florida would violate Section 7 of the Clayton Act, which bars deals that reduce competition. According to data from the American Hospital Association, the two systems combined control 34% of the acute care beds in Pinellas County.
A consent decree was entered into which expires in 2004, that prevents the two systems from merging but allows them to partner on some clinical and administrative services including outpatient services, information systems, and other ancillary services. The intent of the decree hailed as trend-setting by the U.S. Department of Justice was to allow the systems to consolidate some services while remaining competitors. The hospitals admitted to violating some of the terms of the consent agreement. According to settlement documents, the systems violated their consent decree by jointly selling outpatient services to managed-care plans, coordinating their managed-care contracting and sharing pricing information. The court order prohibits the systems from even considering a full merger for 3 years.
The order requires the hospital systems to give some payers the opportunity to cancel contracts, and the hospitals will have to change the way they contract with health plans and discontinue joint ownership is some outpatient facilities.
6/10/02: According to the American Medical Association - 30 state legislatures had physicians in office this past term:
House or assembly: One physician: Arizona, Maryland, Minnesota, Tennessee, Texas, Virginia, Washington, New Hampshire, Alabama, Colorado Two physicians: Mississippi, South Dakota, Wisconsin, Maine, New Jersey, California, Indiana
Senates: One physician: Utah, Alaska, North Dakota, Kansas
Two physicians: Louisiana, North Carolina, New Mexico, Florida, Georgia
Both: One physician in each the house and senate: Kentucky, Michigan, Missouri, Iowa
Per Modern Healthcare (10-4-02): "Sen. Edward Kennedy (D-Mass.) introduced a bill to create a national medical-errors reporting system similar to proposals approved by House committees earlier this month. Under both Kennedy's bill and the House proposals, providers would voluntarily submit data on medical errors and patient safety to new patient-safety organizations, which would compile and disseminate the information. All the proposals include protections for workers reporting errors and would not override stricter state laws. However, unlike the House bills, Kennedy's would provide grants for hospitals to implement technology that can improve patient safety."
Nearly 50% of states have "any willing provider" laws.
In Kentucky Association of Health Plans v. Miller, the state HMO lobby
has challenged Kentucky's "any willing provider" law, which says
health plans must accept all qualified physicians willing to abide by the plans'
contractual terms. The health plans claim that the law is pre-empted by the
federal Employee Retirement Income Security Act of 1974 ("ERISA") and
that it raises healthcare costs and reduces quality. State officials, claim
ERISA does not govern the insurance industry.
In the case, Pharmaceutical Research and Manufacturers of America v. Concannon, a 1999 Maine law will be reviewed allowing the state to act as a pharmacy benefit manager for residents without prescription-drug coverage. Under the law, the state can choose to enact price controls if it decides rebates negotiated with drugmakers have been insufficient.
In a managed care-related ruling earlier this year, the court held that patients in 42 states can demand a second opinion when their HMO rejects coverage of surgery or treatment.
"Silent PPO" type of cases - see New News - Class 2
FTC: Concerns About Ohio Legislation That Would Allow Physician
10-28-02: The Federal Trade Commission (FTC) has prepared a comment in response to a request from Ohio Representative Dennis Stapleton (R) in regard to a bill pending before the Ohio House of Representatives (H.B. 325), which would authorize physicians to engage in collective bargaining with health plans over fee-related and non-fee-related contract items. According to the FTC, an antitrust exemption for physician collective bargaining (1) would authorize physician price-fixing, which is "likely to raise costs and reduce consumer access to care," and (2) would not improve quality of care. FTC has consistently opposed similar legislation on the federal level. The FTC comment concludes, "House Bill 325 poses a substantial risk of harm to Ohio citizens. By authorizing price fixing by health care providers, the bill is likely to increase costs and reduce access to care, without any assurance that the state's interest in promoting quality health care would be furthered."
See text of the legislation at: http://www.legislature.state.oh.us/search.cfm and search on H.B. 325
See FTC's press release at: http://www.ftc.gov/opa/2002/10/physicians.htm
10-27-02: According to Chicago Tribune "FTC Probes hospital Mergers" with subtitle "Evanston healthcare, Waukegan deals part of National Investigation," the Federal Trade Commission has launched a nationwide investigation into hospital mergers in the last decade seeking to determine whether such deals have reduced competition and driven up medical costs. Evanston Northwestern Healthcare's takeover of Highland Park hospital in 2000 and the merger of Waukegan's only two hospitals, Provena St. Therese Medical Center and Victory Memorial Hospital in the same year are being investigated. Hospital costs have grown to more than half of overall health care spending outpacing prescription drugs. Critics claim hospitals are using their clout to demand rate hikes from insurers as high as 40% in some parts of the the country. These claims have gained credibility with the FTC as the number of independent community hospitals are reduced as a result of the mergers. FTC wants to look at the extent that hospitals have been successful by creating efficiencies or synergies - looking at if merger is anti-competitive. The most serious penalty any of the hospitals under scrutiny might face would be a breakup of their systems, divesting the respective hospital subject to the probe.
For example a clear indication of concern according to an assistant director of FTC would be if there was a hospital merger in 1999 and across the country hospital prices went up 5% and if the merged system raised prices by 25%. The federal government has failed in its last seven attempts at challenging hospital mergers that were challenged by the FTC or U.S. Justice since the mid-1990s.
In a major metropolitan area it is not easy to prove that there is not competition.
Hospital costs are rising for many reasons such as: (1) Some say a lot of access to hospitals increases cost for everybody; (2) consumers demand latest and often most expensive medical technology to treat their illness, (3) as political winds favor more mandates for insurers to ease restriction on hospital procedures and treatments which trigger higher costs as managed care companies cede more control to hospitals.
Per American Hospital Association and Center for Studying Health Systems Change the number of U.S. Hospitals has dropped from 1994 : 5,229 and 2000: 4915 and the number of hospitals operating within a system has increased form 1994: 1,956 to 2000: 2,217.
HHS Secretary Tommy G. Thompson today issued the first-ever comprehensive
federal regulation that gives patients sweeping protections over the privacy of
their medical records. The final regulation, which takes effect April 14, 2003. The federal privacy regulation empowers
patients by guaranteeing them access to their medical records, giving them more
control over how their protected health information is used and disclosed, and
providing a clear avenue of recourse if their medical privacy is compromised.
The rule will protect medical records and other personal health information
maintained by certain health care providers, hospitals, health plans, health
insurers and health care clearinghouses.
Under the privacy rule:
|Specific Authorizations. Patients must give specific authorization before entities covered by
this regulation could use or disclose protected information in most
non-routine circumstances - such as releasing information to an employer or
for use in marketing activities. Doctors, health plans and other covered
entities would be required to follow the rule's standards for the use and
disclosure of personal health information.|
|Patient Notice. Covered entities generally will need to
provide patients with
written notice of their privacy practices and patients' privacy rights.
The notice will contain information that could be useful to patients
choosing a health plan, doctor or other provider. Patients would
generally be asked to sign or otherwise acknowledge receipt of the privacy
notice from direct
|Marketing Materials. Pharmacies, health plans and other covered entities must first obtain an individual's specific authorization before sending them marketing materials. At the same time, the rule permits doctors and other covered entities to communicate freely with patients about treatment options and other health-related information, including disease-management programs. Specifically, improvements to the final rule strengthen the marketing language to make clear that covered entities cannot use business associate agreements to circumvent the rule's marketing prohibition. The improvement explicitly prohibits pharmacies or other covered entities from selling personal medical information to a business that wants to market its products or services under a business associate agreement.|
|Access and Accounting. Patients generally will be able to access their personal
records and request changes to correct any errors. In addition,
patients generally could request an accounting of non-routine uses and
disclosures of their health information.|
HHS issued privacy regulations in December 2000 but had to make changes to address the serious unintended consequences of the rule that would have interfered with patients' access to quality care. For example, patients would have been required to visit a pharmacy in person to sign paperwork before a pharmacist could review protected health information in order fill their prescriptions. Similar barriers would have arisen when a patient is referred to a specialist and in other situations.
