COVID-19 Outbreak Update – Two Recent Updates From CMS Affecting Relief From Quality Reporting Requirements, And New Targeted Plan For Healthcare Facility Inspections Including Provider-Self Assessment Tool For Infection Control

(March 25, 2020): As our clients and all members of the health care community are acutely aware, the challenges raised by the Coronavirus /  COVID-19 outbreak are critical and widespread.  Because of these challenges, the Centers for Medicare and Medicaid Services (CMS) and other principal operating components of the United States Department of Health and Human Services (HHS) are issuing frequent guidance to our community.

Additionally, Congress is currently working on the third and large piece of legislation to address both the health care and economic impact of this outbreak.  Over the last two weeks, our attorneys have posted a variety of helpful articles on our Firm’s website that are directly responsive to these activities.  This article provides an update to two pieces of guidance that the CMS recently issued.

I.     COVID-19 Outbreak Relief From Certain Quality Reporting Requirements for Clinicians, Providers, Hospitals and Facilities:

On Sunday, March 22, in response to the COVID-19 outbreak, CMS announced that it was granting exceptions from reporting requirement and extensions for clinicians and providers participating in Medicare quality reporting programs with respect to upcoming measure reporting and data submissions for these programs.  The Press Release states that “[s]pecifically CMS is implementing … extreme and uncontrollable circumstances policy exceptions and extensions for upcoming measure reporting and data submission deadlines for the following CMS programs:”

The Press Release further states:

1. Submission of data for those programs with submission deadlines in April and May 2020 will be optional based on the facility’s choice to report; and
2. CMS will not use data reflecting services provided from January 1, 2020 through June 30, 2020 in calculations for the Medicare quality reporting and value-based purchasing programs.

The Press Release indicates that these actions are being undertaken to reduce data collection and reporting burdens on providers while they are responding to the COVID-19 outbreak pandemic and also because data furnished during this period my not be reflective or certain performance measures during this time, and as a result “seeks to hold organizations harmless for not submitting data during this period.”

The entirety of the Press Release can be found at https://www.cms.gov/newsroom/press-releases/cms-announces-relief-clinicians-providers-hospitals-and-facilities-participating-quality-reporting.             

II.     New Targeted Plan for Health Facility Inspections:

A.  CMS guidance on a short-term re-focusing of the inspection process.

As a result of the recent COVID-19 outbreak, CMS has recognized the increasing stress of the workload being placed on front line clinicians as they care for patients and residents.  This is especially true for nursing facilities which face unique and critical challenges in caring for their patients, and where the shortage of supplies of personal protective gear, while true throughout many sectors of the health care system, is especially acute in these facilities.  Therefore, on Monday, March 23, CMS released guidance that streamlines the survey process for these and facilities and other providers.

The guidance states that as of the date of publication, according to the Centers for Disease Control and Prevention (CDC), 147 nursing facilities across 27 states have at least one resident diagnosed positive as a result of the COVID-19 outbreak.  CMS will be reviewing data as it comes in from the CDC, using that information to identify areas where the virus is likely to strike next and will be targeting inspections accordingly.

B.  Overall general framework of the process.

The guidance stresses three action areas:

1. CMS will continue responsiveness to immediate jeopardy situations;
2. CMS will work with the CDC to identify areas of risk of COVID-19 outbreak spread to ensure that providers are compliant with federal infection control requirements; and
3. the guidance contains two tools/protocols which inspectors will use for infection control during this period, and that CMS strongly encourages providers to use as a voluntary self-assessment tool to review their own compliance with federal infection control requirements – one for nursing facilities and one for hospitals and continuing care.

C.  Specific actions.

During the next three weeks “only,” federal inspections will be prioritized as follows:

*Complaint inspections. These will be conducted for complaints and facility-reported incidents at the immediate jeopardy level, including allegations such as physical or sexual abuse, neglect, or other conditions that are at the IJ level.  Inspectors will use a streamlined Infection Control review tool regardless of the IJ allegation.

*Targeted Infection Control Inspections.  Federal and state inspectors will be conducting targeted infection control inspections for providers identified by CMS in collaboration with the CDC using a streamlined review checklist.  The guidance states that providers will receive immediate feedback to enable them to address shortcomings.

*Self-Assessment.  The guidance includes an infection control checklist to allow for self-assessments in this area.

Additionally, the guidance states that:

*Standard inspections of nursing homes, hospitals, home health agencies, intermediate care facilities for individuals with intellectual disabilities, and hospices and revisit inspections not associated with Immediate Jeopardy will not be conducted.

*CMS will prioritize IJ investigations over recertification surveys for CLIA laboratories.

*Absent IJ, CMS will utilize enforcement discretion.

*Initial inspections will be conducted with current guidance and prioritization.

During this period, CMS has also delayed certain enforcement activities as set forth in the quoted section from the CMS guidance document, below:

“ 4.a. For pending enforcement cycles during the prioritization period where the provider is currently not in substantial compliance or has not had a revisit survey to verify substantial compliance, and a per day civil money penalty (CMP), or DPNA (for nursing homes) or SPNA (for HHAs) was imposed for noncompliance that occurred prior to the prioritization date of surveys: These remedies will be suspended (stopped) as of the start of the survey prioritization date. In other words, the CMP will stop accruing and the DPNA/SPNA will end as of the suspension date. Additionally, CMS will not impose any new remedies to address noncompliance that occurred prior to the start of the survey prioritization period. NOTE: This does not apply to unremoved IJs. Enforcement actions will proceed as usual per the SOM for unremoved IJ deficiencies. CMS will issue guidance on how to reconcile these actions in the next few weeks.

b. For pending enforcement cycles during the prioritization period where the provider is currently not in substantial compliance or has not had a revisit survey to verify substantial compliance, and for pending enforcement cycles with new noncompliance cited after the issuance of this memo, and a per day CMP, or DPNA (for nursing homes) or SPNA (for HHAs) was imposed for IJ level noncompliance (where the IJ has not been removed): Surveyors will follow normal policies and procedures for removing the IJ. CMS will also follow normal policies and procedures for imposing enforcement remedies for remediating the noncompliance. For example, for noncompliance cited at the IJ level, that has not been removed at the time of the survey exit, the CMS Office will impose an enforcement remedy (e.g., CMP, 23 day termination), and the state surveyors will conduct a revisit survey. On the revisit survey, surveyors will either verify substantial compliance, or cite noncompliance at a lower level if warranted.

i. If the IJ noncompliance is reduced and cited at level 3 (LTC) or condition level (non-LTC), an onsite revisit survey will not be conducted during the prioritization period, and these cases will be held. CMS will issue guidance on how to impose enforcement and verify compliance with these in the next few weeks (see 2.c. [elsewhere in the full CMS guidance document]).

ii. If the IJ noncompliance is reduced and cited at level 2 (LTC) or standard level (non-LTC), facilities and survey agencies would verify compliance through normal procedures through a desk review (see 2.d. [elsewhere in the CMS guidance document]). However, CMS should not impose remedies during the prioritization period for any noncompliance that was identified before or after the start of the survey prioritization period, unless the noncompliance is an unremoved IJ.

c. The three-month mandatory DPNA and six-month mandatory termination (nursing homes) for not being in substantial compliance (for nursing homes and HHAs) will not take place, and be deferred for an evaluation at a later date. However, enforcement actions related to IJ remain and continue under normal procedures.

d. If CMS has previously imposed an alternative sanction (e.g., SPNA, CMP) on a HHA for noncompliance identified prior to the suspension, the six-month mandatory termination will not take place, and be deferred for an evaluation at a later date.

e. For existing CLIA enforcement cases where a civil money penalty (CMP) per day of non-compliance was imposed, accrual of CMP will stop as of the survey COVID-19 suspension date. CMS will issue guidance on how to reconcile these actions in the next few weeks. Other CLIA enforcement actions that have been initiated will be handled on a case-by-case basis with consultation DCLIQ managers and staff.

Due to its breadth, we have provided the following links to CMS guidance:

*Fact Sheet:  https://www.cms.gov/newsroom/fact-sheets/kirkland-washington- update-and-survey-prioritization-fact-sheet

*Full Guidance Document, including Infection Control Self-Assessment Tools: https://www.cms.gov/files/document/qso-20-20-allpdf.pdf-0

D. Other activity involving state Medicaid programs.

Additionally, on March 24, CMS granted 11 states’ Medicaid requests for 1135 waivers that allow greater flexibility in the administration of their programs.  We expect to provide a more detailed discussion of this event shortly; however, in the interim, we strongly suggest that all health care entities participating in the Medicaid program check with the states in which they operate to determine whether those states have received such a waiver, and if so, review the waiver to determine any impact that it might have on them.  As we all know, as the full scope of the COVID-19 outbreak develops, both Federal and State regulators will be actively monitoring the adverse impact that this national emergency is having on health care providers and suppliers.

