Swine Flu Treatment & Pandemic Response Information Updated

April 30, 2009

With U.S. officials confirming the first swine flu attributed death in the U.S. yesterday and the number of U.S. reported cases expected to top 100 today, health care providers and organizations are initiating their pandemic response plans to help their organizations, people, patients and communities respond to the rapidly spreading epidemic.

 

Whether or not the swine flu outbreak reaches the level of an official pandemic, official reports reflect a legitimate need for concern.  According to officials from the Centers for Disease Control and Prevention (CDC), victims of the swine influenza A (H1N1) virus infection already have been reported in 10 states, and the number of people known to be infected with the 2009 H1N1 influenza strain grew to 91 in the U.S. as of Wednesday. That number includes the first U.S. swine flu fatality: a 22-month-old child from Mexico who died of the illness Monday at a Houston, Texas hospital while visiting the United States. While swine flu victims have been reported in more than 11 countries, the majority of the incidents of the disease and deaths as of Wednesday morning had occurred in Mexico.  Alarm that the outbreak will reach pandemic proportions continues to grow.

 

In response to the expanding crisis, the CDC yesterday released updated interim guidance on the use of antiviral agents for treatment and chemoprophylaxis of patients with confirmed, probable or suspected swine influenza virus infection and their close contacts. This guidance is only part of a host of growing resources for health care providers and other parties posted at http://www.pandemicflu.gov, the website founded by the U.S government to provide one-stop access to U.S. Government swine, avian and pandemic flu information.  The website links to a growing list of special guidance provided by the CDC and other organizations for health care organizations and providers, public officials, schools, businesses, the public and others.  Health care providers and other concerned parties should check this site regularly for updates about the latest guidance for responding to and treating swine flu.

 

Health care providers, schools, government agencies and others concerned about preparing to cope with pandemic or other infectious disease challenges also may want to review the guidance for health care providers and public health officials as health care providers, employers, and public entities contained in the pandemic and privacy planning workshop materials “Planning for the Pandemic” authored by Curran Tomko Tarski LLP partner Cynthia Marcotte Stamer available at http://www.cynthiastamer.com/documents/speeches/20070530%20Pan%20Flu%20Workplace%20Privacy%20Issues%20Final%20Merged.pdf.

 

Health care providers also should educate employees, patients and the public about the steps they should take to help minimize their risk of contracting the disease.  While the CDC says getting employees and their families to get a flu shot remains the best defense against a flu outbreak, it also says getting individuals to consistently practice good health habits like covering a cough and washing hands also is another important key to prevent the spread of germs and prevent the spread of respiratory illnesses like the flu.  Health care providers, employers, public officials and others should encourage patients, employees and their families and others to take the following steps and to coach others they know to do so as well:

  • Avoid close contact with people who are sick. When you are sick, keep your distance from others to protect them from getting sick too.
  • Stay home when you are sick to help prevent others from catching your illness.  Cover your mouth and nose.
  • Cover your mouth and nose with a tissue when coughing or sneezing. It may prevent those around you from getting sick.
  • Clean your hands to protect yourself from germs.
  • Avoid touching your eyes, nose or mouth.
  • Germs are often spread when a person touches something that is contaminated with germs and then touches his or her eyes, nose, or mouth.
  • Practice other good health habits.  Get plenty of sleep, be physically active, manage your stress, drink plenty of fluids, and eat nutritious food.

To help promote this message, health care providers, public officials and businesses may want to download and circulate some of the many free resources published by the CDC at http://www.cdc.gov/flu/protect/habits.htm. 

 

Cynthia Marcotte Stamer and other members of Curran Tomko and Tarski LLP are experienced with advising and assisting health care providers, public agencies, schools, businesses and others employers with these and other health care, workforce, crisis preparedness and response and related matters. If your organization needs assistance with assessing, , please contact Ms. Stamer at cstamer@cttlegal.com, (214) 270-2402.  For additional information about the experience and services of Ms. Stamer and to access some of her publications, see www.cynthiastamer.com or www.cttlegal.com.

