CMS Continues Focus on Dementia Care in Nursing Homes

The Centers for Medicare and Medicaid Services (CMS) continues its focus on dementia care in nursing homes, particularly the overuse of antipsychotic medications. Several years ago, CMS partnered with federal and state agencies, nursing homes, other providers, advocacy groups, and caregivers to improve comprehensive dementia care. According to CMS, by 2014 nursing homes achieved a 19.4 percent reduction in antipsychotic drug use, exceeding the first year goal of a 15 percent reduction.

CMS announced in recent surveyor guidance that more needs to be done to address issues relating to the care of nursing home residents with dementia. In addition, CMS stated that the agency and the organizations participating in the partnership announced a new goal to achieve a 30 percent reduction in the use of antipsychotic drugs in nursing homes nationwide by the end of 2016. See Survey and Certification Letter: 15-31-NH.

In fiscal year 2014, CMS invited states to participate in focused pilot surveys related to dementia care. Five states participated in the pilot: California, Minnesota, New York, Illinois, and Louisiana. Each state completed one observational visit and four focused surveys. The purpose of the pilot study was to more thoroughly examine the prescription of antipsychotic medications, assess compliance with federal regulations relating to dementia care in nursing homes, and give insights about survey issues relating to dementia care in order to modify the survey process.

CMS announced that it plans to expand the dementia survey pilot project to additional states during 2015. States may volunteer to use the revised dementia survey tools. According to CMS, the 2015 expanded survey project will involve a more intensive, targeted effort to improve surveyor effectiveness in citing poor dementia care and the overutilization of antipsychotic medications than the 2014 pilot project.

Although CMS has not expanded dementia focused surveys nationwide, the new pilot project indicates the agency’s continued focus on dementia care in nursing homes. Whether or not your state takes part in the expanded pilot project, antipsychotic drug use is examined during the regular survey process. In addition, antipsychotic drug use was added in February 2015 to the algorithm used as part of each nursing home’s quality measure score in the CMS Five Star Rating System that is part of the Nursing Home Compare website. Thus, nursing homes should examine their dementia care, particularly the use of antipsychotic drugs.

CMS Announces Electronic Staffing Data Submission System for Nursing Homes

The Centers for Medicare and Medicaid Services (CMS) announced the development of a reporting system, known as the Payroll-Based Journal or PBJ, that nursing homes must use to submit staffing and census data as required by Section 6106 of the Affordable Care Act. This provision of the Affordable Care Act requires nursing homes to submit electronically direct care staffing information based on payroll and other auditable data. CMS plans to collect staffing data on a voluntary basis beginning October 1, 2015 and on a mandatory basis beginning July 1, 2016. Registration for voluntary reporting begins in August 2015. Nursing homes should check the CMS website for updates on the PBJ data collection system.

CMS has posted a draft PBJ policy manual on its website. According to the draft manual, staffing and census data will be collected for each quarter. Data can either be submitted manually and/or uploaded from an automated payroll or time and attendance system. Finally, CMS notes that it will conduct audits to assess the accuracy and completeness of the data. Facilities will be subject to enforcement activity for inaccurate and incomplete data.

HHS/OCR Issues Guidance on HIPAA and Workplace Wellness Programs

Many employers view wellness programs as a way to lower health care costs and promote healthy behavior. With the growth of workplace wellness programs, new guidance from the Office of Civil Rights (OCR) at the Department of Health and Human Services (HHS) is timely. HHS/OCR recently issued guidance in the form of frequently asked questions about HIPAA and workplace wellness programs.

5-19The applicability of HIPAA to a workplace wellness program depends on how the program is structured. An employer may sponsor its own wellness program or offer it through the employer’s group health plan. When a workplace wellness program is offered as part of a group health plan, individually identifiable health information collected from wellness program participants is protected under HIPAA because the group health plan is a covered entity under HIPAA. However, a workplace wellness program that is not offered as part of a group health plan but is offered by an employer directly is not covered by HIPAA since HIPAA applies only to covered entities and business associates, but not to employers in their capacity as employers. However, other federal and state laws may apply to the collection and/or use of information by an employer that directly offers a workplace wellness program.