III.     Conclusion — Responding to the COVID-19 Outbreak:

As a final remark, we wish to emphasize our awareness that the COVID-19 outbreak is a highly stressful situation that changes almost minute by minute.  We also wish to emphasize that as a society, we are all in this together and that we will get through this.  Right now, we need to do everything in our power to protect our residents, patents, and staff (and our loved ones and selves).  At Liles Parker, we will do our utmost to help you in this process by keeping you up to date of major developments and are available to respond to your inquiries during this period.

Michael Cook is a Partner and Co-chair for the Health Care Group at Liles Parker PLLC.  He has more than 40 years representing virtually every form of health care entity in a wide variety of matters across this country, currently is a member of the Board that oversees Virginia’s Medicaid program by appointment of the Governor, has advised a number of candidates for public office at both the state and national levels on health care issues, and has served on health care transition teams for several Governors.  Anyone with questions on the issues discussed in this paper should feel free to contact Michael.  He can be reached at either (202) 298-8750 (office) or (202) 361-2508 (cell) or mcook@lilesparker.com.

Recent Developments in Personal Care and Other Home and Community-Based Services in Medicaid and Medicare

(March 23, 2020): Until recently, personal care services, such as home health aides, were not covered under the Medicare program unless they were part of a skilled service where the beneficiary was homebound.  However, beginning with calendar year 2019, the Medicare program has expanded the ability of plans that participate in the Medicare Advantage program (“MA Plans”) to offer these services as a separate supplemental service at their option.  Additionally, as part of the Bipartisan Budget Act of 2018,[2] Congress expanded the supplemental benefits that MA Plans could offer to encompass certain benefits that were not primarily health related for certain chronically ill patients beginning with calendar year 2020.  This paper will discuss those changes, some of the major compliance issues that providers of personal care services face, and how the Medicaid program addresses these services.

I.   The Medicare Advantage (“MA”) Changes to Cover Additional Supplemental Benefits:

A. The 2019 MA Changes to Cover Personal and Other Home and Community Based Type Services

MA Plans are permitted to cover certain benefits that are not included in the fee for service Medicare program (“Original Medicare”).  Generally, these have taken the form of benefits such as dental and vision services.  However, to be covered as supplemental benefits, the items and services have been required to be “primarily health related.” [3]

Prior to calendar year 2019, the Centers for Medicare and Medicaid Services (“CMS”) has considered an item or service to be “primarily health related” only if the primary purpose is to “prevent, cure, or diminish an illness or injury.”[4] However, CMS had not considered a service to fit within this definition if the primary purpose is daily maintenance.

In the 2019 Final Call Letter, CMS announced that it would change the definition of that term to cover services under certain conditions “even if a significant purpose of the item is daily maintenance.”[5] Thus, under the new interpretation, “in order to be ‘primarily health related’ … [an item or service] must diagnose, prevent, or treat an illness or injury, compensate for physical impairments, act to ameliorate the functional/psychological impact of injuries or health conditions, or reduce avoidable emergency and health care utilization.”

The intent of the change was to provide plans the flexibility to offer supplemental benefits that enhance the quality of life and improve outcomes.  The service, however, also must be medically appropriate, recommended by a licensed provider as part of a plan of care, and cannot include items or services that are solely to induce enrollment.

A letter from CMS to MA Plans dated April 27, 2018 provided further guidance on the new interpretation of “primary health related.”[6]  The letter listed a number of examples of benefits that MA Plans could provide beginning in 2019 under the revised definition including in-home support services, adult day care services, home-based palliative care, support for caregivers enrollees, medically-approved non-opioid pain management, stand-alone memory fitness benefit, home and bathroom safety devices and  modifications, transportation, and over-the-counter benefits.  The letter further described in-home support benefits as:

“in-home services to assist individuals with disabilities and/or medical conditions in performing ADLs and IADLs within the home to compensate for physical impairments, ameliorate the functional/psychological impact of injuries or health conditions, or reduce avoidable emergency and healthcare utilization.  Services must be provided by individuals licensed by the state to provide personal care services, or in a manner that is otherwise consistent with state requirements.” (Emphasis added.)

Finally, in a speech at the Medicare Prescription Drug Plan Spring Conference, Seema Verma, Administrator, CMS, stated that “[t]his means that now Medicare Advantage beneficiaries will be provided adult day care services, respite care for caregivers, and in-home assistance with activities like bathing and managing medications.” (Emphasis added.)[7]

B. The 2020 MA Changes to Cover Benefits that are Not Primarily Health Related for Certain Chronically Ill Patients

The Balanced Budget Act of 2018 further expanded the benefits that MA Plans could offer as supplemental benefits to include certain benefits that are not primarily health related for chronically ill beneficiaries if they chose, beginning in 2020.  In the 2020 Final Call Letter, CMS refers to these benefits as Special Supplemental Benefits for the Chronically Ill (“SSBCI”).[8]

Unlike other supplemental benefits, MA Plans are able to offer SSBCI in a non-uniform manner.  Thus, MA Plans will be allowed to vary or target SSBCI to an individual’s particular medical needs.[9]  However, the 2020 Final Call Letter also states that while MA Plans have broad discretion with respect to both non-uniformity and the form of the benefit, itself, the items or services provided must have a reasonable expectation of improving or maintaining the health or overall function of an individual as it relates to the chronic condition or illness.[10]

For the purpose of SSDI, a chronically ill enrollee is one who: “ 1) has one or more comorbid and medically complex chronic conditions that is life threatening or significantly limits the overall health or function of the enrollee; 2) has a high risk of hospitalization or other adverse health outcomes; and 3) requires intensive care coordination.”[11] Currently, CMS will consider any individual with a condition identified as chronic in the list at section 20.1.2 of Chapter 16b of the Medicare Managed Care Manual to meet this criteria.  However, the 2020 Final Call Letter also states that CMS will convene a technical advisory panel to periodically update the list of conditions that satisfy the necessary criteria.[12]

CMS followed up the 2020 Final Call Letter with additional sub-regulatory guidance in the form of a letter to Medicare Advantage Organizations.[13]  That letter listed as examples of permitted benefits, the following: meals beyond a limited basis; food and produce; transportation for non-medical needs; pest control; indoor air quality equipment and services; social needs benefits; complimentary therapies; services supporting self-direction; structural home modifications; and general supports for living.[14]

C. Status of Implementation by MA Plans

Anecdotal information indicates that plans were experimenting with the types and scope of benefits to cover under the reinterpretation of “primarily health related” during the 2019 calendar year.  This was, in part, due to the fact that the 2019 Final Call Letter was not issued until April 2018, just two months before plan bids were due.  Thus, there was a limit on the time within which MA Plans had to determine how to utilize this new flexibility.  Also, the nature of the benefit, coupled with the competition from traditional supplemental benefits such as dental and vision care, almost dictated a need for experimentation and slow implementation.

Nevertheless, two studies by Milliman attempted to encapsulate the manner in which MA Plans had implemented that flexibility in the initial plan year that they were available.[15]  And a more recent Milliman study that was published in November 2019 appears to indicate that a significantly greater number of plans are offering new types of supplemental benefits for the 2020 calendar year.[16]

II.   Compliance Issues in Personal Care:

Personal care services have become extremely popular as other government programs attempt to rebalance services for the elderly and disabled from those that are provided in institutions to those provided in the home.  Additionally, many individuals who otherwise do not qualify for government sponsored long term care under the traditional benefit package also prefer to use personal care aides to enable them to remain in their homes.

However, from a compliance standpoint, personal care provides a number of challenges.  First, aides are frequently low paid, and thus struggle to make a living wage.  Additionally, the work can be difficult.  From an agency perspective, government rates generally are low, thus furthering the need to retain workers at low wage levels and the needs of elderly and disabled clients can be extremely challenging.  Adding to these difficulties is the fact that because the work takes place in the home, it is more challenging to monitor than care provided in the institutional setting.

Over the past years, there have been a number of investigations and prosecutions of home and personal care aides and agencies.  The issues involved in these cases have taken a number of forms but generally arise under several categories.  Thus, conduct that has been prosecuted can range from aides colluding with clients who otherwise would not be eligible for services, falsification of time sheets by aides and clients, operation of an agency by an excluded individual, and theft from elderly clients.