Secretary Thompson said: "The prior regulation, while well-intentioned, would have forced sick or injured patients to run all around town getting signatures before they could get care or medicine."
HHS' privacy regulation is designed to enhance the protections afforded by many existing state laws. Stronger state laws and other federal laws continue to apply, so the federal regulation provides a national base of privacy protections. The standards for covered entities apply whether its patients are privately insured, uninsured or covered under public programs such as Medicare or Medicaid.
Most covered entities have until April 14, 2003, to comply with the patient privacy rule; under the law, certain small health plans have until April 14, 2004 to comply.
To help people prepare for and meet the rule's requirements, HHS' Office for Civil Rights (OCR) will continue to conduct outreach and education targeted to health plans, health care providers, consumers and others affected by the privacy regulation. Technical assistance materials will be posted on OCR's privacy rule website at http://www.hhs.gov/ocr/hipaa/.
In 1996, Congress recognized the need for national patient privacy standards and, as part of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), set a three-year deadline for it to enact such protections. HIPAA also required that, if Congress did not meet this deadline, HHS was to adopt health information privacy protections via regulation based upon certain specific parameters included in HIPAA. Congress did not enact health
privacy legislation. HHS proposed federal privacy standards in 1999 and, after reviewing and considering more than 52,000 public comments on them, published final standards in December 2000. In March 2001, Secretary Thompson requested additional public input and received more than 11,000 comments, which helped to shape the improvements proposed in March 2002. Today's final
improvements reflect public comments received on that proposal.
Per HHS Weekly Report (8-5-02): Secretary Thompson named Richard M. Campanelli as the new director of HHS' Office for Civil Rights (OCR). OCR also has responsibility for medical privacy issues and OCR's mission is to "promote and ensure that individuals have equal access and opportunity in all HHS programs, without facing unlawful discrimination".
(Per HHS press release:) HHS Secretary Tommy G. Thompson named Richard M. Campanelli as the new director of the department's Office for Civil Rights (OCR). Campanelli began his law career as a trial attorney in the Special Litigation Section of the Civil Rights Division, U.S. Department of Justice (DOJ), investigating and litigating unconstitutional conditions at mental health institutions and prisons pursuant to the Civil Rights of Institutionalized Persons Act. In addition, he participated in litigation on behalf of DOJ to eliminate race-based segregation in state prison systems. Following his initial work at DOJ, Campanelli joined the South Africa Working Group at the U.S. Department of State, where he assisted in developing and implementing U.S. initiatives to end apartheid. From 1987 to 1989, he served as senior special assistant to the attorney general, including service as deputy chief of staff. Campanelli has spent the past 13 years as an attorney at Gammon & Grange, PC, in McLean, Va., especially representing non-profit organizations. He has also served as adjunct professor at George Mason University, teaching non-profit law, governance and ethics in the university's department of public affairs. Campanelli received a bachelor's degree in economics from the University of Virginia and completed his Juris Doctor from the University of Virginia Law School. Prior to entering law school, he directed a program in Vermont for at-risk youth.
For HIPAA update: The Centers for Medicare & Medicaid Services has
announced the planned broadcast of another HIPAA program--"Meeting the
HIPAA Challenge: Implementing the HIPAA Standards and the Administrative
Simplification Compliance Act." This program will be a satellite broadcast
and webcast. The webcast will be available for 90 days after the initial
broadcast, which will occur on June 18, 2002, from 2:00-3:30 P.M. (EDT).
NOTE: More HIPAA Information below
6-10-02: Per JCAHO: The "Patient Safety Improvement Act of 2002," H.R. 4889, introduced in the House last week by House Ways and Means Subcommittee on Health Chairman Nancy Johnson, affords confidentiality protections for reports of serious adverse events and the analyses of their underlying causes. Provisions in the "Patient Safety Improvement Act of 2002" would offer full federal privilege to patient safety information provided to patient safety organizations such as JCAHO.
JCAHO maintains one of the nation's most comprehensive databases of reported serious adverse events and their underlying causes. Information from this database is regularly shared with accredited organizations to help them take appropriate preventive steps. The number of reports to JCAHO each year represents less than one percent of the actual number of adverse events that experts estimate occur in this country each year. The proposed legislation should expand the volume of reports and the opportunities for improving patient safety substantially.
Founded in 1951, the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) seeks to continuously improve the safety and quality of care provided to the public through the provision of health care accreditation and related services that support performance improvement in health care organizations. The Joint Commission evaluates and accredits more than 17,000 health care organizations and programs in the United States, including approximately 9,000 hospitals and home care organizations, and 8,000 other health care organizations that provide long term care, assisted living, behavioral health care, laboratory and ambulatory care services. The Joint Commission also accredits health plans, integrated delivery networks, and other managed care entities. An independent, not-for-profit organization, the Joint Commission is the nation's oldest and largest standards-setting and accrediting body in health care.
Per Modern Healthcare (6-26-02): Under the 1989 New York state law, physicians enrolled in residency training programs can work no more than 80 hours per week average over a 4-week period and no more than 24 consecutive hours. Emergency department residents are limited to no more than 12 hours without time off. New York is the only state that limits residents' work hours and the Accreditation Council for Graduate Medical Education plans to adopt similar requirements in 2003. State health officials are reviewing results of inspections to see if fines are warranted and so far 734-bed New York University Medical Center was fined $24,000 for recurring violations.
2/22/02: According to a news release from Health Systems Change (HSC): At least 7.4 million working-age Americans with chronic conditions - including diabetes, heart disease and depression - lacked health insurance in 1999, according to a new HSC study. And two-thirds also had low incomes, putting them in triple jeopardy.
For more information, see: news release, at http://www.hschange.org/CONTENT/413
Issue Brief No. 49, Triple Jeopardy: Low Income, Chronically Ill and Uninsured in America, at http://www.hschange.org/CONTENT/411/
Issue Brief No. 50, Options for Expanding Health Insurance for People with Chronic Conditions, at http://www.hschange.org/CONTENT/412/
7-24-02: What Does HIPAA Say About Terminations? The security rule addresses termination directly. Section 142.308(a)(11) requires termination procedures - formal, documented instructions for ending employment and closing off internal and external access. Remember to immediately stop access to voice mails, emails, telephone service.
5-21-02: The Centers for Medicare & Medicaid Services has announced
the planned broadcast of another HIPAA program--"Meeting the HIPAA
Challenge: Implementing the HIPAA Standards and the Administrative
Simplification Compliance Act." This program will be a satellite broadcast
and webcast. The webcast will be available for 90 days after the initial
broadcast, which will occur on June 18, 2002, from 2:00-3:30 P.M. (EDT).
For more details on how to receive/view the program and/or webcast,see: http://www.hcfa.gov/medlearn/broadcst.htm
5-7-02: Per AMED News.com (5-13-02): By Oct. 15, physicians, hospitals and health plans that transmit health care data electronically will have to either comply with the new HIPAA transactions standards and code sets or submit a form to Health and Human Services (HHS) asking for an extra year to meet the standards. HHS officials acknowledge that there is a great deal of anxiety in the health care system right now about completing the compliance plan correctly and on time. But there's no need to hurry and there's no need to panic, said Karen Trudel, director of the HIPAA project staff at the Centers for Medicare & Medicaid Services. The compliance plan is basically designed to ask questions that get people thinking about what they need to be doing, such as whether the health care "entity" has completed various requirements for coming into compliance - such as staff training and software installation - or, if not, when they expect to do so.
3-22-02: See proposed changes to to be published in the Federal Register March 27, 2002 with a 30-day comment period regarding HIPAA compliance per HHS Press Release and Fact Sheet on the Privacy Rule.
3-12-02: For an overview about HIPAA see:
Also, see: http://www.ncpdp.org/news_hipaa.asp
2-25-02: The Centers for Medicare & Medicaid
Services (CMS) has complied a list of frequently asked questions (FAQs) to
clarify certain requirements of the Administrative Simplification Compliance
Act (ASCA), which was signed into law on December 27. The ASCA delays for
one year the deadline for certain healthcare plans, providers, and
clearinghouses to comply with a rule, mandated by the Health Insurance
Portability and Accountability Act (HIPAA), on national
standards for exchanging healthcare data electronically. The ASCA sets a
new compliance deadline of October 16, 2003. Among the questions addressed by
CMS are those regarding the ASCA's requirement that covered entities submit to
the Department of Health and Human Services (DHHS) before October 16, 2002 a
plan detailing their strategies for achieving compliance by the new deadline.