The guidance also addresses whether a group health plan may allow an employer as plan sponsor access to protected health information about participants in a wellness program offered through the plan. If the employer does not administer the health plan, the group health plan can disclose to the employer as plan sponsor only information on which individuals are participating in the health plan and summary health information if requested for the purposes of modifying the plan or obtaining premium bids for coverage.

The guidance states that  the group health plan can provide an employer that is a plan sponsor and performs administrative functions on behalf of the group health plan with access to protected health information necessary to perform its plan administrative functions, but only if certain conditions are met. These conditions, which the employer as plan sponsor must include in plan documents and certify agreement to, include the following:

  • There must be adequate separation between employees who perform plan administrative functions and those who do not;
  • Protected health information cannot be used or disclosed for employment-related actions or other prohibited purposes under the privacy rule; and
  • There must be reasonable and appropriate administrative, technical, and physical safeguards to protect any electronic protected health information.

As employers and group health plans begin developing and implementing workplace wellness programs this year, they should review OCR’s recent guidance to ensure that they are in compliance with HIPAA.


Image courtesy of Flickr by Robert Gourley

Recent Compliance Guidance Issued for Health Care Governing Boards

In cooperation with several industry associations, the Office of Inspector General (OIG) at the Department of Health and Human Services (HHS) recently issued guidance to help governing boards of health care organizations perform their compliance duties. The guidance was developed through collaboration between the Association of Healthcare Internal Auditors, the American Health Lawyers Association, the Health Care Compliance Association, and the OIG. The compliance guidance repeats some guidance for other industry groups, such as a compliance program is not a “one size fits all” program. However, the guidance also contains information that is particularly applicable to governing boards.

The guidance addresses the following issues relating to a governing board’s oversight and review of compliance functions: (1) roles of, and relationships between, the organization’s audit, compliance, and legal departments; (2) mechanism and process for reporting within the organization; (3) identifying regulatory risk; and (4) encouraging enterprise-wide accountability for achieving compliance goals and objectives.

The guidance offers some suggestions specific to governing boards about compliance, including the following.

  • The guidance states that boards should develop a formal plan to stay current with the regulatory landscape so that the board can ask more pertinent questions and make informed decisions. The plan may involve periodic updates from staff or review of materials provided by staff or outside educational programs.
  • The guidance states that a board can raise its expertise level about regulatory and compliance matters by adding to the board or consulting with a regulatory, compliance, or legal professional.
  • There should be a process to ensure appropriate access to information, which can be set out in a formal charter document or other documents.
  • The guidance recommends that boards evaluate and discuss how management works together to address risk.
  • The guidance states that the board should set and enforce reporting to the board compliance-related information in a format that satisfies the interests or concerns of board members.

The board may want to consider scheduling regular executive sessions to discuss compliance and quality functions to encourage open communication.

Developing a New Way to Detect Pressure Ulcers

Hospitals and nursing homes frequently encounter patients and residents with or at risk of developing pressure ulcers.  Although hospitals and nursing homes make great efforts to prevent pressure ulcers from developing or worsening, there is no method to detect early tissue damage before it is visible. However, interesting new research may develop in to a promising way to confront the challenges of pressure ulcer prevention.

Researchers at the University of California—Berkeley and the University of California—San Francisco have developed an automated sensing device to detect pressure ulcers before they are visible. This early warning device could assist treatment of high risk patients. The automatic sensing device—dubbed a “Smart Bandage”—uses electrical currents to detect early tissue damage from pressure ulcers before they are visible and when early intervention is possible. The Smart Bandage has electrodes that are printed on to a piece of plastic that measure the strength of the electrical signals on the skin. Detecting the change in electrical resistance that occurs when a pressure ulcer has started to form but is not yet visible will allow early detection and treatment of pressure ulcers. According to an article recently published in the journal Nature Communications, the device was tested on a rat model and demonstrated the feasibility of a Smart Bandage for early detection of pressure ulcers.

The Smart Bandage is an interesting development for health care facilities that treat patients or residents who are at risk for pressure ulcers. Pressure ulcers are particularly challenging for nursing homes and are the focus of the Centers for Medicare and Medicaid Services’ (CMS) quality measures rating system for nursing homes. Pressure ulcers are also often a focus of patient or resident litigation against a health care facility. The Smart Bandage could greatly assist health care providers in the challenge of preventing and treating pressure ulcers.