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Posted by Cynthia Marcotte Stamer

CMS Plans Hospital & Hospital Quality Open Door Forum to Wednesday, May 6, 2009

April 21, 2009

The Centers for Medicare & Medicaid Services (CMS) announced today that it has rescheduled its next Hospital & Hospital Quality Open Door Forum to Wednesday, May 6, 2009 from 2-3pm ET. Interested persons can participate by phone dial 1-800-837-1935 using Conference ID 89323669.  For more information on this or other upcoming or recently recorded forums sponsored by CMS or other Department of Health & Human Services Agencies, see http://www.cms.hhs.gov/opendoorforums or check out the Breaking News link on CynthiaStamer.com.  

For assistance with compliance and risk management policies, practices or programs, assessing the strength of your controls in addressing these laws or other healthcare laws and regulations, or in addressing other compliance or health care concerns, please contact Cynthia Marcotte Stamer at cstamer@CTTLegal.com or (214) 270- 2402.

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Posted by Cynthia Marcotte Stamer

HHS Releases Report Comparing Average Sales Price to Average Manufacturer Prices of Prescription Drugs

April 20, 2009

The Department of Health & Human Services (HHS) Office of Inspector General (OIG) released its latest “Comparison of Third-Quarter 2008 Average Sales Prices and Average Manufacturer Prices: Impact on Medicare Reimbursement for First Quarter 2009″ (the “Report”) on April 17, 2009.  The findings are used to help determined Medicare Part B reimbursement rates for prescription drugs.   You can review the entire Report at http://www.oig.hhs.gov/oei/reports/oei-03-09-00150.pdf.

Mandated by Congress under Section 1847A(d)(2)(B) of the Social Security Act (the Act), the Report reviews the average sales prices (ASP) and average manufacturer prices (AMP) for Medicare Part B prescription drugs to identify the ASPs that exceed AMPs by at least 5 percent. The review also determines the impact of lowering reimbursement amounts for drugs that meet the 5-percent threshold. Pursuant to sections 1847A(d)(3)(A) and (B) of the Act, if OIG finds that the ASP for a drug exceeds the AMP by a certain percentage (currently 5 percent), HHS may disregard the ASP for the drug when setting reimbursement amounts. According to the Report, of the 325 drugs with complete AMP data, OIG found 15 met the 5-percent threshold under the revised ASP payment methodology recently mandated. Twelve of these 15 drugs were previously eligible for price adjustment under the revised methodology, with 2 drugs meeting the 5-percent threshold in each of the past 7 quarters. OIG estimates that, if reimbursement amounts for all 15 drugs had been based on 103 percent of the AMPs, Medicare expenditures would have been reduced by almost three-quarters of a million dollars in the first quarter of 2009. The Report also states that of the 129 drugs with only partial AMP data in the third quarter of 008, 21 had ASPs that exceeded the AMPs by at least 5 percent in the third quarter of 2008.

Under the revised methodology, 12 of the 21 drugs would have met the 5 percent threshold in at least 2 of the past 7 quarters, dating back to the first quarter of 2007. OIG estimates that Medicare expenditures would have been reduced by $9 million during the first quarter of 2009 if reimbursement amounts for all 21 drugs had been based on 103 percent of the AMPs.

If you have questions about the Report, Medicare reimbursement or compliance or any other health care compliance and risk management policies, practices or programs, assessing the strength of your controls in addressing these laws or other healthcare laws and regulations, or in addressing other compliance or health care concerns, please contact Cynthia Marcotte Stamer at cstamer@CTTLegal.com or (214) 270- 2402. For More Information We hope that this information is useful to you. If you need assistance responding to concerns about the matters discussed in this publication or other health care concerns, wish to obtain information about arranging for training or presentations by Ms. Stamer, wish to suggest a topic for a future program or update, or wish to request other information or materials, please contact Ms. Stamer via telephone at (214) 270-2402 or via e-mail to cstamer@CTTLegal.com. You can review other recent updates and other publications by Ms. Stamer and other helpful health care resources and additional information about Ms. Stamer and her experience, see Stamer Health Industry Experience. If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail- by creating or updating your profile at here or by registering to participate in the Solutions Law Press Health Care Update blog at slphealthcareupdate.wordpress.com. For important information concerning this communication click here. If you do not wish to receive these updates in the future, send an e-mail with the word “Remove” in the Subject to support@SolutionsLawyer.net.

