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Archive for the ‘Managed Care Compliance’ 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

 

Co-Branding Requirements Under Medicare Advantage Marketing Standards

Sunday, January 29th, 2017

Plans/Part D Sponsors co-branding relationships

Plans are prohibited from displaying the names and/or logos of co-branded providers on the Plan’s member identification card, unless the provider names and/or logos are related to a member’s selection of a specific provider/provider organization, (e.g., physicians, hospitals).

Part D Sponsors are prohibited from displaying the names and/or logos of co-branded providers/pharmacies on the Part D Sponsor’s member identification card. Plans/Part D Sponsors that choose to co-brand with providers/pharmacies must include on marketing materials (other than ID cards) the language in section 50.9.

Neither the Plan/Part D Sponsor nor its co-branding providers/pharmacies, whether through marketing materials or other communications, may imply that the co-branding partner is endorsed by CMS, or that its products or services are Medicare-approved.
Co-branded marketing materials must be submitted to CMS by the Plan/Part D Sponsor.
Note: Consistent with the National Council for Prescription Drug Program’s (NCPDP’s) “Pharmacy and/or Combination ID Card” standard, the Pharmacy Benefit Manager (PBM) name may be included on a enrollee ID card.

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).

Draft 2018 Medicare Marketing Guidelines Medicare Advantage Plans

Sunday, January 29th, 2017

New draft Medicare marketing requirements have been released The Medicare Marketing Guidelines (MMG) implement the Centers for Medicare Advantage Plans, Medicare Prescription Drug Plan, Employer/Union-Sponsored Group Health Plans, and Section 1876 cost plans. These requirements also apply to Medicare-Medicaid
Plans (MMPs), except as modified or clarified in state-specific marketing guidance for each state’s demonstration. I will post various provisions in the propose marketing requirements as I work through them with my review, so keep tune if you are looking for a summary of requirements.  In the meantime, if you want to review the source document yourself, you can download it from this page.

2018 Draft MMG for Industry Comment

OIG 2017 Annual Work Plan

Monday, January 23rd, 2017

OIG Annual Work Plan for 2017 – Topics Covered

The Health and Human services Office of Inspector General (OIG) recently released its 2017 Annual Work Plan.  Work planning is an ongoing project within the OIG.  Every year, the OIG publishes a work plan that consolidates the OIG audits and evaluations that are being conducted or planned within the organization.  The annual work plan has become a source that compliance officers look to as a tool for the identification of potential risk areas or areas of emphasis within their organization.  It is obviously not the only source for identifying compliance risk areas, but is certainly one reliable source that providers can draw on when setting their annual compliance priorities.

The 2017 OIG Work Plan can be download through the OIG site.

Ruder Ware’s health care group will continue to put out blogs and articles on various issues identified in the 2017 Annual Work Plan.  We will focus primarily on issues that were introduced for the first time in this year’s plan.

A listing of some of the issues addressed in the 2017 annual work plan include:

Hyperbolic Oxygen Therapy Services – Provider Reimbursement in Compliance with Federal Regulations

Incorrect Medical Assistance Days Claimed by Hospital

Inpatient Psychiatric Facility Outlier Payments

Case Review of Inpatient Rehabilitation Hospital Patients Not Suites for Intensive Therapy

Intensity-Modulated Radiation Therapy

Outpatient Outlier Payments for Short-Stay Claims

Comparison of Provider-Based and Freestanding Clinics

Reconciliation of Outlier Payments

Hospital Use of Outpatient Stays Under Medicare’s Two Midnight Rule

Case Review of Inpatient Rehabilitation Hospital Patients Not Suited for Intensive Therapy

Medicare Costs Associated with Defective Medical Device

Payment Credits for Replaced Medical Device That Were Implanted

Medicare Payment for Overlapping Part A Inpatient Claims and Part B Outpatient Claims

Selected Inpatient and Outpatient Billing Requirements

Duplicate Graduate Medical Education Payments

Indirect Medical Education Payments

Outpatient Dental Claims

Nationwide Review of Cardiac Catheterization and Endomyocardial Biopsies

Payments for Patients Diagnosed with Kwahiorkor

Use if Hospital Wage Data Used to Calculate Medicare Payments

CMS Validation of Hospital-Submitted Quality Reporting Data

Long Term Care Hospitals – Adverse Events in Post-acute-Care for Medicare Beneficiaries

