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Until We Meet Again: What You Need to Do in the Next Year
NCPA Multiple Locations Conference
Ronna B. Hauser, PharmD, NCPA vice president of policy and government affairs operations
2020 Checklist for Community Pharmacists
• 2020 and beyond!
• April 21-22, 2020: Attend NCPA’s 2020 Congressional Pharmacy Fly-In
• NCPA’s 2020 Congressional Pharmacy Fly-In
• By June 30, 2020: U.S. Supreme Court to decide Rutledge v. PCMA
• Invest in NCPA’s Legislative/Legal Defense Fund
New Opioid Policies for Medicare Part D
• SUPPORT Act Part D requirements• Jan. 1, 2020 Suspension of payments for fraud • Jan. 1, 2021 Mandated EPCS for Part D• Jan. 1, 2021 Required ePA for Part D drugs • Jan. 1, 2021 Expanded eligibility for MTM
programs in Part D• Jan. 1, 2022 Required drug management programs
(prescriber and/or pharmacy lock-ins) in Part D • For more information, check out NCPA’s summary:
http://www.ncpa.co/pdf/ncpa-member-summary-hr6.pdf
More Medicare Part D Changes
• Jan. 1, 2021 Real Time Benefit Tool (“RTBT”): Requires plan sponsors to implement an electronic RTBT that integrates prescribers’ e-prescribing and electronic medical records.
• Jan. 1, 2021 Explanation of Benefits: Requires the inclusion of negotiated drug pricing information and lower cost alternatives in Part D EOBs.
• For more information, please see: http://www.ncpa.co/pdf/drug-price-transparency-final-rule-summary.pdf.
DMEPOS Gap Period
• Jan. 1, 2019 until Dec. 31, 2020: Temporary gap period in the entire DMEPOS CBP and National Mail Order CBP
• “During that time, Medicare beneficiaries will continue to receive DMEPOS items from any Medicare-enrolled DMEPOS supplier.”
• “During the DMEPOS CBP stop gap period any enrolled supplier may furnish items, including pharmacies. Please note, no auto shipping on diabetic testing supplies, and they must be requested by the beneficiary. For additional guidance please refer to Chap 3 of the DME Supplier Manual or contact your local Medicare Administrative Contractor…”
Compliance with “Track and Trace” Law
• Phase I Requirements:• Authorized trading partner• Specific patient need• SOPs for suspect and illegitimate product investigations• Transaction data
• Phase II Requirements:• Nov. 27, 2018: Serialized product now coming from manufacturers• Nov. 27, 2019: Verification of saleable returns
• FDA enforcement discretion delays this to Nov. 27, 2020 (NCPA ask)• Nov. 27, 2020: Pharmacies can only accept serialized product
Helpful “Track and Trace” Law Tools
• NCPA Resources:• https://www.ncpanet.org/newsroom/details/2020/01/03/here's-a-list-of-helpful-
links-for-dscsa-compliance-issues • https://www.ncpanet.org/newsroom/details/2019/11/18/ncpa-member-benefit-
helps-with-dscsa-compliance
• “Utilize DSCSA requirements to protect your patients” presentation: https://www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/DrugSupplyChainSecurityAct/ucm606945.htm
• FDA Guidances: https://www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/DrugSupplyChainSecurityAct/ucm424963.htm
• FDA one-pager: https://www.fda.gov/downloads/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/DrugSupplyChainSecurityAct/UCM607076.pdf
Compounding
• Jan. 21-22, 2020 Hearing: USP <795> and <797> • Delays still pending • FAQ on Compounding Appeals
• Dec. 1, 2019 USP <800> (hazardous drugs) Implementation• “Compendially applicable”: only those held to <795> and <797>
are held to <800>• Verify with your State Board of Pharmacy
• USP <800> Resources• NCPA’s risk assessment template to help you create your own &
College of Psychiatric and Neurologic Pharmacists’ detailed USP <800> compliance toolkit:
• https://www.ncpanet.org/newsroom/details/2019/11/25/ncpa-has-tools-to-help-you-with-usp-800-implementation
Hazardous Waste Handling
• Even if your state has not yet adopted USP 800, be aware of the following guidances/rules that address hazardous drugs:
• EPA Final Hazardous Waste Rule• Food and Drug Administration (FDA) Draft Insanitary Conditions
Guidance• Occupational Safety and Health Administration (OSHA) Hazardous
Waste Standards
• Effective Aug. 21, 2019 EPA’s Final Rule on Management Standards for Hazardous Waste Pharmaceuticals
Hazardous Waste Handling
• EPA Final Rule:• Outlines what products are considered solid waste and thus subject to EPA’s
streamlined regulations.• Requires healthcare facilities (including pharmacies) to determine what are
hazardous or non-hazardous waste pharmaceuticals and whether this waste is potentially creditable or non-creditable at their pharmacy prior to sending the pharmaceutical to a reverse distributor.