As an example, in 2014 the Federal Bureau of Investigation had a “takedown” of more than twenty individuals and agencies for Medicaid fraud in the District of Columbia.  Allegations involved aides falsifying time sheets for visits that never occurred, sometimes to clients who falsified their eligibility for services, and splitting the Medicaid payments between aides and clients for services that were never provided.  In one instance, an agency owner who had been excluded in Virginia under her maiden name, operated an agency in the District under a different name and allegedly received more than $70 million from the District Medicaid program before being busted.  There were even allegations that one or more aides involved in the conduct transported a patient who had been out of state when services were allegedly delivered, back to the District because they had determined that the company would be making an internal compliance verification visit to check on the delivery of services.[17] These actions resulted in the Director of the District’s Medicaid program estimating that he lost approximately 70% of his providers and temporarily establishing a government operated personal care agency to provide care while the Medicaid program rebuilt its provider pool.

In another example, twelve people, including home care aides and the owners of a home care agency, were indicted for an $87 million Medicaid fraud in Pennsylvania. The allegations included making false Medicaid claims, creating fake employees, misusing customers’ personal information and falsifying documents, and submitting claims for “customers” who were in the hospital, jail, or dead. [18]

As yet another set of examples, two more home care workers were recently sentenced to prison for paying kickbacks to beneficiaries and submitting timesheets to different home care agencies for services that they did not provide, and one for billing for services that she claimed to provide while traveling outside of the United States.  This case also highlights the difficulty of monitoring the service because the aides were alleged to have perpetrated the fraud to the District of Columbia Medicaid program from 2014 through 2018 at eighteen different agencies, despite the major District takedown in 2014.[19]

The Office of the Inspector General at the United States Department of Health and Human Services has issued several reports with recommendations in the area.[20] The most significant would require states to either enroll personal care attendants as providers or require those attendants to register with state Medicaid agencies, assigning each a unique identifier.

Finally, as part of the 20^th Century Cures Act, beginning January 1, 2020, all State Medicaid Agencies must require an electronic visit verification (“EVV”) system for Medicaid-funded personal care services to verify that the visits actually occur.[21] States that fail to implement this requirement on a timely basis are subject to an incremental reduction in their Federal Medical Assistance Percentage for these services which ultimately reaches 1%.  CMS is authorized to provide an exception to states to delay implementation for up to one year if they can demonstrate making a good faith effort to comply but have encountered unavoidable delays.  However, the State must apply for, and be granted, the waiver by CMS.[22]

While this provision only applies to personal care services provided under the Medicaid program, these trackers may be at least a partial solution for those agencies that choose to provide these services for MA Plans.  This is especially so since agencies that also participate in Medicaid will already be required to implement EVV for those services, and MA Plans almost certainly will have their own compliance plan requirements as well.

III.   Personal Care and Home and Community Based Services in Medicaid:

Unlike the Medicare program, states have been able to provide home and community-based services, including personal care services, under Medicaid for many years.  While states will vary on how and when they will provide these services to beneficiaries, virtually every state covers personal care services under either its State Plan or one of several waiver authorities.[23]

States are able to provide personal care services under the following authorities taken from a table in a recent Kaiser Family Foundation report[24]:

1. Home Health Services (required State Plan service):
   • Part-time or intermittent nursing services, home health aide services, and medical supplies, equipment and appliances suitable for use in the home
   • At state option-physical therapy, occupational therapy, and speech pathology and audiology services
2. Personal Care Services (optional State Plan service)
   • Assistance with self-care (e.g. bathing, dressing) and household activities (e.g. preparing meals)
3. Community First Choice (optional):
   • Attendant services and supports for beneficiaries who would otherwise require institutional care
   • Income up to 150% FPL or eligible for benefit package that includes nursing home services; state option to expand financial eligibility to those eligible for HCBS waiver
4. Section 1915(i) (optional):
   • Case management, homemaker/home health aide/personal care services, adult day health, habilitation, respite, day treatment/partial hospitalization, psychosocial rehabilitation, chronic mental health clinic services, and/or other services approved by the Secretary
   • Beneficiaries must be at risk of institutional care
   • Population targeting permitted
5. Section 1915(c) waiver (optional):
   • Same services as available under Section 1915(i)
   • Beneficiaries must otherwise require institutional care
   • Secretary can waive regular program income and asset limits
   • Cost neutrality required (average per enrollee cost of HCBS cannot exceed average per enrollee cost of institutional care)
   • Enrollment caps permitted
   • Population targeting permitted
6. Section 1115 waiver (optional):
   • Secretary can waive certain Medicaid requirements and allow states to use Medicaid funds in ways that are not otherwise allowable under federal rules for experimental, pilot, or demonstration projects that are likely to assist in promoting program objectives
   • Federal budget neutrality required
   • HCBS enrollment caps permitted”

These services can be targeted at a variety of beneficiary populations including such groups as seniors, seniors and adults with physical disabilities, individuals with developmental disabilities, individuals with HIV/AIDS, medical fragile technology dependent children, mental health, and TBI and spinal cord injuries.[25]  What is clear is that state Medicaid programs are attempting to rebalance and focus their spending on long term care towards services in the home and community as opposed to institutional care, and that personal care services play an important role in Medicaid.

For a comprehensive understanding of the services and populations that each State is covering under home and community-based services, readers are referred to the Kaiser Family Foundation reports referenced in note 23.

IV.   Conclusion:

The provision of personal care services and other services that address the social determinants of health in the public programs and under private health insurance is evolving and expanding.  What is clear is that there is now a growing understanding at both the state and federal government levels and in the private health insurance market that these services can play a vital role in reducing costs and improving health.  The expansion of the definition of optional supplemental benefits in the MA program, discussed, above, present significant potential opportunities in this area.  However, issues of compliance that have occurred in the past also make it critical that providers seeking to participate in this area understand both the potential benefits and pitfalls in the manner of any participation.

For more on this please check the presentation here given on this topic at the AHLA LTC conference March 2020

Anyone seeking advice in this area should contact Michael Cook[1] at mcook@lilesparker.com or (202) 298-8750 (office), (202) 361-2508 (cell).  Michael is a partner and Co-chair of Liles Parker’s Health Care Practice Group.

[1] Michael Cook is a Partner and Co-chair of the Health Care Group of Liles Parker PLLC.  This article was prepared for the American Health Lawyers Association Conference on Long Term Care and the Law in 2020.

[2] Pub. L. 115-123 amending section 1852(a) of the Social Security Act

[3] Medicare Managed Care Manual, Chapter 4, section 30.1

[4] Announcement of Calendar Year (CY) 2019 Medicare Advantage Capitation Rates and Medicare Advantage and Part D Payment Policies and Final Call Letter (April 2, 2018) (“2019 Final Call Letter”), p. 207 https://www.cms.gov/Medicare/Health-Plans/MedicareAdvtgSpecRateStats/Downloads/Announcement2019.pdf

[5] Id. at 207-8

[6] Letter from Kathryn Coleman to Medicare Advantage Organizations and Section 1876 Cost Contract Plans, “Reinterpretation of ‘Primarily Health Related’ for Supplemental Benefits,” dated April 27, 2018 https://www.nahc.org/wp-content/uploads/2018/05/HPMS-Memo-Primarily-Health-Related-4-27-18.pdf

[7]https://www.cms.gov/newsroom/fact-sheets/speech-remarks-cms-administrator-seema-verma-medicare-advantage-and-prescription-drug-plan-spring.  While this guidance has been included only in sub-regulatory guidance to date, CMS recently published a proposed rule that, if adopted, will codify this re-interpretation into its regulations.  See 85 Fed. Reg. 9002, 9210 (February 18, 2020)

[8] Announcement of Calendar Year (CY) 2020 Medicare Advantage Capitation Rates and Medicare Advantage and Part D Payment Policies and Final Call Letter (April 1, 2019) (“2020 Final Call Letter”), p. 187 https://www.cms.gov/Medicare/Health-Plans/MedicareAdvtgSpecRateStats/Downloads/Announcement2020.pdf

[9] Id. at p. 190

[10] Id. See also 83 Fed. Reg. 16440, 16481-2 (April 16, 2018)

[11] See 2020 Final Call Letter at p. 188

[12] Additionally, a recently published proposed rule for Medicare Advantage Contract Year 2021 and 2022, if adopted, would allow plans to target additional chronic conditions. See 85 Fed. Reg. 9002, 9012.

