Health Law Blog - Healthcare Legal Issues

Medicaid Reimbursement for Telehealth In Wisconsin Mental Health Programs

August 11th, 2015

Wisconsin Medicaid Reimbursement for Telehealth In Mental Health Programs

A Medicaid enrolled certified mental health or substance abuse treatment program may be eligible for Medicaid reimbursement for telehealth services if it is also certified to provide treatment via telehealth.  Medicaid-covered services provided via telehealth are reimbursed in the same way Medicaid reimburses for face-to-face contacts between providers and consumers.  The Medicaid Handbook Update #2004-88 at  https://www.forwardhealth.wi.gov/kw/pdf/2004-88.pdf, described coverage requirements.

1.            The agency must be a certified program under one of the specified program standards: Wis. Admin. Code DHS34, 35, 36, 40, 61, 63, or 75 (except for the provision of opioid treatment under DHS 75.15).

2.            Persons providing mental health or substance abuse treatment services via telehealth must be a rostered staff member of one of these certified programs.

3.            Medicaid will not accept claims from individual professional staff.

4.            The certified program also is certified for telehealth by the Division of Quality Assurance.

5.            The treatment service must be a covered service under one of the Medicaid mental health or substance abuse benefits.

6.            The treatment service may not be group therapy.

7.            The provider must indicate the “GT” modifier on the claim detail for the specific procedure code. The “GT” modifier definition is “Via interactive audio and video telecommunication systems.”

8.            Providers must continue to follow all Medicaid coverage policies and all other requirements for each underlying service in the same manner as if the service was provided on  face-to-face basis.

For more information concerning telehealth program issues for mental health care or other provider types, contact John Fisher at through the contact information on this site.

Telehealth Certification In Wisconsin Mental Health Programs

August 11th, 2015

Process for Telehealth Certification In Wisconsin

Only certified mental health and/or substance abuse programs, or agencies planning to be certified as a mental health and/or substance abuse provider, may apply for telehealth certification. The first step in the process is for the agency to write a plan addressing each section in the attached template. The plan is then sent to the Behavioral Health Certification Section of the Division of Quality Assurance.

Provider’s must demonstrate compliance with their approved plan to the Division of Quality Assurance surveyor(s) during a site review or other unannounced focus visits.

Requirements for Telehealth Certification

There are several requirements that must be met in order to maintain certification.  Many of these requirements will need to be reflected in compliance policies and made operational as part of the telehealth program. These requirements fall in the following areas subject to additional detail in each area:

  • applicable regulatory requirements for the provider’s specific program (Administrative Code DHS 34, 35, 36, 40, 41, 61, 63, and 75)
  • requirements related to clinical supervision/collaboration for program staff who provide treatment services via telehealth, background checks, maintenance of professional liability insurance, documentation into the consumer’s record in a timely manner, and other requirements.
  • requirements regarding the locations for staff other than the main office of certified program or a certified branch office. Patients must receive the telehealth services at the main office or a certified branch office of the certified program.
  • Restriction against providing the telehealth services to consumers who are in-home or in-community.
  • minimum transmission standards established by the American Telemedicine Association (see http://www.americantelemed.org/resources/telemedicine-practice-guidelines/telemedicine-practice-guidelines)
  • compliance with vendor requirements for the telehealth hardware/software to ensure that the telehealth service is of high quality and as close to a face to face visit as possible.
  • orientation and ongoing training to staff on the use of the telehealth equipment, the clinical application of telehealth, safety and security during telehealth visits, privacy and confidentiality, back-up procedures if there is equipment failure, and consumer preparation for telehealth.
  • Assuring that patients are informed about the provision of services provided through telehealth, the history of telehealth, success rate of telehealth services, how telehealth sessions are conducted, and the extent to which the program is able to provide treatment services face-to-face versus via telehealth.
  • an ongoing method for obtaining consumer satisfaction on telehealth visits and evaluating the results of this survey process for quality assurance purposes
  • patient choice of having a face to face visit with a professional or seeing this person via telehealth, to the extent feasible.
  • workspaces must be secure, private, reasonably soundproof, and have a lockable door to prevent unexpected entry.
  • Efforts to ensure privacy so provider discussion cannot be overheard by others outside of the room where the service is provided.
  • If other people are in either the patient or the professional’s room, both the program staff and the consumer must be made aware of the other person and agree to their presence.
  • Program staff must verify for the consumer the identity of the staff member who is providing the treatment services via telehealth and verify for the staff member providing the treatment services theconsumer’s identity.
  • policy/procedure for technology breakdown that causes a disruption of the session.
  • System to Ensure secure upload and download with the vendor’s server.  At least 128 bit encryption software must be used.
  • assure that no information from a transmission of a telehealth services is stored on the vendor’s servers.
  • use of HIPAA Business Associate Agreement if information is transmitted via the vendor’s servers.

