Recently, the Illinois Supreme Court considered the consequences of violating the Biometric Information Privacy Act (“Act”). The Act has been on the books for ten years, and during that time, the use of biometric data, such as finger prints, voice prints, or facial recognition, has grown by leaps and bounds. It is possible to unlock an iPhone merely by looking at it—using facial geometry.
As health care facilities move to biometric methods of identifying staff or clients, they will need to consider the ramifications of doing so. The Act requires entities that collect biometric data to first obtain informed consent, in writing, by the individual or their representative. In addition, the entity must have a policy and procedure for destroying the biometric data in accordance with the Act.
According to the Supreme Court, failure to abide by these procedures causes damage to the person whose biometric data was gathered. As a result, the entity can face liability in the amount of $1,000 to $5,000 per violation, or actual damages, plus attorneys’ fees. Considering the real risk of identity theft in this digital age, actual damages could easily exceed the statutory amounts.
Last month I wrote about the hearing to be held by the House Committee on Energy and Commerce Subcommittee on Oversight and Investigations regarding federal efforts to ensure quality of care and resident safety in nursing homes.
The Director of Health Care for the GAO focused his opening remarks on the GAO study of nursing homes that concluded in 2015. The next year, CMS instituted sweeping regulatory changes. So it remains to be seen how CMS’ new requirements of participation will impact the issues found in the GAO report. Ruth Ann Dorrill, Regional Inspector General, HHS OIG noted that the OIG previously made two recommendations to CMS to improve quality of care in nursing homes. First, to provide guidance to nursing homes about detecting and reducing harm to be included in facility Quality Assurance and Performance Improvement programs. Second, to instruct State Agencies to review facility practices for identifying and reducing adverse events, and link related deficiencies specifically to resident safety practices. CMS implemented these recommendations on adverse events in nursing homes as of August 2018.
The focus on deficiencies by the State Agencies is disappointing. Deficiencies result in civil money penalties, further reducing the resources available to care for nursing home residents. Ms. Dorrill testified that nursing home residents often have care needs similar to patients in hospitals. However, nursing homes are not reimbursed at the same rate as hospitals and, yet, are expected to provide similar care. It seems as though the residents are getting lost in the ever increasing cycle of regulation and enforcement. Regulatory oversight sounds good on paper, but does it work?
The federal government cannot agree on whether to increase or decrease regulatory burdens on nursing facilities. Yesterday, the United States House Committee on Ways and Means and the Subcommittee on Health wrote to the Centers for Medicare and Medicaid Services urging further reduction of regulatory burdens on health systems, hospitals, and nursing homes. Tomorrow, the House Committee on Energy and Commerce Subcommittee on Oversight and Investigations will hold a hearing examining federal efforts to ensure quality of care and resident safety in nursing homes.
The Ways and Means Committee’s letter noted that providers with post-acute care beds devote 8.1 full-time employees to compliance with regulatory requirements. Over half of those employees are clinical staff who could otherwise be caring for residents. The letter applauded recent efforts to reduce the regulatory burden and urged further reductions.
In contrast, the Committee on Energy and Commerce suggests that CMS isn’t doing enough to ensure quality care in the nation’s nursing homes. The Committee’s background report recites a number of news reports in which seniors died or were abused in nursing homes. Three witnesses have been invited to testify: Kate Goodrich, M.D., Chief Medical Officer of CMS; Ruth Ann Dorrill, Regional Inspector General, HHS OIG; and John Dicken, Director, Health Care GAO. Topics to be addressed include efforts made to ensure that nursing homes are meeting the federal regulatory standards and CMS’ oversight of state agencies that work with CMS to inspect nursing homes. The undertone of the Committee’s background report is that CMS needs to increase enforcement, including higher civil money penalties and exclusion from participation in federal health care programs.
It is hard to see how higher monetary penalties will improve quality care as it further reduces the resources available to care for residents.
The Supreme Court has agreed to hear a case involving the implied certification theory under the False Claims Act. Implied false certification occurs when an entity has previously undertaken to expressly comply with a law, rule, or regulation, and that obligation is implicated by submitting a claim for payment even though a certification of compliance is not required in the process of submitting the claim. Many relators have tried to use this theory to turn a regulatory violation into a false claim–with its concomitant treble damages and statutory damages.
There has long been a split in the circuits regarding the viability of the implied certification theory. As recently as June 2015, the Seventh Circuit rejected the theory, stating that the “FCA is simply not the proper mechanism for government to enforce violations of conditions of participation contained in—or incorporated by reference into—a PPA [Program Participation Agreement].” Rejection of this theory recognizes that there administrative procedures designed to address regulatory violations.