[13] Letter from Kathryn Coleman to Medicare Advantage Organizations, “Implementing Supplemental Benefits for Chronically Ill Enrollees,” dated April 27, 2019

[14]https://www.cms.gov/Medicare/HealthPlans/HealthPlansGenInfo/Downloads/Supplemental_Benefits_Chronically_Ill_HPMS_042419.pdf.  As with the guidance on the new interpretation of primarily health related, the guidance on SSBCI has been sub-regulatory to date.  However, the proposed rule cited at note 7, if adopted, would codify much of this guidance into regulations.  See 85 Fed. Reg. 9002, 9213

[15] LTSS Services in Medicare Advantage Plans – The 2019 Market Landscape and the Challenges Ahead http://www.qa.milliman.com/insight/2019/LTSS-services-in-Medicare-Advantage-Plans/; Review of contract Year 2019 Medicare Advantage Supplemental Health Benefit Offerings https://www.bettermedicarealliance.org/sites/default/files/2018-12/20181207%20Milliman%20%20MA%202019%20Supplemental%20Benefits%20-%20Final.pdf

[16] Review of Contract Year 2020 Medicare Advantage Supplemental Healthcare Benefit Offerings https://www.bettermedicarealliance.org/sites/default/files/2019-11/Review_of_Contract_Year_2020_Medicare_Advantage_Supplemental_Healthcare_Benefit_Offerings.pdf

[17] See FBI Press Release, “More Thank 20 People Arrested Following Investigation Into Widespread Health Care Fraud in D.C. Medicaid Program,” February 20, 2014 https://archives.fbi.gov/archives/washingtondc/press-releases/2014/more-than-20-people-arrested-following-investigations-into-widespread-health-care-fraud-in-d.c.-medicaid-program

[18] See “12 Home Health Workers Indicted for $87 Million Medicaid Fraud,” Home Health Care News, November 27, 2018 https://homehealthcarenews.com/2018/11/12-home-health-workers-indicted-for-87-million-medicaid-fraud/); see also US Department of Justice Press Release, “Two More Defendants Plead Guilty in Multi-Million Dollar Home Health Care Fraud Conspiracy,” January 21, 2020 https://www.justice.gov/usao-wdpa/pr/two-more-defendants-plead-guilty-multi-million-dollar-home-health-care-fraud-conspiracy

[19] See US Attorneys Office for the District of Columbia Press Release, “Two former Personal Care Aides Sentenced to Prison for Defrauding Medicaid,” February 14, 2020 https://www.justice.gov/usao-dc/pr/two-former-personal-care-aides-sentenced-prison-defrauding-medicaid; see also US Attorneys Office for the District of Columbia Press Release, “Former Personal Care Aide Pleads Guilty to Health Care Fraud,” November 22, 2019 https://www.justice.gov/usao-dc/pr/former-personal-care-aide-pleads-guilty-health-care-fraud-1

[20] See “Medicaid Fraud Control Units: Investigation and Prosecution of Fraud and Beneficiary Abuse in Medicaid Personal Care Services,” HHS OIG Brief, OEI-12-16-00500 (December 2017) https://oig.hhs.gov/oei/reports/oei-12-16-00500.pdf; “Solutions to Reduce Fraud, Waste, and Abuse in HHS Programs: OIG’s Top Recommendations (July 2019) https://oig.hhs.gov/reports-and-publications/compendium/files/compendium2019.pdf; “OIG Calls for Additional Oversight of Home Health, Personal Care Service Providers,” Home Health Care News (July 25, 2019) https://homehealthcarenews.com/2019/07/oig-calls-for-additional-oversight-of-home-health-personal-care-service-providers/

[21] Section 12006(a) of the Cures Act (2016)

[22] See CMCS Information Bulletin from Calder Lynch, “Additional EVV Guidance,” dated August 8, 2019

[23] See “Key State Policy Choices About Medicaid Home and Community-Based Services,” M. Musumeci, M. O’Malley Watts, and P. Chidambaram, Kaiser Family Foundation (February 2020) https://www.kff.org/report-section/key-state-policy-choices-about-medicaid-home-and-community-based-services-issue-brief/; “Medicaid Home and Community-Based Services Enrollment Spending, M. O’Malley Watts, M. Musumeci, and P. Chidambaram, Kaiser Family foundation (February 2020) https://www.kff.org/medicaid/issue-brief/medicaid-home-and-community-based-services-enrollment-and-spending/

[24] See note 23, “Medicaid Home and Community-Based Services,” supra, Table 1 at p.4

[25] Id. at pp. 8-9

Providers Should Ensure That They Are Fully Aware of All of the Collateral Consequences that May Occur When Settling with the Government

(December 2, 2019):  Over the past several years, several clients have come to our Firm who have resolved disputes through such mechanisms as settlement agreements, criminal pleas, or consent orders, either because they specified minimal penalties or because they did not include any time in incarceration.  Later they discover that agreeing to these resolutions has resulted in collateral consequences that have far reaching consequences that they did not anticipate.

In one matter, a provider had signed a consent order before a professional board that contained a fine that was not substantial, only to later be terminated from the Medicaid program which was the sole source of that person’s practice.  In another instance, a provider had accepted a plea in a Medicare fraud case that avoided incarceration, only to discover that the he was later excluded from federal health programs and faced possible disciplinary action by the state professional board.  In each of these cases, the providers had been represented in those actions by counsel who were extremely competent in their specialty — litigation, but who did not specialize in health care and thus were unfamiliar with the special nuances of the health care statutes, rules and practices.

I. Collateral Consequences — Traps for the Unwary:

It is essential that you be aware of the possible derivative collateral consequences that may flow from settling matters that involve federal health programs, tort or insurance matters, or other government bodies.  These include such actions as:

• Medical malpractice payments made for the benefit of a health care practitioner resulting from a written claim or judgment.
• Certain adverse licensure actions related to professional competence or conduct .
• Professional review actions based on reasons related to professional competence or conduct adversely affecting clinical privileges for a period longer than 30 days, or voluntary surrender or restriction of clinical privileges while under, or to avoid, an investigation.
• Professional review actions based on reasons relating to professional competence or conduct adversely affecting membership
• DEA administrative actions seeking to revoke a provider’s Certificate of Registration.
• Exclusions from participation in Medicare, Medicaid, and other federal health care programs.
• Negative actions or findings by peer review organizations or private accreditation actions.
• A variety of adverse actions by state licensing and certification authorities.
• A variety of law enforcement or administrative activities involving health care related actions.
• A variety of federal licensure and certification actions.

A report that is made to the NPDB can have a number of derivative collateral consequences such as adversely affecting hospital admitting privileges, credentialing for purposes of participating in insurance or public programs, and the ability to obtain professional liability insurance or the rates that a clinician pays for such coverage.  In the initial case discussed, above, the health care practitioner who was terminated from the Medicaid program was able to have privileges and enrollment restored, but only after significant legal expense and time away from the practice that likely could have been avoided had health care counsel been involved in the earlier proceeding.

Additionally, there are a number of grounds under federal health care law that provide for mandatory or permissive exclusion from all federal health care programs including the Medicare and Medicaid programs.  Thus, any provider, practitioner, or entity that is convicted of a program related crime, patient abuse, or a felony related to health care fraud or manufacture, distribution, prescription or dispensing of a controlled substance must also be excluded from participation in federal health care programs, generally for at least five years.

Also, among the grounds for permissive exclusions are:  convictions relating to fraud in a variety of areas, including misdemeanors; obstruction of an investigation or audit; misdemeanor relating to controlled substances; license revocations – probably the most often used ground for permissive exclusion; exclusion or suspension under another federal or state health care program; and a variety of other grounds.  And, there are also a number of insurance and state-specific health care statutes that can generate consequences that would not be readily apparent without familiarity in the area.

II. The Lesson to be Learned About Collateral Consequences:

In short, anyone who operates in the health care space and who is considering entering into a voluntary resolution of a dispute that involves a governmental entity, needs to make sure that the proposed resolution won’t trigger unanticipated collateral adverse consequences. Here, as in many other aspects of participating in the health care system, an ounce of prevention is worth a pound of cure.  And, it literally can be the difference between successfully managing the consequences of an adverse event and suffering a serious and career-ending experience.

Liles Parker attorneys are experienced in handling these types of matters, and acutely aware of the collateral consequences that can occur from resolving what can sometimes appear to be minor disputes. Anyone having questions in this area should feel free to contact Michael Cook for a free initial consultation.  Attorney Michael Cook can be reached at (202) 298-8750 or mcook@lilesparker.com.

Home Health Agency Alert: The Review Choice Demonstration Project start dates for Ohio, Texas, North Carolina and Florida are Around the Corner!

(August 7, 2019): This article further updates our articles of February 19th and April 9th on the announcement by CMS of the implementation of the new five year “Review Choice Demonstration Project’ in five states – Illinois, Ohio, Texas, North Carolina and Florida, and the start date for the Demonstration Project in Illinois.

I. Background of the Review Choice Demonstration Project:

As background, the Review Choice Demonstration Project is an outgrowth of the Pre-Claim Review Demonstration Project that was initiated in Illinois in August 2016 and paused in April 2017.  Instead of continuing the Pre-Claim Review Demonstration, the Centers for Medicare and Medicaid Services (CMS) announced a new initiative – the Review Choice Demonstration Project to be phased in for the five states listed, above.