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Posted by Cynthia Marcotte Stamer

Hearing On Texas Medical Board Reforms Scheduled April 14, 2009

April 7, 2009

The 11 member Texas House Committee on Public Health has scheduled a hearing Tuesday, April 14th to consider Texas Medical Board reforms proposed in HB 3816.  Advocates of the legislation are urging supporters to attend the hearing and/or communicate their support for the legislation now.

 

Supported by a broad range of physician and other health care organizations, HB 3816 and a companion bill pending in the Texas Senate, SB 2336, seek to regulate certain practices by the Board which many physicians and others perceive as overly heavy handed.  As currently proposed, HB 3816 would implement the following reforms effective September 1, 2009:

·         Require that the Executive Director of the Board be a physician licensed in good standing

·         Require that individuals filing complaints swear under oath to the truth of the statements in the complaint

·         Require that the Board have “good cause” to file a complaint on its own initiative

·         Require the Board to encourage each person with a complaint to attempt to resolve the complaint with the license holder directly before filing a formal complaint with the Board, in situations where that would be appropriate.  Preprinted complaint forms provided by the Board would be required to include a prominent statement encouraging persons with complaints to attempt to resolve their complaints directly with the physician, when appropriate, before filing a formal complaint with the Board.

·         Require that the Board notify physicians charged in a complaint be personal delivery or certified mail

·         Prohibit the Board from considering or acting on a complaint involving care provided more than 4 years after the date the complaint is filed

·         Deny civil, criminal, or regulatory immunity to persons filing complaints when the complaint is filed with malice or with an anticompetitive purpose.

·         Require that the Board provide the physician charged in the complaint with an unredacted copy of the complaint unless there is a risk of harm to the public or unless it would jeopardize a criminal investigation. 

·         Ensure that physicians subject to a complaint receive at least 30 days after receiving a copy of the complaint to prepare and submit a response

·         Establish a schedule for conducting each phase of a complaint that is under the control of the Board not later than the 30th day after the date the physician’s time for preparing and submitting a response expires.

·         Restrict the physicians qualified to serve on the expert physician panel for a complaint to physicians actively practicing medicine in the State of Texas

·         Require that the Board review a report concerning a physician’s medical competency prepared by an expert at the request of the physician who is the subject of the complaint

·         Require that any review by a second expert be independent of the first review, without knowledge by the second reviewer of the identity of the first reviewer, and without any communication between the two reviewers.

·         When the first and second reviewer disagree, require that the physician subject of the complaint be notified of the conflict and provided with copies of the conflicting reports and require that the final written report include a copy of the dissenting report.

·         Requires that before using a report under this section, the Board provide the identity and qualifications of each expert physician who reviewed the complaint to the physician subject to the complaint

·         Require considerations of the medical competency of the physician charged be conducted only by a physician engaged in an active practice in the same or similar specialty as the physician in the year preceding the review.

·         Requires that the identity of the members of the expert panel considering medical competency be promptly disclosed to the physician who is the subject of the complaint

·         Would require that a report concerning the medical competency of a charged physician be in the form of an affidavit sworn under oath to qualify for consideration by the Board

·         Would excuse a charged physician from the obligation to provide evidence concerning patient records in the absence of a court order where the patient objects to this disclosure of the records for reasons of patient privacy

·         Require “clear and convincing evidence” that, through the practice of medicine, the physician poses a continuing threat to the public welfare before the Board could deny or restrict a physician’s license or otherwise discipline a physician.

·         Prohibit the Board from ordering or requiring a physician to practice medicine in a particular manner, to practice medicine, or to direct anyone in the practice of medicine, except by ordering that a physician not engage in a practice that causes actual harm or an imminent risk of harm to a patient

·         Prohibit the Board from imposing a penalty, sanction, or other disciplinary action that is different from the action recommended by the panel in an informal proceeding and agreed upon by the license holder

·         Prohibit the Board from involving itself in fee disputes or taking disciplinary action against a license holder for using the “fee for service” method of billing

·         Prohibit the Board from taking disciplinary action against a license holder based upon the manner in which the license holder maintains the license holder’s office or records, unless the conduct has a likelihood of causing an actual harm or an imminent risk of harm to a patient

·         Requires that a physician receive notice at least 48 hours prior to a an Informal Settlement Conference proceeding of the identity of the panel members presiding over the Informal Settlement Conference proceedings; and the opportunity to have an  audio or video record or arrange for transcription of the Informal Settlement Conference proceedings

·         Provide that decisions of the administrative law judge be binding on the Board

·         Protect the right of a license holder may access and obtain a copy of any information relating to the license holder

·         Provide that the district court reviewing a Board disciplinary action may only sustain the discipline on a finding by clear and convincing evidence that the action was supported by facts and law.