Access to Experimental Drugs and State “Right to Try” Laws

In November 2014, Colorado (Colo. Rev. Stat. §§ 25-45-101—108) became the first state to pass a “right to try” law giving terminally ill patients the right to try experimental drugs. Since Colorado’s law passed, several other states including Arizona (Ariz. Rev. Stat. §§ 36-1311—1314) , Michigan (Mich. Stat. § 16221), Missouri (Mo. Stat. § 191.480), and most recently Wyoming (to be codified at Wyo. Stat. §§ 35-7-1801—1806), have passed similar laws. Legislators in other states are considering similar bills to allow terminally ill patients access to experimental drugs.

HC Blog 3.24“Right to Try” legislation is controversial. Supporters argue that the laws will give dying patients faster access to potentially lifesaving treatment than the Food and Drug Administration’s (FDA) compassionate use program. Detractors argue that the laws give false hope because there is no guaranteed access to the experimental treatment, no financial support, the unstudied treatments could cause harm and hasten death, and drug companies may not want to risk providing unapproved drugs and treatment for fear of angering federal regulators.

The Colorado law, which is similar to laws in other states, allows an eligible patient access to investigational drugs, biological products, or medical devices by allowing (but not requiring) doctors to prescribe and companies to provide these experimental treatments. An investigational drug, biological product, or device is defined as a drug, biological product, or device that has successfully completed phase one of a clinical trial but has not yet been approved for general use by the FDA and remains under investigation in an FDA-approved clinical trial.

Colorado defines an “eligible patient” as a person who has documentation from his or her physician that he or she meets the following requirements:

  • Has a terminal illness, defined as a disease that, without life-sustaining procedures, will soon result in death or a state of permanent unconsciousness from which recovery is unlikely, as attested to by the patient’s treating physician;
  • Considered all other treatment options currently approved by the FDA;
  • Has been unable to participate in a clinical trial for the terminal illness within 100 miles of the patient’s home or has not been accepted to the clinical trial within one week of completing the clinical trial application process;
  • Has received a recommendation from his or her physician for an investigational drug, biological product, or device; and
  • Has given written, informed consent or if a minor or lacks capacity, a parent or legal guardian has given written, informed consent.

Colorado has specific requirements for written, informed consent to receive investigational drugs, biological products, or devices. Informed consent must be contained in a written document signed by the patient and attested to by the patient’s physician and a witness. At a minimum, the informed consent must contain the following:

  • An explanation of the currently approved products and treatments for the disease or condition from which the patient suffers;
  • An attestation that the patient concurs with his or her physician that all currently approved and conventionally recognized treatments are unlikely to prolong the patient’s life;
  • A clear identification of the specific proposed investigational drug, biological product, or device that the patient want to use;
  • A description of the potentially best and worst outcomes of using the investigational drug, biological product, or device, including a realistic description of the most likely outcome and the possibility that new, unanticipated, different or worse symptoms might result and that death could be hastened, based on the physician’s knowledge of the proposed treatment in conjunction with an awareness of the patient’s condition;
  • A clear statement that the patient’s health insurer and provider are not obligated to pay for any care or treatments as a consequence of the investigational drug, biological product, or device;
  • A clear statement that the patient’s eligibility for hospice care may be withdrawn if the patient begins curative treatment but that hospice may be reinstated if the curative treatment ends and the patient meets hospice criteria;
  • A clear statement that in-home health care may be denied if treatment begins; and
  • A statement that the patient understands that he or she is liable for all expenses as a consequence of using the investigational drug, biological product or device, and that this liability extends to the patient’s estate, unless a contract between the patient and the manufacturer state otherwise.

Finally, there are several other interesting provisions in Colorado’s law. The law prohibits a licensing board from revoking, failing to renew, suspending, or taking any action against a health care provider’s license based solely on the provider’s recommendation to an eligible patient concerning access to or treatment with an investigational drug, biologic product, or device as long as the advice is consistent with medical standards of care. In addition, the law clarifies that the Colorado statute does not create a private cause of action unless there was a failure to exercise “reasonable care.” Thus, the statute does not grant immunity to a manufacturer or any person or entity involved in the care of an eligible patient from a negligence lawsuit.