Hospital Preparedness and Response to Emerging Infectious Diseases

Nursing Home Complaint Investigation Data Brief

Skilled Nursing Facilities – Unreported Incidents of Potential Abuse and Neglect

Skilled Nursing Facility Reimbursement

Skilled Nursing Facility Adverse Even Screening Tool

National Background Checks for Long Term Care Employees – Mandatory Review

Skilled Nursing Facility Prospective Payment System Requirements

Potentially Avoidable Hospitalizations of Medicare and Medicaid Eligible Nursing Facility Residents

Medicare Hospice Vulnerabilities and Recommendations for Improvement

Review of Hospices Compliance with Medicare Requirements

Hospice Home Care – Frequency of Nurse On-Site Visits to Assess Quality of Care and Services

Comparing HHS Survey Documents to Medicare Claims Data

Home Health Compliance with Medicare Requirements

Part B Services During Non Part-A Nursing Home Stays; Durable Medical Equipment

Medicare Market Share of Mail-Order Diabetics Testing Strips

Positive Airway Pressure Device Supplier – Supplier Compliance Documentation Requirements for Frequency and Medical Necessity

Orthotic Braces – Reasonableness of Medicare payments Compared to Amount Paid by Other Payors

Osteogenesis Simulators – Lump Sum Purchase Versus Rental

Power Mobility Devices – Lump Sum Purchase Versus Rental

Competitive Machines and Related Drugs – Supplier Compliance with Payment Requirements

Access to Durable Medical Equipment in Competitive Bidding Areas

Orthotic Braces – Supplier Compliance with Payment Requirements

Nebulizer Machines and Related Drugs – Supplier Compliance with Payment Requirements

Access to Durable Medical Equipment in Competitive Bidding Areas

Monitoring Medicare Payments for Clinical Diagnostic Laboratory Tests – Mandatory Review

Medicare Payments for Transitional Care Management

Medicare Payments for Chronic Care Management

Data Brief on Financial Interests Reported Under the Open Payments Program

Health Care Compliance Attorney – Certified CHC Lawyer

Tuesday, January 10th, 2017

Health Care Compliance Attorney

Compliance Representation – Certified Health Care Compliance

The Ruder Ware Compliance Team provides a variety of compliance-related services across a number of industry sectors.  Our compliance practice in the health care industry is lead by Attorney John Fisher.  John is a practicing health care attorney who has substantial expertise in the compliance area.  He is certified in both Health Care Compliance and Corporate Compliance and Ethics.

Aggressive Governmental Fraud and Abuse Investigations

Government enforcement practices and ever changing regulatory requirements require health care providers of all types and specialties to function in a highly complex environment.  Government enforcement operates under a “return on investment” mentality which leads to extremely aggressive and sometimes unfairly overbroad enforcement actions.  This leaves even the most well intentioned health care provider feeling targeted and overburdened with regulatory requirements.

Ruder Ware Provides a Full Range of Compliance Services

The Ruder Ware compliance team has provided a broad range of compliance related legal services to a wide range of health care providers such as hospitals, mental health programs, skilled nursing facilities, ambulatory surgery centers, a variety of medical groups, diagnostic facilities, home health care providers, personal care agencies, clinically integrated provider groups, accountable care organizations and other providers.  Each provider that we represent has unique features and characteristics that require creative approaches to mitigate the impact of overzealous governmental enforcement and private whistleblowers.

We Help You Prepare for an Eventual External Examination of Your Compliance Process

Our compliance practice functions under the philosophy that all providers will eventually be called upon to defend their compliance programs.  This may come through a self-disclosure after an infraction that is discovered through self assessment or audit.  Less ideally, it could come from a money hungry whistleblower who will not let go of a case until there is a payday.  It could also come at the hands of a government criminal or civil prosecutor.  Regardless of the source of challenge, at some point in the future, a compliance program will be put to the test.  When this happens, it must be effective to detect and correct potential compliance problems.  This requires both a well designed plan.  It also requires a showing that the plan is actively operating to identify risk areas, audit for anomalies in areas where risk may be present, and comes full circle to take appropriate action to correct potential problems that are identified.  If this is happening when your time comes; when your compliance program is put to the test, you will have gone a long ways toward mitigation of potential negative consequences.

Penalties Are Increasing and the Scope Activity Considered Abusive Continues to Expand

Some may wonder how the government plans to pay for changes in the health care system.  One of the primary sources of payment in the future will be through enforcement of actual or perceived fraud and abuse.  Currently, the Federal government received an 800% return on every dollar that it invests on pursuing health care fraud and abuse.  With increased penalties and more draconian enforcement systems in place, the government is poised to turn the enforcement business into an even more lucrative proposition.  The stage is set with laws that increase penalties to such an astronomical level that even a much less than certain case will be settled rather that risk being dragged through a proceeding that a provider is likely to lose in the end.