How Does Wisconsin Medicaid Reimburse for Telehealth?  Check Out The Article Here: Telemedicine Reimbursement Mental Health Programs

New Memorandum On Telehealth In Mental Health and Substance Abuse Programs

August 11th, 2015

 

On August 5, 2015 the  the Wisconsin Division of Quality Assurance (DQA), issued new DQA Memo 2015-011 (the “Telehealth Memorandum”) to provide background information and update a previous memo (Memo #2004-14, issued in September 2004) on the use of telehealth in certified mental health and substance abuse treatment programs/services in the State of Wisconsin.

Recognizing that significant technological advances have been made since the earlier memo, the DQA details revisions to the minimum requirements for telehealth certification by mental health and substance abuse programs in the State of Wisconsin.  The new standards for certification purport to permit use of hardware and software that may be less costly and easier to use.  This may result in facilitating broader use of telehealth to benefit patients with the state of Wisconsin.

The Telehealth Memorandum outlines basic certification requirements and references the application form for Mental Health and Substance Abuse Telehealth certification for additional detail.  Specific requirements are outlined  that certified mental health and substance abuse treatment programs must follow in order to use telehealth technology as a means of service provision for counseling, psychotherapy, medication management or related clinical consultation.  Services may include outpatient services, crisis services, community support services, comprehensive community services, day treatment programs, inpatient, and other services.

Some of the requirements that must be met in order to achieve certification of a telehealth program in Wisconsin include the following:

  • All staff employed by these programs may provide services using telehealth technologies provided they have received the necessary training and meet program and telehealth certification standards.
  • The certified program should identify specific staff providing the services in its telehealth plan and policies as required in the certification process.
  • Telehealth services cannot be provided in Wisconsin by narcotic treatment services certified under Chapter DHS 75.15 or mental health inpatient services certified under Chapter DHS 61.71 and Chapter DHS 61.79.
  • Telehealth technology cannot be used in lieu of the face-to-face assessment for continuing use of the restraint/seclusion in an inpatient setting.
  • Telehealth equipment may be used for the purpose of clinical supervision and clinical collaboration.
  • All the requirements for supervision and collaboration continue to apply such as transmission quality, ensuring that the transmitted information is not stored, and other requirements and restrictions outlined in DQA guidance.
  • The memo cautions providers regarding the use of telehealth equipment for clinical supervision for substance abuse counselors which require at least one in-person meeting per month.

CMS Comments On ACO Participation Agreement Requirements

August 7th, 2015

MSSP ACO Agreement Requirements

CMS Comment Describing Provider Agreement Requirements for Participation In the Medicare Shared Savings Program

ACO Participation Agreement MSSP Participation Section 1899(b)(2)(B) of the Act requires participating ACOs to “enter into an agreement with the Secretary to participate in the program for not less than a 3-year period.” If the ACO is approved for participation in the Shared Savings Program, an executive who has the ability to legally bind the ACO must sign and submit a participation agreement to CMS (Sec.  425.208(a)(1)). Under the participation agreement with CMS, the ACO agrees to comply with the regulations governing the Shared Savings Program (Sec.  425.208(a)(2)).

In addition, the ACO must require its ACO participants, ACO providers/suppliers, and other individuals or entities performing functions or services related to the ACO’s activities to agree to comply with the Shared Savings Program regulations and all other applicable laws and regulations (Sec.  425.208(b) and Sec.  425.210(b)). The ACO must provide a copy of its participation agreement with CMS to all ACO participants, ACO providers/suppliers, and other individuals and entities involved in ACO governance (Sec.  425.210(a)). As part of its application, we currently require each ACO to submit a sample of the agreement it executes with each of its ACO participants (the “ACO participant agreement”). Also, as part of its application and when requesting the addition of new ACO participants, we require an ACO to submit evidence that it has a signed written agreement with each of its ACO participants. (See guidance on our Web site at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/sharedsavingsprogram/Downloads/Memo_Additional_Guidance_on_ACO_Participants.pdf.)