While the “right to try” laws codify that the state will not interfere with a terminally ill patient’s access to experimental treatments, the laws cannot eliminate the FDA’s authority to regulate these treatments. To date, the FDA has not taken an official position on state right to try laws. However, the FDA recently decided to streamline the process for patients to obtain access to unapproved investigational drugs. On February 4, 2015, the FDA released a draft guidance that when finalized is intended to streamline the individual patient expanded access application process. In addition, there is a provision that would allow emergency expanded access for an individual patient by allowing an FDA official to give authorization for emergency use over the telephone.

It is likely that there will be new developments in right to try legislation as the year progresses. Health care providers and drug manufacturers should pay attention to these developments, particularly the FDA’s actions.


Image courtesy of Flickr by epsos .de

CMS Announces Next Generation ACO Model

The Centers for Medicare and Medicaid Services (CMS) recently announced a new Accountable Care Organization (ACO) model called the Next Generation ACO Model.  The Next Generation ACO Model differs from current Medicare ACO initiatives by offering financial arrangements with higher levels of risk and reward than are available under the current ACO programs.  In addition, the Model has alternative payment mechanisms to enable a transition from fee-for-service to capitation.  According to CMS, the goal of the Next Generation ACO Model is to test whether strong financial incentives for ACOs can improve outcomes and reduce the amount spent on health care for Medicare fee-for-service beneficiaries.

The Next Generation ACO Model has several unique tools to improve engagement with beneficiaries.  These tools include the following:

  1. Enhanced access to home visits, telehealth services, and skilled nursing facilities
  2. Ability to receive a reward payment for receiving care from the ACO
  3. A process allowing beneficiaries a decision in their alignment with ACOs and
  4. Collaboration between CMS and ACOs to inform beneficiaries about the characteristics and potential benefits of ACOs in relation to their care.

CMS expects that 15 to 20 ACOs will participate in the Next Generation ACO Model.  CMS has issued a request for applications outlining specific eligibility criteria.  There will be two rounds of applications in 2015 and 2016.  The deadline to submit a letter of intent in round one is May 1, 2015, with applications due on June 1, 2015.  The round two deadlines are one year later.

New Mexico Peer Review Case with Implications in Other States

In Yedidag v. Roswell Clinic Corp., a case of first impression with implications for hospital peer review in many other states, the New Mexico Supreme Court affirmed an appeals court ruling that a physician who spoke up against another physician at a peer review meeting could sue his hospital-employer for using confidential peer review information to justify his termination.  The court affirmed the jury’s award of compensatory and punitive damages based on its conclusion that the hospital violated New Mexico’s peer review statute, N.M. Code §§ 41-9-1 through 41-9-7, and breached its employment contract with the physician by terminating him based on his conduct at a peer review meeting.

Dr. Yedidag, a physician employed by the hospital, participated in a peer review meeting concerning another physician’s treatment of a patient.  A hospital administrator who was present at the meeting reported that Dr. Yedidag had “verbally attacked” the physician being reviewed.  The hospital subsequently fired Dr. Yedidag for unprofessional conduct.

The court concluded that the New Mexico peer review statute, which contains a provision protecting the confidentiality of peer review records, creates an implied private cause of action.  Because the acquisition and use of confidential peer review information for employee discipline is not a statutorily permissible use of peer review information and Dr. Yedidag’s confidentiality was violated, the court determined that Dr. Yedidag had an implied cause of action against the hospital.

Many states have peer review statutes that are similar to the New Mexico statute by providing for the confidentiality of peer review proceedings.  Thus, in light of the Yedidag decision, hospitals should examine their policies and practices concerning physician discipline in order to maintain the confidentiality of peer review proceedings.

Responding to Medical Record Requests: Changes in Colorado Law Affect Health Care Facilities

Last year Colorado, like many other states, passed new legislation that affects patient requests for medical records and the fees that may be charged for copies of the medical records.  House Bill 14-1186, codified at C.R.S. § 25-1-801, with related regulations at 6 CCR 1011-1, Ch. 1, Part 5.  The law changes the fees that may be charged for providing copies of records and adds provisions relating to the delivery of records in electronic format.  These provisions apply to medical records in the custody of a broad range of health care facilities (see C.R.S. § 25-1.5-103(1)) , including hospitals, nursing homes, assisted living residences, and hospice.