Under the Review Choice Demonstration Project, agencies in the affected states will initially select from three options to have their home health claims reviewed:

• Pre-claim review;
• Post-payment review; or
• Minimal post-payment review with a 25% reduction.

After each six-month period agencies with a 90% affirmation or approval rate will be able to choose from two additional options that may be preferable depending upon the circumstances of each agency.  Our February 19th article discusses each of these options.

II. Illinois Home Health Claims are Under the Microscope:

The Review Choice Demonstration Project initially began in Illinois on June 1 for all episodes of care beginning on that date. Prior to that date, Illinois agencies were required to make a selection as to the initial option that they chose for this period between April 17 and May 16.

On July 29, 2019, CMS announced that Ohio will be the second State to implement the Review Choice Demonstration Project.  Home health agencies in Ohio will have from August 16th to September 15th to select an option for the first six-month period, which will begin on September 30, 2019 for all episodes of care starting on or after that date.  Any agency that fails to select an option during this period will be assigned to the second option, above – post-payment review.[1]

CMS also announced that it anticipates 60 – 90 days between beginning the Demonstration in the remaining states of Texas, North Carolina and Florida, and will provide 60-days’ notice in advance of the start date.  While the announcement is somewhat unclear as to whether this period will be spread out for each remaining state or that all three will start on the same date, it is clear that agencies in each of those states and Ohio should begin planning now for that implementation if they have not already done so.

CMS has published links to the Palmetto GBA portal for selecting and registering an option during this period as well as a number of additional resources at https://www.cms.gov/Research-Statistics-Data-and-Systems/Monitoring-Programs/Medicare-FFS-Compliance-Programs/Review-Choice-Demonstration/Review-Choice-Demonstration-for-Home-Health-Services.html.

III.  Planning for Implementation – Especially in Light of PDGM:

Our February 19th article goes into greater depth in explaining the various options.  However, most importantly, both articles emphasize the importance of thinking through which option makes the most sense for your agency.

Each one presents risks and benefits and the correct choice may differ depending upon the agency’s comfort and experience with denials and documentation, as well as operational capability – the one exception being that the third option – a 25% rate reduction, does not appear to be viable for any agency.  Our earlier articles also sets forth several examples of those risks and benefits and while not exhaustive, is meant to focus agencies on the thought process that your agency will want to consider in making this determination.  We thus cannot strongly enough recommend that each agency take the necessary time to consult with knowledgeable individuals both internal and external in making this determination for each 6-month period, and not wait until the last minute to do so.

Of equal, or perhaps greater, importance is the need for agencies in affected states to have procedures in place to prepare and quickly access documentation to properly support coverage for the cases that they take, and to move this documentation through the system quickly, accurately, and comprehensively.  This is especially important given the advent of the Patient- Driven Groupings Model (PDGM) on January 1, 2020.  For example, coding will be a key issue in driving coverage and payment, and “getting it right” in your documentation will be critical.  Also, addressing initial non-affirmation determinations quickly for agencies that select option 1 will be critical.

Finally, agencies should be updating their compliance and quality assurance programs to respond both to the PDGM payment model and to the Review Choice Demonstration Program.

Liles Parker attorneys have substantial experience in advising and working with home health agencies in preparing them for the audit process which is similar to the process that they will need in responding to the Review Choice Demonstration Project, and in identifying the risks of choosing one option in relation to the others.  For example, one of the additional two options available to agencies that score above the 90% affirmation or approval level in options 1 or 2 during a 6-month period may result in the inadvertent development of a statistical sample that can be utilized to broaden the scope of any denials and recovery.  A number of our attorneys are also Certified Professional Coders who have substantial experience in evaluating home health claims documentation. Finally, we have substantial experience in working with home health agencies in developing and updating their compliance plans.

Any person wishing a free consultation in this area should contact Michael Cook, the author of this article and Co-chair of the Health Care Group.  Michael Cook can be reached at (202) 298-8750 and mcook@lilesparker.com.

[1] We would also note that there was a misprint in our article of April 9.  That article inadvertently referenced that Illinois providers failing to make a choice during the initial registration period would be assigned to the third option.  The corrected reference is to the second option.

Home Health Agency Alert: The Review Choice Demonstration Project is Moving Forward in Illinois Effective June 1, 2019

(April 9, 2019): This article updates our article of February 19 on the lifting by the Centers for Medicare and Medicaid Services (“CMS”) of the moratorium on the enrollment of new home health agencies in Florida, Illinois, Michigan and Texas, and the announcement by CMS of the implementation of a new five year “Review Choice Demonstration Project” in three of those four states (Florida, Illinois, and Texas) as well as Ohio and North Carolina (with a possible extension to other states within the Palmetto/JM jurisdiction).

At the time of that article, CMS had announced that the project would begin in Illinois, with implementation in the other four states in the near future thereafter.  However, CMS had not specified a “start date” for Illinois because it was awaiting approval by the Office of Management and Budget (“OMB”) at that time.  CMS has now received that approval and has announced implementation in Illinois to begin on June 1, 2019.  All episodes of care beginning on or after that date during the period of the demonstration will be subject to the requirements of the project.

I.  Background of the Review Choice Demonstration Project:

As background, under the Review Choice Demonstration Project, home health agencies in the affected states will initially select from three options to have their claims reviewed:

• Pre-claim review
• Post-payment review, or
• Minimal post-payment review with a 25% reduction.

After each six-month period, agencies with a 90% affirmation or approval rate under one of the first two options, above, will also be able to choose between two additional options.  Each of these options is described in our February 19 article.

II.  Illinois Home Health Agencies are Under the Microscope:

Home health agencies located in Illinois must choose and register for one of the three options, above, between the dates of April 17 and May 16 on a portal established by Palmetto GBA.  Any agency that fails to make a choice during that period will be assigned to the third option and will not be able to change that option during the entire five-year period, and thus will receive a 25% payment reduction during this entire time.

As discussed in our February 19 article, the Review Choice Demonstration is an outgrowth of the Pre-claim Review Demonstration for Home Health Services that had been initially implemented in Illinois and then “paused” and never “restarted.”  However, Illinois agencies that had met the 90% full provisional affirmation rate under that project (based on a minimal 10 request submission between August 2016 and March 2017) will be permitted to begin the Review Choice Demonstration by selecting from any of the options including the additional ones available to agencies with a 90% affirmation or approval rate during a 6-month period.

CMS has established links to both the Palmetto GBA portal described, above, and to an operational guide and Special Open Door Forum Presentation that describes the program at https://www.cms.gov/Research-Statistics-Data-and-Systems/Monitoring-Programs/Medicare-FFS-Compliance-Programs/Review-Choice-Demonstration/Review-Choice-Demonstration-for-Home-Health-Services.html.

III.  Is Your Home Health Agency Ready for an Audit?

Our earlier article goes into greater depth in describing the various options.  That article also emphasizes the critical nature of the choice that each agency makes in selecting an option.

Each of the options presents a separate set of risks and benefits as opposed to the others – the one exception being that the third option of a 25% payment denial does not appear to be a viable one for any agency.  Our earlier article also sets out several examples of these risks.  We thus recommend that every agency take the necessary time to consult with knowledgeable individuals, both internal and external, in making this selection during each 6-month period.

Additionally, as stated in that article, we cannot recommend strongly enough that agencies in the affected states have procedures in place to properly document coverage for all the cases that they handle, and also a process to prepare and move documentation through the system quickly and comprehensively.  They also should be updating their compliance and quality assurance programs to respond to these changes.

Liles Parker attorneys have substantial experience working with home health agencies in preparing them for the audit process which is similar to the processes that they will need to follow in responding to the Review Choice Demonstration Project, and in identifying the risks of choosing one option in relation to the others.  A number of our attorneys are also certified coders who have substantial experience in developing a format to justify coverage.  Finally, we have substantial experience working with agencies in developing and updating their compliance plans.

Any person wishing a free consultation in the area should contact Michael Cook, the author and Co-chair of our Health Care Group. Michael can be reached at (202) 298-8750 or mcook@lilesparker.com

CMS has Ended its Moratorium on New Home Health Agencies in Texas, Illinois, Michigan and Florida. Unfortunately, the Lifting of the Moratorium Isn’t Necessarily a Good Thing for Existing Home Health Agencies.

(February 19, 2019):  CMS has now ended, at least for the current time, the moratorium that it placed on the approval of new home health agencies.  At the same time, home health providers that operate in Illinois, Ohio, North Carolina, Florida and Texas, and potentially other states within the Palmetto/JM jurisdiction (Alabama, Arkansas, Georgia, Indiana, Kentucky, Louisiana, Mississippi, New Mexico, Oklahoma, South Carolina, and Tennessee) face the likelihood that a revised pre-payment demonstration model will be implemented in the near future.

