Health Law Blog - Healthcare Legal Issues

Archive for the ‘Medicare Reimbursement Rules’ Category

Anti-Discrimination Plans/Part D Sponsors

Monday, January 30th, 2017

Anti-Discrimination Rules in Medicare Advantage Plans

42 CFR 422.110, 422.2268(c), 423.2268(c)

Plans/Part D Sponsors may not discriminate based on race, ethnicity, national origin, religion, gender, sex, age, mental or physical disability, health status, claims experience, medical history, genetic information, evidence of insurability or geographic location. Plans/Part D Sponsors may not target beneficiaries from higher income areas or state/ imply that plans are only available to seniors rather than to all Medicare beneficiaries. Only Special Needs Plans (SNPs) and MMPs may limit enrollments to individuals meeting eligibility requirements based on health and/or other status. Basic services and information must be made available to individuals with disabilities, upon request.

Requirements Pertaining to Non-English Speaking Populations Medicare Health Plans

Sunday, January 29th, 2017

Requirements Pertaining to Non-English Speaking Populations

42 CFR 422.111(h)(1), 422.112(a)(8), 423.128(d)(1)(iii), 422.2264(e), 423.2264(e)

All Plans’/Part D Sponsors’ call centers must have interpreter services available to call center personnel to answer questions from non-English speaking or limited English proficient (LEP) beneficiaries. Call centers are those centers that receive calls from current and prospective enrollees. This requirement is in place regardless of the percentage of non-English speaking or LEP beneficiaries in a plan benefit package (PBP) service area. Plans/Part D Sponsors must make the marketing materials identified in sections 30.6, 30.7, 30.9, and the Part D Transition Letter(s) available in any language that is the primary language of at least five (5) percent of a Plan’s/Part D Sponsor’s PBP service area. Final populated translations of all marketing materials must be submitted in HPMS (see section 90.2 for material submission process).

Historically, regardless of the five (5) percent service area threshold, CMS required that all Plans/Part D Sponsors communicated the availability of language assistance services in the fifteen most common non-English languages spoken in the US via the Multi-Language Insert (MLI). The MLI was required to accompany the Summary of Benefits (SB), Annual Notice of Change (ANOC)/Evidence of Coverage (EOC), and the enrollment form. Because Section 1557 of the Patient Protection and Affordable Care Act contains a similar yet more robust requirement, CMS will now defer to the requirements under Section 1557 when it comes to communicating the availability of language assistance services. Plans/Part D Sponsors should consult with the Office for Civil Rights (OCR), the Federal Agency responsible for Section 1557, for questions pertaining to Section 1557 Compliance. In addition, OCR has a Section 1557 resource website that can be accessed at: https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.html

 

Medicare Advantage Marketing Standards 2018 Draft Requirements

Sunday, January 29th, 2017

Marketing Material Subject to CMS Guidelines for MA Marketing Materials

Medicare broadly defines the types of marketing materials that must comply with with CMS requirements. (42 CFR Section 417.428, Section 422.2260, and Section 423.2260) Examples of the types of marketing materials that must meet the CMS requirements include, by way of example, materials such as:

  • General audience materials, such as general circulation brochures, direct mail, newspapers, magazines, television, radio, billboards, yellow pages, or the Internet;
  • Marketing representative materials, such as scripts or outlines for telemarketing or other presentations;
  • Presentation materials, such as slides and charts;
  • Promotional materials, such as brochures or leaflets, including materials circulated by physicians, other providers, or third-party entities;
  • Membership communication materials, including: membership rules, subscriber agreements, enrollee handbooks, and wallet card instructions to enrollees (e.g., Annual Notice of change (ANOC), Evidence of Coverage (EOC));
  • Communications to enrollees about contractual changes, such as changes in providers, premiums, benefits, plan procedures;
  • Communications related to membership activities (e.g., materials on rules involving non-payment of premiums, confirmation of enrollment or disenrollment, or non-claim specific notification information); and
  • The activities of a Plan’s/Part D Sponsor’s employees, independent agents or brokers, Third Party Marketing Organizations (TMO) (downstream contractors), or other similar organizations that contribute to the steering of a potential enrollee toward a specific plan or limited number of plans, or may receive compensation directly or indirectly from a Plan/Part D Sponsor for marketing activities, among others.
  • The following types of materials are not subject to CMS marketing review,  should not be submitted in HPMS, and do not require a material ID number. However, Plans/Part D Sponsors are still responsible for maintaining such materials and must make them available, through HPMS or other means, upon request.
  • HIPAA Privacy notices (which are subject to enforcement by the Office for Civil Rights);
  • OMB-approved forms/documents, except when otherwise specified by CMS;
  • Press releases that do not include any plan-specific information (examples of plan-specific information include information about benefits, premiums, co-pays, deductible, how to enroll, networks);
  • Enrollee newsletters that do not include any plan-specific information (examples of plan-specific information include information about benefits, premiums, co-pays, deductible, benefits, how to enroll, networks);
  • Blank letterhead/fax coversheets/blank pages that do not include promotional language;
  • General health promotion materials that do not include any specific plan related information (examples of general health promotion materials include health education and disease management materials). In general, health promotion materials should meet CMS’ definition of “educational” (Refer to section 70.8, Educational Events);
  • Non-Medicare beneficiary-specific materials that do not involve an explanation or discussion of Part D, MA, or Section 1876 cost plans (examples of materials within this category include notice of check return for insufficient funds, letter stating Medicare ID number provided was incorrect, billing statements/invoices, sales, and
    premium payment coupon book);
  • Documents to recruit or train sales/marketing representatives;
  • Medication Therapy Management (MTM) program materials (see definition in Appendix 1);
  •  Ad hoc Enrollee Communications Materials (see definition in Appendix 1);
  • Educational materials, such as those used at educational events for the education of beneficiaries and other interested parties (also see section 70.8), that do not contain plan specific information;
  • Coordination of Benefits notifications (as provided in Chapter 14 of the Medicare Prescription Drug Benefit Manual);
  • Health Risk Assessments;
  • Mail order pharmacy election forms;
  • Enrollee surveys and focus groups;
  • Value-Added Items and Services (refer to Chapter 4 of the Medicare Managed Care Manual) See definition in Appendix 1;
  •  Documents encouraging enrollees to use preventive services;
  • Mid-year Change Enrollee Notifications (see section 60.7);
  • Informational Scripts;
  • Marketing materials created by State government; and
  • Password protected websites that only current enrollees can access;
  • Marketing materials included on the website are still subject to review (e.g., Plan/Part D Sponsor advertisements).

Off-Campus Provider-Based Departments Neutrality

Friday, December 23rd, 2016

Off-Campus Provider-Based Departments Site-Neutrality

The 21st Century Cures Act contains new provisions that prohibits the Centers for Medicare & Medicaid Services (CMS) from paying different rates for services provided in for services furnished in off-campus provider-based department (PBD) of a hospital.    The CY 2015 Outpatient Prospective Payment System Final Rule (79 FR 66910-66914) created a HCPCS modifier for hospital claims that is to be reported with every code for outpatient hospital items and services furnished in an off-campus provider-based department of a hospital. This 2-digit modifier was be added to the HCPCS annual file as of January 1, 2015, with the label ‘‘PO.’’ Reporting of this new modifier was voluntary for CY 2015, with reporting required beginning on January 1, 2016.

The 21st Century Cures Act revises this policy beginning January 1, 2017, with some exceptions. One exception is for OPBDs that billed for services furnished as of November 2, 2015 (the date the law was enacted). The 21st Century Cures Act expounds on this exception and permits providers to be grandfathered under the old rules if the Secretary received a properly filed provider-based attestation for the site from the provider prior to December 2, 2015.  Furthermore, if  an off-campus provider-based department was in development as of November 2, 2015 and made a timely filing of a certification to CMS,  the old rules can be applied even though the department was not operating as of the cut-off date.

John H. Fisher, CHC, CCEP is a health care attorney at the Ruder Ware law firm.  John is actively involved representing clients on legal and compliance issues.  He has represented clients in creating compliance programs and in a variety of operational issues.  He also assists providers in addressing risk areas and potential compliance issues including preparing self-disclosure and working with the government to resolve disclosed compliance issues and overpayment.  John consults as a subject matter expert and provider legal backup to other attorneys and law firms from around the country on specialized compliance, regulatory and health care issues.  John has followed legal issues impacting health care provider for over 25 years.  As such, he is knowledgeable on the current legal standards as well as the historic perspective that is often relevant to an appropriate analysis.  

