• Revised Advanced Directives - F Tag 155

    Monday March 18, 2013

    The Centers for Medicare and Medicaid Services have made additional revisions to Surveyor Guidance at F Tag 155 in Appendix PP of the State Operations Manual.The attached document below includes the Memorandum, F155, and the Surveyor Training slides which include Interpretive Guidance and Investigative Protocol.

    Revised F155 attached below.

    Revised Advanced Directives - F Tag 155

  • F322-Gastric Tubes Revised

    Tuesday March 12, 2013

    The Centers For Medicare & Medicaid Services have revised F322 - Naso Gastric Tubes. The memo date March 8, 2013 stated that since the release of S&C 12-46-NH, CMS conducted further review of the interpretive guidelines for F tag 322 in Appendix PP of the SOM. Based on the additional internal and external stakeholder feedback the guidance and related training materials have been revised to provide additional clarification when determining compliance.


    The memo, revised F322, and training material are attached below.

     F322 Naso-Gastric Tubes Revised


    Tuesday March 19, 2013

    Recently at St. Peter's Hospital in Albany, U.S. Senator Charles E. Schumer joined Capital Region senior citizens and hospital executives to push his plan to change the Medicare law, so that elderly patients are not charged unfairly for receiving needed nursing home care after being hospitalized. Schumer noted that "observation" stay cases in hospitals, when the elderly individual is not technically an inpatient, have been on the rise in recent years, costing America's seniors thousands of dollars in medical bills. Currently, Medicare will only cover post-acute care in a skilled nursing home facility if a beneficiary has three consecutive days of hospitalization as an inpatient. Under Schumer's plan, the Improving Access to Medicare Coverage Act, "observation" stays will be counted toward the 3-day mandatory inpatient stay for Medicare to cover rehabilitation post-hospital visit.

     For example, Mr. Ike Cassuto recently broke his pelvis and spent four days at St. Peter's Hospital. In accordance with current law, St. Peter's listed him under "observation status" because no operation or procedure was performed. The consequence of this meant that Medicare will not pay for his 3-weeks in rehab that followed his hospital stay. Schumer emphasized it is the flawed Medicare law which is costing Capital Region seniors thousands of dollars.

     "In recent years, there's been a huge uptick in elderly patients under 'observation status' at Capital Region hospitals - and it's leaving seniors high and dry and hospitals no better off. A flawed Medicare law is to blame, and I have a plan to change that, so hundreds of thousands of seniors, like Mr. Cassuto, are not hit with huge rehabilitation bills after a lengthy hospital visit. This new Improving Access to Medicare Coverage Act  would allow senior citizens to count time spent under this 'observation status' towards Medicare-covered rehabilitation. If you are holed up in a hospital bed for days on end, it shouldn't matter what your billing status is, and this plan will save Capital Region seniors thousands."

     Schumer was joined by James K. Reed, President & CEO of St. Peter's Heath Partners; Mr.& Mrs. Ike Cassuto; James Barba, CEO of Albany Medical Center; Gail Myers of Statewide Senior Action and representatives from AARP. Schumer highlighted Mr. Cassuto's recent case, and explained that this is one example of hundreds of thousands. The number of observation cases has been on the rise in recent years, a consequence of policies meant to reduce Medicare expenditures. According to the Albany Times Union, St. Peter's Hospital, serving the Albany community since 1930, has reported that observation cases have nearly doubled in the past three years, with 2,560 cases in 2009 and 5,000 in 2012. This can lead to massive bills - in the tens of thousands of dollars - that senior citizens must pay for rehabilitation and nursing home care post-hospital visit.

     Schumer vowed to fight for the bipartisan Improving Access to Medicare Coverage Act  to address the flawed Medicare law. Currently, Medicare will only cover post-acute care in a skilled nursing facility if a patient has three consecutive days of hospitalization as an inpatient, not counting the day of discharge. Because of the uptick in observation cases, patients are enduring lengthier hospital stays in observation status and may unknowingly be treated under outpatient observation status for the entirety of their hospital visit. Under Schumer's legislation, observation stays will be counted toward the 3-day mandatory inpatient stay for Medicare coverage of skilled nursing facility services after a hospital visit. The Improving Access to Medicare Coverage Act of 2013 would amend title XVIII of the Social Security Act. Without being involved in billing technicalities between the hospitals and Medicare, Schumer's plan would ensure that patients 65 and older are eligible for coverage for their rehabilitation services, as long as they are in the hospital for three days.

    "Observation stays" are specific, clinically appropriate services that treat and assess a patient in a hospital while a decision is being made as to whether patients will require further treatment as hospital inpatients, or if they are able to be discharged from the hospital. Hospitals, like St. Peter's, are following a flawed Medicare law in their treatment of many patients above 65 years old. In fact, Schumer noted, that hospitals are reimbursed less from Medicare for the treatment of patients under "observation" status than those that are inpatient. Hospitals also devote a significant amount of time and money to assuring that patients are properly classified as inpatients or outpatients.