ACO Participation In MSSP Will Not Be Approved Unless The ACO Has An Agreement In Place With Participating Providers.

An ACO’s application to participate in the Shared Savings Program and any subsequent request to add new ACO participants will not be approved if the ACO does not have an agreement in place with each of its ACO participants in which each ACO participant agrees to participate in the Shared Savings Program and to comply with the requirements of the Shared Savings Program.

CMS Describes inadequate Provider Agreements From Previous Application Periods

In our review of applications to participate in the Shared Savings Program, we received many ACO participant agreements that were not properly executed, were not between the correct parties, lacked the required provisions, contained incorrect information, or failed to comply with Sec.  425.304(c) relating to the prohibition on certain required referrals and cost shifting. When we identified such agreements, ACOs experienced processing delays, and in some cases, we were unable to approve the ACO applicant and/or its ACO participant to participate in the Shared Savings Program. Consequently, we issued guidance for ACO applicants in which we reiterated the required elements for ACO participant agreements and strongly recommended that ACOs employ good contracting practices to ensure that each of their ACO participant agreements met our requirements (see http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/sharedsavingsprogram/Downloads/Tips-ACO-Developing-Participant-Agreements.pdf).

The ACO participant agreements are necessary for purposes of program transparency and to ensure an ACO’s compliance with program requirements. Moreover, many important program operations (including calculation of shared savings, assignment of beneficiaries, and financial benchmarking), use claims and other information that are submitted to CMS by the ACO participant. Our guidance clarified that ACO participant agreements and any agreements with ACO providers/suppliers must contain the following:

  • An explicit requirement that the ACO participant or the ACO provider/supplier will comply with the requirements and conditions of the Shared Savings Program (part 425), including, but not limited to, those specified in the participation agreement with CMS.
  • A description of the ACO participants’ and ACO providers’/suppliers’ rights and obligations in and representation by the ACO.
  • A description of how the opportunity to get shared savings or other financial arrangements will encourage ACO participants and ACO providers/suppliers to follow the quality assurance  and improvement program and evidence-based clinical guidelines.
  • Remedial measures that will apply to ACO participants and ACO providers/suppliers who do not comply with the requirements of their agreements with the ACO.

Agreement Must Be Direct With the Provider and Not Through an IPA

Our guidance also requires that the ACO participant agreements be made directly between the ACO and the ACO participant. We believe it is important that the parties entering into the agreement have a direct legal relationship to ensure that the requirements of the agreement are fully and directly enforceable by the ACO, including the ability of the ACO to terminate an agreement with an ACO participant that is not complying with the requirements of the Shared Savings Program.

Additionally, a direct legal relationship ensures that the ACO participant may, if necessary, terminate the agreement with the ACO according to the terms of the agreement without interrupting other contracts or agreements with third parties. Therefore, the ACO and the ACO participant must be the only parties to an ACO participant agreement; the agreements may not include a third party to the agreement. For example, the agreement may not be between the ACO and another entity, such as an independent practice association (IPA) or management company that in turn has an agreement with one or more ACO participants. Similarly, existing contracts between ACOs and ACO participants that include third parties should not be used.

We recognize that there are existing contractual agreements between entities (for example, contracts that permit organizations like IPAs to negotiate contracts with health care payers on behalf of individual practitioners). However, because it is important to ensure that there is a direct legal relationship between the ACO and the ACO participant evidenced by a written agreement, and because ACO participants continue to bill and receive payments as usual under the Medicare FFS rules (that is, there is no negotiation for payment under the program) we believe that typical IPA contracts are generally inappropriate and unnecessary for purposes of participation in the Shared Savings Program. An ACO and ACO participant may use a contract unrelated to the Shared Savings Program as an ACO participant agreement only when it is between the two parties and is amended to satisfy the requirements for ACO participant agreements under the Shared Savings Program.