The Danger of Whistleblower Claimants

Whistleblowers also are incentivized to file cases as they seek to benefit personally from provider activity that may not fully conform to regulatory expectations. No provider is immune, no matter how effective its corporate responsibility program. For these reasons, all providers need experienced Compliance Counsel to assist them in trying to prevent regulatory violations, to determine the scope of and assist with correcting identified compliance issues and to defend them in the event they do become a target of government investigative activities.

Whistleblowers can come from a number of different places.  Disgruntled employees are a prime candidate to bring a whistleblower complaint.  How these complaints are handled is extremely important to minimizing their potential negative impact on you operations.  Once a Whistleblower attorney becomes financially committed to a case, they tend not to let go easily.  Settlement can be very difficult to attain on reasonable terms.  It is fair to say that in many cases the government gives more latitude to settle cases if the provider cooperates.

There are some reasonable government enforcement individuals who appropriately utilize their discretion when a provider cooperates and has not intentionally bilked the system.  Whistleblowers on the other hand, have their sites set on the full maximum amount of calculated False Claims Act damages.  They are looking for a pay day.  We can help you avoid this type of situation altogether by helping establish an effective compliance program that takes appropriate action to mitigate exposure if infractions are discovered.

General Compliance Counsel Services

We act as general compliance counsel to numerous health care providers and companies as well as business in other industries such as transportation, finance, manufacturing, securities, and other industry areas.  Ruder Ware represents businesses with worldwide operations who we routinely counsel regarding the impact of anti-bribery laws and other laws that impact international operations.  Our multidisciplinary approach enables us to apply our expertise in compliance process and investigations to various industry sectors that are represented by other attorneys in our firm who have extensive knowledge of the regulatory requirements that impact their business or industry sector.  For example, we have applied our compliance knowledge with our significant clientele in the transportation industry, paper manufacturing industry, financial sector, and heavy manufacturing for international distribution.

Roots in the Highly Regulated and Ever Changing Health Care Industry

Our compliance practice got its start primarily in the health care industry and has flourished into other areas building on our experience and success in health care.  The health care industry has historically been out in front of many other industries which enabled our firm to get into the compliance service industry early and gained significant experience that has served our team well. Our compliance team has gained substantial experience handling compliance that impact the Federal False Claims Act, Civil Monetary Penalties Law, Stark Law and Anti-Kickback Statute. We routinely counsel our clients on how to apply systems to proactively comply with a multitude of regulations that apply to their regulations.  We recommend processes that apply to all types of health care providers and across all industry sectors.

Proactive and Aggressive Risk Identification Process

Our recommended process creates a “living and breathing” process that is continually at work within an organization to identify potential risk areas.  Those identified areas where risk is likely to be present can then be further analyzed to ascertain the types of potential risks and a behaviors that create those risks.  A process can then be applied to mitigate risk through establishment of policies and procedures, checklists, and process flow that are intended to reduce risk.  Employees are trained on these processes and monitoring and auditing occurs to assure that processes are being regularly followed.  The entire process must be documented to the detail.  If incidents occur in spite of the risk reduction process, proof of the proactive activities that were taken to prevent these occurrences will be of great assistance in mitigating the negative consequences of the discovered infraction.  Generally, self disclosure, with confidence that you are backed up by a continually operating compliance system are your best defensing most cases to the negative consequences of the discovered non-compliance.

Compliance Program Development and Assessment

Our compliance attorneys have experience creating and implementing compliance programs to fit the specific needs of our business and health care clients.  Compliance programs are not “one size fits all.”  A program must be tailored to address the specific risks that are presented by the type and scope of business.   We are adept at creating solutions that leverage compliance resources to achieve the most efficient and effective compliance operation.  We have developed compliance programs for national and multinational business in a variety of industries.  We have also helped small businesses develop compliance programs that are scaled to the size of their businesses and the resources that are necessary to mitigate compliance risk.  Contrary to some professional, legal forms sites, and novice compliance professionals, there is no single set of forms that can be used to craft a proper compliance program.  Some elements are common in most plans, but the failure to customize a compliance program to the specific business is perhaps the most common mistake that can be made and results in a major threat to the effectiveness of the program and the ability to use the program to mitigate potential legal exposure.

In additions to creating compliance program structures, Ruder Ware’s compliance team has developed a series of comprehensive compliance program assessment and effectiveness tools that we use to identify gaps in compliance program operations.  We use a systematic approach to evaluating compliance programs to assure that they are operated effectively to identify and mitigate compliance risk.  A compliance program is of little value if it cannot be demonstrated to be effective.  We can provide an independent, detailed and systematic evaluation of any compliance program.  The results of this assessment can be integrated into the compliance cycle to enhance effectiveness and improve efficiencies.  We also use variations on this process to assist clients in creating compliance work plans that identify and prioritize compliance operations, audit and monitoring areas, and achievement of specific compliance goals.