• Haz Waste Resources:• http://www.ncpa.co/pdf/ncpa-summary-epa-haz.pdf• Food and Drug Administration’s (FDA) Draft Insanitary Conditions Guidance• Occupational Safety and Health Administration’s (OSHA) Hazardous Waste
Standards
Help Protect Your Business!!• Visit the NCPA Legislative Action Center for action alerts and
locating your elected officials.• Sponsor a Pharmacy Visit NCPA members can find additional tips
in the grassroots toolkit.• Meet With Your Elected Officials Find your elected official here. • Local Media NCPA members have access to sample media
materials, such as letters to the editor and news releases, which can be personalized for submission to local news outlets.
NCPA Advocacy Center Online
For more information on NCPA’s legislative priorities and advocacy resources visit our webpage at www.ncpanet.org/advocacy
Thank You!Questions?
Ronna B. Hauser, PharmDNCPA VP Policy & Government Affairs
Operations [email protected]
703-838-2691Twitter: @ronnasb
Take 5!Point-of-care Testing
NCPA Multiple Locations Conference
Shane Clarambeau, RPh Pharmacist, Owner/CEO
Shane’s Pharmacy
Point-of-care Testing
• Defined as medical diagnostic testing at or near the point of care – that is, at the time and place of patient care.
~ Efficiency ~ Speed of diagnosis and treatment~ Portable devices~ Improved patient outcomes
ADVANTAGES OF POINT-OF-CARE TESTING
Take 5!Adding Online Credit Card Payments
NCPA Multiple Locations Conference
Darrin Silbaugh, RPhHarrisburg Pharmacy
Vaping
Payday loans
Gambling
Gentleman’s clubs
Firearms
Pharmacy
Pawn Shops
Fantasy Sports
+ InternetPharmacy = Internet Pharmacy!
Sounds Simple
Challenges
• Fees, Multi-locations
• Posting
• Tabs, Emails, and Reports
Get in the game
Challenges
• Fees, Multi-locations
• Posting
• Tabs, Emails, and Reports
Opportunities
• Cash is King
• Cash FLOW is King
• Amount of time to set up
• Pay your bill
• Pay for item
• Establish a history
• E-Commerce
Medical-at-HomeA New Model for Aging in Place
2020 Multiple Locations Conference
Christopher Mangione President, GeriMed
Describe the medical at home population and associated pharmacy services.
Identify the pharmacy services required to qualify your pharmacy to provide medical at home prescriptions as long-term care prescriptions.
Describe methodologies implemented by NCPDP and CMS to identify these patients and how to process claims for prescriptions dispensed for medical at home patients.
What methods exist to distinguish between convenience packaging and compliance packaging for medical at home patients in the LTC space.
What we will cover today
LTC Provider Markets
• Group/Personal Care Homes
• Hospice
• Chronic Psychiatric Facilities/Drug/Alcohol Inpatient Rehabilitation Facilities
• Correctional Facilities
• Medical at Home
• Skilled Nursing Facilities (nursing homes)
• Assisted Living• Developmentally Disabled Group
HomesICF-MR (intermediate care mentally retarded) ICF-IID (intermediate care for intellectually developmentally disable)
CMS Performance and Service Criteria for Network LTC Pharmacies (NLTCPs)
Comprehensive Inventory and Inventory Capacity
Pharmacy Operations and Prescription Orders
Special Packaging
IV Medications
Compounding/Alternative Forms ofDrug Composition
Pharmacist On-Call Service
Delivery Service
Emergency Boxes
Emergency Log Books
Miscellaneous Reports, Forms, and Prescription Ordering Supplies
2023Born 1943
80 yoa
2040Born 1960
80 yoa
2018Born 1938
80 yoa
US Population > 80 Years of Age
Top Diseases Treated by LTC
• Alzheimer’s disease/Other dementias• Arthritis• Chronic Kidney Disease• COPD• Depression• Diabetes• Heart Disease• Hypertension• Osteoporosis
NCHS, “Long-term Care Providers and Services Users in the United States: 2015-2016, “ Figure 24
Packaging Is Very Important for Adherence
Assisted Living Acuity
Currently 28,900 assisted living and other residential care facilities (group homes, personal care, etc.) According to NCAL (National Center for Assisted Living) in 2019 there are 996,100 total licensed beds and growing annually. Average number of licensed beds is 33 per facility.