Assure That Agreements Are In Correct Legal Names and Are Consistent With PECOS Information

It is the ACO’s responsibility to make sure that each ACO participant agreement identifies the parties entering into the agreement using their correct legal names, specifies the term of the agreement, and is signed by both parties to the agreement. We validate the legal names of the parties based on information the ACO submitted in its application and the legal name of the entity associated with the ACO participant’s TIN in the Provider Enrollment Chain & Ownership System (PECOS). We reject an ACO participant agreement if the party names do not match our records. It may be necessary for the ACO to execute a new or amended ACO participant agreement.

Although the ACO participant must ensure that each of its ACO providers/suppliers (as identified by a National Provider Identifier (NPI)) has agreed to participate in the ACO and will comply with program rules, the ACO has the ultimate responsibility for ensuring that all the ACO providers/suppliers that bill through the TIN of the ACO participant (that is, reassign their right to receive Medicare payment to the ACO participant) have also agreed to participate in the Shared Savings Program and comply with our program regulations. The ACO may ensure this by directly contracting with each ACO provider/supplier (NPI) or by contractually requiring the ACO participant to ensure that all ACO providers/suppliers that bill through its TIN have agreed to participate in, and comply with the requirements of, the Shared Saving Program. If the ACO chooses to contract directly with the ACO providers/suppliers, the agreements must meet the same requirements as the agreements with ACO participants. We emphasize that even if an ACO chooses to contract directly with the ACO providers/suppliers (NPIs), it must still have the required ACO participant agreement. In other words, the ACO must be able to produce valid written agreements for each ACO participant and each ACO provider/supplier. Furthermore, since we use TINs (and not merely some of the NPIs that make up the entity identified by a TIN) as the basis for identifying ACO participants, and we use all claims submitted under an ACO participant’s TIN for financial calculations and beneficiary assignment, an ACO may not include an entity as an ACO participant unless all Medicare enrolled providers and suppliers billing under that entity’s TIN have agreed to participate in the ACO as ACO providers/suppliers.

CMS Illustrations of Contracting Requirements for ACO Participation Agreements

To illustrate the requirement that all ACO providers/suppliers must agree to participate in and comply with the terms of the Shared Savings Program before the ACO can include the ACO participant’s TIN on its list of ACO participants, we offer the following scenarios that describe when an ACO participant’s TIN may and may not be included on the applicant’s ACO participant list:

Correct: A large group practice (Medicare-enrolled TIN) decides to participate in an ACO as an ACO participant. Its owner signs an agreement with the ACO on behalf of the practice to participate in the program and follow program regulations. Also, all practitioners that have reassigned their right to receive Medicare payments to the TIN of the large group practice have also agreed to participate and follow program regulations. Therefore, the ACO may include this group practice TIN on its list of ACO participants.

Incorrect: A large group practice (Medicare-enrolled TIN) decides to participate in an ACO as an ACO participant. Its owner signs an agreement to participate in the program and follow program regulations. However, not all practitioners that have reassigned their right to receive Medicare payment to the group practice TIN have agreed to participate in the ACO and follow Shared Savings Program regulations. Therefore, the ACO may not include this group practice TIN on its list of ACO participants.

Incorrect: Several practitioners in a large group practice (Medicare-enrolled TIN) decide to participate in an ACO. However, the group practice as a whole has not agreed to participate in the program. Therefore, the ACO may not include this group practice TIN on its list of ACO participants.

We propose to codify much of our guidance regarding the content of the ACO participant and ACO provider/supplier agreements.

b. Proposed Revisions

First, we propose to add new Sec.  425.116 to set forth the requirements for agreements between an ACO and an ACO participant or ACO provider/supplier. We believe the new provision would promote a better general understanding of the Shared Savings Program and transparency for ACO participants and ACO providers/suppliers. It is our intent to provide requirements that would facilitate and enhance the relationships between ACOs and ACO participants, and reduce uncertainties and misunderstandings leading to rejection of ACO participant agreements during application review. Specifically, we propose to require that ACO participant agreements satisfy the following criteria:

  • The ACO and the ACO participant are the only parties to the agreement.
  • The agreement must be signed on behalf of the ACO and the ACO participant by individuals who are authorized to bind the ACO and the ACO participant, respectively.
  • The agreement must expressly require the ACO participant to agree, and to ensure that each ACO provider/supplier billing through the TIN of the ACO participant agrees, to participate in the Shared Savings Program and to comply with the requirements of the Shared Savings Program and all other applicable laws and regulations (including, but not limited to, those specified at Sec.  425.208(b)).
  • The agreement must set forth the ACO participant’s rights and obligations in, and representation by, the ACO, including without limitation, the quality reporting requirements set forth in Subpart F, the beneficiary notification requirements set forth at Sec.  425.312, and how participation in the Shared Savings Program affects the ability of the ACO participant and its ACO providers/suppliers to participate in other Medicare demonstration projects or programs that involve shared savings.
  • The agreement must describe how the opportunity to receive shared savings or other financial arrangements will encourage the ACO participant to adhere to the quality assurance and improvement program and evidence-based medicine guidelines established by the ACO.
  • The agreement must require the ACO participant to update enrollment information with its Medicare contractor using the PECOS, including the addition and deletion of ACO professionals billing through the TIN of the ACO participant, on a timely basis in accordance with Medicare program requirements. The Agreement must also require ACO participants to notify the ACO within 30 days after any addition or deletion of an ACO provider/supplier.
  • The agreement must permit the ACO to take remedial action against the ACO participant, and must require the ACO participant to take remedial action against its ACO providers/suppliers, including imposition of a corrective action plan, denial of shared savings payments (that is, the ability of the ACO participant or ACO provider/supplier to receive a distribution of the ACO’s shared savings) and termination of the ACO participant agreement, to address noncompliance with the requirements of the Shared Savings Program and other program integrity issues, including those identified by CMS.
  • The term of the agreement must be for at least 1 performance year and must articulate potential consequences for early termination from the ACO.
  • The agreement must require completion of a close-out process upon the termination or expiration of the ACO’s participation agreement that requires the ACO participant to furnish data necessary to complete the annual assessment of the ACO’s quality of care and addresses other relevant matters.

Although we propose that the term of an ACO participant agreement be for at least 1 performance year, we do not intend to prohibit early termination of the agreement. We recognize that there may be legitimate reasons to terminate an ACO participant agreement. However, because care coordination and quality improvement requires commitment from ACO participants, we believe this requirement would improve the likelihood of success in the Shared Savings Program. We are also considering whether and how ACO participant agreements should encourage participation to continue for subsequent performance years. We seek comment on this issue.

ACOs That Choose To Contract Directly With ACO Providers/Supplier 

In the case of an ACO that chooses to contract directly with its ACO providers/suppliers, we propose virtually identical requirements for its agreements with ACO providers/suppliers. We note that agreements with ACO providers/suppliers would not be required to be for a term of 1 year, because we do not want to impede individual practitioners from activities such as retirement, reassignment of billing rights, or changing employers. In the case of ACO providers/suppliers that do not have a contract directly with the ACO, we are considering requiring each ACO to ensure that its ACO participants contract with or otherwise arrange for the services of its ACO providers/suppliers on the same or similar terms as those required for contracts made directly between the ACO and ACO providers/suppliers.

In addition, we propose to add at Sec.  425.204(c)(6) a requirement that, as part of the application process and upon request thereafter, the ACO must submit documents demonstrating that its ACO participants, ACO providers/suppliers, and other individuals or entities performing functions or services related to ACO activities are required to comply with the requirements of the Shared Savings Program. In the case of ACO participants, the evidence to be submitted must, consistent with our past guidance, include executed agreements or sample form agreements together with the first and last (signature) page of each form agreement that has been fully executed by the parties to the agreement.

However, we reserve the right, to request all pages of an executed ACO participant agreement to confirm that it conforms to the sample form agreement submitted by the ACO. We further propose at Sec.  425.116(c) that executed ACO participant agreements must also be submitted when an ACO seeks approval to add new ACO participants. The agreements may be submitted in the same form and manner as set forth in Sec.  425.204(c)(6). Finally, although we would not routinely request an ACO to submit copies of executed agreements with its ACO providers/suppliers or other individuals or entities performing functions or services related to ACO activities as part of the ACO’s application or continued participation in each performance year, we reserve our right to request this information during the application or renewal process and at any other time for audit or monitoring purposes in accordance with Sec.  425.314 and Sec.  425.316.