To read the FAQs, see: http://www.healthlawyers.org/ofnotes/ofnote_cmsascafaq.cfm
The following DRAFT forms are provided by the AMA Health Law Division to assist physicians in HIPAA compliance efforts. Reproduction and use of the forms by physicians and their staff is permitted. Any other use, duplication or distribution of the forms by any other party requires the prior written approval of the American Medical Association, Health Law Department.
The forms are formatted so they can be copied and pasted from most browsers into word processing programs.
Derived From American Health Lawyers Association, Health Law Highlights, 12-17-01:
Congress Votes To Delay HIPAA Transaction Standards
Congress voted to delay for one year the Health Insurance Portability and Accountability Act's (HIPAA) deadline for health
plans, clearinghouses, and providers to comply with the administrative simplification standards for electronic transactions and code sets in all
electronic billing and records. The compliance deadline will now be October 16, 2003.
The delay will not affect the April 14, 2003, deadline for health plans, clearinghouses, providers, and suppliers to comply with the new rules
protecting the privacy of individual medical records (small health plans will get an extra twelve months to comply). The bill, the Administrative
Simplification Compliance Act (H.R. 3323), sped through both houses without a dissenting vote after lawmakers heard from both private health plans and
some state Medicaid agencies that it would be hard for them to meet the October 2002 deadline. The House voted 410-0 on December 4 in favor of H.R.
3323, authored by Rep. David L. Hobson (R-OH), who began the push to standardize healthcare transactions back in 1993. The Senate then accepted
Dobson's version by unanimous consent without amendment on December 12, as lawmakers rushed to finish business for the year.
The standards cover transactions including the submission of healthcare claims, healthcare payments and remittances, coordination of benefits transactions, enrollment and disenrollment, referrals and authorizations, and injury reports. Before the House acted, Hobson scrapped a controversial, provision that would have imposed a $1 fee on every paper claim submitted to Medicare. Instead, the bill requires providers to bill Medicare electronically (with exceptions for facilities with fewer than twenty-five full-time employees or a physician practice with fewer than ten employees). Any plan or provider seeking to take advantage of the one-year delay must file a plan with the Secretary of the Department of Health and Human Services (DHHS) explaining the steps they will take to reach compliance by October 16, 2003. The bill also would authorize DHHS to spend $44 million to help Medicare prepare for the transition. Those funds would help DHHS finish
writing the standards, provide education and assistance, and pay for
See http://thomas.loc.gov/ and search under H.R. 3323.
On November 27, the U.S. Senate passed a bill (S. 1684) that will provide a one-year extension for compliance by certain covered entities with the
administrative simplification standards for electronic transactions and code sets issued under the Health Insurance Portability and Accountability Act of
1996 (HIPAA). The bill, sponsored by Senator Byron Dorgan (D-ND) will delay the deadline for compliance until October 16, 2003. The standards set
uniform national formats for the electronic exchange of patient data.
See S. 1684, at http://thomas.loc.gov, and search by
bill number on "S. 1684".
www.hcfa.gov/medicaid/hipaa/default.asp has a link to an interactive tool, HIPAA OnLine, that helps consumers, employers, state regulators, and self-funded plans answer questions about rights and protections under the Health Insurance Portability and Accountability Act ("HIPAA"). HIPAA OnLine guides you to an answer by asking you questions about your health coverage and situation.
2/23/01: Secretary of Health and Human Services Tommy Thompson said the department is reopening the Health Insurance Portability and Accountability Act (HIPAA) privacy act regulations for a new, 30-day comment period. Thompson said, "Our goal is to achieve privacy protection that works. I believe we should be open to the concerns of all those who care strongly about health care and privacy. And after we hear those concerns, our commitment must be to put strong and effective patient privacy protections into effect as quickly as possible." Thompson confirmed that the effective date of the privacy regulations has been extended to April 14 due to bureaucracy reasons.
Note: The following may be accessible to Hospital Association members only: For sample of model consent and notice forms for hospitals to help evaluate current practices on use and disclosure of protected health information under the final Privacy Rule issued in December 2000, which goes into effect February 26, 2001, with full compliance required by February 26,2003 as posted on the American Hospital Association ("AHA") Web site; See:
7-31-01: The Association of American Physicians and Surgeons ("AAPS") said it would sue the Department of Health and Human Services ("DHHS") in federal district court in Houston to block implementation of the final privacy rule issued in December 2000 pursuant to the Health Insurance Portability and Accountability Act ("HIPAA"). AAPS alleges the regulations are unconstitutional based on their content and outcomes (a different theory from the suit filed earlier in July by two state medical associations - South Carolina Medical Association and another medical association - that challenged Congress' authority to delegate to DHHS the authority to write the regulations). AAPS claims the regulations violate the Fourth Amendment by requiring physicians to allow government access to personal medical records without a warrant and authorizing the government to construct a centralized database of personal medical records with personal health identifiers and that the regulations violate HIPAA and lack statutory authorization to the extent they regulate medical records other than electronic transmissions.
4-8-02: Tom Scully, the Administrator of the Centers for Medicare & Medicaid Services (CMS), summarized the Bush Administration's priorities on healthcare at a conference held by the American Health Lawyers Association this April in Baltimore, MD: (1) a top healthcare goal is to "modernize" Medicare - as making the Medicare system work more like the government's Federal Employees Health Benefits Program. and this program would probably remain predominantly fee-for-service; (2) need for Medicare prescription drug benefit - however, Medicare program must be reformed to add expense of such a major benefit. Scully listed the following goals as key to modernizing Medicare: subsidizing a prescription drug benefit (especially for low income individuals); providing better coverage for preventative care; providing stronger health insurance options for beneficiaries; strengthening the long term financial security of the program; updating and streamlining Medicare regulations and processes; and making needed improvements in the fee-for-service program.
6-21-02: See U.S. Supreme Court decision on the Moran case as specified under New News in Class 5 - upholding Illinois law for independent third party medical reviewers and discussing ERISA preemption issue.
See: Rush Prudential HMO, Inc. v. Moran etal.; certiorari to the united States Court of Appeals for the Seventh Circuit, No. 001021 - Argued January 16, 2002 - Decided June 20, 2002
1/21/02: The U.S. Supreme Court heard oral arguments on January 16,
2002 in a case involving ERISA and the law in Illinois regarding independent
third party medical reviewers - on whether section 4-10 of the Illinois Health Maintenance Organization Act (HMO Act), which
requires HMOs to provide an independent medical review when a patient's primary physician and an HMO disagree over a course of treatment, was pre-empted by the Employee Retirement Income Security Act (ERISA) of 1974. Rush is claiming the state of Illinois breached the federal law of ERISA by imposing on health plans its own remedy for dealing with dissatisfied customers. Moran's attorney argued that the HMO Act was simply "a state insurance law." Thirty-seven states have similar statutes as in Illinois. In this particular case, the plaintiff, Debra Moran sued her HMO, Rush Prudential HMO Inc. (Rush), in Illinois state trial court after the HMO denied coverage of a surgery recommended by a non-network specialist and refused to comply with Sect. 4-10 of the HMO Act. Rush removed the case to federal district court, arguing ERISA pre-empted Moran's claim. After additional proceedings, the district court agreed with Rush. On appeal, the Seventh Circuit reversed, holding that Sect. 4-10 avoided pre-emption within ERISA's savings clause because it regulated insurance. Justice David H. Souter at one point said, "The facts do not put this in a clear category."
See: Moran v. Rush Prudential HMO, Inc., 230 F.3d 959 (7th Cir. Oct. 19, 2000).
