Prohibition on Re-Disclosure – Changes in New SAMHSA Final Rules (§ 2.32)

One of the primary new operative provisions that was created in the 2017 Final Rules is an expanded prohibition against re-disclosure of records that are covered under SAMHSA. Even when a disclosure is permitted, the 2017 rules required the disclosure to be accompanied by a lengthy written statement, notifying the recipient of the special status of the information and the prohibition against re-disclosure. The notification was rediculously long:

This information has been disclosed to you from records protected by Federal confidentiality rules (42 CFR part 2). The Federal rules prohibit you from making any further disclosure of this information unless further disclosure is expressly permitted by the written consent of the person to whom it pertains or as otherwise permitted by 42 CFR part 2. A general authorization for the release of medical or other information is NOT sufficient for this purpose. The Federal rules restrict any use of the information to criminally investigate or prosecute any alcohol or drug abuse patient.

The new 2018 Rules create an abbreviated notice that is 80 characters long to fit in standard free-text space within health care electronic systems. The abbreviated notice in this final rule reads ‘‘Federal law/42 CFR part 2 prohibits unauthorized disclosure of these records.’’

The 42 CFR part 2 regulations have always required that a notice of the prohibition on redisclosure accompany each disclosure made with the patient’s written consent. With the adoption of electronic health record systems, it became difficult to comply electronically with the longer notification form due to character limits in freetext fields within electronic health record systems. Many electronic record systems contain a free text space with a maximum character capacity of 80 characters. The new 2018 Rules reflect SANHSA’s belief that offering an abbreviated notice option will be beneficial to providers who use electronic health record systems to exchange data.

SAMHSA recognizes concerns that an abbreviated notice could be insufficient to convey understanding of part 2 requirements. SAMHSA encourages part 2 programs and other lawful holders of restricted records that chose to use the abbreviated notice to discuss the restriction and redisclosure requirements applicable to SAMHSA protected records with those to whom they disclose patient identifying information.

First Article in SAMHSA Series

New SAMHSA Clarifying Regulations for Part 2 Program Records

New Final regulations were issued on January 2, 2018 by the Substance Abuse and Mental Health Services Administration (SAMHSA). The new Final regulations supplement SAMHSA’s major regulation change that was finalized in regulations that were released in January of 2017. The new, 2018 Final regulations add some clarification and more specificity to some of the requirements of the 2017 rule.

These rules, commonly known as the “SAMHSA Rules” or “Part 2” describe special confidentiality restrictions that apply to Substance Use Disorder Patient Records related to certain substance use disorder treatment programs that receive federal financial assistance. The confidentiality requirements that apply to treatment records covered by the SAMHSA Rules are more stringent than apply to general patient health records. The special restrictions on these records has been in existence for decades, with the last major re-write occuring in 1987.

SAMHSA began a process of reconstituting the SAMHSA Rules in February of 2016, when it published a Notice of Proposed Rulemaking (NPRM) in the Federal Register (81 FR 6988). SAMHSA’s stated purpose for revising the rules was to reflect development of integrated health care models and the use of electronic exchange of patient information. At the same time, SAMHSA’s aim was to accomodate new technologies while maintaining confidentiality protections for patients of covered treatment programs who could encounter discrimination if their information is not properly protected.

The  Final Rules that we published on January 18, 2017, provided for greater flexibility in disclosing patient identifying information within the health care system while continuing to address the need to protect the confidentiality of substance use disorder patient records. At the same time that it published the 2017 Final Rule’s, SAMHSA issued a supplemental notice of proposed rulemaking (SNPRM) to solicit public comment on additional proposals in a variety of areas covered by the SAMHSA Rule. The new Final Rules that were issued on January 2, 2018, address many of the issues suggested in the SNPRM and integrate some of the 55 regulatory comments that SAMHSA received in response to the SNPRM.

