On September 5, 2019, the Centers for Medicare and Medicaid Services (“CMS”) issued a final rule that strengthens a number of enforcement measures. The new rules go into effect beginning November 4, 2019. The goal for CMS is to keep those providers and suppliers that have committed fraud out of the federal healthcare programs.
For one, the new final rules provide CMS with new revocation and denial authorities, as part of the Provider Enrollment Process, for “affiliations” that pose an undue risk of fraud, waste or abuse. Continue reading New CMS Final Rule Strengthens Enforcement Authorities To Bolster Fraud and Abuse Prevention
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.
Neville M. Bilimoria
With all the regulatory changes facing nursing homes these days, it is no wonder most are behind in the world of compliance. It seems nursing homes are constantly berated with new regulations and more issues to deal with on a daily basis. The recent article in the May 22, 2017 edition of Modern Healthcare was, therefore, not a surprise: “Regulation: Nursing homes and hospice providers face looming emergency preparedness deadline.”
The article discusses the real November 15, 2017 deadline for nursing homes to comply with the emergency preparedness regulations promulgated by the Centers for Medicare & Medicaid Services (“CMS”) in September 2016. The article further discusses how most facilities are not close to complying by the November 15, 2017 deadline. The problem is that while nursing homes have historically had some emergency preparedness policies and procedures, the new CMS rules impose more robust policies, procedures, and mechanisms to be in place prior to November 15, 2017. That would require nursing homes to partner with local hospitals, police and fire departments to make sure their preparedness plans are up to date, robust, and systematically applied. The rules mandate, among other things, back-up generator contingencies, cybersecurity attack back up plans, and widespread training on a myriad of emergency preparedness policies and procedures that need to be developed by nursing homes. The rules even require disaster drills to be conducted by the nursing home in conjunction with local emergency response agencies.
Continue reading Nursing Homes Ready For Emergency Preparedness Rules?
On January 13, 2017, the Centers for Medicare and Medicaid Services (“CMS”) sent a Memorandum (“Memo”) to State survey agency directors encouraging long-term care providers to “consider cybersecurity when developing or reviewing their emergency preparedness plans.” The Memo was a follow-up to the CMS long-term care emergency preparedness rule published in the Federal Register on September 16, 2016: “Medicare and Medicaid Programs; Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers.” Under that final rule, long-term care facilities were held to additional standards, including requirements to have emergency and standby power systems in place. Nursing homes were also required to create plans regarding missing residents that could be activated regardless of whether the facility has activated its full-scale emergency plan. The rule was spurred on by recent flooding in Baton Rouge, Louisiana, and other emergency disasters, such as Hurricane Sandy and the 2009 H1N1 pandemic, according to CMS.
Whether State surveyors will actually enforce lack of cybersecurity plans for emergency preparedness as violations remains to be seen from this Memo. But certainly, a State survey agency could impose deficiencies for failure to have a proper cybersecurity plan and/or a proper cybersecurity back‑up plan as part of a facility’s emergency preparedness going forward. It is not clear why CMS decided to send this encouragement Memo three months after the Final Rule on emergency preparedness, but it likely has something to do with the fact that 2016 was a banner year for HIPAA privacy infractions and HIPAA enforcement by the Office for Civil Rights (“OCR”), the entity responsible for HIPAA compliance. In 2016, payouts for HIPAA violations skyrocketed to record heights of $23.51 million from OCR enforcers against health care providers. That number was triple the previous record of almost $7.94 million in payouts in 2014, followed by $6.19 million in payouts in 2015.
Continue reading Cybersecurity and Emergency Preparedness for Long-Term Care
By Susan V. Kayser
CMS has released the final version of a broad-based proposed rule update that will take effect November 28, 2016. One of the most notable provisions is a prohibition on including a mandatory arbitration provision in a nursing home admission agreement. Long a bone of contention, with strong advocacy efforts on each side of the question of whether such mandatory clauses should be allowed, it remains to be seen whether the rule will be challenged in court. Those against mandatory arbitration say it deprives individuals of their day in court; those in favor say there are benefits, including less expensive and quicker resolution of claims.
Only admissions agreements of future residents will be affected by the new rule. Providers should note too that arbitration clauses are not banned altogether. In a blog post on September 28, 2016, Acting CMS Administrator Andy Slavitt stated “[f]acilities and residents will still be able to use arbitration on a voluntary basis at the time a dispute arises.” He went on to say that “[e]ven then, these agreements will need to be clearly explained to residents, including the understanding that these arbitration agreements are voluntary, and that these agreements should not prevent or discourage residents and families from talking to authorities about quality of care concerns.”
The new rule includes a number of other new or modified provisions, which according to CMS were designed to set higher standards for quality and safety in long-term care facilities and protect and empower residents, with a focus on preventing abuse and neglect in facilities.
On August 5, 2016, the Centers for Medicare and Medicaid Services (CMS) published a Survey and Certification Memorandum (Notice) urging State health departments to enforce violations by nursing homes in posting patient images on social media. This development was interesting given that the Office for Civil Rights (OCR), the enforcer of the Health Insurance Portability and Accountability Act (HIPAA) Privacy and Security Rules, presumably should already be cracking down on any such violations of resident rights as a violation of HIPAA. According to Modern Healthcare, increased instances of nursing home staff inappropriately posting resident pictures on social media may have sparked this pronouncement by CMS.
Specifically, CMS will more strictly enforce, through State agencies, corrective actions to ensure that employee postings of residents in a degrading manner do not occur in the nursing home setting. Interestingly, the Notice does not discuss nursing homes reporting such employee conduct to OCR, but does indicate that employees should report such postings on social media of residents as abuse “to at least one law enforcement agency.” Continue reading Government Cracks Down On Nursing Home Use of Social Media
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.
In a recent 5-4 decision by the U.S. Supreme Court, Armstrong v. Exceptional Child Center, Inc., Slip. Op., 575 U.S. ____ (March 31, 2015), Justice Scalia, writing for the majority, took aim at health care providers seeking to enforce Medicaid rate-setting provisions against a state that refused to incorporate those provisions in the state’s Medicaid plan, and instead reimbursed providers for Medicaid services at lower rates.
In Armstrong, the plaintiffs, providers of habilitation services under Idaho’s Medicaid plan sought an injunction to prevent Idaho’s State Department of Health from violating Section 30(A) of Medicaid, 42 U.S.C. § 1396(a)(30)(A), which requires a state to “assure that payments are consistent with efficiency, economy, and quality of care,” while “safeguard[ing] against unnecessary utilization of. . . care and services.” The Court reversed the Ninth Circuit’s decision that the Supremacy Clause gave the providers an implied right of action to seek an injunction requiring Idaho to comply with Section 30(a). Continue reading SCOTUS Limits Claims Brought by Healthcare Providers’ for Denied Medicaid Reimbursement
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.