In contrast, the Ninth Circuit has embraced the implied certification theory, stating “”[i]t is the false certification of compliance which creates liability when certification is a prerequisite to obtaining a government benefit.” The problem in the health care arena is that facilities promise to comply with a myriad of regulations when entering into PPAs, and certify compliance when submitting bills. Thus, under this theory, every single regulatory violation can turn into a false claim.
The health care industry will be closely watching the Supreme Court’s ruling on this important issue.
The Centers for Medicare and Medicaid Services (CMS) released its Focused Dementia Care Surveyor Worksheets on November 27, 2015. The Worksheets were developed for a pilot project in 2014 as part of CMS’ continuing effort to reduce the use of antipsychotic medication. The Worksheets are to be used by surveyors in reviewing dementia care at post-acute care facilities. The Worksheets were released so that facilities can use these tools to assess their own practices in providing resident care.
The Worksheets contain specific topics for review, and state that failure of the facility to perform certain practices will result in a deficiency of F309. F309 addresses quality of care, and requires that each resident receive (and the facility provide) the necessary care and services to attain or maintain the highest practicable physical, mental, and psychosocial well-being, in accordance with the comprehensive assessment and plan of care.
Facilities that serve individuals with dementia should have policies and procedures based upon nationally-recognized dementia care guidelines, such as CMS’ Hand in Hand series, the OASIS program, the University of Iowa program, the VA Program (STAR), Johns Hopkins’ DICE program, Alzheimer’s Association materials, NHQCC or other QIO guidelines, Advancing Excellence medication management tools, or the AHCA toolkit.
The Worksheets also evaluate supervision, staff training, and Quality Assessment and Assurance, as well as the care provided to specific residents. All facilities that serve individuals with dementia should obtain and use the Worksheets to evaluate their own practices.
The Centers for Medicare and Medicaid Services (CMS) and Office of Inspector General (OIG) issued the final rule regarding waivers of the application of the physician self-referral law, the Federal anti-kickback statute, and the civil monetary penalties (CMP) law provision relating to beneficiary inducements to specified arrangements involving accountable care organizations (ACOs) under section 1899 of the Social Security Act (the Act) (the “Shared Savings Program”). For purposes of the Shared Savings Program, providers must integrate in ways that potentially implicate fraud and abuse laws addressing financial arrangements between sources of Federal health care program referrals and those seeking such referrals. The Shared Savings Program focuses on coordinating care between and among providers, including those who are potential referral sources for one another—potentially in violation of the fraud and abuse laws.
In order to provide flexibility for ACOs and their constituent parts, the following five waivers have been created:
- ACO pre-participation waiver – waives the physician self-referral law and the Federal anti-kickback statute that applies to ACO-related start-up arrangements in anticipation of participating in the Shared Savings Program, subject to certain limitations, including limits on the duration of the waiver and the types of parties covered.
- ACO participation waiver – waives the physician self-referral law and the Federal anti-kickback statute that applies broadly to ACO-related arrangements during the term of the ACO’s participation agreement under the Shared Savings Program and for a specified time thereafter.
- Shared savings distributions waiver – waives the physician self-referral law and the Federal anti-kickback statute that applies to distributions and uses of shared savings payments earned under the Shared Savings Program.
- Compliance with the physician self-referral law waiver – waives the Federal anti-kickback statute for ACO arrangements that implicate the physician self-referral law and satisfy the requirements of an existing exception.
- Patient incentive waiver – waives the Beneficiary Inducements CMP and the Federal anti-kickback statute for medically related incentives offered by ACOs, ACO participants, or ACO providers/suppliers under the Shared Savings Program to beneficiaries to encourage preventive care and compliance with treatment regimes.
The waivers apply uniformly to each ACO, ACO participant, and ACO provider/supplier participating in the Shared Savings Program. The waivers are self-implementing; parties need not apply for a waiver. Rather, parties that meet the applicable waiver conditions are covered by the waiver.
The Federal False Claims Act (and many similar state false claims acts) allow an individual—called a “relator”—to file a lawsuit on behalf of the United States Government. If successful, the relator stands to collect a portion of the amount collected. Since the False Claims Act provides for treble damages and statutory penalties of up to $11,000 per false claim, the reward to the relator can be considerable.
Complaints by relators must filed under seal. This allows the Government time to investigate the relator’s allegations before deciding whether to intervene in the case. Cases in which the Government intervenes tend to have higher judgments or settlements. Once the Government makes this decision, the complaint is unsealed and the case can move forward.
Earlier this week, an Alabama judge ruled that the relators could not keep their identities secret, even though they voluntarily dismissed their lawsuit against Great Bend Regional Hospital. Frank Coyle and Randy Bruce argued that their careers in health care may be damaged if their identities are revealed. However, the court agreed with the Government, that the reason for sealing the complaint is for the limited purpose of protecting the Government’s investigative process.