I.  Lifting of the Moratorium:

Effective January 30, 2019, CMS has officially ended the “temporary” moratorium on new home health agencies, sub-units and branch locations (collectively referred to as “HHAs,” “home health agencies,” or “agencies”) in Illinois, Michigan, Texas and Florida.[1]  This means that there is no longer in effect a federal prohibition on enrolling new home health agencies in the Medicare program in these or any other states, and that agencies in these states that wish to enroll in Medicare can now begin the process of doing so.

II.  Background of the Home Health Agency Moratorium:

CMS initially imposed a temporary moratorium to prevent the enrollment of new home health agencies in Miami-Dade County, Florida and Cook County, Illinois and surrounding counties in 2013.  CMS then extended the existing moratoria and expanded them to cover Broward County, Florida, Dallas and Harris Counties, Texas, Wayne County, Michigan and surrounding counties.  Finally, in August 2016, CMS extended and expanded the moratoria on new HHA’s to Florida, Illinois, Michigan and Texas, and further extended those moratoria through January 2019.  CMS has justified the imposition of the moratoria and selection of the geographic areas based on its view that those areas were especially at high risk for fraud, waste, and abuse.  Finally, CMS lifted the moratorium on home health agencies in these states effective January 30.

III.  What is the Anticipated Impact of Lifting the Moratorium?

As noted, above, this means that providers that wish to enroll new home health agencies in Medicare in these states may now begin that process.  However, experience has demonstrated that CMS is not reticent to take these, and other, actions when the agency believes that there is a high risk of fraud and abuse in particular localities.  Additionally, federal law and regulations require states to impose temporary moratoria on enrollment in the Medicaid and CHIP programs except in certain circumstances in areas and over time periods where Medicare takes these actions.  Finally, this relief affects only CMS approval.  It does not eliminate the need to check and comply with any restrictions that state or local governments may place on the establishment of new agencies.  Thus, as always, we continue to recommend to all home health agency providers that they establish and maintain strong compliance programs to alleviate the perceived need of moratoria in the future, and also to minimize the likelihood that their agencies will be the subject of investigation or sanctions.

IV.  CMS’s Review Choice Demonstration Project:

CMS’s Review Choice Demonstration Project is an outgrowth of the what was called the Pre-Claim Review Demonstration Project.  In August 2016, CMS initiated the Pre-Claim Review Demonstration Project for Illinois home health agencies under which these agencies were required to submit all of their Medicare claims and documentation for a pre-claim review prior to submitting them for payment.  It was only after the claim was “affirmed” that the agency could submit it for payment.

Initially, according to CMS, there was a wide variation of affirmation rates among agencies.  However, according to CMS, by the end of the first six-month period, agencies had on the average much higher affirmation rates.  The demonstration project was paused in April 2017 and has not been re-instituted or expanded past Illinois.

In light of the various problems encountered when implementing the Pre-Claim Review Demonstration Project, CMS has chosen not to re-initiate the program.  Instead, CMS revised its approach and announced that a new initiative, the Review Choice Demonstration Project was being implemented.  Once it goes “live” in a state, the Review Choice Demonstration Project will be in effect for five years.  As noted above, the Review Choice Demonstration Project is scheduled to cover services provided in Illinois, Ohio, North Carolina, Florida, and Texas, with the option to expand it to other states under Palmetto’s jurisdiction.

The Review Choice Demonstration Project was initially scheduled to be implemented in December in Illinois, with a rollout in other states to follow with a 60-day advance notice. However, the Illinois rollout has been delayed awaiting approval under the Paperwork Reduction Act, after which the agency will announce the start date for the demonstration in Illinois.

Under the Review Choice Demonstration Project, agencies will have their choice of three options for the first six-month period: (1) 100% Pre-Claim Review; (2) 100% Post-Payment Review; or (3) Minimal review with an automatic 25% payment reduction.

V.  Initial Options Under the Review Choice Demonstration Project:

Under the Review Choice Demonstration Project, a home health agency will have the option of choosing among three alternatives with respect to how its claims will be handled.  These three alternatives include the following:

• Option #1: 100% Pre-claim Review

Under the first option, a home health agency will submit the pre-claim with all relevant documentation.  If the pre-claim receives an affirmation notice, the agency can submit the claim and will receive full payment, and absent evidence of possible fraud or gaming, the claim will not be subject to post-payment review by the MAC, RAC or Supplemental Medical Review Contractor.  If a pre-claim receives a non-affirmative decision, it can be submitted again for pre-claim review with additional documentation or explanation. If a claim is submitted with a non-affirmative pre-claim decision, it will be denied with full appeal rights.   Claims submitted without receiving a pre-claim determination will be subject to prepayment review and even if determined to be payable, will be subject to a 25% reduction in payment rate.

After six months, the agency will have its affirmation rate calculated.  If it has submitted at least 10 claims and if it obtains at least a 90 % affirmation rate, the agency will be allowed to continue in this option or to choose between two other options, described, below.  If the agency’s affirmation rate for the six-month period was lower than 90% or it did not submit 10 claims during that period, it must choose between one of the three initial options.

• Option #2: 100% Post-Payment Review

Under this option, the agency will be paid in the normal course, but will have all of its claims during a six-month period undergo complex medical review.  Subsequent to the review, the MAC will recover for any claims that it has paid during this period that it finds not to meet Medicare requirements, and the agency may appeal the decision through the normal appeals process.  If the agency has obtained at least a 90% approval rate during the six-month period, it will be able to choose either option one or one of the additional two options discussed, below.  Otherwise, it will have the option of choosing one of the initial three options for the next six-month period.

• Option #3: Minimal Review with 25% Payment Reduction

An agency that chooses this option will have its claims reviewed under the normal process, but the payment amount will have an automatic 25% reduction.  Claims will not be subject to post-payment MAC reviews but will be subject to RAC and UPIC review under the normal review process, and any denied claims will be subject to the normal appeal process.  The 25% reduction in payment amount, however, is neither transferable to the beneficiary nor subject to appeal.  Any agency that chooses this option will not be able to change options for later periods and will remain under this option for the entire five-year “demonstration.”

VI.  Subsequent Options Under the Review Choice Demonstration Project:

An agency that has selected either Option 1 or 2, above and that has an affirmation rate of at least 90% in the prior six-month period may choose either Option 1, above – 100% Prepayment Review, or one of the two options, below – Options 4 (selective post-payment review) or 5 (spot check review).

• Option #4: Selective Post-Payment Review

Under Option #4, the agency will be paid under normal claim processing procedures.  However, the MAC will select “a statistically valid random sample” every six months for complex review.  An agency selecting this option at any time will not be able to change options at a later point in time.

• Option #5: Spot-Check Review

Under Option #5, the MAC will select 5% of claims to be subject to pre-payment review every six months.  The agency is able to remain in this option for the remainder of the demonstration provided that “the spot check shows that the agency is compliant with Medicare coverage rules and policy.”  If the agency fails to meet that standard, it will then be required to choose between the first three options for the next six-month period.

VII.   Recommendations:

For those agencies in one of the states selected for the demonstration, the selection of an option – whether initial or subsequent – will require some thought and analysis.  For example, Option 1 could well affect agency’s cash flow depending upon its ability to submit quickly the necessary documentation in a manner that clearly demonstrates coverage.  While CMS has suggested that the MAC will make every effort to review and make pre-claim determinations within 10 days of the first submission and within 20 days of subsequent submissions for the same claims, the continued ability of the MAC to meet these time frames will also have an impact upon cash flow.

In contrast, Option #2 will subject the agency to complex review of every claim that it submits and as those agencies that have been through the appeals process understand, the backlog of appeals has caused a substantial delay in resolution no matter how worthy the appeal on its merits.  Thus, unlike the pre-claim review process, the agency may not have the opportunity to correct its documentation and correct errors for a substantial period.

Option #3 guarantees a 25% payment reduction for all claims, while Option #4 will result in the selection of what the government may argue is a statistically valid random sample for purposes of any subsequent denials.

Under these circumstances, several things are clear.  Now more than ever, agencies in these states must have procedures in place to properly document coverage for all cases that they handle, and also a form and process to be able to support coverage and simplify the process for the MAC to come to that determination quickly and without the need for appeal or multiple submissions, depending upon the option chosen.

Liles Parker attorneys have substantial experience in working with agencies in the enrollment process for Medicare certification.  Additionally, a number of our attorneys are also certified coders and have substantial experience in developing a format to justify coverage of claims.

Any person wishing a free consultation in either area should contact the author and Co-chair of our Health Care Group, Michael Cook.  Michael can be reached at (202) 298-8750 or mcook@lilesparker.com.