Typical Services Healthcare services
• 24 hour supervision and assistance 83.6% Pharmacy Services
• Exercise, health and wellness programs 82.8% Dietary and Nutrition
• Housekeeping and maintenance 71.4% Therapy (Physical, Occupational, etc)
• Meals and dining service 67.7% Hospice
• Medication management or assistance 66.1% Skilled Nursing
• Personal care services 55.0% Mental health or counseling
51.1% Social Work
• Transportation
National Center for Health Statistics. Long –Term care providers and services users in the United States: Data from the National Study of Long-Term Care Providers. 2015-2016
(such as Activities of Daily Living [ADLs])
Many elderly patients steadfastly resist the nursing home environment and instead remain in the familiarity of there home under the care supervision of an agency or in many cases a family member.
Many of the candidates for traditional, recognizable nursing home care are remaining in their homes. The elderly population is growing as the Baby Boomers age into Medicare.
While the government is working on waiver and independence projects for these elderly community dwelling to remain at home, these programs currently only represent a portion of the elderly requiring care.
The Face of Long-term Care is Changing
46
Medical at home is a population of community dwelling adults and children having functional and/or medical impairments that prevent them from leaving their homes independently*
What is being recognized is the expansion of an elderly population within the LTC segment that desires to remain in their homes as evidenced by the following:
**2019 CDC LTC statistics showing flat SNF population growth in an environment where 10,000 people per day age into the Medicare pool
***Increasing acuity in Assisted Living Facilities as a result of longer stays in the community setting (home)
*Ornstein KA, Leff B, Covinsky KE, Ritchie CS, Federman AD, Roberts L, Kelley AS, Siu AL, Szanton SL. (2015). Epidemiology ofthe Homebound Population in the United States. JAMA Intern Med. 175(7): 1180-1186. PMCID: PMC4749137
**National Center for Health Statistics. Long –Term care providers and services users in the United States: Data from the National Study of Long-Term Care Providers. 2015-2016
***Best Practices for Managing Acuity Creep in Assisted Living, American Health Lawyers Association-Long Term Care and the Law, New Orleans, Louisiana February 23-25, 2015
Pharmacy Affiliation and Medical at Home Patients
in the Care Continuum• Home Health Care 4,455,700 (growing)• Hospice 1,426,723 (growing) • Nursing Home 1,347,600 (no growth)• Adult Day Care 286,300 (growing)• Residential Care 811,500 (growing)
The latest *CDC demographic information, as published biennially as the National Study of Long-Term Care Providers, shows Home Health Agency pharmacy service representation to be the smallest as a percentage of that segment but having 54% of the population as a whole. Note that Medical at Home is a subset of the Home Health Care Population
NOTES: Pharmacy services refer to the filling and delivery of prescriptions. See Appendix II for definitions of the provision of pharmacy services for each sector. See the Appendix I Technical Notes for an explanation of differences in how serviceAs were measured in 2012, 2014, and 2016. The available administrative data did not have information on whether or not hospices provided pharmacy or pharmacist services. Percentages are based on unrounded estimates. SOURCE: NCHS, “Long-term Care Providers and Services Users in the United States: 2015–2016,” Figure 16.
The fastest growing segment of long-term care is Medical at Home, consisting of
an underserved population in excess of
The Medical at Home Patient is defined as community dwelling adults or children having functional and/or medical impairments that prevent them from leaving there homes independently.
Where the Medical at Home Populations are Found
Family member or Agency refers patient that qualifies for LTC level of care and lives at home (see definition)
Primary care physician refers patient to pharmacy (multiple medications and disease states) and that patient qualifies for LTC level of care and lives at home (see definition)
Patient receiving care under the States’ Home Community-Based Services (HCBS) waiver §1915(c) or 1115
Patient participates in a CMS Independence at Home Demonstration Project
Patient participates in a Managed Medicaid program in your state (dual eligible beneficiary)
*National Center for Health Statistics. Long-Term care providers and services users in the United States: Data from the National Study of Long-Term Care Providers. 2015-2016
Medical at Home is Long-Term CareEmulating the requirements from CMS for the LTC pharmacy network, the grid below compares
the services required for pharmacies servicing the Medical at Home population
= always provided
= provided as needed
= not provided
* https://www.cms.gov/Medicare/Prescription-Drug-Coverage/PrescriptionDrugCovContra/Downloads/MemoPDBManualChapter5_093011.pdf accessed via internet 6/16/19
Community
LTC
Mail Order
Medical at Home
Prescription Fulfillment
Door-to-Door Delivery Network
Specialized Packaging
24/7Emergency Coverage IV Services E-Kits
How do you determine if you can service these patients as an LTC Pharmacy?