    Isadore "Ike" Cassuto's case is among the hundreds of thousands of elderly Americans who have been placed under "observation" status during a hospital stay, and who now face medical bills that Medicare refuses to cover for rehabilitation services. Mr. Cassuto came to St. Peter's Hospital after breaking his pelvis and was a patient for four days, but the hospital had him under observation without admitting him as an inpatient. Mr. Cassuto then underwent three weeks of rehabilitation, which was not covered under his Medicare plan, leaving him with $6,000 in medical bills.

    "We thank Senator Schumer for his leadership on legislation that will promote fairness for Medicare patients who need rehabilitation following a hospitalization. Because of the uptick in the number of Medicare observation status billing codes throughout our state, NY StateWide Senior Action Council has developed a Patients' Rights Toolkit, available at  1-800-333-4374.  We encourage Medicare patients to ask about their status so that they can make informed decisions regarding their discharge plan, and uphold their rights to care through the appeals process when needed. Patients should not be forced to pay out of pocket for otherwise covered Medicare services due to institutional billing issues," said Gail Myers of the NY StateWide Senior Action Council.


    Schumer's New Plan Would Change Three-Day Requirement & Allow Time Spent In 'Observation' To Count Toward Medicare-Covered Rehabilitation - Saving Seniors Huge Costs

    Schumer Highlighted That 'Observation' Stay Cases Are Skyrocketing In Hospitals Across the Capital Region And Country, As Hospitals Comply With Flawed Medicare Law

    Schumer Will Join Ike Cassuto Who Was Put Under 'Observation Status' At the Hospital- For Days-After Breaking His Pelvis, Meaning Medicare Won't Cover Nursing Home Recovery Care, Which Can Cost Thousands


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  • The Importance of Marmet v Brown to Nursing Home Malpractice and Wrongful Death cases

    Tuesday March 19, 2013

    The U.S. Supreme Court case of Marmet Health Care Center v. Brown, decided on Feb 21, 2012, shows the advantage of a properly written and signed arbitration agreement in order to keep claims out of court where jurors decide and instead allow an arbitrator to decide the outcome.

    Before Marmet, several states completely prohibited nursing homes from compelling residents to give up their right to a jury trial and declared all arbitration agreement in nursing home admission contracts to be unconscionable.

    After Marmet Health Care Center v. Brown, nursing home owners and operators can have confidence that properly drafted and executed arbitration agreements will keep inevitable claims away from jurors.

    Litigating claims in court can lead to unexpectedly high awards. Arbitration of claims is generally seen as offering significantly less potential for runaway jury awards by eliminating the emotions that fuel them. More predictable losses should result in lower overall claim payments, safeguarding funds that are better spent caring for residents. For these reasons, many long-term-care facilities have sought to use arbitration agreements when contracting with their residents upon admission. Plaintiffs often seek grounds to avoid the enforcement of arbitration agreements, in order obtain for themselves the potential of a much larger jury award.

    The U.S. Supreme Court noted that in Marmet, arbitration agreements signed predispute, were enforceable and not void as a matter of public policy.  That Court went on to say "Congress did intend for the federal arbitration act (FAA) to take precedent over state law.

    Properly drafted and executed arbitration agreements between facilities and their residents are generally enforceable. The impact that arbitration has on dispute resolution is so important that we expect to see it used routinely. Of course, care must be taken to avoid unenforceability, as is the case with any contract.

    The most significant of these are a lack of mental capacity to consent, fraudulent inducement to sign, duress and unconscionability. Long term care facilities who choose not to utilized arbitration agreements will be well-advised to reconsider.

    Arbitration agreements will go a long way toward reducing inappropriate and huge jury awards, allowing for better provision of care for nursing home residents.

    For information on the provisions needed in arbitration agreements to increase the likelihood of being enforced or how the train your facility in getting them signed by the appropriate person(s), please contact:

    Lavonya K. Chapman, Esq., RN.|Director of Claims/Litigation
    Arthur J. Gallagher Risk Management Services, Inc.

    2200 Woodcrest Place, Suite 250

    Birmingham, Alabama 35209





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  • OSHA to Continue Aggressive Enforcement in 2013

    Wednesday March 20, 2013

    Occupational safety and health concerns are not limited to the construction and general industries anymore. Over the past four years, OSHA has become increasingly aggressive in its enforcement practices in every employment sector, rejecting collaborative efforts with employers, such as partnerships, to enhance workplace safety in favor of enforcement with higher citation classifications and enhanced penalties. With the reelection of President Obama and the understanding that Dr. David Michaels, Assistant Secretary of Labor, will remain the head of the OSHA for another four years, employers across the board can expect the agency to continue its aggressive enforcement tactics in 2013 and beyond.