SAMHSA received numerous comments asking it to consider alignment of the special restrictions applicable through the SAMHSA Rules with the Health Insurance Portability and Accountability Act (HIPAA) or the Health Information Technology for Economic and Clinical Health (HITECH) Act. It is challenging for providers to establish different requirements for special status records. By its very nature, the more restrictive requirements that are applicable to SAMHSA covered records requires providers to “triage” record requests to be certain that they are not covered by the special restrictions of the SAMHSA Rules. This is especially problematic when a provide that does not provide alcohol or substance abuse treatment receives SAMHSA protected records from another provider. SAMHSA Rules not subject receiving providers to a direct prohibition against redisclosure.

SAMHSA says that it has attempted to align the final rule with HIPAA, the HITECH Act, and their implementing regulations to the extent feasible. Yet, the more stringent SAMHSA restrictions will be difficult to completely harmonize with HIPAA and HITECH. Part 2 provides more stringent federal protections than other health privacy laws such as HIPAA and seeks to protect individuals with substance use disorders who could be subject to discrimination and legal consequences in the event that their information is improperly used or disclosed. A similar issue exists with respect to many state laws that provide more stringent privacy restrictions on records related to mental health related services. Decision trees applicable to disclosure of special treatment records can be quite complex; particularly when HIPAA premption concepts are applied as an overlay to the base analysis.

Follow our article series on the SAMHSA Regulations on this site.

Next Article in Series

Notice of Restriction on Re-Disclosure

Texting of Physician Orders : CMS Statement Clarifies Position on Texting

The CMS Center for Clinical Standards and Quality/Survey & Certification Group recently released a Memorandum clarifying its position regarding texting of health care information. In S&C 18-10-ALL, dated December 28, 2017, CMS clarifies the following issues:

• Texting of PHI Within Health Care Team.  CMS says that this is permissible on a secure platform.  Providers should develop policies covering texting among the care team.  Providers may want to consider special conditions, or even limiting or prohibiting this practice.  CMS, HIPAA and other standards need to be considered when developing provider specific policy.  State laws may differ and certain types of information may be subject to special restrictions.
• Texting of Patient Orders.  Even though texting communication between care team members is permissible, CMS clarifies that texting patient orders is always prohibited; even on a secure platform.
• Preferred Use of CPOE.  CMS clarifies that Computerized Provider Order Entry (CPOE) is the preferred method for a provider to enter a patient order.  Providers should review their policies regarding acceptable order platforms.  Special attention should be paid to texting practices.  Verbal orders are also an area of significant compliance and liability concerns.  Over-use of verbal orders and non-compliance with authentication requirements is very common and is a significant risk area.

You can reference the CMS Texting Guidance Letter on this issue directly.

I have been posting a series of articles on compliance issues relating to physician orders that you can also reference for additional guidance.  And as always, if you have additional questions, please do not hesitate to contact me thhrough the contact form on this blog or directly through contact information on my law firm web site.

Physician Orders Legal and Regulatory Article Series

Physician Order Reimbursement Issues

Physician Orders – Why Are They So Important?

The Verbal Order Minefield

Authenticating Verbal Orders : Compliance Requirements

Third Party Authentication of Verbal Orders

Physician Order – CMS Guidelines on Texting Physician Orders

Authentication of Verbal Orders

In a past blog article, I discussed the need for physicians to promptly authenticate verbal orders. The failure of a physician to timely sign a verbal order can have reimbursement implications. In some cases, in some states, another responsible provider can sign a verbal order that is originally given by another practitioner. This option is not always available and depends a lot on whether state law permits the practice. Some states require the practitioner who gave the verbal order to authenticate the order. With the use of electronic medical records, practitioners cannot expect leniency on these types of requirements.

In states that permit one practitioner to authenticate for another, the authenticating proxy practitioner should understand that he or she is accepting responsibility for the authenticated verbal order. State scope of practice rules apply to cross authentication of orders. In otherwords, the practitioner authenticating the order must have practice authority to have provided the original verbal order. Facilities can develop policies that a more restrictive then what the law permits. Policy can eliminate or restrict cross authentication practices. There is inherent risk in permitting cross authentication because the authenticating provider did not give the original verbal order. Additionally, as covered in previous blog articles, verbal orders are over-used in many facilities and carry inherent risks. Facilities can enact policies to curtail the use of verbal orders. At minimum, facility policy should echo the CMS comments regarding the appropriate scope of use of verbal orders. Practices can be audited to determine whether a practitioner is overusing verbal orders.