• *Ten (10) services required by CMS for Medicare Part D LTC qualification – including compliance packaging, 24/7 service – Does your pharmacy have the capacity to do these services?
• Can the patient go to the drug store and get medications and take them appropriately themselves? Or can you walk into a community pharmacy and get the services offered by this pharmacy as a regular patient? Is the answer no – patient should qualify
• Is the patient responsible for their own medication administration or is a caregiver administering it? Caregiver – patient should qualify
• These patients cannot be supported by a mail order service due to unique compliance packaging and clinical needs – Traditional mail order is bulk 90 day bottles
https://www.cms.gov/Medicare/Prescription-Drug-Coverage/PrescriptionDrugCovContra/Downloads/MemoPDBManualChapter5_093011.pdf(CMS Prescription Drug Manual Chapter 5 Benefits and Beneficiary Protections 9/30/2011)
Example of Attestation
Why Medical at Home Pharmacy Services are
Important• Adherence• Compliance• Decrease admission to hospitals and
emergency rooms• Decrease admission to nursing homes and
assisted living facilities• Better quality of life• Less expensive health care costs for
complex chronic care patients
Percentage of long-term care services users with overnight hospital stays, emergency department visits, and falls, by sector:
United States, 2015 and 2016
- - Data not available.
NOTES: Denominators used to calculate percentages for adult day services centers, nursing homes, and residential care communities were the number of participants enrolled in adult day services centers, the number of residents in nursing homes, and the number of residents in residential care communities on a given day in 2016, respectively. The denominator used to calculate the percentage for home health agencies was the number of patients whose episode of care ended at any time in 2015. For adult day services centers and residential care communities, adverse events refer to the 90 days prior to the survey. For home health agencies, adverse events refer to a period since the last Outcome and Assessment Information Set. For nursing homes, falls refer to the period since admission or since the prior assessment, whichever is more recent. For hospices, data were not available for overnight hospital stays, emergency department visits, or falls. See the Appendix I Technical Notes for more information on the data sources used for each sector. See Appendix II for definitions of each adverse event used for each sector. Percentages are based on unrounded estimates.
SOURCE: NCHS, “Long-term Care Providers and Services Users in the United States: 2015–2016,” Figure 26.
Definition from Medicare Part D Manual Chapter 13 –Premium and Cost Sharing Subsidies for Low Income Beneficiaries
Individual Receiving Home and Community-Based Services: A full-benefit dual eligible individual who is receiving services under a home and community-based waiver authorized for a State under section 1115 or subsection (c) or (d) of section 1915 of the Social Security Act or under a State plan amendment under subsection (i) of such section or if such services are provided through enrollment in a Medicaid managed care organization with a contract under section 1903(m) or under section 1932 of the Social Security Act
Definition from Medicare Part D Manual Chapter 13 –Premium and Cost Sharing Subsidies for Low Income Beneficiaries (cont.)
60.2.2 - Individuals Receiving HCBS (Rev. 13, Issued: 07-29-11, Effective Date: 01-01-11; Implementation Date: 01-01-11) The Affordable Care Act extended the elimination of cost sharing to individuals who would be an institutionalized individual (or couple) as described in 60.2.1 of this chapter, if the full benefit dual eligible individual was not receiving HCBS under title XIX of the Act. The effective date of this change will be no earlier than January 1, 2012. Plans will receive an indicator of “3” to the institutional indicator on the daily TRR when a beneficiary begins receiving HCBS under Medicaid.
