CMS Publishes Final Rule: Sweeping Changes to Home Health Agency CoPs

On January 13, 2017, CMS published its final rule revising the conditions of participation (CoPs) that home health agencies (HHAs) must meet to participate in Medicare and Medicaid programs. The final rule implements the proposed rules published in the Federal Register October 9, 2014 (79 FR 61164), and becomes effective July 13 2017.

Among its many changes, the final rule redefines terms and establishes new standards for the content of comprehensive patient assessments, care planning, coordination of services, quality of care, quality of assessments and performance improvement (QAPI), skilled professional services, home health aid services, and clinical record keeping. The rule also makes changes to personnel requirements including limiting who can be an HHA administrator. To review the final rule in its entirety, click here.

CMS ISSUES CHANGES TO REQUIREMENTS OF PARTICIPATION AFFECTING LTC FACILITIES: ARBITRATION IS OUT—ARE WAIVER OF JURY TRIALS IN?

Effective November 28, 2016, long-term care facilities that participate in Medicare and Medicaid will no longer be able to enter into “pre-dispute” agreements for binding arbitration with their residents.  The Centers for Medicare & Medicaid Services (CMS) issued the final rule on September 28, 2016, after consideration of extensive comments from key stakeholders in the long-term care community regarding proposed revisions.

Under the rule, a facility can ask a resident or a resident’s representative to enter into an arbitration agreement after a dispute arises.  However, the facility must comply with several requirements, such as ensuring that the agreement provides for the selection of a neutral arbitrator and a venue convenient to both parties.  Further, a resident’s right to remain in the facility cannot be contingent upon entering into the arbitration agreement and the agreement cannot contain language that discourages communications with federal, state or local surveyors and other officials.

As one of the more controversial changes, critics of the new arbitration rule have reacted strongly against the change and have commented that this part of the rule “clearly exceeds” CMS’s statutory authority.  In its response to public comments, CMS explains that the Secretary of Health and Human Services has the authority to administer the program under the Social Security Act by setting general practice parameters for payment under Medicare and Medicaid.  CMS further cites to its authority to promulgate regulations for residents’ health, safety and well-being and states that there is “significant evidence that pre-dispute arbitration agreements have a deleterious impact on the quality of care for Medicare and Medicaid patients.”  Nevertheless, there are several legal bases upon which to challenge the agency’s ability to preclude an arbitration agreement.

While CMS’s comments cite to a resident’s waiver of the right to a jury trial as a major factor considered in its decision to disallow pre-dispute arbitration agreements, the final rule does not expressly preclude jury trial waiver provisions within facility admissions agreements.  Jury waivers may help to address runaway verdicts that have become a concern in negligence cases in past years, while still respecting expressed concerns that arbitration presents undue costs to residents and creates an environment of “secrecy.”  Note that state law may vary on whether such waivers are enforceable.

Also remarkable is CMS’s comment that it will not address waiver of class-action litigation in this rule, but rather reserve the issue for consideration during future rulemaking.

The broad-sweeping final rule also contains several other provisions that directly affect compliance programs, training of nursing staff, updating infection and control programs, and other key requirements that long-term care facilities must comply with in order to participate in the Medicare and Medicaid programs.  It is advisable for long-term care facilities to promptly consult with a knowledgeable healthcare attorney to assess modifications to admissions packets and to otherwise establish the framework necessary to comply with the revised Requirements of Participation.

CMS Releases Nursing Home Enforcement Information

On June 3, 2016, the Centers for Medicare and Medicaid Services (CMS) posted information about nursing home provider enforcement from 2006 to 2014 as part of the agency’s “ongoing efforts to ensure transparency, consistency of application of enforcement remedies, and data management to track enforcement actions across the nation.” The report includes general information about nursing home enforcement, frequently asked questions about enforcement, and enforcement reports detailing the distribution of federal enforcement remedies from 2006 to 2014.

The CMS enforcement reports provide information about CMS and state survey agency enforcement actions for all Health Inspection and Life Safety Code Standard and Complaint surveys from 2006 to 2014. The reports show the percent of providers with remedies in effect (rather than imposed) and detail civil monetary penalties by region, as well as the frequency of per day and per instance civil monetary penalties in effect. There is additional data on the number of facilities by region with the following enforcement remedies: denial of payment; discretionary and mandatory denial of payment for new admissions; directed in service training; directed plan of correction; termination; state monitoring; temporary management; transfer of residents; and facility closure.

The CMS report also discusses the impact of the recession that began in December 2007 and officially ended in June 2009. The period before the recession showed an increase in survey activities, initiatives, and deficiency citations, while there was a decline in overall survey activities and enforcement actions after the recession began.

CMS Releases Final Rule On Return of Overpayments

The Centers for Medicare & Medicaid Services released its final rule today on the return of overpayments. The final rule requires providers and suppliers receiving funds under the Medicare/Medicaid program to report and return overpayments within 60 days of identifying the overpayment, or the date a corresponding cost report is due, whichever is later. As published in the February 12, 2016 Federal Register, the final rule clarifies the meaning of overpayment identification, the required lookback period, and the methods available for reporting and returning identified overpayments to CMS. See https://www.federalregister.gov/articles/2016/02/12/2016-02789/medicare-program-reporting-and-returning-of-overpayments.

