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Teaching Hospital Update - January 19-25, 2009


Email Alert

By Jennifer Viegas*

January 23, 2009

Survey Finds More Americans Skipping Necessary Prescriptions

One in seven Americans under age sixty-five went without prescribed medicines in 2007 as drug costs spiraled upward in the United States, a nonprofit research group said on Thursday.

That figure is up substantially since 2003, when one in ten people under sixty-five went without a prescription drug because they couldn't afford it, according to the Center for Studying Health System Change in Washington, DC.

Researchers say their findings are particularly troublesome, given the increased reliance on prescription drugs to treat chronic conditions. People who go without their prescriptions experience worsening health and complications.

The people who were least able to afford medicine were often those who needed it most—uninsured, working-age adults suffering from at least one chronic medical condition. Almost two-thirds of them in the survey said they had gone without filling a prescription.

But even those with private health insurance provided by their employers were affected—one in ten working-age Americans with employer-sponsored coverage went without a prescription medication in 2007, up from 8.7% in 2003, the study found.

A number of factors were said to have contributed to the trend, including rising drug prices, physicians' tendencies to prescribe drugs more frequently, the introduction of expensive new specialty medications, and skimpier drug coverage that shifts a greater share of costs onto patients.

Overall, 5% of children did not have prescriptions filled in 2007 because of cost, up from 3.1% in 2003, and 17.8% of working-age adults could not afford drugs in 2007, up from 13.8% in 2003, the survey found. That translates into about 36.1 million Americans under sixty-five who were affected.

Roni Caryn Rabin, More Americans Skipping Prescriptions, Survey Finds, N.Y. TIMES, Jan. 22, 2009.

Disclosure of Patient's Protected Information Permitted to Doctor Treating Family Member

According to the Department of Health and Human Services, a provider is permitted but not required to disclose the protected health information (PHI) of a patient to another provider to treat a family member of the patient.

In an answer to a frequently asked question, the Office for Civil Rights said the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule permits—but does not require—a provider covered under the regulation to disclose this PHI.

Answers to these and other related questions are posted on the Office of Civil Rights website, at the Surgeon General's family health history portal, "My Family Health Portrait," a new version of the web-based tool that enables individuals to electronically record, save, and email family medical information in formats that are compatible with electronic health records (EHRs).

Family Member's Treatment

Under 45 CFR § 164.522, individuals have the right to request additional restrictions on the use or disclosure of protected health information for treatment, payment, or healthcare operations purposes. If the healthcare provider has agreed to the requested restriction, then the doctor is bound by that agreement and, except in emergency treatment situations, would not be permitted to share the information.

For example, an individual who has obtained a genetic test may request that the healthcare provider not use or disclose the test results. If the healthcare provider agrees to the restriction, the information could not be shared with providers treating other family members who are seeking to identify their own genetic health risks. However, the Office of Civil Rights said the healthcare provider does not have to agree to the requested restriction.

Doctor's Limits

An answer to another frequently asked question said the HIPAA privacy rule limits how a covered healthcare provider may use or disclose family medical history.

The HIPAA Privacy Rule allows a covered healthcare provider to use or disclose protected health information (other than psychotherapy notes), including family history information, for treatment, payment, and healthcare operation purposes without obtaining the individual's written authorization or other agreement. The HIPAA Privacy Rule also generally allows covered entities to disclose protected health information without obtaining the individual's written authorization or other agreement for certain purposes to benefit the public, such as circumstances that involve public health research or health oversight activities.

When a healthcare provider covered under the privacy rule collects or otherwise obtains a patient's family medical history, the data become protected health information about the individual and are covered under the HIPAA privacy rule.

Thus, the individual—and not the family members included in the medical history—may exercise the rights under the HIPAA Privacy Rule to this information in the same fashion as any other information in the medical record, including the right of access, amendment, and the ability to authorize disclosure to others.

Not Covered by the Rule

The Office of Civil Rights said the privacy rule does not limit how individuals who are not covered entities disclose identifiable health information. The rule does not prevent individuals from gathering information about family members or from deciding to share this information with family members or others.

Disclosure of Patient's Protected Information Permitted to Doctor Treating Family Member, BNA'S HEALTH L. REP. Jan. 21, 2009 (note: registration is required to view this content).

FDA Approves Human Embryonic Stem Cell Study

Federal regulators have cleared the way for the first human trials of human embryonic stem-cell research, authorizing researchers to test whether the cells are safe to use in spinal injury patients. The patients will be those with the most severe spinal cord injuries—complete spinal cord injuries.

The primary purpose of the trial will be to see whether injecting these cells into patients is safe, but researchers will also look for any signs of recovery. Scientists will monitor the patients for a year after the injections to see if they are regaining any function below the injured point.

The trials will involve eight to ten patients who are completely paralyzed below the third to tenth vertebra, and who sustained their spinal cord injury within seven to fourteen days. The tests will use stem cells cultured from embryos left over in fertility clinics, which otherwise would have been discarded.

Using the stem cells, researchers have developed cells called oligodendrocytes, which are precursors to nerve cells and produce a protective layer around nerve cells known as myelin. Researchers will inject these nerve cells directly into the part of the spine where the injury occurred.

At least two other companies have said they plan to begin conducting embryonic stem-cell tests in humans, but only one has received FDA approval. Another U.S. company, Reneuron, plans to conduct trials involving stem cells taken from fetal tissue in Britain this year. Other companies have developed stem cells from adult tissue, sidestepping the controversy.

The trials are not expected to start until summer because many of the preparations could not begin until the company had FDA approval. Researchers have to be educated about how to use the stem cells, how to prepare their laboratories for the research, and how to read all the magnetic resonance imaging (MRI) of the patients in the same way.