We believe that the proposed requirements regarding agreements between ACOs and ACO participants, together with our earlier guidance regarding good contracting practices, would enhance transparency between the ACO, ACO participants, and ACO professionals, reduce turnover among ACO participants, prevent misunderstandings related to participation in the Shared Savings Program, and assist prospective ACOs in submitting complete applications and requests for adding ACO participants. We believe that codifying these requirements would assist the ACO, ACO participants, and ACO providers/suppliers in better understanding the program and their rights and responsibilities while participating in the program. We solicit comment on the proposed new requirements and on whether there are additional elements that should be considered for inclusion in the agreements the ACO has with its ACO participants and ACO providers/suppliers.

Major Revamp of Nursing Home Regulations Proposed By CMS

July 17th, 2015

Nursing Home Regulations Proposed Revision CMSThe Centers for Medicare & Medicaid Services (CMS) has release new proposed regulations that would implement the first major rewrite of the long-term care Conditions of Participation in over 25 years. The proposed regulations were published on On July 13, 2015 in proposed form and are subject to a 60 day comment period before CMS issues them in final form. It is possible that CMS would revise the proposed rules based on input from the public duringthe comment period.

By changing nursing home regulations, CMS intends to improve the quality of care and safety affecting long-term care residents. The proposed changes would implement a number of safeguards including some protections that were required under the Affordable Care Act.

Providers involved in the nursing home industry should study the proposed regulations and may wish to provide comments to CMS to be addressed prior to finalization of the proposed regulations. Some of the items addressed in the proposed regulations include:

- Regulations regarding reduction of unnecessary hospital readmissions and infections

-increased quality of resident care

- New requirements to assure training of nursing home staff

- increased focus on patients with dementia and prevention of elder abuse.

- New rules regarding staffing decisions.

- Rules that help assure that staff members have the right skill sets and competencies to provide person-centered care to residents.

- Increased emphasis on resident preferences when developing care plans.

- Improvements to the process of care planning and discharge planning

- Increased authority of dietitians and therapy providers to write orders in their areas of expertise subject to physician delegatino and state law compliance.

- Requiring greater food choice for residents.

- Updating of infection prevention and control programs and establishment of new requirements for infection prevention and control.

- Enhancement of nursing home resident rights

More details can be obtained by reviewing the proposed regulations. We will be issuing additional updates regarding topics that are covered in the proposed regulations as we review the proposal in greated depth.

Medicare Shared Savings Program Changes Under 2016 Physician Fee Schedule Regulations

July 17th, 2015

Physician Fee Schedule Regulations Propose Changes to the Medicare Shared Savings Program

physician fee schedule mssp changesThe 2016 Physician Fee Schedule proposed rule that was published on July 8, 2015 includes proposals specific to certain sections of the Shared Savings Program regulations and solicits feedback from stakeholders. Following are a few of the proposed revisions to the Shared Savings Program that were contained in the PFS Regulations.

 

  • Proposed addition of a measure of Statin Therapy for the Prevention and Treatment of Cardiovascular Disease in the Preventive Health domain of the Shared Savings Program quality measure set to align with PQRS;
  •  Preservation of flexibility to maintain or revert measures to pay for reporting if a measure owner determines the measure no longer aligns with updated clinical practice or causes patient harm;
  • Clarification of how PQRS-eligible professionals participating within an ACO meet their PQRS reporting requirements when their ACO satisfactorily reports quality measures; and
  • Proposed amendment to the definition of primary care services to include claims submitted by Electing Teaching Amendment hospitals and exclude claims submitted by Skilled Nursing Facilities.

HCQIA and Clinically Integrated Provider Networks

July 7th, 2015

Health Care Quality Improvement Act and Clinically Integrated Provider Networks 

Clinical Integration HCQIAClinically integrated networks present unique credentialing issues that are normally not present in hospital or facility credentialing.  These unique issues stem from the very nature of integrated networks which require providers to comply with evidence-based protocols, individualized care plans, quality metrics, efficiency standards, and other system standards.

In order to assure compliance with these standards, integrated networks need to assert much more control over the clinical practices of its provider members than has historically been exercised in the hospital setting.  Credentialing and recredentialing processes need to be put in place to assure that providers practice in conformance with evidence-based practice protocols, coordinate care with other network providers, and otherwise work well within the system.

Integrated networks face a number of choices when determining how to structure their credentialing and recredentialing processes.  A threshold decision is whether the credentialing process should be structured to take advantage of the immunities that are available under the Health Care Quality Improvement Act (“HCQIA”).