[1] https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/MedicareProviderSupEnroll/ProviderEnrollmentMoratorium.html. 

Michael Cook is Moderating a panel of State Medicaid Directors

Michael Cook will be moderating a panel of State Medicaid Directors and Deputies on “The Future of the Medicaid Program in Long Term Care – A Panel of State Government Experts” at the American Health Lawyers Association Symposium on Long Term Care.  The Symposium will be held in Phoenix, Arizona from February 27 – March 1, 2019, and in addition to Michael, the panel will include the Directors of the State Medicaid programs from Virginia, Washington state and Arizona.

Michael has practiced as a health care lawyer for more than 35 years.  During that time, he has represented hospitals, nursing homes, long term care facilities, home health agencies, physicians, and a wide variety of other licensed health care professionals.  Prior to joining Liles Parker, Michael worked at several large, nationally-recognized law firms.  He current serves as Practice Leader for Liles Parker’s health care practice and serves as a mentor and trainer for several of Liles Parker’s younger staff attorneys.  Notably, Michael has worked as both legal counsel for the U.S. Department of Health and Human Services (HHS) and as a Special Assistant U.S. Attorney (SAUSA) in the Northern District of Illinois.   Michael is well known in health law circles and is regularly sought-out to speak at national and regional conferences.  His knowledge of State Medicaid issues is extensive and he has represented health care providers around the country in numerous complex Medicaid hearings, audits and investigations.   

For more information or for assistance with a Medicaid audit or investigation, give Michael a call.  For a free consultation, call: 1 (800) 475-1906.

DMAS Volunteers at the Wise County Free Clinic

(August 14, 2018): On the weekend of July 20 – 22, I joined a number of people from the Virginia Department of Medical Assistance Services (DMAS) in traveling to Wise County Virginia to volunteer for the annual free clinic that is offered in that County.  Our group was led by the Director of DMAS, Jennifer Lee, MD, who is trained as and ER physician.  As background, DMAS is the State agency that administers the Medicaid program in Virginia, and I was appointed several years ago by Governor McAuliffe to the Board that advises DMAS.

The Wise County free clinic offers a once a year opportunity for people in Wise and surrounding counties and states to obtain free medical, dental, vision care, PT and radiology, as well as to receive free food and clothing.  The clinic is held outside in a Fair Ground, although certain dental services, such as dentures, were provided at another proximate offsite location, and resembles what I would imagine a MASH unit, to look like.

A significant number of dentists and dental students and medical and medical students were perhaps the most important volunteers.  In the past, Ralph Northam, Virginia’s current Governor and a pediatric neurologist, has also volunteered and this year visited clinic.  The remainder of us volunteered in such capacities as “runners” – individuals who make sure that patients are appropriately moved through the process and also to assist in delivering the free food to patients who are awaiting services and do not wish to lose their place in the cue, staff to make corrective lenses and fit them into optical frames that are offered on that date, preparation and delivery of snack and meals to people at the clinic and volunteers, and frankly, anything else that the clinic needs.

As a volunteer, I had the opportunity, not only to assist, but also to meet a number of people who were having multiple dental and medical needs attended.  These people by and large had many needs but also a stoicism and gratitude for the assistance that they were receiving that was both heart-warming and tragic.  I cannot tell you the number of people who I escorted to the dental tent who were facing the need to extract all of their remaining teeth.  It is a tragedy that a country such as ours should never allow to occur.

There is a real silver lining here.  The Virginia legislature recently voted to expand the Medicaid program effective January 1, 2019.  Virginia’s Medicaid program does not cover adult dental care, and many medical needs are related to the lack of adequate dental care.  However, there is hope that the expansion will enable a number of folks who have needed to rely on the Wise County free clinic, and thus avoid waiting at least a year (and sometimes many years since the clinic cannot serve everyone who presents), to receive medical care on a regular basis throughout the year.

The importance of the expansion to these folks is best demonstrated by the fact that as part of service that weekend, the DMAS contingent also offered outreach to alert the attendees of the advent of the expansion on January 1.  The receptiveness of the patients can only be described as overwhelming.

I was privileged to join a group of committed individuals from DMAS who gave up their weekend and traveled at their own expense to assist.  I was even more privileged to be able participate and assist in the delivery of care to so many needy folks.  I can only hope that at some point in my life time, this becomes obsolete and that routine medical and dental care becomes accessible for everyone.

Michael Cook is a Partner and Co-chair of the Health Care Practice Group at Liles Parker PLLC.  Mr. Cook has extensive experience in representing providers and suppliers of all types, including home and personal, and home health, agencies in regulatory, compliance, policy, and business matters throughout the country.  Mr. Cook also serves on the Board of the agency that advises Virginia’s Medicaid program. Anyone interested in discussing the DMAS program discussed in this article should contact Michael Cook at 202-298-8750 or mcook@lilesparker.com

CMS has Confirmed the Coverage of Personal Care Services by Medicare Advantage Plans Starting 2019

(June 26, 2018):  The coverage of personal care services by Medicare has been advocated by advocacy groups for many years.  As we reported last April, the Centers for Medicare and Medicaid Services (CMS) announced in its Final Call Letter for bids from plans that participate in the Medicare Advantage program (MA) for 2019.  In that Bid Letter, CMS announced that MA plans would be permitted to cover as supplemental benefits, certain types of health-related services even if the primary purpose of those services is daily maintenance.  Previously, CMS had considered an item or service to be primarily health related “…if the primary purpose of the service is to prevent, cure or diminish an illness or injury,” but not if the primary purpose is simply daily maintenance. As I noted in that article, that will change beginning in 2019.

I.  CMS Has Confirmed the Coverage of Personal Care Services by Medicare Advantage Plans in 2019:

At the time that I wrote that article, we posited that it was likely, but not made clear, that plans would be able to cover personal care services under the revised standards for supplemental benefits.  However, that appears to have now been confirmed that the new definition covers these services. In a speech that she made in May of this year at a conference presented at CMS Headquarters, Seema Verma, the Administrator of CMS stated:

“For the first time ever, Medicare Advantage beneficiaries can access significant new flexibility for additional benefits that can help them live healthier, more independent lives. [MA] plans can offer benefits [beginning in 2019] that compensate for physical impairments, diminish the impact of injuries or health conditions, or reduced avoidable emergency room utilization.  This means Medicare Advantage beneficiaries will be provided adult day care services, respite care for caregivers, and in-home assistance with activities like bathing and managing medications.  Additionally, Medicare Advantage beneficiaries will have access to safety devices to better prevent injury in the home ….”[1]

Also at the conference, two CMS employees made a presentation the slide deck for which listed as examples of supplemental benefits that plans will now be able to cover in 2019, “Adult Day Care Services, Home-Based Palliative Care, In-Home Support Services, Transportation for Non-Emergent Medical Services, and Home & Bathroom Safety Devices and Modifications.”  That same slide deck describes the type of In-Home Support Services that MA plans will be able to cover as:

“In-home support services performed by a personal care attendant or by another individual that is providing these services consistent with state requirements in order to assist individuals with disabilities and/or medical conditions with performing ADLs and IADLs as necessary to compensate for physical impairments, ameliorate the functional/psychological impact of or health conditions, or reduce avoidable emergency and healthcare utilization.  Services must be performed by individuals licensed by the state to provide personal care services, or in a manner that is otherwise consistent with state requirements.[2]

Thus, it is clear that MA plans will now be authorized to cover personal care services in the home beginning in January 2019, if they so choose.  The slide show presentation also specifies as requirements that the services: (a) must be medically appropriate; (b) must focus directly on an enrollee’s health care needs; (c) must be recommended by a physician or licensed medical professional as part of a care plan if not directly provided by one; must not be used primarily for comfort, general use, or other non-medical reasons; and (d) must not include items or services used to induce enrollment.[3]

II. NEXT STEPS FOR YOUR AGENCY:

Agencies and other providers that wish to provide these services to plan beneficiaries in 2019 should already have been speaking with the appropriate people at the MA plans that provide coverage in their service areas about covering these services in 2019, and should be speaking with the plans regarding their interest and requirements for becoming participating providers of these services.  If the plans are not covering these services in 2019, these agencies should be developing and presenting data that demonstrate cost-effectiveness of these programs, e.g.in preventing or reducing ER and hospital utilization, in order to convince the plans to cover these services in 2020 and thereafter.

Additionally, as I pointed out in our April article on the topic, the Bipartisan Budget Act of 2018 expands even further the supplemental benefits that MA plans may provide in 2020 and thereafter, to cover services that address certain social determinants that we now are discovering to be related to health.  Agencies should be tracking the progress of implementation of this provision as CMS begins to provide additional guidance on implementation, and also should begin speaking with their MA plans and developing data that support coverage of certain of these services that they wish to provide.