1-23-02: Chicago Tribune article "California Sets Nurse-patient Ratios," reports that California is the first state to pass a law specifying mandatory staffing standards of registered nurses in emergency room and at the bedside. The California Healthcare Association claimed cookie-cutter standards should not be dictating minimum staffing decisions. The law established minimum nurse-to-patient ratios in 22 categories, such as one nurse for every infant under anesthesia, one nurse for every six patients on general medical wards and a nurse for every trauma patient in the emergency room. Federal inspection reports at the U.S. Department of Health and Human Services show that California hospitals and at least four Illinois facilities have assigned just one nurse for up to 20 patients, sometimes with "disastrous results". According to this article, this law represents a victory for organized labor groups seeking to bolster ranks.
Per HHS Weekly Report (8-5-02): Margaret J. Giannini, M.D., F.A.A.P.,
currently the principal deputy assistant secretary for aging at the
Administration on Aging, has been appointed to lead the new office of HHS Office
on Disability to oversee the coordination, development, and implementation of
programs and special initiatives within HHS that impact people with
June 14, 2001 According to a press release from HHS:
HHS Secretary Tommy G. Thompson announced in an effort to reform the Health Care Financing Administration (HCFA) the federal agency that runs the Medicare and joint federal-state Medicaid programs that HCFA will now be named the Centers for Medicare & Medicaid Services. Thomas Scully is the new Administrator CMS formerly known as Health Care Financing Administration ("HCFA").
There are nearly 70 million Medicare and Medicaid beneficiaries.
The new name reflects the increased emphasis at the Centers for Medicare & Medicaid Services on responsiveness to beneficiaries and providers, and on improving the quality of care that beneficiaries receive in all parts of Medicare and Medicaid.
To achieve these goals, the Centers for Medicare & Medicaid Services
|launch a national media campaign to give seniors and other Medicare beneficiaries more information to help them make decisions about how they want to get their health care;|
|instill a new culture of responsiveness at the Centers for Medicare & Medicaid Services in serving beneficiaries, physicians and other health care providers, states and lawmakers;|
|enhance 1-800-MEDICARE (1-800-633-4227) to a 24-hour a day, seven days a week service that will provide far more detailed information to help beneficiaries to make Medicare decisions;|
|restructure the agency around three centers that reflect the agency's major lines of business;|
|reform the contractor process to improve the quality and efficiency of the Medicare claims processing services (Medicare carriers and fiscal intermediaries) that pay nearly a billion fee-for-service Medicare claims each year.|
Tom Scully, Medicare & Medicaid administrator said: "Too many consumers just don't understand Medicare coverage options and the costs associated with them, from their Medigap options to Medicare+Choice to the cost of prescription drugs. We need to get that information to them and their family members, while working closely with the doctors and other health care providers who give them medical care."
The Centers for Medicare & Medicaid Services will launch a $35 million national media campaign in the fall of 2001 to highlight the health care options and information resources available, including http://www.medicare.gov and 1-800-MEDICARE (1-800-633-4227). The Centers for Medicare & Medicaid Services will also expand the capacity of the toll-free phone line with call center experts available 24 hours a day, seven days a week and develop a program with public libraries to train librarians to help Medicare beneficiaries gather information about Medicare at http://www.medicare.gov. The toll-free phone line currently works only during business hours.
The three new business centers being created as part of the reforms are the Center for Beneficiary Choices, the Center for Medicare Management, and the Center for Medicaid and State Operations.
The Center for Medicare Management focuses on the management of the traditional fee-for-service Medicare program, including development and implementation of payment policy and management of the Medicare carriers and fiscal intermediaries. The Center for Beneficiary Choices focuses on beneficiary education, providing beneficiaries with the information they need to make their health care decisions. This center also includes management of the Medicare+Choice program, consumer research and demonstrations, and grievance and appeals. The Center for Medicaid and State Operations focuses on programs administered by the states, including Medicaid, the State Children's Health Insurance Program, private insurance, survey and certification and the Clinical Laboratory Improvement Amendments (CLIA).
To manage the Medicare program more effectively and responsively, the Centers for Medicare & Medicaid Services will develop a legislative proposal to be submitted to Congress that would provide for competitive bidding of claims processing services. Medicare contracts with private health insurance companies to process and pay Medicare claims. Collectively, these contractors employ about 22,000 individuals and handle more than 900 million Medicare claims each year.
Currently, these contracts are governed by laws that are more restrictive than general federal contract laws. The Centers for Medicare & Medicaid Services will be working with Congress to develop legislation that will allow the agency to competitively award these contracts by using performance based incentives to improve the level of service to beneficiaries and providers, reduce administrative costs and improve efficiency.
Note: All HHS press releases, fact sheets and other press materials are available at http://www.hhs.gov/news
On 12/12/01 the House passed legislation (H.R. 3448) to combat Bioterrorism
authorizing nearly $3 billion to improve the nation's ability to prevent,
prepare for, and respond to biological attacks. The measure provides $1 billion for
preparedness grants to states and other public or private entities; $1 billion for DHHS to augment the nation's stockpiles of drugs and vaccines;
$100 million for food safety; and $100 million to protect drinking water. The bill also authorizes $450 million for the Centers for Disease Control
and Prevention to use in upgrading its facilities.
See: http://www.house.gov/house/Legproc.html, click on Bill Status, and type in H.R. 3448 under Bill Number
From JCAHOnline - December 2001: JCAHO Issues Special Perspectives on
Emergency Preparedness - On Nov. 15, 2001, JCAHO issued a special 24-page Joint Commission Perspectives,the official JCAHO newsletter, that provides guidance to health care
organizations in preparing for terrorist attacks that may involve nuclear, biological or chemical incidents. It also offers
lessons learned from hospitals located near the World Trade Center and the
Pentagon. As part of this effort, JCAHO is paying particular attention to emergency management
planning during its ongoing, onsite evaluations of health care organizations.
"HHS PRESS RELEASE--ADDITIONAL $1.5 BILLION PROPOSED TO COMBAT BIO TERRORISM"
[This is from a HHS Press Release on 10/17/0] President Bush's $20 billion emergency relief budget request includes $1.5 billion for HHS to further strengthen the nation's ability to respond to and treat potential bioterrorism attacks. The emergency budget request will support efforts at the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), other HHS agencies, and state and local efforts. Key elements include:
Expanding the National Pharmaceutical Stockpile; Expanding smallpox vaccine supplies;
Speeding the development of new bioterrorism tools; Increasing state and local readiness;
Expanding HHS response capabilities; Improving food safety; and other recovery and
In a bioterrorism event, HHS has special responsibilities, including
detecting the disease, investigating the outbreak, and providing stockpiled drugs and emergency supplies in the large amounts needed. In July, Secretary Thompson named Scott Lillibridge, a physician who had coordinated the Centers for Disease Control and Prevention's bioterrorism response efforts, as special advisor to lead the department's coordinated bioterrorism initiative.
10/8/01: Janet Rehnquist, Inspector General ("IG") for the Department of Health and Human Services ("DHHS") was the keynote speaker at the AHLA/HCCA Fraud and Compliance Forum on Monday, October 1. Rehnquist indicated that she intends to focus on corporate integrity agreements ("CIAs") and that she would work to make some changes including increasing flexibility as that she was aware of the significant financial burden on providers in complying with the False Claims Act. She urged providers to make an investment upfront and bring themselves into compliance, rather than run the risk of spending more money after a CIA is in place. She also said a priority is streamlining the settlement process for False Claims Act cases and that Office of Inspector General ("OIG") will focus on improving the quality of care in nursing homes. On the same day, the OIG released its work plan for fiscal year 2002 which introduced new initiatives such as examining whether inconsistent coding of outpatient services by hospitals and physicians for the same service is a persistent problem, developing a national payment error rate for Medicare fee-for-service mental health claims, and increasing joint initiatives between the OIG and other federal and state agencies.
See OIG's FY 2002 work plan at: http://www.hhs.gov/oig/wrkpln
The Office of Inspector General (OIG) Work Plan is set forth in four chapters encompassing the various projects to be addressed during Fiscal Year (FY) 2002 by the Office of Audit Services, Office of Evaluation and Inspections, Office of Investigations, and Office of Counsel to the Inspector General.