58
NCPDP adds Level of Service to External Code List (ECL)
• NCPDP added a new Level of Service code to support pharmacies providing special services to medical at home patients
• Level of Service = “07” for Medical at Home with special pharmacy services identical to Long Term Care beneficiaries with the exception of emergency kits
• Available in the 10/17 ECL list from NCPDP
• PBMs have to agree to adding this designation and any changes in contract payments for this new Level of Service
• PBMs today pay at retail rates for patients serviced in their homes
Transition of Care Program
• Discharge patients from hospitals, nursing homes, assisted living need assistance with reconciliation and ensuring they receive their medications in a timely manner
• Billing for nursing home patient residence code “03” ends on the day of discharge from the facility
• Medical at Home Pharmacy Services may be a service that LTC pharmacies can continue to provide to patients that may continue to need medication assistance and other medical needs at home
Other Services Pharmacies
Should Offer to Medical at Home
Patients
• Medication Reconciliation• Synchronization of Medications• Medication Management including
communication with patients, caregivers, and prescribers
• Medication Therapy Management Reviews
• Medication in home visits
Legal Considerations for Physician Collaboration
Multiple Locations Conference
Jeffrey S. Baird, Esq.Chairman, Health Care Group, Brown & Fortunato, P.C.
Introduction
Introduction
• There are two overriding reasons for a pharmacy desiring to collaborate with physician.
• Coordination of Care• Historically, health care remuneration has been based on the fee-
for-service (“FFS”) model.• Under the FFS model, providers are paid for the services and
products they provide … regardless of patient outcome.• Under this model, there is little coordination among the providers
treating the same patient.• The FFS model has proven to be expensive and inefficient.• As such, third party payors (“TPPs”) are pushing providers into the
collaborative care (“CC”) model.
Introduction
• Coordination of Care (cont.)• Under the CC model, providers are expected to coordinate with
each other with the goal of healing the patient … and keeping the patient healthy.
• Therefore, pharmacies, physicians and other providers are motivated to work with each other.
Introduction
• Generate referrals• Physicians are important referral sources for pharmacies• If a physician knows the pharmacy and is confident in the
pharmacy’s abilities to service patients, then it is likely that the physician will refer patients to the pharmacy.
• However, if the collaborative relationship results in remuneration (“anything of value”) to the physician, then federal and state anti-fraud laws are implicated.
• As such, it is important that collaborative relationships fall within exceptions or “safe harbors” to the anti-fraud laws.
• Note that most of the legal guidelines contained in these slides also apply to Nurse Practitioners and Physician Assistants.
Anti-Fraud Laws
Federal Anti-Kickback Statute
• The federal anti-kickback statute (“AKS”) prohibits a pharmacy from giving “anything of value” to a physician in exchange for the physician (i) referring federal health care program (“FHP”) patients to the pharmacy, (ii) arranging for the referral of FHP patients to the pharmacy, or (iii) recommending the purchase of a service or product from the pharmacy that is covered by an FHP. The term “anything of value” is quite broad and includes (i) payment of money, (ii) payment of expenses, and (iii) providing gifts.
Federal Anti-Kickback Statute
• A violation of the AKS is a criminal offense. But there are a number of “safe harbors” to the AKS. If an arrangement falls within a safe harbor, then as a matter of law, the AKS is not violated. If an arrangement does not fall within a safe harbor, that does not necessarily mean the AKS is violated; rather, it means that a thorough examination of the arrangement will need to be made under the wording of the AKS, court decisions, and other published legal guidance.
Federal Stark Physician Self-Referral Statute
• The federal Stark physician self-referral statute (“Stark”) prohibits a physician from referring Medicare and Medicaid patients, for designated health services (“DHS”), to a pharmacy with which the physician (or an immediate family member of the physician) has a financial relationship … unless the financial relationship fits within a Stark exception.
• The term “financial relationship” includes (i) an ownership interest by the physician (or an immediate family member of the physician) in the pharmacy and/or (ii) compensation (or anything else of value) from the pharmacy to the physician (or an immediate family member of the physician).
Federal Stark Physician Self-Referral Statute
• DHS includes prescription drugs. • Violation of Stark results in civil liability. • There are a number of exceptions to Stark, including the
Non-Monetary Compensation Exception (“NMC Exception”) that allows a pharmacy to spend money each year on gifts, meals and entertainment for a physician … so long as the amount spent does not exceed a set amount. For 2020, that amount is $423.
State Anti-Fraud Laws
• In addition to federal laws, there are state laws that need to be examined. These include:
• State anti-kickback statutes - Some statutes apply only when the payor is the state Medicaid program. Other statutes apply even if the payor is a commercial insurer or a cash-paying patient.
• A number of states have physician self-referral statutes that are similar to Stark.
• Each state has a set of statutes that are specific to physicians.• Health care attorneys can fairly easily locate these state laws.
The non-attorney can obtain a basic understanding by going to Google, typing in the name of the state, and then typing in the following key words: kickback, anti-kickback, referral, fee splitting, patient brokering and/or self-referral.