Physician Orders Legal and Regulatory Article Series

Physician Order Reimbursement Issues

Physician Orders – Why Are They So Important?

The Verbal Order Minefield

Authenticating Verbal Orders : Compliance Requirements

Third Party Authentication of Verbal Orders

Physician Order – CMS Guidelines on Texting Physician Orders

The Verbal Order Minefield

Physicians often provide orders over the telephone in cases where action must be taken immediately. For example, verbal orders must be given by a physician who is on call or off duty but an issue arises that requires staff to take immediate action. Physician orders are generally effective when they are given, subject to appropriate documentation. Verbal orders are effective when provided verbally, but must be properly recorded in the medical records and authenticated or signed by the ordering physician.

Verbal Order Policies and Procedures

Normally, the facility will have policies in place that provide guidance on how staff should handle verbal orders. Those policies will define who is authorized to receive a verbal order from a physician as well as the process for taking a verbal order. Many facilities use a “read-back” requirement that requires the provider who receives the order to read the order back to the physician and receive confirmation. The receiving provider is required to document the receipt of the verbal order in the chart.

Over-use of Verbal Orders

Medicare policy (and many state laws) clarifies that verbal orders are not to be used as common practice. Verbal orders are not to be used for the convenience of the physician, but only when the patient’s condition or status requires immediate attention and when it is impossible or impractical to enter the order without creating unacceptable delays in needed treatment. Even though verbal orders are to be used infrequently under Medicare policy, their use has become very commonplace in many facilities. Frequent use of verbal orders increases risk in a variety of ways. Verbal orders leave room for error. This can be mitigated by using a read-back process, but risk of misinterpretation or incorrect fulfillment will be enhanced when verbal orders are used. Verbal orders contribute significantly to the risk of medication error and a variety of other potential adverse patient incidents.

Another significant risk of using verbal orders relates to the need to meet authentication requirements. CMS rules direct medical reviewers to disregard orders that are not properly authenticated. All orders, including verbal orders, are required to be dated, timed, and authenticated promptly by the ordering practitioner.

Authentication of Verbal Orders by Ordering Physician

In terms of timing, Medicare guidance requires the ordering physician to sign the verbal order promptly. Some states, such as Wisconsin, require the ordering physician to sign the order within 24 hours of providing the verbal order. Medicare ties into state law requirements in this area. This is an area of significant potential risk for a facility where physician’s routinely use verbal orders during off-shift times. It can be days before the physician is back at the facility. It used to be that reviewers provided a lot of slack on the followup physician signature requirement. With the integration of electronic medical records and the use of electronic signatures, the timing requirements for physician signatures on verbal orders are enforced strictly.

CMS has gotten a bit more lenient on certain delayed medical record entries. Amendments, corrections, and delayed medical record entries are now given credit in medical review. This leniency does not apply with respect to certain types of physician orders. For example, late or corrected entries to support orders for inpatient admission or outpatient observation services are not accepted and are treated as they do not exist on medical review. Again, failure to properly and timely authenticate an “order” in contrast to an “entry,” has reimbursement implications. This makes it critical to assure that orders are completely documented. Verbal order use should be limited to appropriate cases. Verbal orders are over-used in many facilities. When verbal orders are used, prompt authentication requirements should be enforced. Strict time limitations may exist under state law. For example, Wisconsin requires verbal orders to be be signed by the ordering provider within 24 hours.

Physician Orders Legal and Regulatory Article Series

Physician Order Reimbursement Issues

Physician Orders – Why Are They So Important?