9/01: One of the Federal Trade Commission's ("FTC") top priorities, according to the FTC's Howard Beales to the Senate Special Committee on Aging during a September hearing is to combathealth fraud, particularly deceptive acts or practices affecting the elderly. According to Beales the elderly in particular are susceptible to fraudulent claims for products marketed as treatments for serious illness because of the higher incidence of such health problems among older Americans and that in addition to aggressive law enforcement, the FTC would continue its efforts to educate the public on how to identify and avoid health fraud.
10/26/01: Recently, North Carolina Governor Mike Easley (D) signed
into law a bill (S.B. 199) that is widely viewed as the strongest piece of
patients' rights legislation in the nation. This act states that it is:
"AN ACT TO IMPROVE PATIENT ACCESS TO HEALTH CARE ADVICE, INFORMATION, AND SERVICES TO COVERED PERSONS UNDER HEALTH BENEFIT PLANS BY PROVIDING FOR: CONTINUITY OF CARE IN HMOS, EXTENDED OR STANDING REFERRAL TO A SPECIALIST, SELECTION OF SPECIALIST AS PRIMARY CARE PROVIDER, DIRECT ACCESS TO PEDIATRICIANS, ACCESS TO NONFORMULARY AND RESTRICTED ACCESS PRESCRIPTION DRUGS, ESTABLISHMENT OF THE MANAGED CARE PATIENT ASSISTANCE PROGRAM, PATIENT'S RIGHT TO CHOOSE THE PROVIDER OF SERVICES UNDER A HEALTH BENEFIT PLAN AND PROHIBITION OF DISCRIMINATION AGAINST PROVIDERS AS PARTICIPATING PROVIDERS BASED ON THE PROVIDER'S LICENSE OR CERTIFICATION, PROHIBITION ON CERTAIN MANAGED CARE PROVIDER INCENTIVES, MANAGED CARE REPORTING AND DISCLOSURE REQUIREMENTS, PROVIDER DIRECTORY INFORMATION, DISCLOSURE OF PAYMENT OBLIGATIONS, MANDATED COVERAGE FOR CLINICAL TRIALS AND NEWBORN HEARING SCREENING, AND STANDARDS FOR INDEPENDENT REVIEW OF NONCERTIFICATIONS BY AN INSURER OR MANAGED CARE PLAN; AND TO HOLD MANAGED CARE ENTITIES LIABLE FOR HARM CAUSED TO INSUREDS OR ENROLLEES BY THE FAILURE TO EXERCISE ORDINARY CARE IN MAKING HEALTH CARE DECISIONS."
See: http://www.ncga.state.nc.us then enter S199
8/13/01: Illinois Representative Mary Flowers (D-Chicago) writes in the Editorial section of the Chicago Tribune (August 13, 2001) that as a chief sponsor of the Illinois Managed Care Reform and Patients' Rights Act that the creation of the Office of Consumer Health Insurance under the Illinois Department of Insurance is a critical element of the Act because it can help (as she writes in terms of seemingly suggesting this type of approach for the national patient's bill of rights process currently underway) "patients cut through the large, complex bureaucracies and red tape, and to better understand and exercise their rights".
8/3/01: According to an article in the Chicago Tribune on August 3, 2001, "Patients' Rights Bill OK'd by House," the House bowed to President Bush's veto threat and narrowly approved his patient's rights legislation. This plan gives Americans greater rights to sue health plans but limits financial penalties insurers could suffer. Patients denied treatment would be allowed to sue for punitive damages but only when an HMO had refused to abide by the ruling of an independent review board. Punitive damages would be capped at $1.5 million. Damages for pain and suffering would be capped at $1.5 million.
This article looks at some of the behind the scenes politics in the passing of this bill by the House involving Charlie Norwood (R-Ga.), a dentist, the "conservative who has led the fight for patients' rights legislation. Democrats said this bill resulting from a compromise between Norwood and Bush was not bipartison because it was worked out without the consent of Norwood's co-sponsors (John Dingell (d - MI) and Greg Ganske (R- Iowa). It received only three votes from Democrats.
6/19/01: According to an article in the Chicago Tribune on June 19, 2001, "Senate Takes on Patient's Rights Bill" with sub-title "Bush Threatens Veto if HMO suits aren't limited" indicates that some believe, such as the proposal of Sens. Edward Kennedy (D-Mass), John McCain (R-Ariz.) and John Edwards (D -N.C.) that there should be legislation subjecting HMOs to the same liability for the consequences of their negligent behavior as others and guaranteeing access to specialists and emergency room care and the right to appeal HMOs decisions on coverage and treatment and the right to sue in state and federal courts while others believe as indicated by the statements of the president of the American Association of Health Plans group that such legislation would be a boon for trial layers and result in increased health insurance premiums for consumers.
7/5/01: HHS is about to issue privacy "guidances"
for Privacy, Security & Internet Security, Enforcement. They are expected to address several contentious issues, including the right of family members or friends to pick up prescriptions, oral communications, patient consent provisions and "minimum necessary" disclosures.
Secretary Thompson announced that a cross-Departmental Task Force on Regulatory Reform is being created immediately to steer an ongoing review of HHS regulations and to oversee changes in regulations. The regulatory reform effort will include expanded review of Medicare and Medicaid regulations as part of a reform of the HHS' Health Care Financing Administration. "At the very time when we are trying to attract more managed care plans to offer their services to Medicare beneficiaries, do we really need 854 pages of regulations standing in the middle of the front door to the program?" Thompson said. "And today, 15 years after we moved away from cost-based reimbursement, do we still need to require hundreds of pages of cost information from every Medicare hospital? We need to examine our real needs and be sure we're not imposing unnecessary burdens on our health care providers."
6/11/01: 52 Senior Medicare Patrol Project grants administered by the
Administration on Aging (AoA) were issued to help educate and train senior volunteers in reviewing health care benefit statements and outlining the steps seniors can take to protect themselves. This is considered an important role in helping the Medicare program avoid unintended errors and detect deliberate abuses.
July 6, 2001: Department of Health and Human Services (HHS) issued the first in a series of guidance materials on new federal privacy protections for medical records and other personal health information. Providing this guidance is part of an ongoing process to help health care providers and health plans come into compliance with the regulation by April 14, 2003. The guidance – available on the Web at http://www.hhs.gov/ocr/hipaa – answers common questions about the new protections for consumers and requirements for doctors, hospitals, other providers, health plans and health insurers, and health care clearinghouses.
APRIL 12, 2001: HHS announced that it will will immediately begin the process of implementing President Bush's patient privacy rule dealing with patient privacy protections and keeping medical records confidential. This rule is to give patients greater access to their own medical records and more control over how their personal information is used.
The following is from a press release by HHS on 8/16/01: HHS PROPOSES NEW MEDICAID MANAGED CARE REGULATION
TO ENSURE PATIENT RIGHTS' PROTECTIONS FOR BENEFICIARIES
HHS Secretary Tommy G. Thompson today proposed new regulations to give Medicaid beneficiaries in managed care plans the same types of protection that participants in managed care plans would receive under patient rights' legislation now pending in Congress.
The regulations, which Secretary Thompson pledged to have in place by early next year, will guarantee Medicaid beneficiaries access to emergency room care, a second opinion when needed, a timely right to appeal adverse coverage decisions, and other essential patient protections. At the same time, the rule will give states flexibility to provide these protections in a workable manner.
"Medicaid beneficiaries deserve the same rights and protections as all other Americans enrolled in managed care plans," Secretary Thompson said. "This proposed rule provides needed patient protections and gives states flexibility to implement these protections without jeopardizing Medicaid beneficiaries' access to health care."
The proposed regulations build on protections for Medicaid beneficiaries
that were created under the Balanced Budget Act of 1997.
The proposed rule retains and expands upon all the protections already
available to Medicaid beneficiaries under the 1997 statute. Under the rule, beneficiaries will have the following rights:
· Emergency Room Care. Health plans must pay for a Medicaid beneficiary's emergency room care whenever and wherever the need arises.
· Access to second opinion. All beneficiaries will be allowed to get a
second opinion from a qualified health professional.
· Direct access for women's health services. Women will be allowed to
directly access a woman's health specialist in the network for the care
necessary to provide routine and preventive health care services as already available in Medicaid fee-for-service.