Qualifying under the HCQIA has some benefits but also carries some burdens.  In order to qualify for HCQIA immunities, the organization must implement a formal credentialing, hearing, and appeal process in order to qualify for immunities.

A CIN must also register with the HRSA and is required to make reports to the Practitioner Databank if adverse peer review determinations are made.  The CIN receives a Data Bank Identification Number and can be penalized for not reporting adverse determinations.  The reporting requirement is an issue that provider networks may wish to avoid.  The obligation to report has the practical effect of making peer review actions much more controversial and prone to litigation because a database report is a serious negative mark on a physician’s record.

On the other hand, the immunities offered by the HCQIA can be extremely valuable to a clinically integrated network.  One of the immunities that is available under the HCQIA is from the treble damage provisions under federal antitrust laws.  This immunity cannot be discounted; particularly with provider networks that make more aggressive credentialing decisions based on achievement of quality and cost issues and infirmity with system protocols.

If a choice is made to secure the HCQIA immunities, a comprehensive credentialing, peer review and fair hearing process is required as is use of the Practitioner Databank.  Furthermore, in order to qualify, adverse actions only be taken in furtherance of quality healthcare, after a reasonable effort to develop the facts, with adequate notice and hearing to the affected practitioner.  The Act and interpreting case law have created rather detailed requirements for notice and hearing.  The end result is that extensive procedural processes must be in place and consistently followed by the organization.  This of course adds another layer of complexity and cost to the organization.  At the same time, it greatly decreases the organization’s potential liability exposure which under certain circumstances could greatly exceed the cost of complying with HCQIA requirements.

Medigap PHO Discount Program Receives OIG Approval

June 23rd, 2015

OIG Releases Yet Another Advisory Opinion 15-08

Medigap Arrangment Involving PHO Discounts

Medigap PHO Discount ProgramSomeone must be busy at the Office of Inspector General’s Office. Last week they released two new advisory opinions and a Special Fraud Alert. This week they released another Advisory Opinion, this time addressing sharing savings from a preferred hospital network between a Medigap insurer and its policy beneficiaries. The program at issue provided a premium credit of $100 toward the policyholder’s next renewal premium for participating in a discount program involving price reductions from a physician-hospital organization.

The second part of the program involved negotiated service rates with a physician-hospital organization (PHO). The PHO agreed to discounts of up to 100% of the Medicare Part A inpatient deductibles which would normally be paid by the Medigap plan. The PHO received an administrative fee from the Medigap plan for each discount that was provided by the PHO.

The OIG analysed the program under the civil monetary penalty (CMP) provisions and the Anti-Kickback Statute (AKS) and concluded that the arrangement would not constitute grounds for civil monetary penalties or administrative sanctions.

The OIG found that discounting of the inpatient deductible created a low risk of fraud or abuse because the Medicare Part A payments are fixed and the discount would not impact reimbursement amounts. Additionally, the OIG observed that patients would not generally haveknowledge of the discount and would not be encouraged to seek additional care. The program did not offerfinancial rewards to the physicians involved in the patient’s care and the program was open to all providers who agreed to the discount program through participation in the PHO.
The OIG also found that the premium credits that were provided to beneficiaries created minimal risk of program abuse.

The OIG also noted that the proposed arrangement has the potential of lowering costs for policyholder under the Medigap plan and that the savings would be reported to the state regulatory agency.

OIG Fraud Alert – Medical Director Compensation Arrangements

June 23rd, 2015

medical director compsnation

Medical Director – Fraud Alert – Physician Compensation

The Office of Inspector General of the Department of Health and Human Services release a new Fraud Alert on June 9, 2015.  The Fraud Alert relates to physician compensation for medical directorships and other services and warns that the compensation arrangements under these arrangements must be at fair market value and must require legitimate services to be performed in return for that compensation.  This is nothing new for those involved in physician compliance issues. However, the fact that the OIG chose this issue for a special Fraud Alert is significant in itself.

Medical director compensation has gained the attention of governmental enforcers over the years with some high profile cases that have focused on fraudulent medical director arrangements.  The compliance industry has tightened its belt on these issues; requiring strict adherence to policies and guidelines for medical director compensation. Clearly there is a legitimate need for health care providers to retain physicians to provide medical direction of various service lines.  In fact, regulations require medical director oversight in many areas.  Even where there is a legitimate need, it is necessary to carefully structure the medical director arrangement to be legally compliant.