The Verbal Order Minefield

Authenticating Verbal Orders : Compliance Requirements

Third Party Authentication of Verbal Orders

Physician Order – CMS Guidelines on Texting Physician Orders

The Importance of Physician Orders in Health Care

In my last article on physician orders, I more or less ranted about the lack of a clear regulatory definition of physician orders. Yet, physician orders serve a variety of important purposes including communicating the physician’s direction for ancillary services and required diagnostic tests and securing the ability to receive reimbursement for services that flow from the physician’s encounter with the patient. The systematic use of physician orders also serves as proof that the physician is directing services to the patient and that conditions of participation of the facility, which require a physician driven process, are being complied with on a systematic basis.

Physician Orders as Conditions of Participation

Medicare law draws a distinction between conditions of participation and conditions of payment. Conditions of participation are compliance items, failure of which can result in corrective action and citations on survey. Failure of physician orders can result in survey deficiencies. The good news here is that a facility will normally be able to take action to correct a cited deficiency. If the failure of physician orders is systematic, other sanctions can attach; even including exclusion from governmental health program. But the garden variety, relatively isolated failure of a physician to timely sign an order can normally be corrected without devastating consequences.

Physician Orders As Condition of Payment

Physician orders can also be conditions of payment for specific services flowing from the physician’s encounter with the patient. This is where the real, serious regulatory exposure for failure to document physician orders occurs. Where an order is a condition of payment, claiming and accepting reimbursement results in an overpayment that should be repaid to Medicare. Failing to repay within 60 days of identification of the overpayment results in significant False Claims Act penalties that can far outweigh the original overpayment amount. Identification occurs when a provider “should know” that an overpayment exists which is why health care providers need to proactively look for missing physician orders as an identified risk as part of their compliance programs.

Physician Order Documentation Requirements

Health care providers will be familiar with the adage that “if it is not documented, it didn’t happen.” The same is true with respect to physician orders. A physician order that is not properly documented will be treated by payors as if the order does not exist. Even failure of seemingly technical failures to sign orders on a timely basis can result in payment denial or overpayment claims. In these cases, the provider is not entitled to reimbursement. If reimbursement is received, an overpayment will exist and I describe above the consequences of not repaying overpayments.

So it is important for physicians and other providers to understand the requirements for physician orders as they pertain to the services that they provide. Not getting it right can have very serious consequences. False Claims Act penalties are triple the original overpayment, plus up to $22,000 per claim. A systematic failure to properly use physician’s orders can result in draconian levels of damages under the False Claims Act.

Physician Orders Legal and Regulatory Article Series

Physician Order Reimbursement Issues

Physician Orders – Why Are They So Important?

The Verbal Order Minefield

Authenticating Verbal Orders : Compliance Requirements

Third Party Authentication of Verbal Orders

Physician Order – CMS Guidelines on Texting Physician Orders

Physician Orders – Big Implications but Few Definitions

I wanted to talk a bit about physician orders. Physician orders hold a great deal of significance in health care. The root purpose of a physician order is to direct other providers to furnish certain services. Services ordered by a physician might include things like therapy services, skilled nursing services, home health, diagnostic testing, and a variety of other therapeutic and/or diagnostic services that might flow from the physician’s examination of the patient.

In addition to the practical application of directing care, health care payors look to physician orders to make payment determinations. The Medicare program places a great deal of importance on physician orders to support claims for ancillary and diagnostic services. Certain services require a physician’s order as a prerequisite to payment on a claim for service. In other cases there may be no direct, fee-for-service payment implication to a physician’s order, but they are still critical to patient safety and to communicate matters that may impact care and treatment of patients.

A few weeks back, my trials and tribulations as a health care compliance lawyer resulted in my need to locate a definition of what constitutes a physician’s order. I looked in the Medicare regulations and was surprised to find that there is no statutory or regulatory definition of what constitutes the order of a physician. This seemed odd given the importance of physician orders as conditions for payment of many Medicare claims. There are references throughout the regulations that require physician orders. I was finally able to locate a definition in a CMS Policy Manual. But if push comes to shove in the context of a case, these policy manuals are not binding on the interpretation of regulatory terms. CMS may define physician orders internally, but that does not necessarilly mean that a court will uphold that definition.