Colorado law requires that health care facilities make medical records available for inspection by a current patient or the patient’s personal representative at reasonable times and upon reasonable notice, except for certain records withheld in accordance with 45 § C.F.R. 164.524(a).  A reasonable time for inspection should normally not exceed 24 hours from the date of the request (excluding weekends and holidays) for an inpatient or current resident.  The patient or designated representative may not be charged for inspecting the records.

With regard to a discharged patient or resident, a health care facility must make a copy of the record available or make the record available for inspection within a reasonable time from the date of the signed request, normally not to exceed ten days, excluding weekends and holidays.  However, if the health care provider or designated representative is not available to acknowledge the request, the facility shall inform the patient of the situation and provide the records as soon as possible.  Discharged patients or their representatives cannot be charged for inspecting patient records.

Health care facilities should be aware of certain provisions of Colorado law relating to electronic records and films.  Medical records must be delivered in electronic format if the records are requested in electronic format, they are stored in electronic format, and are readily producible in electronic format.  Finally, a health care facility must release the original film if a licensed health care professional determines that a copy is not sufficient for diagnostic or other treatment purposes.

The amount that may be charged for medical records varies, depending upon the requesting party.  When a patient or a personal representative requests a copy of medical records, the fees are set in accordance with HIPAA.  Under HIPAA, a covered entity may charge a patient or a personal representative a reasonable, cost-based fee for providing a copy of medical records; this fee may encompass the cost of copying (including the cost of supplies for and labor of copying) and postage.  However, health care facilities may charge third parties fees that are established under state law.  Thus, the HIPAA fee limitations do not apply  when records are released under other HIPAA-compliant situations, such as requests that are based on an individual’s authorization.

Colorado law establishes the following reasonable fees that a health care facility may charge a third party.  The fees may not exceed the following:

  • For the first ten pages:  $18.53
  • For the next thirty pages (pages 11 through 40):  85 cents per page
  • Each additional page after page 40 :  57 cents per page (all records except those stored on microfilm) or $1.50 per page (records stored on microfilm)
  • Actual reproduction costs for each copy of a radiograph
  • Certification of medical records, if requested:  $10.00 fee
  • Actual postage and electronic media costs if applicable
  • Applicable taxes

Under certain circumstances, third parties may not be required to pay any fees or a different fee schedule may apply.  If a patient record is requested under the Laura Hershey Disability-Benefit Support Act, C.R.S. §§ 24-30-2201 through 2207, the third party may obtain one free copy of the record for the application process or for an appeal or reapplication when required by the disability benefits administrator.  Where a statute or rule for a state or local government entity establishes maximum rates, these rates prevail.  Finally, the statutory fee schedule does not apply to coroners requesting medical records.

Health care facilities should review their policies on releasing and charging for copies of medical records to ensure that they are in compliance with recent changes in Colorado law.

CMS Updates Nursing Home CPR Guidance

HC BLOG_CPROn January 23, 2015, the Centers for Medicare and Medicaid Services (CMS) revised surveyor guidance regarding Cardiopulmonary Resuscitation (CPR) in nursing homes.  The guidance clarifies a facility’s obligation to provide CPR.  CMS requires that nursing home staff maintain current CPR certification through a CPR provider whose training includes hands-on practice and in-person skills assessment.  Online-only certification is not sufficient.  However, the program may have an on-line knowledge component if it also requires an in-person demonstration or skills assessment to obtain certification or recertification.

The revised  surveyor guidance also incorporates CMS’ prohibition against a facility-wide “no CPR” policy because this may prevent implementation of a resident’s advance directives and does not meet the quality standards found in 42 C.F.R. § 483.20(k).  If a resident experiences a cardiac arrest and does not show obvious signs of clinical death, facility staff must provide basic life support, including CPR, prior to the arrival of emergency medical services in accordance with the resident’s advance directives or in the absence of any advance directives or a Do Not Resuscitate Order.   Finally, the guidance reiterates CMS’ requirement that CPR certified staff must be available at all times.