Finally, MA plans will expect providers of home and personal care that wish to be participating providers to have developed and implemented an effective compliance plan.  This will be especially critical given some of the compliance issues that have arisen in the past, of which they almost certainly will be aware.  In this regard, MA plans will almost certainly require that providers have a system for tracking their aides, which will also be required under state Medicaid programs in the future.

III. CONCLUSION:

This article should be read in conjunction with the April article which goes into a bit more depth on the issues in the prior section.  CMS has now confirmed that MA plans will be afforded the opportunity to cover home and personal care services beginning in 2019.  Michael Cook and other Liles Parker attorneys have extensive experience in assisting clients throughout the health care industry, including home and personal care and home health agencies, in responding to new government and payor initiatives, and in establishing and maintaining an effective compliance program.  Anyone seeking a copy of either the speech by Seema Verma or the slide deck should contact Michael at the contact information provided, below.

Michael Cook is a Partner and Co-chair of the Health Care Group at Liles Parker PLLC.  Mr. Cook has extensive experience in representing providers and suppliers of all types, including home and personal, and home health, agencies in regulatory, compliance, policy, and business matters throughout the country.  Mr. Cook also serves on the Board of the agency that advises Virginia’s Medicaid program. Anyone interested in discussing the material presented in this article should contact Michael Cook at 202-298-8750 or mcook@lilesparker.com.  

[1] Speech: Remarks by Administrator Seema Verma at the Medicare Advantage and Prescription Drug Plan Spring Conference (As prepared for delivery – May 9, 2018).

[2] Slide deck, Medicare Advantage Benefit Flexibility (Supplemental Benefits and Uniformity) presented by Heather Kilbourne, Division of Policy, Analysis, and Planning, Medicare Drug and Health Plan Contract Administration Group, Center for Medicare, CMS and Brandy Alston, Division of Policy, Analysis, and Planning, Medicare Drug and Health Plan Contract Administration Group, Center for Medicare, CMS.

[3] Id.  These requirements should not present a burden to home care agencies that participate in Medicaid given that many, if not all, states place similar requirements on personal or home care providers under that program.

Medicare Advantage Plans May Soon Offer Personal Care Services

(April 10, 2018):  On April 2, the Centers for Medicare and Medicaid Services (CMS) announced an expansion of the benefits that private health plans may offer Medicare beneficiaries under the Medicare Advantage (MA) program in 2019.  In its Final Call Letter for bids from plans that participate in the MA program (“MA plans”) for 2019, CMS expanded the services that plans would be permitted to offer in 2019 as supplemental health related benefits, even if the primary purpose of those benefits includes daily maintenance.  While these benefits are not required to be included in MA plans, plans are provided the latitude to include them if they choose and may very well change the reimbursement landscape for personal care agencies around the country.

I.  Background:

As background, MA Plans are permitted to offer certain benefits that are not included as part of the Medicare fee for service, or Original Medicare, benefits, if those benefits are, among other things, primarily health related.  As discussed in the Final Call Letter, CMS considers an item or service to be primarily health related “…if the primary purpose of the item or service is to prevent, cure, or diminish an illness or injury.”  However, CMS previously has not considered a service to fit within this category if the primary purpose is daily maintenance.

II.  Expansion of Coverage for Personal Care Services:

In the Final Call Letter, CMS recognizes that there is value in certain services that “diminish the impact of injuries or health related conditions and reduce avoidable emergency and health care utilization.”  The Letter does not specify the benefits that would fall under this rubric, but includes as an example, fall prevention devices for individuals at risk high risk for falling and similar products that protect against injury resulting from falls.  The Letter further states that services that diminish the impact of injuries and health conditions and reduce avoidable utilization can be included as supplemental benefits under certain circumstances, “even if a significant purpose of the item is daily maintenance.”

As further described in the Letter, “[u]nder the new interpretation, in order … to be ‘primarily health related’ … [an item] must diagnose, prevent, or treat an illness or injury, compensate for physical impairments, act to ameliorate the functional/psychosocial impact of injuries or health conditions, or reduce avoidable emergency and healthcare utilization.”  The intent is to provide plans with the flexibility to offer supplemental benefits that can enhance quality of life and improve health outcomes.

The service must, however, be medically appropriate, recommended by a licensed provider as part of a plan of care, and cannot include items or services that are solely to induce enrollment.  The Letter also indicates that CMS will be issuing more detailed guidance in the future.

As noted, above, while not entirely clear, it is quite possible that MA plans will be permitted to cover personal care services under the revised standards for supplemental benefits.  Indeed, in a press release issued by CMS announcing a draft of the Bid Letter for comment in early February, CMS described the proposal as allowing supplemental benefits to “include services that increase health and improve quality of life, including coverage of non-skilled in-home supports, portable wheel chair ramps and other assistive devices and modifications when patients need them.” (Emphasis supplied.)  While neither the press release accompanying the Final Bid Letter nor the Letter, itself, includes any language specifically referencing these items, the broader language of the Final Letter can certainly be read to permit plans to offer personal care services under certain circumstances.

III.  What Steps Should Your Personal Care Agency Take?

So what can a provider that wishes to offer these services, including personal care services, as part of an MA plan for 2019, do at this point?  First, providers can be watchful for additional guidance from CMS that should be forthcoming.  Second, they can begin to approach the MA plans that cover a significant number of MA subscribers in their service area to discuss both including these items or services as supplemental benefits in the plans’ upcoming bids to CMS for the 2019 year, and to discuss pricing.   In doing so, providers should be prepared with data or other information demonstrating that offering the service will reduce costs without harming patients.  For example, a provider that wished to offer personal home care services would attempt to prepare a cost benefit analysis showing that home visits reduce the incidence for hospital admissions or admissions to skilled nursing facilities. Additionally, if the MA plan is also a provider of Medicaid managed care services, the provider may also include in the analysis the cost/benefit of lowering admissions to the nursing facility long stay side of the equation.  There are other permutations to the analysis, but the key is to begin discussions with the various plans, and to accumulate data that demonstrate both the short term and long-term cost and health benefits of the particular service.

Providers that wish to take advantage of this opportunity should also note that the Bipartisan Budget Act of 2018 expands supplemental benefits for chronically ill enrollees to also encompass benefits that are not primarily health related in certain circumstances beginning in 2020.  This change recognizes the importance of certain social determinants to health status – something that some state Medicaid programs are beginning to recognize as well.  However, this change only affects “chronically ill” beneficiaries and does not begin until 2020, whereas the expanded definition of supplemental benefits in the Bid Letter affects services provided to all MA beneficiaries and begins in 2019.  Additionally, the Final Bid Letter notes that the expanded definition of supplemental benefits in that Letter requires that the benefit address specific illnesses and/or injuries, and reiterates that it will be issuing further guidance on both expansion options in the future.

We would also note that all MA plans are required to have compliance programs in place that meet the seven elements of an effective program.  Under this program, they are also responsible for providing certain training for providers under their programs, as well as for the compliance of those providers.  While Liles Parker attorneys, and in fact, virtually all knowledgeable health care attorneys, have long counseled their clients on the importance of establishing and maintaining effective compliance programs, and while some segments of the industry are required to maintain such programs by law, any entity that wishes to contract with MA plans to provide health care related services almost certainly will be required by the plan to maintain a compliance program.  Thus, any entity that wishes to take advantage of the expanded coverage of services under the Final Bid Letter should be prepared to demonstrate that it has an effective compliance program.

With respect to providers of personal care services, there are a number of areas of vulnerability.  One major such area is ensuring that aides actually perform the services for which a program is billed.  Several years ago, there were a number of investigations and prosecutions where aides were alleged to have colluded with clients to defraud the Medicaid program by failing to provide the service for which the aides were paid, and paying the client a portion of the payments.  There are mechanisms to monitor this type of activity; however, it is a major risk area for home care agencies and should be addressed in any compliance program.

IV.  Conclusion:

In short, the Final Bid Letter for 2019 presents the possibility of expanding the services that certain MA plans will cover, including the possibility of covering personal care services.  However, providers that wish to contract with MA plans for these services should be taking the actions described, above. Liles Parker attorneys have extensive experience in assisting clients throughout the health care industry, including home care and home health, in responding to new government and payor initiatives, including establishing and maintaining an effective compliance program.

Michael Cook, J.D., is a Partner at the firm Liles Parker, Attorneys & Counselors at Law.  Mr. Cook represents nursing home, assisted living, home health and personal care clients in regulatory matters.  Anyone interested in discussing the material discussed in this article should feel free to contact Michael Cook at 202-298-8750 or mcook@lilesparker.com.       

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