Telemedicine Medicare Reimbursement Expansion Proposed

Friday, September 9th, 2016

Telemedicine Reimbursement; 8 New Codes Proposed by CMS

The Center for Medicare and Medicaid Services (CMS) has released proposed regulations that would increase telehealth coverage. The proposed regulations would add 8 new CPT codes to the list of Medicare covered telehealth encounters. If adopted, the new codes would be available beginning January 1, 2017. by 8 new Current Procedural Terminology (CPT) codes for services beginning January 1, 2017. This is part of the proposed rule making for Part B physician and practitioner services. Four of the new codes involve services related to end-stage renal disease (90969, 90970, 90968, 90967). Two new temporary codes are proposed for critical care evaluation and management (GTTT1, GTTT2). Lastly, two codes are proposed related to explanation and discussion of advance directives (99497, 99498).

The rue has a comment period and the new codes are not effective until January 1, 2017 even if adopted in final form.

300 Pages of New Regulations Ruining Health Care Attorney Lives Across the Country

Wednesday, November 18th, 2015

 

Mountain of New Regulations Issued By CMS

Health Care Regulations 2016Just a tip to my colleagues in health care law.  Do not send these new regulations to printer before giving them an eyeball.  They are long and if you share a printer you will be buying coffee for your colleagues for at least a week.

True to their nature, there are a number of things that are unrelated to physician payment scattered throughout this poorly indexed document.  We have new Stark Law exceptions, changes to “incident to” billing rules, telemedicine reimbursement standards, and a whole host of additional little morsels that we health care attorneys need to locate, study, and update our clients on; all before the next guy down the street beats us to the rap.On November 16, 2015, the Department of Health and Human Services officially published their final rules Revising Payment Policies Under the Physician fee Schedule and Other Revisions to Part B for CY 2016.

Have a pleasant rest of your week gang.  Anyone who does not want to wade through all of these regulations can come on back to this blog as we post articles on various pieces of the new rules.

And remember; here at Ruder Ware, Health Care Never Sleeps!

Incident To Billing Rules Changed In New CMS Regulations

Wednesday, November 18th, 2015

New regulations issued by the Center for Medicare and Medicaid services on November 16, 2015 change the way that services that are furnished “incident to” the service of a physician must billed. The new regulations provide clarification that the billing provider must be the provider that actually supervises the incident to service.

Previously, regulations stated that the physician supervising the auxiliary personnel need not be the same physician upon whose professional service the “incident to”services base. The provisions in previous regulations that permitted another physician to supervise the incident to service have been removed. Now, the physician who is actually available and actually supervises must be the party whose billing number is connected with the incident to service.

The service that is performed “incident to” the services of a physician can generally be billed at 100% of the physician’s rate under the Medicare fee schedule.  However, supervision and billing standards must be complied with to avoid creating a compliance issue and potential overpayment.

All providers must look at their billing policies and procedures to be certain that they integrate the new “incident to” billing standards into their compliance policies and procedures and appropriately implement the new standard through proper training of their billing staff, physicians and support staff.  This is also a good time to refresh provider training on the extent of supervision that is required in various care settings.

ACO Primary Care Exclusivity Requirement – Not As Broad As Some Believe

Tuesday, September 1st, 2015

Exclusivity of Primary Care Physicians Under MSSP Rules

MSSP Primary Care ExclusivityThere has been a lot of confusion across the country about the primary care exclusivity requirement that applies to Accountable Care Organizations under the Medicare Shared Savings Program.  Some providers are under the mistaken belief that primary care doctors must be exclusive with the ACO under all payment types, including private commercial contracts.  This extent of exclusivity is not required under the MSSP rules.  In fact, exclusivity is a huge factor that is indicative of antitrust violation except where required under the MSSP regulations.

The exclusivity requirement for primary care physicians is limited to participation in the MSSP program.  Primary care physician are not required to be exclusive to an ACO for commercial contracts.  Below are some quotes that were made by the Center for Medicare and Medicaid Services in the recently released revised MSSP regulations.  This information clearly indicates the scope and purposes of the exclusivity requirement for primary care physicians.

CMS Statement On Exclusivity of Primary Care Providers

Response: We regret that some of the language in the preamble about  the exclusivity of ACO participants (defined by the Medicare-enrolled  billing TIN) created unnecessary confusion about the proposal. The  point of our proposal was that, for us to appropriately evaluate ACO performance, we must evaluate performance based on a patient population  unique to the ACO. Therefore, some ACO participants, specifically those  that bill for the primary care services on which we proposed to base  assignment, would have to be exclusive to an ACO, for the purpose of Medicare beneficiary assignment, for the duration of an agreement  period. In the absence of such exclusivity and in a situation where an ACO participant is associated with two or more ACOs, it would be  unclear which ACO would receive an incentive payment for the  participant’s efforts on behalf of its assigned patient population.