    To read more about OSHA enforcement, click on the link below.

    OSHA Goodbye Carrot Hello Stick

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  • Court Lowers “Burden” of Proof for OSHA Citations

    Thursday March 21, 2013

    The U.S. Court of Appeals for the 10th Circuit rendered an opinion that not only altered the agency's burden of proof for OSHA citations but effectively reduced that burden to little more than a semantic impediment. The Court declared that OSHA, or the Secretary of Labor need not establish the elements of the long established four-part Atlantic Battery test to prove a violation but instead must only prove that a "reasonably prudent employer" would have anticipated the hazard at issue and done more to prevent it. Further, the Court found this burden met where the Secretary had simply asserted that the employer at issue failed to act as a reasonably prudent employer without offering any evidence regarding whether a reasonably prudent employer in the same industry would have even recognized the hazard and, if so, what protective measures, if any, would have been taken.


    In effect, the employer's liability is viewed in a vacuum with no reference to some recognized norms of safety recognition in the employer's industry. According to the Court, the Secretary only need to allege and prove that the specific employer's actions were "imprudent" and the violation will stand. 


    For more details please read the following attachment:


    Reasonably Prudent Employer

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  • Medical Record Documentation

    Thursday March 21, 2013

    The patient/resident medical record is the best evidence in a medical malpractice lawsuit. It is the medical record documentation, not the physician recall of details, which can most effectively defend a physician against a malpractice claim.



    Medical Record Documentation 

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  • Liberty Mutual Study - Cost of Late Accident Reporting

    Friday March 22, 2013

    The prompt reporting of claims is one of the easiest ways to lower your total cost of risk; the sooner we learn about the claim the quicker we can engage in medical and disability management.  The results of this study emphasize the importance of reporting claims as soon as possible.

    Below is a link to view the Liberty Mutual Study.

    Liberty Mutual Study - Cost of Late Accident Reporting

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  • CMS Issues Final Rule on the Requirements for for Long-Term Care Facilities; Notice of Facility Closure

    Tuesday March 26, 2013

    On March 19, CMS issued in the Federal Register, a final rule that outlines steps that long-term care facilities need to take if they decide to cease business operations.


    In the case of a facility closure, any individual who is the administrator of the facility must provide written notification of the closure and the plan for the relocation of residents at least 60 days prior to the impending closure or, if the Secretary terminates the facility's participation in Medicare or Medicaid, not later than the date the Secretary determines appropriate, according to the rule.


    It also identifies penalties for non-compliance and clarifies the responsibility of the administrator of the facility to ensure that no new residents are admitted after written notice is submitted and that the notice of closure must include a plan for transfer and adequate relocation to another facility.

    See the attachment below for details for: Medicare and Medicaid Programs; Requirements for Long Term Care (LTC) Facilities; Notice of Facility Closure

    Notice of Facility Closure

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  • Megace: Potential Liability and Regulatory Impact

    Sunday March 31, 2013

    Megace: Potential Liability and Regulatory Impact

    Par Pharmaceutical Co., has agreed to pay $45 million to settle allegations it improperly labeled and marketed its prescription drug Megace ES to elderly patients, the U.S. Department of Justice said.


    Among other things, the company was accused of criminally misbranding Megace, which was approved by the FDA to treat weight loss tied to AIDS, as a treatment for non-AIDS-related geriatric wasting.


    Despite being aware of harmful side effects, Par also targeted sales to nursing home residents with weight loss, and launched a sales force specifically for this market, according to the Justice Department.


    A representative from the company didn't immediately respond to a request for comment. On behalf of Par, Chief Executive Paul V. Campanelli pleaded guilty to criminal misdemeanor charges in a New Jersey federal court on Tuesday, the Justice Department said. The company was fined $18 million and ordered to pay $4.5 million in criminal forfeiture, and agreed to pay $22.5 million to resolve its civil liability. "Today's resolution emphasizes the importance of the U.S. government's coordinated efforts to combat health care fraud," said Stuart F. Delery, of the Justice Department's civil division. "We expect companies to make honest, lawful claims about the drugs they sell."


    Megace, a megestrol acetate drug, lacked adequate directions for use in the treatment of geriatric wasting unrelated to AIDS, a use that wasn't approved by the FDA, the Justice Department said. The civil allegations against the company were related to claims submitted to federal health-care programs for uses that weren't approved by the FDA. U.S. officials alleged that Par was aware that megestrol acetate carried potentially fatal risks for elderly patients, including a heightened potential for deep vein thrombosis and toxic reactions in patients with impaired kidney function.


    Please see the attached release from the U. S. Department of Justice for additional details. 


    We wanted you to be aware of the above information as you continue to review all medications in conjunction with your Pharmacist and physician and work with your physician on providing documentation in the event medications are used for off-labeled use. 

      US Department of Justice - Misbranding of Megace


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