It may have been a bad choice for Coyle and Bruce to ask for anonymity. If they had merely dismissed their case, the dismissal may have been a mere footnote or back page news item. By seeking anonymity and losing, it is front page news. When filing a case, relators may think that they will no longer have to work once they win millions of dollars. As these relators have learned, you don’t always win. And there are consequences to your actions.
On January 26, 2015, the United States Department of Health & Human Services (HHS) announced its timeline for shifting Medicare reimbursements from volume-based criteria to value-based criteria. HHS has adopted a framework that categorizes health care payments according to how providers receive payment to provide care:
• Category 1—fee-for-service with no link of payment to quality
• Category 2—fee-for-service with a link of payment to quality
• Category 3—alternative payment models built on fee-for-service architecture
• Category 4—population-based payment
In Monday’s announcement, HHS disclosed its initiative to drive more of the Medicare payments to categories 3 and 4. This is the first time in history that HHS has set explicit goals for alternative payment models and value-based payments. HHS declared: “Improving the quality and affordability of care for all Americans has always been a pillar of the Affordable Care Act, alongside expanding access to such care. The law gives us the opportunity to shape the way health care is delivered to patients and to improve the quality of care system-wide while helping to reduce the growth of health care costs.”
By the end of 2016, HHS has set a goal of tying 30 percent of traditional, fee-for-service, Medicare payments to quality or value through alternative payment models, such as Accountable Care Organizations (ACOs) or bundled payment arrangements. By the end of 2018, the goal is 50 percent of these payments.
An ACO is an organization of health care providers that agree to be accountable for the quality, cost, and overall care of a group of Medicare beneficiaries. Reimbursement is tied to quality metrics to reduce the total cost of care for the assigned population of patients. Hospitals and physicians have been forming ACOs, and HHS’s most recent initiative should drive even more dollars in this direction.
However, in our experience, long-term care facilities (LTC Facilities) have been slow to adopt the ACO model. Refusal to join an ACO could result in fewer referrals from hospitals and other providers, since ACO members will refer to the facility (or facilities) within the ACO. LTC Facilities with high ratings for their Quality Measures (on Nursing Home Compare) and low re-hospitalization rates will be more attractive to ACOs. Now is the time to join an ACO, before it is too late.
1. Since most text messaging is not a secure form of communication, it raises HIPAA concerns if any protected health information is included in the text message. There is the possibility of a data breach in the transmission of the text message, as well as in the event of a lost or stolen phone.
2. Relevant information about a patient may be omitted from the patient’s medical chart if it is communicated via text message. Text messages are difficult to print or archive, resulting in the information being lost or deleted. This can have adverse consequences in the patient’s care due failure to communicate important information regarding the patient to everyone who needs the information.
3. Important evidence may be lost, resulting in adverse consequences in the event of a lawsuit. Any time a lawsuit is anticipated, all relevant evidence must be preserved, including text messages. However, since the messages reside on individual employees’ phones, they may be omitted from the document preservation efforts, or accidentally (or intentionally) deleted by the employee. Such loss of evidence could result in the court’s imposition of an “adverse inference,” meaning that the jury must determine that lost evidence would have been adverse to the health care facility (even if that is not true).
The safest course is to ban text messaging in a health care setting. Health care facilities which allow the use of text messaging should implement policies and procedures to ensure that they avoid these problems.
The Centers for Medicare & Medicaid Services (CMS) is continuing its efforts to reduce the national prevalence of antipsychotic drug use in long-stay nursing home residents. Its initial goal of a 15.1% reduction in antipsychotic drug use was met, so CMS now seeks to reduce antipsychotic drugs by 25% by the end of 2015 and 30% by the end of 2016. The national average of antipsychotic drug prevalence was 19.8% in early 2014.
CMS has been publishing each facility’s antipsychotic drug use on the Nursing Home Compare web site. Now in 2015, as further incentive to nursing homes, CMS will use antipsychotic drug use as a factor in calculating each facility’s Five-Star Rating. A low Five-Star Rating can have a direct impact on a facility’s census and profitability.
Nursing homes need to develop strategies to reduce antipsychotic drug use. They cannot depend upon physicians to change the drug orders; they need to partner with physicians to develop creative approaches for treatment. Each resident should be thoroughly evaluated to determine the root cause of behaviors that trigger the use of antipsychotic drugs. Frequently, the undesirable behaviors are caused by an unmet need. Once the need or cause is determined, individualized, person-centered approaches can be developed to prevent or respond to the behaviors. This is the beginning of a new year, now is the time to start some new interventions to reduce antipsychotic drug use and enhance your Five-Star Rating.