Some states do a better job than Medicare at defining what constitutes a physician’s order. Medicare policy sometimes defers to state law, particularly regarding some of the technical aspects of physician orders such as what constitutes a valid electronic signature. State law should always be referenced when determining issues relating to physician orders, attestation, signatures, and other issues. This does not always provide clarification and, in fact, sometimes it causes confusion. But it is necessary for a full analysis and identification of where there may be uncertainty.

So no I am inspired to do some further exploration on physician orders. When are they necessary? When are they required? What technical requirements apply? Stay tuned to this blog for additional articles and hopefully some fairly comprehensive coverage of physician orders.

Physician Orders Legal and Regulatory Article Series

Physician Order Reimbursement Issues

Physician Orders – Why Are They So Important?

The Verbal Order Minefield

Authenticating Verbal Orders : Compliance Requirements

Third Party Authentication of Verbal Orders

Physician Order – CMS Guidelines on Texting Physician Orders

Development and Maintenance of Quality Measures for Long-Term Care – Hospital Quality Reporting Program (LTCH QRP)

The technical expert panel (TEP) has published a new summary report covering the Development and Maintenance of Quality Measures for Long-Term Care Hospital Quality Reporting Program.  The new report related to a meeting of the TEP that was held on Tuesday, March 28, 2017 focusing on   current LTCH QRP quality and resource use measures.  The objective was to report on existing measures and to make recommendations for future measures.

The new TEP Report can be accessed on the  TEPs webpage.

Other reports on that page include:

• Claims-Only and Hybrid Hospital-Wide (All-Condition, All-Procedure) Risk-Standardized Mortality Measures
• Development of the Hospice Quality Reporting Program HEART Comprehensive Patient Assessment Instrument
• Quality Measure Development: Supporting Efficiency and Innovation in the Process of Developing CMS Quality Measures
• Development of Outpatient Outcome Measures for the Merit-based Incentive Payment System (MIPS)
• Development and Maintenance of Quality Measures for Skilled Nursing Facility (SNF) Quality Reporting Program (QRP)
• Development and Maintenance of Post-Acute Care Cross-Setting Standardized Patient Assessment Data
• Inpatient Psychiatric Facility (IPF) Outcome and Process Measure Development and Maintenance
• Quality Measure Development (QMD): Dual Enrollees, Managed Long-Term Services and Supports (MLTSS), and Medicaid Innovation Accelerator Program (IAP).
• Task: Technical Expert Panel: Medicaid Innovation Accelerator Program (IAP)-Substance Use Disorder, Beneficiaries with Complex Needs, and Physical-Mental Health Integration
• Hospital Inpatient and Outpatient Process and Structural Measure Development and Maintenance (Hospital-MDM)
• Development and Maintenance of Quality Measures for Long-Term Care Hospital Quality Reporting Program (LTCH QRP)

Expressions of Interest Can Lead to Medicare Settlement for Eligible Appellants

The Centers for Medicare and Medicaid Services recently announced that beginning February 5, 2018, it will begin accepting what it terms as “expressions of interest” for a limited settlement from providers who have fewer than 500 appeals pending at the Office of Medicare Hearing and Appeals and the Medicare Appeals Council.  The option is made available to certain Medicare fee-for-service providers, physicians and suppliers.  The new administrative settlement process will be to settle portions of pending appeals that involve $9,000 or less total billed amounts.  The trade-off would be a timely partial payment of 62% of the net new amount that is approved by Medicare.

Providers and suppliers who meet qualifications can commence the process by submitting an Expression of Interest (EOI) using the process established by CMS.

Eligible appellants include Medicare Part A and Part B providers, physicians, and suppliers that have less than than 500 appeals pending.  Some appellants are ineligible for participation in the program.  Ineligible appellants include beneficiaries, enrollees, their family members, or estates. State Medicaid Agencies, Medicare Advantage Organizations (Medicare Part C), those that filed for bankruptcy or expect to file for bankruptcy, some appellants who may have had False Claims Act problems or other program integrity issues.