· Patient-Provider Communication. Managed care plans will be prohibited
from establishing restrictions, such as gag rules, that interfere with
· Network Adequacy. Managed care plans will be required to assure that they have the capacity to serve the expected enrollment in their service area.
· Marketing Activities. States will be required to approve marketing
materials used by the managed care plans to enroll Medicaid beneficiaries.
Plans are prohibited from using door-to-door, telephone, and other forms of "cold call" marketing.
· Grievance Systems. All managed care plans must have a system in place to accommodate enrollee grievances and appeals. Grievances must be resolved within state established timeframes that may not be longer than 90 days and must be resolved by managed care organizations within 45 days. However, expedited timeframes exist for resolving appeals when the life or health of the enrollee is in jeopardy.
Managed care plans serving Medicaid beneficiaries also must provide
consumers with comprehensive, easy-to-understand information about the managed care plan in which they are enrolled.
The proposed regulations will replace a rule put forth by the Clinton
administration last January. Under the new regulations, states will have
significantly more flexibility to decide how best to provide patient
protections and use managed care in their Medicaid plans. The new rule's provisions are more concise and understandable and will reduce the regulatory burden on the states and health plans.
In addition, the rule will allow states, many of which have already
implemented protections through state laws and regulations, to keep in place important aspects of their existing programs. The new rule also will require states to submit to HHS clear plans for providing beneficiaries with high quality care and to measure the quality of the care that is actually provided.
"I want to have patient protections in place as quickly as possible.
However, the previously issued rule went far beyond what Congress intended with the Balanced Budget Act, and its excessive mandates actually threatened beneficiaries' access to care under Medicaid," Secretary Thompson said. "The new proposed rule will ensure that states have the flexibility they need to protect patients while protecting the programs they may already have established."
The proposed regulation will be published in the Federal Register on Monday, Aug. 20 and will be available online today at www.hcfa.gov/medicaid/omchmpg.htm. The 60-day comment period for the proposed rule will end on Oct. 19, 2001. CMS will review those comments for the final regulation, which will be issued early next year.
According to Chicago Tribune (March 22, 2001), section 1, page 11, "Bush Urges Tight Caps on Patients' Lawsuits": It appears that overall there is agreement by lawmakers in Congress that: Americans deserve comprehensive patient protection and: should be allowed to see obstetricians, gynecologists and pediatricians without first going through a primary care physician, health plans should be required to offer access to other sorts of specialists, and that patients should be able to go to the nearest emergency room without worrying about health insurance coverage. However, there is a disagreement on the issue of the ability to sue HMOs in state courts and if able to then the damages limit for pain and suffering.
Bipartisan Patient Protection Act
On February 6, 2001 federal legislators introduced "Bipartisan Patient Protection Act(s) of 2001". Senators John McCain (R-AZ), John Edwards (D-NC), Edward Kennedy (D-MA), Lincoln Chafee (R-RI), Tom Harkin (D-IA), and Bob Graham (D-FL) introduced the Senate bills and Representatives Greg Ganske, M.D., (R-IA) and John Dingell (D-MI) introduced the House bills. The proposed legislation aims to: give every American the right to choose their own doctor; cover all Americans with employer-based health insurance; ensure that all external reviews of medical decisions are conducted by independent and qualified physicians; and hold a plan accountable when the plan makes a decision that harms or kills someone. The proposed law would respect state-enacted patient protections; provide a federal cause of action for negligent plan administration (which will provide uniformity on how the health plans are administered); protect businesses from frivolous lawsuits; and hold insurers accountable for injuries arising from their actions.
See: Senator McCain's press release on the new bills at: http://www.senate.gov/~mccain/pbor01.htm
See the bills, posted on Senator McCain's Web site at: http://www.senate.gov/~mccain/ and click on S. 283 and S. 284
As of press time, these bills had not been posted on the Library of Congress Web site at: http://thomas.loc.gov.
On the day after bipartisan patient rights legislation was introduced in the Senate and the House, President George W.
Bush issued a press release containing "Principles for a Bipartisan Patients' Bill of
Rights" including the following: patient protections should apply to all
Americans enrolled in health plans; a federal patients' rights law should provide rights such as access to emergency room and specialty care,
direct access to certain doctors, access to needed prescription drugs and approved clinical trials, and a prohibition on "gag clauses"; patients
should have a rapid medical review process for denials of care; physicians should make medical decisions and patients should receive care in a timely manner; federal remedies should be expanded to hold health plans accountable for wrongful denial of care; and employers should be protected from frivolous or unnecessary lawsuits.
See: President's February 7 press release at: http://www.whitehouse.gov/news/releases/20010207-2.html
See: Letter from President to House and Senate Democratic Leaders at: http://www.whitehouse.gov/news/releases/20010207-3.html
See: Letter from the President to the House Speaker and
Majority Leader at: http://www.whitehouse.gov/news/releases/20010207-4.html
5-14-02: Geneva, Switzerland -- HHS Secretary Tommy G. Thompson signed a Memorandum of Understanding (MOU) with Canadian Minister of Health A. Anne McLellan to improve the health status of indigenous communities through enhanced international collaborations, identification and reinforcement of best practices, and through innovative approaches to learning opportunities
8--17-01: HHS today announced the launch of a new Web site that addresses the link
between domestic and international health issues with global health issues and worldwide health statistics, reports and
publications, and links to the department's global health partners. This website is administered by HHS' Office of International and Refugee Health. With the ease of travel in today's global economy means that no nation can be isolated from global health threats. The movement of more than 2 million people each day across national boarders and the growth of international trade in goods are responsible for increased health risks, including infectious diseases, contaminated foods, and biological and chemical threats.
Under the quality agreement, the U.S. and U.K. plan to share data and
experiences related to quality of care, including efforts to enhance the use of information technology, expand common criteria for measurement of quality of care, and achieve mutual quality research goals. Efforts will be aimed at improved monitoring and reporting, including reporting on medical errors and patient safety; improving primary care and cost effectiveness of care; and reducing disparities in the care available to patients.
10/10/01: Life expectancy for the U.S. population reached a record high of 76.9 years in 2000 as mortality declined for several leading causes of death.
8/16/01: "HHS PROPOSES NEW MEDICAID MANAGED CARE REGULATION
TO ENSURE PATIENT RIGHTS' PROTECTIONS FOR BENEFICIARIES": HHS Secretary Tommy G. Thompson today proposed new regulations to give
Medicaid beneficiaries in managed care plans the same types of protection that participants in managed care plans would receive under patient rights' legislation now pending in Congress.
According to this press release: "The proposed rule retains and expands upon all the protections already
available to Medicaid beneficiaries under the 1997 statute. Under the rule, beneficiaries will have the following rights:
· Emergency Room Care. Health plans must pay for a Medicaid beneficiary's emergency room care whenever and wherever the need arises.
· Access to second opinion. All beneficiaries will be allowed to get a
second opinion from a qualified health professional.
· Direct access for women's health services. Women will be allowed to directly access a woman's health specialist in the network for the care necessary to provide routine and preventive health care services as already available in Medicaid fee-for-service.
· Patient-Provider Communication. Managed care plans will be prohibited from establishing restrictions, such as gag rules, that interfere with patient-provider communications.
· Network Adequacy. Managed care plans will be required to assure that they have the capacity to serve the expected enrollment in their service area.
· Marketing Activities. States will be required to approve marketing
materials used by the managed care plans to enroll Medicaid beneficiaries. Plans are prohibited from using door-to-door, telephone, and other forms of "cold call" marketing.
· Grievance Systems. All managed care plans must have a system in place to accommodate enrollee grievances and appeals. Grievances must be resolved within state established timeframes that may not be longer than 90 days and must be resolved by managed care organizations within 45 days. However, expedited timeframes exist for resolving appeals when the life or health of the enrollee is in jeopardy.