Examples of Collaborative Arrangements
Clinical Study
• The pharmacy and physician can participate together in a clinical study.
• Ideally, the clinical study will be sponsored by a hospital or medical school...and will be overseen by an Institutional Review Board (“IRB”). It is important that the clinical study not be a disguised kickback scheme designed to funnel compensation to referring physicians.
• The pharmacy can use the results of the clinical study to show physicians, hospitals and third party payors (i) that the pharmacy has a sophisticated business model and (ii) that the pharmacy’s products and services are successful in treating conditions and keeping patients out of the hospital.
Medical Director
• A physician (regardless of whether or not he is a referring physician) can be a 1099 independent contractor Medical Director for the pharmacy.
• If the physician refers to the pharmacy, then the Medical Director Agreement (“MDA”) needs to comply with (i) the Personal Services and Management Contracts safe harbor to the AKS and (ii) the personal services exception to Stark.
• Among other requirements, (i) the MDA needs to be in writing, (ii) the MDA must have a term of at lease one year, (iii) the compensation must be fixed on year in advance, and (iv) the compensation must be the fair market value (“FMV”) equivalent of the physicians’ services … and cannot take into account the anticipated number of referrals from the physician to the pharmacy.
• Further, the services provided by the physician to the pharmacy must be substantive and valuable. They cannot be “made up” services.
Education Workshops
• The physician can set up times for the pharmacy to send representatives to the physician’s office to educate the physician’s employees regarding (i) products and services offered by the pharmacy and (ii) how the pharmacy’s products/services can treat specific conditions.
• The physician can set up times for the pharmacy to send representatives to the physician’s office to present workshops to the physician’s patients who have conditions that can be treated by the pharmacy’s products and services.
Sponsoring the Physician as a Speaker
• The pharmacy can pay the physician for speaking at educational workshops and dinners.
• In order to avoid problems with the AKS and Stark:• The topic presented by the physician must be substantive and
relevant to the audience.• The audience must be made up of individuals who will benefit
from what the physician has to say.• The compensation to the physician must be FMV.
Renting Space to/from a Physician
• The pharmacy can rent space from...or to...a physician.• The arrangement needs to comply with the Space Rental safe
harbor to the AKS and the space rental exception to Stark. The safe harbor and exception say the same thing. Among other requirements:
• The rental agreement must be in writing with a term of at least one year.
• The rent paid must be fixed one year in advance and be FMV.
Renting Equipment to/from a Physician
• The pharmacy can rent equipment from...or to...a physician.• The arrangement needs to comply with the Equipment Rental
safe harbor to the AKS and the equipment rental exception to Stark. The safe harbor and exception say the same thing. Among other requirements:
• The rental agreement must be in writing with a term of at least one year.
• The rent paid must be fixed one year in advance and be FMV.
Employee Liaison
• The pharmacy can place an employee liaison in the physician’s office. The liaison can be present in the physician’s office for as many...or as few...hours as the physician and pharmacy agree on.
• The employee liaison cannot perform any duties that the physician is responsible to perform. Doing so will save the physician money...which constitutes “something of value” to the physician...hence, a violation of the AKS.
Employee Liaison
• Examples of what the liaison can and cannot do are:• The liaison can educate the physician’s employees regarding the
products and services provided by the pharmacy. The liaison can do so through formal educational lunches and through informal one-on-one conversations with the physician’s employees.
• The liaison can educate the physician’s patients regarding the products and services provided by the pharmacy. The liaison can do so by presenting formal educational workshops and through informal one-on-one conversations with the physician’s patients.
• If a patient of the physician decides that he/she will use the pharmacy, then the liaison can work with the patient to transition him/her to the pharmacy.
Employee Liaison
• Unless the physician pays fair market value compensation to the pharmacy for the liaison’s services:
• The liaison cannot handle preauthorization calls on behalf of the physician.
• The liaison cannot provide billing services on behalf of the physician.
• The liaison cannot provide data input services on behalf of the physician.
Annual Wellness Visits (“AWVs”)/Remote Patient Monitoring (“RPM”)/Chronic Care Management (“CCM”)
• Assume that the physician (i) has AWVs with patients, (ii) provides RPM to patients and/or (iii) provides CCM to patients.
• Assume that the pharmacy assists the physician in (i) conducting AWVs and (ii) providing RPM and CCM.