Identification

The point in time in which an overpayment is identified is significant because it triggers the start of the 60-day period in which overpayments must be returned. CMS originally proposed that an overpayment is identified only when “the person has actual knowledge of the existence of the overpayment or acts in reckless disregard or deliberate ignorance of the overpayment.” The final rule changes the meaning of identification, stating that “a person has identified an overpayment when the person has or should have, through the exercise of reasonable diligence, determined that the person has received an overpayment and quantified the amount of the overpayment. The change places a burden on healthcare providers and suppliers to have reasonable policies and programs in place which monitor the receipt of Medicare/Medicaid payments.

6-Year Lookback Period

The final rule also softens the period for which health care providers and suppliers may be liable for the return of overpayments. As the rule was originally proposed, CMS required a 10-year lookback period, consistent with the False Claims Act. Now, overpayments must be reported and returned only if a person identifies the overpayment within six years of the date the overpayment was received.

Guidance in Reporting and Returning Overpayments

The final rule provides that providers and suppliers must use an applicable claims adjustment, credit balance, self-reported refund, or other appropriate process to satisfy the obligation to report and return overpayments. If a health care provider or supplier has reported a self-identified overpayment to either the Self-Referral Disclosure Protocol managed by CMS or the Self-Disclosure Protocol managed by the Office of the Inspector General (OIG), the provider or supplier is considered to be in compliance with the provisions of this rule as long as they are actively engaged in the respective protocol.

OIG Expresses Concerns about Medicare Skilled Nursing Therapy Billing

Calling for a reevaluation of the Medicare payment system for skilled nursing facilities (SNFs), the Department of Health and Human Services’ (HHS) Office of Inspector General (OIG) recently issued a report expressing concerns about Medicare payment for therapy services. The OIG found that Medicare payments for therapy “greatly exceed” SNFs’ therapy costs. The difference between Medicare therapy payments and facility costs for therapy averaged 29 percent—twice as high as the 14 percent overall Medicare margin for SNF payments in 2012. The OIG stated that Medicare payments for therapy rose faster than therapy costs between 2002 and 2010. According to the OIG, one factor leading to the increased payments was that SNFs increasingly billed for the highest level of therapy even though beneficiary characteristics remained largely unchanged. The OIG report also notes that SNFs used strategies to optimize revenues, such as providing the minimum number of therapy minutes for the higher levels of therapy. Finally, the OIG found that increases in SNF billing resulted in $1.1 billion in Medicare payments in 2012 and 2013.

As a result of this and prior OIG reports, the OIG called for the Centers for Medicare and Medicaid Services (CMS) to reevaluate the Medicare SNF payment system. The OIG recommended that CMS take the following actions: (1) evaluate the extent that Medicare therapy payment rates should be reduced; (2) change the method used to pay for therapy; (3) adjust Medicare payments to eliminate any increases that are not related to beneficiary characteristics; and (4) strengthen oversight of SNF billing. CMS agreed with all of the OIG’s recommendations. Accordingly, it is possible.

New York Federal Court Issues First Interpretation of “Identified” Under the Affordable Care Act’s 60-Day Rule

In Kane v. Healthfirst, Inc. et al., a New York federal court became the first court to interpret when the clock starts running on the 60 days allowed to report and return an overpayment of Medicare and Medicaid funds under the Affordable Care Act. The Affordable Care Act requires a person who receives an overpayment of Medicare or Medicaid funds to report and return the overpayment within 60 days of the “date on which the overpayment was identified.” 42 U.S.C. § 1320a-7k(d)(2)(A). Any overpayment that is kept beyond the 60 days may be a reverse false claim under the False Claims Act, which imposes liability for any person who “knowingly and improperly avoids or decreases an obligation to pay or transmit money or property to the Government.” 31 U.S.C. § 3729(a)(1)(G).

Kane is significant for health care providers because the Affordable Care Act does not define the term “identified,” nor has the Centers for Medicare and Medicaid Services (CMS) defined this term in the Medicaid context. However, CMS has issued a final rule that applies to Medicare Advantage and the Medicare Part D Prescription Drug Program stating that an overpayment is identified when there is actual knowledge of the existence of an overpayment or if a person or entity acts in deliberate ignorance of, or with reckless disregard to the overpayment’s existence. 79 Fed. Reg. 29,844 (May 23, 2014). CMS has also issued a proposed rule applicable to Medicare providers and suppliers that adopts the same definition of “identified” that the agency adopted for Medicare Parts C and D. 77 Fed. Reg. 9,179 (Feb. 16, 2012). In this proposed rule, CMS noted that a provider or supplier may receive information about a potential overpayment that creates an obligation to inquire about whether or not there is an overpayment. If the inquiry reveals an overpayment, the 60-day deadline to report and return the overpayment runs from the date that the inquiry reveals the overpayment. CMS cautions that a failure to make a reasonable inquiry after receiving information about a potential overpayment could result in the provider knowingly retaining an overpayment. Id.