Managed care plans serving Medicaid beneficiaries also must provide
consumers with comprehensive, easy-to-understand information about the managed care plan in which they are enrolled. The proposed regulations will replace a rule put forth by the Clinton administration last January. Under the new regulations, states will have significantly more flexibility to decide how best to provide patient protections and use managed care in their Medicaid plans. The new rule's provisions are more concise and understandable and will reduce the regulatory burden on the states and health plans. In addition, the rule will allow states, many of which have already implemented protections through state laws and regulations, to keep in place important aspects of their existing programs. The new rule also will require states to submit to HHS clear plans for providing beneficiaries with high quality care and to measure the quality of the care that is actually provided."
July 12, 2001: President Bush today announced a new Medicare-endorsed prescription drug discount card program designed to immediately help Medicare beneficiaries lower their out-of-pocket drug costs. Enrollment in the Medicare Rx Discount Card Program will begin as early as November 1.
Discount cards are expected to save Medicare beneficiaries some 10 percent to 25 percent on prescription drug prices. Medicare serves about 40 million beneficiaries, and over 10 million of them do not have prescription drug coverage in addition to their Medicare coverage.
The United States Supreme Court case, Circuit City Stores, Inc. v. Adams", legitimized and endorsed mandatory arbitration of
employment-related claims under the Federal Arbitration Act. This case has generated renewed interest in mandatory arbitration programs among healthcare employers.
Health and Human Services (HHS) has released a final regulation establishing for the first time national standards to protect patients' personal medical records. For a summary of the final regulation see the fact sheet issued December 20, 2000 at:
On December 29, 2000, HCFA issued technical corrections to the regulations protecting the privacy of patients' medical records (65 Fed.
Reg. 82944), addressing language that had been inadvertently excluded from the preamble of the Standards for Privacy of Individually Identifiable Health Information, which were published on December 28, 2000 (65 Fed. Reg. 82462). The regulations will not be enforced before those dates, nor will the regulations pre-empt state laws before those dates.
See technical corrections to final rule, at: http://www.access.gpo.gov/su_docs/fedreg/a001229c.html
See final privacy rule as published in Federal Register, at: http://www.access.gpo.gov/su_docs/fedreg/a001228c.html
3/24/01: HHS press release announced that President Bush intends to nominate Claude Allen as deputy secretary of the Department of Health and Human Services. Allen led Gov. Gilmore's initiative for Virginia's Patients Bill of Rights passed in 1999 that gave patients the right to appeal adverse coverage decisions made by their health plan and receive direct access to physician specialists.
3/14/01; According to the article "Without 'Barefoot Doctors,' China's Rural Families Suffer" by Elisabeth Rosenthal, many of China's 800 million rural residents have stopped seeing doctors except in extreme emergencies because they cannot afford the health care costs that have increased 400 to 500 percent from 1990 to 1997. The number of tuberculosis cases has quadrupled in 15 years, infant mortality is starting to increase though for the past 40 years it had been basically declining steadily and immunization rates have started to drop.
2/27/01: According to Health and Human Services (HHS) nine more states have received grants to develop plans extending health insurance coverage to all citizens. HHS Secretary, Tommy G. Thompson, stated that "The grants will help states identify who remains uninsured, why they are uninsured and develop ways to get them the coverage they need."
See: http://www.hcfa.gov/medlearn/faqphys.htm for answers to frequently asked questions regarding the physician referral law.
Freedom of Speech - First Amendment Rights - Advertising
An Illinois Appellate court reversed a trial courts decision by claiming that the trial court erred in affirming sanctions imposed against a chiropractor for violation of Section 26 of Medical Practice Act. Prohibition against using testimonials in advertising violates first amendment rights. The court found that this particular regulation of commercial speech is more extensive than is reasonable necessary because testimonials are not "inherently misleading."
See: 4th Dist. Snell v. Dept. of Prof. Reg. No. 4-99-0876 (January 26, 2001) Champaign County.
According to the Chicago Tribune ((January 9, 2001),section 1, page 8, "Canada Doctors Strike Over Governmental Fees": Doctors in eastern Canadian province of New Brunswick turned away patients in a dispute over how much they get paid by government-run health insurance. No figures were available of how many of the province's 1300 doctors closed their offices. Some Hospitals reported an increase in their emergency rooms activity. The government offered the doctors a fee increase of about 12.5% or $15,333, over four years but the physicians want a 30% increase.
According to HHS OIG posting, Inspector General June Gibbs Brown retired January 3, 2001 and until a replacement is named, Michael F. Mangano, Principal Deputy Inspector General will serve as the Acting Inspector General
Note: for HMO Liabiality under ERISA see Class 9 New News
Health Plan Appeals
Department of Labor (DOL) Pension and Welfare Benefit Administration issued a final regulation (65 Fed. Reg. 70246) for benefit claims procedures of employee benefit plans covered by Title I of the Employee Retirement Income Security Act of 1974 ("ERISA").
The regulation was issued by the Clinton administration after it became unlikely that Congress would enact a patients' bill of rights this session. This regulation revises the minimum requirements for benefit claims procedures of the 130 million employees enrolled in employee benefit plans covered by Title I of ERISA. This regulation establishes new standards for processing claims under group health plans and plans providing disability benefits and further clarifies existing standards for all other employee benefit plans. Plans will have seventy-two hours to tell patients whether treatments in potentially life-threatening situations would be covered, and fifteen days for advance clearance of routine operations. Patients could appeal those decisions to the health plan, which would have to respond within an expedited timetable. The new standards are intended to ensure more timely benefit determinations, to improve access to information on which a benefit determination is made, and to assure that participants and beneficiaries will be afforded a full and fair review of denied claims. This regulation applies to all claims filed on or after January 1, 2002.
Note: Be careful with medical records releases, even if signed, as there may be certain laws requiring specific types of information to permit the release of the records without breach of confidentiality. See Illinois case in which a hospital relying on a generic medical records release signed by plaintiff released records to insurance company containing reference to plaintiff's prior treatment for alcohol abuse. Illinois Appellate Court held that the trial court erred in dismissing the claim filed by plaintiff against hospital for breach of confidentiality for releasing records because the released did not contain sufficient detail to authorize hospital to divulge information about previous treatment for alcohol abuse, as required by 42 C.F.R. section 1.01.
See: M.A.K. v. Rush-Presbyterian St. Luke's Medical Center No.
3-99-0618 (October 11, 2000) Will County (BRESLIN) Reversed and
remanded. CIVIL INSURANCE MEDICAL RECORDS 3rd Dist.
10/26/00: According to the article by Thomas M. Burton, "Doctors Raise Warnings About a Form of Clozapine" with sub-heading "FDA-Approved Generic Version of Schizophrenia Drug Has Disturbing Effects in Studies," in The Wall Street Journal (October 24, 2000) pages B1 and B4: This article looks at how there is increasing evidence that a generic pill for schizophrenia varies in some notable way with the brand-name drug. This article illustrates some possible varying positions between brand name drug companies and generic drug companies. For example, generic drug companies may claim that certain research is misinformation and based on phony studies that brand companies use to deceive patients into paying high prices. Federal regulators say the this is a very unusual case and that people need not be suspicious of other generics in their medicine cabinets. the brand name drug company.
See the Department of Health and Human Services strategic plan for the next five years at its website at: http://www.aspe.hhs.gov/hhsplan/index.htm.
Some health care issues getting various attorney's attention, as indicated by an Internet memo dated October 13, 2000 sent by James Sheehan, vice-chair of American Health Lawyers Association's Healthcare Fraud and Abuse Compliance and Enforcement program informing readers about an upcoming seminar:
Prescription drug issues affecting physicians, hospitals, health plans,
employer sponsors, pharmacy benefit managers, and manufacturers. The commitment of both presidential candidates to Medicare prescription drug plans will result in greatly increased scrutiny of the relationships in these areas by law enforcement. Get ready to advise your clients on how to prepare for this scrutiny.
-- Privacy issues arising out of the new HIPAA privacy regulation, promised for late October. It is likely that this will be the first conference in which the speakers have had a chance to digest the new mega-regulation, and its impact on healthcare fraud enforcement, defense, and compliance.
-- Issues relating to corporate integrity agreements - -over a thousand health care providers are now party to these agreements, and some are now the subject of second investigations and prosecutions. How should counsel and managers assure compliance with agreements? How independent must the independent reviewer of corporate integrity be? Can you insist on seeing and changing the "independent reviewer's" independent review before it goes to the government?