·         Guarantee a jury trial right for physicians seeking to challenge the revocation of their license in the courts

·         Require greater proof that a drug or treatment is nontherapeutic and that the prescribed treatment be have a “likelihood of harm to a patient” to constitute grounds for discipline. 

You can review the current language of the bill at http://www.legis.state.tx.us/tlodocs/81R/billtext/doc/HB03816I.doc.  For a list of the current members of the Texas House Committee on Public Health, see http://www.house.state.tx.us/committees/list81/410.htm.

If you need assistance evaluating or responding to these or other proposed legislative or regulative changes, responding to a licensing board complaint, peer review, or other disciplinary investigation or matter, or other health care matters, contact Cynthia Marcotte Stamer or other members of Curren Tomko and Tarski LLP. please contact Ms. Stamer at cstamer@cttlegal.com, (214) 270-2402 or see CTTLegal.com or CynthiaStamer.com.

 

 

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Posted by Cynthia Marcotte Stamer

HIPAA Complaint Basis For Texas Whistleblower Claim

April 4, 2009

In a March 19, 2009 ruling, the U.S. District Court for the Northern District of Texas recently recognized that the Texas Whistleblower Act prohibits health care organizations run by the State of Texas from retaliating against employees for making good faith complaints of violations of the Privacy Rules of the Health Insurance Portability Act (“HIPAA”).Nevertheless, the court dismissed the wrongful discharge lawsuit brought by a former Terrell State Hospital security guard who alleged he was wrongfully fired for complaining to the U.S. Department of Health and Human Services Office of Civil Rights (”OCR”) that the Hospital violated the HIPAA Privacy Rules because the plaintiff had failed to present sufficient proof that he was terminated in retaliation for filing a HIPAA complaint.

 

Illustrative of a growing number of state law retaliatory discharge claims brought be employees claiming to have been retaliated against for complaining about alleged violations of HIPAA’s Privacy Rules, Faulkner v. Department of State Health Servs., 2009 U.S. Dist. LEXIS 22419 (N.D. Tex. Mar. 19, 2009), involved claims made by plaintiff Anthony Faulkner (”Faulkner”) that the Texas Department of State Health Services (”DSHS”); Terrell State Hospital; Texas DSHS Commissioner David L. Lakey, M.D.; Terrell State Hospital Superintendent Fred Hale; and Terrell State Hospital Risk Management Coordinator Clent Holmes, R.N. violated the Whistleblower Act and the First and Fourteenth Amendments by firing him seven days after he complained to OCR that Terrell State Hospital violated the HIPAA Privacy Rule by leaving admissions logs containing patient names and admission dates in a public area.

The Texas Whistleblower Act generally prohibits a state or local governmental entity from terminating or taking any other adverse personnel action against a public employee who in good faith reports a violation of law by the employing governmental entity or another public employee to an appropriate law enforcement authority.See Tex. Gov’t Code § 554.002(a).While the Court affirmed that the Texas Whistleblower Act permits a public employee of the State of Texas discharged or otherwise retaliated against for complaining in good faith to OCR that his public employer or its employee violated the HIPAA Privacy Rules, the Court nevertheless granted summary judgment to the defendants.

According to the court, Faulkner’s failure to introduce evidence rebutting defendant’s affidavit that he was terminated for repeatedly violating rules requiring him to report suspected abuse of patients precluded him from proving his termination was in retaliation for his filing of the HIPAA complaint.Meanwhile, the court also ruled that Faulkner’s claims against the individual defendants should be dismissed as the Whistleblower Act only creates a cause of action against governmental entities and not their employees. Having found Faulkner’s constitutional claims also without merit, the District Court granted the defendant’s motion for summary judgment.

While the defendants were able to overcome Faulkner’s retaliatory discharge claim, the decision highlights the need for health care providers and other HIPAA covered entities to take appropriate precautions to defend against potential wrongful discharge, retaliation or other claims by employees or other service providers for complaining of possible HIPAA violations or for attempting to exercise other HIPAA-protected rights.HIPAA covered entities now should avoid engaging in actions that might unnecessarily fuel claims of retaliation.  They also should carefully document and preserve evidence necessary to demonstrate the legitimacy of their disciplinary actions on an ongoing basis.