The Kane litigation arose out of a software glitch that mistakenly generated codes telling providers that they could seek additional payment from secondary payors such as Medicaid. The providers should have been told that they could not seek secondary payment for the services, except for co-payments from certain patients. As a result of this software glitch, three hospitals that were part of a network of non-profit hospitals incorrectly submitted claims to Medicaid.

Approximately 21 months after the hospitals began to bill improperly for Medicaid services, the New York State Comptroller’s office approached the hospitals with questions about the incorrect billing, ultimately revealing that there was a software problem. After the problem was discovered, an employee, relator Kane, was assigned to investigate what claims had been improperly billed to Medicaid. Five months after the Comptroller told the hospital network about the software problem, Kane informed management about 900 potential claims that contained the erroneous billing code. Kane indicated that further analysis would be needed to confirm his findings. The parties did not dispute that Kane’s listing of the incorrect billings was overly inclusive and included claims that were improperly billed as well as some claims that were billed appropriately.

Acknowledging that CMS’ rules do not technically apply in the context of Medicaid, the Kane court nonetheless adopted CMS’ interpretation of the term “identified” that the agency adopted for Medicare Parts C and D and proposed to adopt for Medicare suppliers and providers. Thus, the court concluded that Kane’s e-mail triggered the 60-day timeframe to report and return overpayments. The court reasoned that Kane had put the hospital network on notice of potential overpayments, rejecting the hospitals’ argument that the court should adopt a definition of “identified” that means “classified with certainty.”

As the first court to interpret the term “identified” under the 60-day rule, Kane is an important decision for health care providers. It is possible that other courts will also side with CMS’ interpretation of “identified.” Thus, absent further guidance from CMS or the courts, health care providers should proceed to investigate carefully and quickly all allegations of alleged overpayments and document their efforts, in order to defend against any possible violation of the 60-day rule.

CMS Proposes Rule Updating Nursing Home Conditions of Participation

On July 16, 2015, the Centers for Medicare and Medicaid Services (CMS) issued a lengthy proposed rule revising the requirements that long term care facilities must meet to participate in the Medicare and Medicaid programs. This is the first comprehensive revision of long term care facilities’ conditions of participation since 1991. CMS states that it revised many of the requirements to reflect current clinical practice standards, noting that innovations in resident care and quality assessment practices have emerged since the last revision. Comments on the proposed rule will be accepted until 5 p.m. on September 14, 2015.

Some of the major provisions in the proposed rule include the following.

  • CMS proposes updating resident rights provisions, including addressing roommate choice. Under the proposed rule, a resident has the right to share a room with the roommate of his or her choice.The rooming arrangement could include a same-sex couple, siblings, other relatives, long term friends, or another combination as long as certain requirements are met.
  • The rule proposes a new section that focuses on facility responsibilities, bringing together many of the facility responsibilities dispersed throughout the current regulations. CMS proposes to revise visitation requirements to establish open visitation.
  • The rule would add a new section titled “Comprehensive Person-Centered Care Planning.” This proposal would require facilities to develop a baseline care plan for each resident within 48 hours of admission, which includes instructions about providing effective and person-centered care. This section also adds several other requirements, including expanding the required members of the interdisciplinary care team to add a nurse aide, a member of the food and nutrition services staff, and a social worker.
  • While CMS considered establishing minimum nurse hours per resident day, the proposed rule does not impose minimum staffing numbers or ratios. However, the proposed rule does include some new requirements related to staffing. The proposed rule adds a competency requirement for determining sufficient nursing staff based on a facility assessment. The facility assessment includes the number of residents, resident acuity, ranges of diagnoses, and care plan contents.
  • The proposed rule changes some pharmacy requirements. The rule proposes requiring a pharmacist to review a resident’s medical chart at least every six months when the resident is new, a prior resident returns or is transferred from a hospital or other facility, and during each monthly drug regimen when the resident has been prescribed or is taking a psychotropic drug, an antibiotic, or any drug the Quality Assessment and Assurance Committee has requested be included in the pharmacist’s month review. In addition, there are several proposed revisions to requirements regarding antipsychotic drugs, which the proposed rule revises to be referred to as psychotropic drugs, defined to include any drug that affects brain activities associated with mental processes and behavior.
  • The rule proposes specific requirements for binding arbitration agreements, including provisions to ensure that the agreement is voluntary, not permitting admission to be contingent on signing an arbitration agreement, and not allowing arbitration agreements to prohibit or discourage a resident or anyone else from communicating with federal, state, or local health care or health-related officials.
  • There are several new physical environment provisions in the proposed rule. CMS proposes that facilities certified after the effective date of the regulation accommodate no more than two residents in a bedroom and have a bathroom equipped with at least a toilet, sink, and shower in each room.
  • The proposed rule adds a new section on training requirements setting out all the requirements of an effective training program that facilities must develop, implement, and maintain.
  • There are also new provisions relating to laboratory, radiology, and other diagnostic services; dental services; food and nutrition services; food safety; specialized rehabilitative services; administration; quality assurance and performance improvement; and infection control.

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.

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.