The details of the program and various forms and guidance are included on the CMS website.  Medicare Low Volume Appeal Program

 OIG Advisory Opinion 17-09

The Office of Inspector General (“OIG”) recently released a new advisory opinion (Advisory Opinion 17-09 – January 5, 2018), addressing a gainsharing arrangement between a group of neurosurgeons and a health center.  Under the proposed arrangement, a neurosurgery group agreed to implement measures to reduce the costs associated with a defined scope of surgical procedures.  As part of its agreement with the health center, the neurosurgeons were to participate in a portion of the cost savings that resulted from the implementation of the measures.

The OIG has historically issued around a dozen Advisory Opinions addressing gainsharing arrangements.  However, the OIG had not issued an advisory opinion in the gainsharing area since the passage of the Medicare Access and CHIP Reauthorization Act (known as MACRA) in 2015.  That law made modifications to Civil Monetary Penalty provisions that are applicable in the gainsharing area by removing some of the impediments to gainsharing arrangements that previously existing in the Civil Monetary Penalty laws.

Gainsharing arrangements have emerged as a way to align the economic interests of hospitals and physicians in efforts to work together to reduce cost and enhance quality of care.  A gainsharing arrangements provides doctors with economic incentives to adhere to practices that reduce the hospital’s costs associated with defined procedures or treatment courses.  Under traditional fee-for-service reimbursement, a financial incentive is created for physicians to provide more service to maximize reimbursement.  A properly structured gainsharing arrangement creates incentives for appropriate levels of service and rewards physicians for efficiencies and quality outcomes.  Interests are aligned because the facility and the physician, who is often the engine driving the level of care, share in the savings.

Prior to the passage of MACRA in 2015, the OIG expressed suspicion about gainsharing through Special Advisory Bulletins as well as advisory opinions.  This has the effect of chilling the proliferation of gainsharing arrangements because providers were cautious about potential regulatory issues. A major impediment prior to 2015 was the CMP law that restricted hospitals from compensating physicians in order to induce a reduction or limitation on services provided to Medicare and Medicaid beneficiaries.  MACRA clarified that the CMP law was only violated if the payment to the physician is for purposes of reducing services that are medically necessary.  This subtle yet significant change opened the door for the proliferation of gainsharing arrangements.

Coming full circle to Advisory Opinion 17-09, the OIG concluded that the specific gainsharing arrangement described in the opinion would not result in sanctions under the Civil Monetary Penalty rules or the Federal Anti-kickback Statute.  The OIG acknowledged that both the CMP laws and the Anti-kickback had potential implication but that the structural issues of the particular arrangement between the neurosurgeons and the health system would not result in the OIG pursuing sanctions.

By their very nature, Advisory Opinions only apply to the requesting party.  However, we can gain useful concepts from the analysis and conclusions of the OIG relating to the specific facts that formed the basis of their opinions.

Fair market value will always remain an issue in gainsharing arrangements.  The Federal Stark Law, Anti-kickback Statutes, and applicable state laws will require adherence to fair market value standards when payment is made between a referring party and the provider of a service. Advisory Opinion 17-09 provides us with some useful guidance regarding some of the consideration that should go into establishing fair market value and structuring a gainsharing arrangements.  Fair market value concepts in these arrangements are often subtle and must be well thought out to avoid regulatory issues. In addition, concepts of commercial reasonableness, which has emerged as a related but distinct issue impacting payments must be considered in addition to fair market value.

Advisory Opinion 17-09 is worth a review to anyone involved in structuring gainsharing arrangements. By no means should 17-09 be the only guidance that you rely upon because the opinion only touches on a few considerations that were relevant to the structure of the specific arrangement.  Some important factors to keep on your radar when structuring a gainsharing arrangement relate to the determination of baselines that are used to measure cost savings through program implementation.  The frequency and method of calculating available gainsharing amounts is subtle but important for regulatory compliance.  Of course the specific protocols or description of the method for reducing costs should be described in detail, together with a method for determining the level of compliance with those protocols.  Another issue that often arises in these arrangements involves the scope of costs that are allocated to the program.  It is important that costs allocated be reasonable to avoid potential disguised kickbacks.

If you require additional information regarding this article, gainsharing arrangements, or health care issues in general, please contact us through the contact section of this blog.