We hope you found this information helpful. If your organization needs assistance with understanding or managing its responsibilities or liabilities under HIPAA or other health care or employment laws or wishes to inquire about HIPAA training or other services and experience of Cynthia Marcotte Stamer, please contact Ms. Stamer via e-mail at Cstamer@Solutionslawyer.net or by telephoning Ms. Stamer at 469.767.8872.You also can review other helpful resources and register to receive other updates at CynthiaStamer.com.

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Posted by Cynthia Marcotte Stamer

Connecticut Man Pleads Guilty To Multi-Million Dollar Tax Fraud Conspiracy Involving False Charges For Hospital Maintenance & Insulation Services

April 4, 2009

A Connecticut resident faces  five years in prison, three years of supervised release and a $250,000 fine after pleading guilty this week to conspiracy to aid another in filing false tax returns between approximately 2000 and February 2005 through a fraudulent check cashing scheme for the owner of a corporation that was engaged in the business of providing maintenance and insulation services to New York Presbyterian Hospital (NYPH).  The action reflects the risks to individuals and businesses that illegally claim tax deductions, bill for services or violate other federal criminal laws.

Krzysztof Koczon plead guilty in U.S. District Court in Manhattan to charges he provided false documentation to co-conspirators indicating that he had performed construction services and received more than $2.3 million in checks from the co-conspirators as payment for the construction services, the Department of Justice announced Thursday, April 2, 2009.   Koczon cashed the checks but returned the bulk of the money to the co-conspirators in exchange for a fee. The co-conspirators then took false deductions for those payments made to Koczon’s businesses.

The tax fraud conspiracy that Koczon is charged with carries a maximum penalty of five years in prison, three years of supervised release and a $250,000 fine. The maximum fine may be increased to twice the gain derived from the crime or twice the loss suffered by the victims of the crime, if either of those amounts is greater than the statutory maximum fine.

In April 2007, as part of the same investigation, Michael Theodorobeakos and two maintenance and insulation companies he co-owned–Monosis Inc. and STU Associates Inc. pleaded guilty to conspiring to rig bids on the supply of maintenance and insulation services to NYPH and Mount Sinai Medical Center (Mount Sinai). In addition, Michael Vignola and Mister AC Ltd. pleaded guilty in November 2007 to conspiring to rig bids on heating, ventilation and air conditioning (HVAC) services provided to NYPH and paying kickbacks to former NYPH purchasing officials. In April 2008, Aaron S. Weiner pleaded guilty to participating in a conspiracy wherein Weiner acted as a conduit in another million-dollar kickback scheme also involving one of the same former NYPH purchasing officials involved with the Vignola kickback schemes. On March 25, 2009, Mariusz Debowski pleaded guilty to participating in the same tax fraud conspiracy at NYPH.

These charges arose from an ongoing federal antitrust investigation of fraud, bribery, tax-related offenses and bidding irregularities relating to contracts administered by the Facilities Operations Department and the Engineering Department at NYPH and the Engineering Department at Mount Sinai conducted by the Antitrust Division’s New York Field Office, the FBI and the Internal Revenue Service Criminal Investigation’s New York Field Office.

Cynthia Marcotte Stamer, Ed Tomko and other members of Curren Tomko and Tarski LLP are experienced with assisting health industry and other clients establish and administer internal and external fraud and other controls, investigate potential fraud or other misconduct, defend Federal or state criminal or civil investigations, audits and prosecutions.  If your organization needs assistance with assessing or managing its compliance responsibilities or liabilities under health care, employment, environmental, antitrust, securities or other federal or state laws, wishes to inquire about compliance audit or training or other services; or would like to review or engage and experience of Ms. Stamer, Mr. Tomko or other Curren Tomko Tarski LLP attorneys, please contact Ms. Stamer at cstamer@cttlegal.com, (214) 270-2402;  or Mr. Tomko at etomko@cttlegal.com, (214) 270-1405, or see CTTLegal.com or CynthiaStamer.com.

 

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Posted by Cynthia Marcotte Stamer

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