CNN Health, FDA Approves Human Embryonic Stem Cell Study, CNN Online News, Jan. 23, 2009.

Cancer Predicted to be No. 1 Killer by 2010

Cancer will overtake heart disease as the world's leading cause of death by 2010 and will disproportionately affect low- and middle-income countries, according to the latest edition of the World Cancer Report, released last month by the World Health Organization's International Agency for Research on Cancer (IARC).

According to the IARC report, the global burden of cancer is projected to double by 2020 and nearly triple by 2030. As many as 26 million new cancer diagnoses and up to 17 million deaths worldwide are projected for 2030, compared with an estimated 12 million new cancer diagnoses and more than 7 millions deaths in 2008.

Global increases in cancer incidence of about 1% are expected each year, with larger increases in China, Russia, and India. Factors contributing to increased rates in less-developed countries include adoption of Western-style habits such as tobacco use and higher-fat diets, and a projected population increase of 38% by 2030.

Stephenson, Joan, Cancer No. 1 Killer by 2010, 301 JAMA 3, 2009 (note: registration is required to view this content).

Court Denies Motion to Dismiss Allegations of Hospital's 'Pay to Play' Kickback Scheme

A federal district court denied a motion to dismiss a False Claims Act qui tam action alleging a Cincinnati hospital engaged in a "pay to play" kickback scheme by tying access to a hospital's outpatient testing unit to the revenues generated by a cardiology group (United States ex rel. Fry v. Health Alliance of Greater Cincinnati, S.D. Ohio, No. 1:03-cv-00167-SAS-TSB, 12/18/08).

The U.S. District Court for the Southern District of Ohio determined that the United States' complaint in intervention of the FCA qui tam action filed in 2003 by cardiologist Harry Fry pleaded enough facts to state a claim of relief that was plausible on its face.

The court found that, taking the allegations in the complaint as true, the government adequately alleged that The Christ Hospital (TCH) and owner Health Alliance of Greater Cincinnati operated a cross-referral scheme with the Ohio Heart and Vascular Center Inc. to cause Medicare and Medicaid to pay for illegal kickbacks.

Any claims by the hospital that it did not benefit from the alleged kickback scheme were not well taken, the court found, because certainly the hospital's heart station was used in the scheme, for which use TCH was paid in addition to payment made to doctors. Accordingly, the court denied the joint motion to dismiss the complaint by TCH and Health Alliance, and also rejected the arguments presented in the separate memorandum of Ohio Heart, in support of the motion to dismiss.

Government Intervention

In April 2008, the Department of Justice intervened in Fry's whistleblower lawsuit, which alleged TCH from 1999 to 2004 referred patients to Ohio Heart, whose physicians were, in turn, allocated time at the hospital's outpatient testing unit based on the amount of coronary artery bypass graft procedures and catheter lab revenues they generated for the hospital during the previous year. Cardiologists were rewarded with the opportunity to bill for the patients they treated at TCH's heart station and for any follow-up procedures, which gave cardiologists an incentive to perform certain procedures at TCH and prevented otherwise qualified cardiologists—who failed to generate income for the hospital during the preceding year—from working at the facility.

In denying the motion to dismiss, the court found well-taken the government's position that the complaint alleged a knowing and willing violation of the anti-kickback statute, which TCH conceded. The complaint alleged that after Fry alerted TCH about the "probably illegal" referral system, TCH allegedly took steps to conceal the system by shifting its implementation to an "alter ego," Medical Diagnostic Associates Inc., a billing company under the hospital's control, to conceal the scheme.

"Such factual allegations reflect that [TCH and Alliance] knowingly and voluntarily acted so as to preserve a profitable system that they knew they had to conceal from detection by the government," Judge S. Arthur Spiegel wrote. "The Court rejects [TCH's and Alliance's] argument that the government must prove specific intent to violate the Anti-Kickback Statute, and agrees with the government that its allegations meet the applicable standard of 'purpose to commit a wrongful act.'"

Court Denies Motion to Dismiss Allegations Of Hospital's "Pay to Play" Kickback Scheme, BNA'S HEALTH L. REP. Aug. 9, 2007 (note: registration is required to view this content).

Obama Team Puts New, Pending Regulations on Hold; Review Planned

HHS' implementation of ICD-10 and several other rules issued last week could potentially be delayed, as the White House proceeds with a review of any new or pending regulations issued under the Bush administration.

A memorandum released by White House Chief of Staff Rahm Emanuel has put a hold on all regulations that have either not been published or those that have not yet taken legal effect.

Although the CMS has yet to produce a list of the affected regulations, it's likely that at least four recent rulemakings could be put on hold, including HHS' final rule for transitioning to the International Classification of Diseases, 10th Revision, the spokesman said.

The final rule for implementing ICD-10 CM (Clinical Modification) and ICD-10 PCS (Procedure Coding System) was issued on January 15, 2009. However, the rule itself does not become effective until March 17, 2009, which means the ICD-10 regulation would fall within this additional layer of review by the White House. ICD-10's compliance deadline is not scheduled to take effect until Oct. 1, 2013.

Other recent rules that may be put on hold include an interim final rule to identify protected classes of prescription drugs under Medicare Part D; a proposed rule to make improvements to the cervical cancer proficiency testing program; and another interim final rule that addresses steps to restart the CMS' competitive bidding program for durable medical equipment, prosthetics, orthotics, and supplies.

Jennifer Lubell, Obama Team Puts New, Pending Regulations on Hold; Review Planned, Modern Healthcare's Daily Dose, Jan. 22, 2009 (note: registration is required to view this content).

*We would like to thank Jennifer Viegas, Esquire (Hall Render Killian Heath & Lyman PLLC, Troy, MI) for providing this week's Teaching Hospital Update.

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