• It is the physician that is paid for AWVs, RPM and CCM. If the pharmacy assists with AWVs, RPM and CCM for free, then such assistance constitutes “something of value” to a referral source, thereby implicating the AKS and Stark.
• In order to avoid AKS and Stark problems, the physician must pay fair market value compensation to the pharmacy for the pharmacy’s services.
Loan Closet
• If the pharmacy sells DME, then it can store inventory at the physician’s office. If the physician orders a DME item, and if the patient elects to obtain the items from the pharmacy, then the physician can “pull the item from the loan closet,” hand the item to the patient, and send the patient home.
• It would be wise for the physician and pharmacy to memorialize the arrangement in a written Equipment Placement Agreement.
Rural Community
• If the pharmacy qualifies as a “rural provider” under Stark, then a physician can own a percentage interest in the pharmacy ... and can refer Medicare and Medicaid patients to the pharmacy. This will comply with the “rural provider” exception under Stark.
• In addition to satisfying Stark, it will be important that the arrangement not violate the AKS. Ideally, the arrangement will comply with the Small Investment Interest safe harbor to the AKS. If that is not possible, then the arrangement needs to comply with the (i) OIG’s 1989 Special Fraud Alert (“Joint Ventures”) and (ii) the OIG’s April 2003 Special Advisory Opinion (“Contractual Joint Ventures”). Among other requirements:
Rural Community
• The physician must purchase, at FMV, his percentage ownership interest in the rural pharmacy.
• Profit distributions to the physician must be based on his percentage ownership interest in the pharmacy. The profit distributions cannot be tied to the number of (or dollar amount resulting from) the physician’s referrals.
Non-Rural Community
• If the pharmacy does not qualify as a “rural provider,” then a physician can nevertheless own a percentage interest in the pharmacy. However, to avoid problems under Stark, the physician cannot refer Medicare and Medicaid patients to the pharmacy. Stark does not prohibit a physician from referring commercial insurance patients to the pharmacy.
• The physician and pharmacy will also need to examine state law to determine if there are any prohibitions or restrictions against the physician referring commercial insurance patients to a pharmacy in which the physician has an ownership interest.
Preferred Provider
• The physician and pharmacy can enter into a Preferred Provider Agreement in which, subject to patient choice, the physician will refer patients to the pharmacy.
• In return, the pharmacy will commit to provide extraordinary services (i.e., services) in order to keep the patient healthy.
Continuing Education Conference
• The pharmacy may desire to subsidize the expenses of a physician for him to attend a continuing education conference that addresses disease states that the pharmacy treats with its products and services.
• The pharmacy may do this...but only up to a specific dollar limit. One of the Stark exceptions is the non-monetary compensation exception which allows a pharmacy to spend up to a specified annual dollar amount on a physician. For 2020, this dollar amount is $423.
ACO
• A physician can lobby an ACO for a pharmacy to be a “preferred provider” for hospitals and physicians that comprise the ACO.
Provision of Equipment to the Physician
• In addressing this scenario, the Office of Inspector General (“OIG”) contrasted situations in which a lab provides a computer to a physician (i) that can only be used to print results of lab tests vs. (ii) one that the physician is free to use for a variety of purposes.
• With regard to the first situation, the OIG stated “that the computer has no independent value apart from the service being provided and … the purpose of the free computer is not to induce an act prohibited by the [anti-kickback] statute ...” With regard to the second situation, the OIG stated that “the computer has a definite value to the physician, and, depending on the circumstances, may well constitute an illegal inducement.”
Provision of Equipment to the Physician
• Based on OIG guidance, the safest way for a pharmacy to reduce the kickback risk associated with the provision of free equipment is to limit the functionality of the equipment so that it can only be utilized in conjunction with the pharmacy’s services.
• For example, if the pharmacy furnishes an iPad in order to enable the physician, or his employees to submit orders and documentation to the pharmacy, that is all the physician and his employees should be able to do with the iPad.
• The physician and his employees should not be able to access personal email accounts, surf ESPN.com, change a Facebook status, etc.
Collaboration With Hospital to Prevent Readmissions
Hospital Readmissions Reduction Program
• The Hospital Readmissions Reduction Program states that if a Medicare patient is treated in the hospital for one of six conditions (e.g., congestive heart failure, pneumonia, COPD) and is discharged, then if the patient is readmitted within 30 days for that some condition, the hospital will be subjected to future payment reductions by Medicare.
Preferred Provider Agreement
• A hospital can partner with a number of providers to help keep recently discharged patients healthy: SNFs, home health agencies, pharmacies, and DME suppliers.
