Top Five Compliance Topics for Independent Owners CAHF Independent Owners Symposium, May 1-2, 2012 Mark A. Johnson Mark E. Reagan 101 W. Broadway 575 Market St. Suite 1200 Suite 2300 San Diego, CA 92101 San Francisco, CA 94105 (619) 744-7300 (415) 875- 8500 [email protected][email protected]
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Top Five Compliance Topics for Independent Owners CAHF Independent Owners Symposium, May 1-2, 2012 Mark A. JohnsonMark E. Reagan 101 W. Broadway 575 Market.
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Common Drivers Lack of standard discharge processes Lack of engagement or activation of patients and families Patients call 911 or return to emergency departments instead
of accessing a different type of medical service Ineffective or unreliable sharing of relevant clinical
information Patients did not understand/did not correctly take medications
Federal Anti-Kickback Statute is a criminal statute that prohibits payments as inducement for referrals of patients for services paid for by Federal health care programs Key terms: criminal, payment or remuneration,
inducement, referral Both sides of transaction have liability
Federal Anti-Kickback Statute – including addressing free goods and services, marketing arrangements, financial arrangements with physicians and other sources of referrals Prohibition against remuneration (in any form, whether
direct or indirect) made purposefully to induce or reward the referral or generation of Federal health care program business
Referral sources – physicians, other health care professionals, hospitals and hospital discharge planners, hospices, home health agencies and nursing facilities
SNFs refer to – physicians, hospices, DME, laboratories, pharmacies, hospitals, therapy companies, dentists, and nursing facilities
Payment or Remuneration – any type of cash or in-kind benefit that can be assigned a monetary value Long-term credit arrangements Discounts Rebates Supplies, equipment, space Gift cards, lunches, meals?
No “de minimis” exception Only exists for Stark Law Stark Law regulations – Nonmonetary compensation.
(1) Compensation from an entity in the form of items or services (not including cash or cash equivalents) that does not exceed an aggregate of $300 per calendar year, as adjusted for inflation
Not related to volume/value of referrals Not solicited by referral source
PPACA or Health Care Reform amended the Anti-Kickback Statute to provide that any claim that “result[s] from” an AKS violation is now a false or fraudulent claim under the FCA Any AKS violation self-disclosure should result in an
Ambulance provider – SNF accepts a low price from ambulance provider on Part A transfers in exchange for referring the Part B transfers Ambulance bills SNF for Part A transfers - $200 Ambulance bills Medicare for Part B transfers - $400
OIG – “Arrangements prone to swapping problems are those with ambulance providers, clinical laboratories and DME suppliers”
Discounts – A reduction in the amount a buyer is charged for an item or service based on an arms-length transaction 42 C.F.R. § 1001.952(h)(5) – Does not include:
Cash payments or cash equivalents (except rebates, as defined)
Supplying one good or service at a reduced charge to induce the purchase of a different good or service, unless both are reimbursed by a Federal program using same methodology and fully disclosed and reported
A reduction in price applicable to one payor but not to Medicare/Medicaid or other Federal programs
Point person for negotiations Discussion of policies and procedures Form contracts developed by legal counsel Other reasons for selecting vendor – quality,
Multiple active investigations throughout California and nationwide Ambulance providers Physician relationships Referral companies SNF – Hospital relationships Hospices Home Health Agencies
Elements of Effective Compliance Program Implementing written policies, procedures and standards of
conduct Designating a compliance officer and compliance committee Conducting effective training and education Developing effective lines of communication Conducting internal monitoring and auditing Responding promptly to detected offenses and developing
Environment Audits began in February 2011 Results started getting issued in February 2012 DPH has centralized the review in Sacramento Inconsistencies at the facility level Lack of training/experience/understanding by some
Meal periods deducted from total nursing hours for the timeframes identified on the “assignment sheet”
*Meal periods NOT identified will be deducted as follows: 30 minutes for every 6 hours worked 1 hour for every 10 hours worked *Unless documentation provided that services
Meal periods For 10 hours or more of continuous time worked
where only 30 minutes of meal time was taken and 30 minutes of meal time was paid, facility must provide documentation that the employee opted to be paid in lieu of the second 30 minute meal break
Recently, there has been a focus on whether patients in SNFs who are receiving psychotherapeutic drugs actually give informed consent to the treatment.
Patients have a right to be free from psychotherapeutic drugs and physical restraints used for the purpose of patient discipline or staff convenience and to be free from psychotherapeutic drugs used as a chemical restraint. (Title 22, Section 72527(a).)
Title 22, Section 72528 states that the information that is material to a patient’s decision concerning the administration of a psychotherapeutic drug (or physical restraint) shall include: The reason for the treatment and the nature and seriousness
of the patient’s illness. The nature of the procedures to be used in the proposed
treatment including their probable frequency and duration. The probable degree and duration (temporary or
permanent) of improvement or remission, expected with or without treatment.
Title 22, Section 72528 (cont’d): The nature, degree, duration and probability of the side
effects and significant risks, commonly known by the health professions.
The reasonable alternative treatments and risks, and why the health professional is recommending this particular treatment.
That the patient has the right to accept or refuse the proposed treatment, and if he or she consents, has the right to revoke his or her consent for any reason at any time.
Importantly, Title 22, Section 72528 requires that before initiating the administration of psychotherapeutic drugs (or physical restraint) facility staff shall verify that the patient’s health record contains documentation that the patient has given informed consent to the proposed treatment or procedure.
Title 22 also includes an exception for emergency treatment – where there is an unanticipated condition in which immediate action is necessary for preservation of life or the prevention of serious bodily harm to the patient or others.
Previously found that unchanged, pre-existing orders for psychotherapeutic drugs/physical restraints or prolonged use of certain devices did not require verification of informed consent in medical records
DPH now requires verification present in medical records in AFL 11-08
The AFL discusses the provisions of current law regarding informed consent for prescribing antipsychotic medication pursuant to Health & Safety Code 1418.9.
The H&S Code section referenced above pertains to residents who have the capacity to offer consent.
If a resident does not have the capacity, then a designated family member may offer consent. A physician makes the determination on whether capacity exists.
If the attending physician of a resident in a SNF prescribes, orders, or increases an order for an antipsychotic medication for the resident, the physician shall do the following: Obtain informed consent of the resident for
purposes of prescribing, ordering, or increasing an order for the medication;
Seek the consent of the resident to notify the resident’s interested family member, as designated in the medical record.
If the resident consents to notifying the interested family member, the physician shall make reasonable attempts, either personally or through a designee, to notify that family member within 48 hours of the prescription, order, or increase of an order.
Notification of an interested family member is not required if any of the following circumstances exist: There is no interested family member designated in the
medical record; The resident has been diagnosed as terminally ill by
his physician and is receiving hospice services from a licensed, certified hospice agency in the facility;
The resident has not consented to the notification.
The AFL reiterates that the law does not require the attending physician to obtain consent from an interested family member in order to prescribe, order, or increase an order for antipsychotic medication.