Exclusivity of the assignment-based ACO participant TIN ensures unique  beneficiary assignment to a single ACO.  However, exclusivity of an ACO  participant TIN to one ACO is not necessarily the same as exclusivity  of individual practitioners (ACO providers/suppliers) to one ACO. We did state somewhat imprecisely in the preamble to the proposed rule that “ACO professionals within the respective TIN on which beneficiary  assignment is based, will be exclusive to one ACO agreement in the  Shared Savings Program.  This exclusivity will only apply to the primary care physicians.” This statement appears to be the basis of the  concerns expressed by many commenters, and we understand the reasons  for those concerns. However, we stated the policy (76 FR 19563) we  intended to propose more precisely elsewhere in the preamble, when we  stated that “[t]his exclusivity will only apply to primary care physicians (defined as physicians with a designation of internal medicine, geriatric medicine, family practice and general practice, as discussed later in this final rule) by whom beneficiary assignment is established when billing under ACO participant TINs. (Emphasis added).

Thus, the exclusivity necessary for the assignment process to work  accurately requires a commitment of each assignment-based ACO participant to a single ACO for purposes of serving Medicare  beneficiaries. It does not necessarily require exclusivity of each primary care physician (ACO provider/supplier) whose services are the  basis for such assignment.   For example, exclusivity of an ACO  participant leaves individual NPIs free to participate in multiple ACOs  if they bill under several different TINs. Similarly, an individual NPI  can move from one ACO to another during the agreement period, provided  that he or she has not been billing under an individual TIN. A member of a group practice that is an ACO participant, where billing is  conducted on the basis of the group’s TIN, may move during the  performance year from one group practice into another, or into solo practice, even if doing so involves moving from one ACO to another.

This degree of flexibility is, in fact, one reason for our preference  to use TINs to identify ACO participants over NPIs: adopting NPIs in  place of TINs would result in the much stricter exclusivity rules for  individual practitioners to which so many commenters objected, than the  use of TINs to identify ACOs. This flexibility is limited, once again,  only in cases where the ACO participant billing TIN and individual TIN  are identical, as in the case of solo practitioners. Even in those  cases, moreover, it was not our intent (and it is no part of the policy that we are adopting in this final rule) that an individual  practitioner may not move from one practice to another. But while solo  practitioners who have joined an ACO as an ACO participant and upon  whom assignment is based may move during the agreement period, they may  not participate in another ACO for purposes of the Shared Savings  Program unless they will be billing under a different TIN in that ACO.

We are therefore finalizing our proposal that each ACO participant  TIN is required to commit to an agreement with us.  In addition, each  ACO participant TIN upon which beneficiary assignment is dependent must  be exclusive to one ACO for purposes of the Shared Savings Program. ACO  participant TINs upon which beneficiary assignment is not dependent are  not required to be exclusive to a single ACO for purposes for the  Shared Savings Program.  As we discuss in section E found later in this  final rule we are also providing for consideration of the primary care  services provided by specialist physicians, PAs, and NPs in the assignment process subsequent to the identification of the  “triggering” physician primary care services. We are therefore also   extending our exclusivity policy to these ACO participants. That is,  the TINs under which the services of specialists, PAs, and NPs are  included in the assignment process would have to be exclusive to one  ACO for purposes of the Shared Savings Program. (We emphasize that we  are establishing this policy for purposes of Shared Savings Program  ACOs only: Commercial ACOs may or may not wish to adopt a similar  policy for their purposes.

CMS Comments On ACO Participation Agreement Requirements

Friday, 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.

Medicare Shared Savings Program Changes Under 2016 Physician Fee Schedule Regulations

Friday, 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.

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

Search
Disclaimer
The Health Care Law Blog is made available by Ruder Ware for educational purposes and to provide a general understanding of some of the legal issues relating to the health care industry. This site does not provide specific legal advice and you should not use the information contained on this site to address your specific situation without consulting with legal counsel that is well versed in health care law and regulation. By using the Health Care Law Blog site you understand that there is no attorney client relationship between you and Ruder Ware or any individual attorney. Postings on this site do not represent the views of our clients. This site links to other information resources on the Internet; these sites are not endorsed or supported by Ruder Ware, and Ruder Ware does not vouch for the accuracy or reliability of any information provided therein. For further information regarding the articles on this blog, contact Ruder Ware through our primary website.