• It is a good idea for the pharmacy to think outside the box and ask: “Why not me?”
• There is an opportunity for the pharmacy to approach the hospital and ask to be the hospital’s “preferred pharmacy.”
• In return, the pharmacy will offer to provide value-added services for the recently discharged patients.
Preferred Provider Agreement
• These services can be as mundane as calling the patient and caregiver to remind the patient to take his medication as prescribed … or to see his physician as scheduled … or to take his breathing treatments as directed … or to drink plenty of water.
• Though these services may be mundane, they are effective in keeping patients from being readmitted.
• The pharmacy can coordinate its services with a home health agency, therapy clinic, and/or a DME supplier.
Collection of Data
• In rendering these value-added services, it will be important for the pharmacy to collect data (i) describing the services that the pharmacy is rendering and (ii) describing the outcome of the services.
• The pharmacy can use this data to (i) justify, in the hospital’s eyes, the “preferred provider” arrangement and (ii) pitch the same type of arrangement to other hospitals.
• The hospital can use the pharmacy’s data to show to payors that the hospital is providing cost-efficient care.
From Prescriptions to Patients: Assessing and Addressing Operations
From the Outside InNCPA Multiple Locations Conference
Kelsey Schwander, Pharm.D.Clinical Specialist
Good Day Pharmacy: Colorado
Objectives Pharmacist and Pharmacy Technician Learning Objectives:• Discuss attributes and implementation strategies of
a longitudinal-care pharmacy model.• Discuss motivating factors for achieving employee
buy-in for enhanced services.
OutlineTo successfully transform your pharmacy to a sustainable longitudinal care plan model you must master:
I. Implementation II. Employee Buy-In III. Sustainability
Introduction
Good Day Pharmacy• 10 Pharmacies in Northern Colorado • Corporate Office in Loveland
Clinical Specialist
I. Implementation Recipe for Success
Workflow integration
Recipe for Success
Goal
• Clarity and importance
Implement
• Webinar or conference
call
Scoreboard
• Tangible goals
Adapt
• Utilize Feedback
• Roll out each enhanced service in a similar format• Measurable goals: Pharmacists are analytical creatures
Examples of Scoreboards January: Completed eCare Plans
Goal 01/13 01/28Johnstown At least 25 3 28
Dougs At least 25 5 18Greeley At least 25 0 12Sprouts At least 25 13 25
Workflow Integration
• Everyone needs to be involved• Use non-pharmacist staff
• Make it as easy as possible • Create keys, “how to” documents, helpful
hints
• Let the team have input• Not all stores will have the same workflow
Examples of “Cheat Sheets”
Example of a Counseling Sheet Example of Intake Key
II. Employee Buy-InChanging Mindset
Empowering All Employees to Level Up
Role PlayTurn to your neighbor:
• Person A: Owner• Person B: Employee
• Person A must explain you are starting a new smoking cessation service, which requires time, documentation and more training.
• How do you get employee B to be on board and successful with this service?
Changing Mindset
KNOW THE WHY REMINDERS OF IMPACT
CREATE COMPETITION AND EXCITEMENT
FIND STRENGTHS
Empowering All Employees to Level Up
Clerks
Techs
Pharmacists
Students
• Chance for clerks to be more involved
• Chance for advancement • Levels of techs
• Great way to involve residents and students
• Allow them to practice at the top of their license
• Lean on non-pharmacist staff
III. SustainabilityPartnershipsMake Money
Adapt
Partnerships • Make partnerships not competition
• Local MD offices • Concierge MD• Local Community• Pharmacy Schools
• Tell them exactly what you do • “You don’t know what you don’t know”
• Figure out what they need • Supplement what they are already doing
Make Money
• Do a pilot at 1 store before rolling it out to other stores• Set the price higher and use coupons
Enhanced Services
• Share with your doctors what you are doing • Ask what would be usefulCare Planning
• Do more than pharmacist CPT codes*Incident to
billing
Adapt “The definition of insanity is doing the same thing over and over
again expecting different results” –Albert Einstein
ConclusionSuccessfully transform your pharmacy to a sustainable longitudinal care plan model you must master:
Implementation Employee Buy-In Sustainability
• Recipe for Success• Workflow
integration
• Changing Mindset• Empowering all employees to level
up
• Partnerships• Make Money
• Adapt
Kelsey Schwander, Pharm.D.Clinical Specialist
From Prescriptions to Patients: Assessing and Addressing Operations From the Outside In