You may find your compliance officer of health lawyer advising even more restrictive structuring of medical director arrangements as a result of this Fraud Alert.  The OIG uses Fraud Alerts to place emphasis on areas of concern.  These issuance must be taken seriously and should cause providers to review their policies, procedures and contracts to assure that they are legally compliant and could withstand scrutiny by external government investigators.

A few things to consider include:

  • Specifically defining the precise services that are required of the medical director.
  • Assuring that contracts are current, validly executed, and have not expired.
  • Require regular logs to be provided by the medical director which detail the services that are actually performed.
  • Require the service logs to correspond to specific duties that are described in the director agreement.
  • Support compensation with external fair market value opinions.
  • Cap compensation to assure that fair market value is never exceeded.

These are just a handful of issues providers need to consider when entering these arrangements with physicians.  For further details, contact your health care attorney or compliance officer.  By all means, pull your medical director agreements off the shelf and make certain that they are legally compliant.  You cannot assume that those arrangements will not be scrutinized by government enforces.

See – Fraud Alert: Physician Compensation Arrangements May Result in Significant Liability June 9, 2015.

Final Rule Under the Medicare Shared Savings Program Released

June 11th, 2015

CMS Releases Final Revised Shared Savings Program Regulations

Shared Savings Program regulationsThe Center for Medicare and Medicaid Services (CMS) has issued final regulations revising requirement applicable to Accountable Care Organizations (ACOs) under the Medicare Shared Savings Program (MSSP).  CMS previously issued proposed rules and a notice of rulemaking in December of 2014 which were finalized on June 9, 2015 after consideration of comments received during the comment period.  The new rules are effective in August with just a few exceptions and contain some fairly significant changes in the rules that govern ACOs and applications under the MSSP.

We will be reviewing the regulations in detail and providing a comprehensive summary, so check back or grab our RSS feed.

A bullet form listing of some of the key changes in the final regulations include:

  • New requirements for ACO specific contracts or contract amendments.
  • Additional details on the ACO requirement to establish mechanisms for shared governance among ACO participants.
  • New standards for submitting a list of ACO participants/supplier.
  • Expansion of program integrity and provisions to protect beneficiaries.
  • Rules regarding adjustment to benchmarks resulting from mergers or acquisitions.
  • ACOs are required to maintain a dedicated webpage and are required to post certain information using CMS templates on that web page.  Information that must be posted included:
    • identification key clinical and administrative leaders
    • identification of the types of ACO participants involved in the ACO
    • quality measurement performance information
    • information regarding shared savings payments and losses
  • Specific requirements for ACOs to submit executed provider agreements along with their initial application and upon renewal.
  • CMS authority to take action against or terminate and ACO that does not continue to meet the minimum assigned beneficiary standards.
  • Rules regarding modification to benchmarks during a pending performance year.
  • A prohibition on an ACO provider filling the “beneficiary representative” slot on the ACO’s governing body.
  • Additional flexibility regarding the qualifications of the ACO’s medical director.
  • A transitional process from the Pioneer program to the MSSP.
  • Revised process for beneficiaries to elect to opt out of data sharing.  Beneficiaries will only be permitted to opt out directly through CMS.
  • Expansion of beneficiaries that are included in aggregate reports.
  • Removal of the requirement for ACOs to provide opt-out information to beneficiaries before requesting claims data.
  • Waiver of the three-day inpatient stay rule for certain nursing home admissions during Track 3.
  • Several revisions to the beneficiary assignment process.
  • Changes to the annual shared savings repayment mechanisms.
  • Permitting a second year of Track 1 participation for certain ACOs.
  • Revisions to the manner in which ACOs may select their MSR/MLR under Track 2.
  • Provision for prospective assignment of beneficiaries to Track 3.
  • Sharing of up to 75% of savings in Track 3.
  • First year benchmarking remains unchanged.
  • Revision of  benchmarking methods applicable to ACOs entering their second and subsequent contract periods.   Benchmarking years will be equally weighed to reflect the average per capita shared savings.

John H. Fisher

Health Care Counsel
Ruder Ware, L.L.S.C.
500 First Street, Suite 8000
P.O. Box 8050
Wausau, WI 54402-8050

Tel 715.845.4336
Fax 715.845.2718

Ruder Ware is a member of Meritas Law Firms Worldwide

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