Mike Hash, Acting Administrator of the Health Care Financing Administration ("HCFA"), announced on December 1, 2000 his resignation effective December 15. He did not announce his future plans. Hash had been promoted from Deputy Administrator to Acting Administrator when former Administrator Nancy-Ann Min DeParle left HCFA October 1. Dr. Robert Berenson, Director of HCFA's Center for Health Plans and Providers, will assume the position of Acting Deputy Administrator and will run HCFA pending the search for a new Administrator.
The Wall Street Journal, September 12, 2000, "Health-Care Agency Chief to be Fellow at Harvard": Nancy-Ann DeParle took over the Health Care Financing Administration, the federal agency that oversees Medicare and Medicaid in 1997 and has announced that she ahs accepted an offer to become a fellow at Harvard University's John F. Kennedy School of Government for the fall semester, lasting one year, beginning Oct. 1.
According to Crain's Chicago Business, September 11, 2000, "Physicians' Records Accessible on Web," activists, such as from the Chicago-based Coalition for Consumer Rights, say the Illinois Department of Professional Regulation's (DPR) decision last month to post physicians' disciplinary records on the Internet of reprimands and license revocation in Illinois within the last 10 years is not enough and want malpractice data as well as used in Massachusetts and New York. DPR and doctor groups claim that the malpractice information will be misconstrued because there is not "necessarily a correlation between being sued and being a bad doctor," says Dr. LeRoy Sprang, president of the Illinois State Medical Society, that a physician who takes on sicker and higher-risk patients may be sued more often than a doctor who doesn't.
See: Bush's fact sheet on the prescription drug plan, at: http://www.georgewbush.com
See: Gore-Lieberman "Prosperity for America's Families," economic plan,
George W. Bush, Republican presidential candidate, released on September 5 a
$158 billion plan to pay at least 25% of Medicare beneficiaries' prescription drug costs and to improve Medicare benefits. Key elements of
the plan include spending $110 billion over ten years to modernize Medicare and giving $48 billion to states over the next four years to fund the
prescription drug program. Bush's plan also restores $40 billion in Medicare cuts made by the Balanced Budget Act of 1997. Al Gore, Democratic presidential candidate, has proposed spending an estimated $253 billion over ten years to add a
prescription drug benefit to Medicare, an economic plan of "Prosperity for America's Families," which, among other actions,
puts Social Security and Medicare surpluses in a lockbox for use for Social Security and Medicare
only and it predicts that such action would protect the
solvency of Social Security for fifty-five years and Medicare for thirty
Advocate Health Care System sued the Service Employees International Union (SEIU) for "defamatory" statements about Advocate’s pricing and bill-collection practices. Advocate runs a network of 10 hospitals in the Chicago area claims the union released inaccurate reports about the hospital chain's prices to pressure Advocate into letting SEIU to organize its employees. (Crains 2-20-04)
"Medical Residents Get More Benefits," Chicago Tribune (September 8, 2000): Northwestern Memorial Hospital is offering residents retirement plans, expanded health insurance coverage and other benefits typically reserved for conventional employees in an attempt to defuse the residents push for unionization.
According to The Korea Times on August 19, 2000:
An ongoing strike by doctors protesting against medical reforms in South Korea. The leader of the collective action, Shin Sang-Jin, a representative of a committee of the Korean Medical Association (KMA), was arrested for "masterminding the illegal strike". There are about 45,000 doctors par of the KMA.
Most general hospitals were refusing to accept new patients due to the strike, while maintaining only the operation of emergency rooms, intensive care units and infant delivery rooms. Many patients complained that they were left without proper medical care and that medical professionals were taking people as hostages to put forward their own demands.
Allegedly, a growing number of doctors running clinics returned to work after the arrest of their leader, Shin Sang-jin. Around 12,000 interns and residents at general hospitals continued to go on strike Friday.
According to Crain's Chicago Business, August 7, 2000:
See: Issues 2000 at www.issues2000.org for presidential and all other candidate's views on issues including health care. You can find the candidate that most matches your own views by choosing "votematch", answering questions to determine your political views and then a computer will match you with a candidate who most agrees with your opinions.
According to Crain's Chicago Business, September 4, 2000:
The Chicago based American Medical Assn. leads all health care interest groups in donations to congressional campaigns across the country with more than $1 million in contributions so far in the 2000 election.
See Massachusetts newly enacted Genetic Privacy law at:
On August 22, 2000, Massachusetts enacted a law protecting the
privacy of genetic test results and prohibiting employers and insurers from requiring such tests (Ch. 254 of the Acts of 2000). Among its provisions are: prohibiting disclosure of results of genetic tests without the consent of the person to whom the information pertains; prohibiting the requirement of such results of genetic tests as a condition of employment or insurance; and prohibiting discrimination by insurance institutions based on the use of such results of genetic tests. The law states that "it is the goal of the commonwealth to achieve these purposes without limiting the potential for medical research and permitting certain uses for life insurance underwriting"; a commission is to be created to investigate the feasibility of the use of genetic tests in insurance underwriting.
11/30/01: According to a HHS press release: Dean Clancy, a senior policy advisor in Congress, will serve as the first executive director of President Bush's new national Bioethics Council, HHS Secretary Tommy G. Thompson announced today. Clancy will oversee the administrative functions of the new council, which will advise the President on the ethical and moral implications of biomedical research and new technologies, including embryonic stem-cell research and human cloning. President Bush created the council through a Nov. 28 executive order. The council will have up to 18 members drawn from the fields of science and medicine, law and government, philosophy and theology, and other areas of the humanities and social sciences. As part of its mission, the council may investigate and advise the President about issues related to specific biomedical technologies and research, as well as general bioethical issues such as appropriate protections for human research subjects.
According to "Quality of Care for Coronary Heart Disease in Two Countries," by Dr. Ayanian and Thomas Quinn in Health Affairs (May, 2001), the United States and England have different quality improvement (QI) strategies for improving care for coronary heart disease, the leading cause of death in both countries. The US is strong in evaluating the effectiveness of various QI strategies for improving cardiac care and lacks in comprehensive national standards and monitoring systems to determine whether cardiac care is actually improving. In contrast, England has implemented more rapidly national and regional standards for cardiac care and evaluative mechanisms are still under development. Compliance with coronary care clinical guidelines is mandatory in England and voluntary in the US. Due to the centralized nature of health care funding and planning in the British National health Service, national standards for cardiac care is a much more prominent QI strategy in England.
Office of Inspector General--U.S. Department of Health and Human Services (www.hhs.gov/oig)
This website includes a variety of information relating to Federal health care programs, including the following:
Advisory Opinions Anti-Kickback Information Compliance Program Guidance Corporate Integrity Agreements Fraud Alerts Links to web pages for the: Office of Audit Services (OAS) Office of Evaluation and Inspections (OEI) Office of Investigations (OI) OIG List of Excluded Individuals/Entities OIG News OIG Regulations OIG Semi-Annual Report OIG Workplan
Health Care Financing Administration (www.hcfa.gov)
This website includes information on a wide array of topics, including the following:
Medicare National Correct Coding Initiative Intermediary-Carrier Directory Payment Program Manuals Program Transmittals & Memorandum Provider Billing/HCFA Forms Statistics and Data Medicaid HCFA Regional Offices Letters to State Medicaid Directors Medicaid Hotline Numbers Policy & Program Information State Medicaid Contacts State Medicaid Manual State Survey Agencies Statistics and Data
HCFA Medicare Training (www.medicaretraining.com)
This site provides computer-based training on the following topics: HCFA 1500 Form Fraud & Abuse ICD-9-CM Diagnosis Coding Adult Immunization Medicare Secondary Payer (MSP) Women's Health Front Office Management Introduction to the World of Medicare Home Health Agency HCFA 1450 (UB92)
Government Printing Office (www.access.gpo.gov)
This site provides access to Federal laws and regulations pertaining to Federal health care programs.
The U.S. House of Representatives Internet Library (uscode.house.gov/ usc.htm)
This site provides access to the United States Code, which contains laws pertaining to Federal health care programs.