Our compliance attorneys are active in national compliance organizations.  We are also committed to maintaining active certifications in compliance and ethics as a means to assure that we are up to date on legal and regulatory requirements as well as the standards that must be met to achieve effective compliance operations.

Internal Compliance Audits Under the Attorney-Client Privilege/Work Product Doctrine

We regularly work through the attorney-client privilege and work product doctrine, as necessary, to internally investigate compliance issues with the provider. We are familiar with the intricacies of various state and federal laws that relate to privilege.  We are also attuned to enforcement policies relating to waiver of privilege and the relationship of privilege to the ability to secure cooperation credit from investigative agencies.

Privilege issues are intricately involved with internal investigations and we take great pains to assure that the process that we use to conduct investigation maintain privilege to the greatest extent possible.  In order to maintain privilege, it is generally necessary to retain outside counsel to direct and control the investigation including securing necessary consultants, experts, and support personnel.  We have relationships with external support consultants and experts in several industries and technical areas.

Educating Clients and Their Employees On Compliance Related Issues

Education of staff is a critical element of an effective compliance program.  Without training individuals within the organization, a compliance plan is little more than a set of policies gathering dust on a shelf.

Our compliance team can assist clients in creating training systems, preparing training material, and performing training programs.  Out compliance attorneys will often provide training sessions on compliance oversight responsibilities to the Board of Directors of a company or to key committee members, officers, and upper management staff.  It is critical for the success of a compliance program that there be acceptance from the top of the organization.  This is where the environment of compliance is created.

We have assisted clients conducting in person compliance training and have conducted web based compliance training modules in basic and special compliance subject areas.  We have also been called in to provide training as part of a corrective action program after compliance risks are detected.  We are also involved in specialized training on issues such as Stark Law compliance, physician compensation, and other issues that are unique to the provider but present unusually complex regulatory requirements.

Extension to Provider Certification and Deficient Surveys

In addition to providing proactive compliance advice, our team provides legal representation in connection with deficiency reports and survey findings.  We can assist providers through the informal dispute resolution process in connection with state and federal surveys.  In cases of serious deficiencies we can represent providers in the appeal process and related proceedings.  Where Civil Monetary Penalties are assessed, we can often negotiate as part of the appeal process for a reduction in penalties, severity or scope of findings.   In extreme cases, deficiencies can also involve overpayments and self-disclosure.  We have can assist providers in the assessment of whether a self-disclosure may be necessary and in appropriate cases, we can conduct the necessary investigations and prepare self disclosure submissions.

Other  Areas Handled By Compliance Team

Although our compliance practice grew originally out of our health care practice, it now extends beyond the health care industry into manufacturing, global transportation, relocation services, financial institutions, and other industry segments.  Our systematic approach to compliance can be applied to virtually any industry together with regulatory experts in that area.

Our health care compliance attorney has also received certification in Corporate Compliance and Ethics which includes global compliance issues.  We are routinely called upon to apply our industry and compliance knowledge to develop compliance operations across a variety of industries.

Beyond the false claim and fraud and abuse inquiries, our compliance team also routinely handles a number of other regulatory compliance matters such as provider certification, provider specific requirements, Sarbanes-Oxley and international compliance areas such as the Foreign Corrupt Practices Act, the UK Anti-Bribery Act, and a variety of other laws that require  effective compliance efforts application to identify and systematically address mitigation of risk.

Government Investigations and Defense

Federal and state governmental regulatory agencies have become very aggressive in investigating and prosecuting compliance failures.  Our compliance investigation team can conduct internal investigations and can often work with governmental agencies to coordinate investigative functions.   We can assist providers who are under scrutiny of the governmental in formulating a proper response to governmental audits, formal and informal investigations, subpoenas and other information requests. We can work with provider clients to shape appropriate response depending on the issues involved and the positions and approach being taken by governmental authorities.  We are also able to coordinate internal investigations to assure that privilege is retained where necessary and to preserve the ability to obtain cooperation credit from the government.

Compliance With Voluntary Self Disclosure Protocols and Process

We have experience with the self disclosure protocol and processes established by the Office of Inspector General and Center for Medicare and Medicaid Services.  We have assisted clients in the assessment of potential compliance risks to determine whether self-disclosure is necessary or appropriate.   We have also conducted investigations of various issues to assess the nature and extent of potential risk.  When it is determined that self disclosure is prudent, we assist clients in preparing necessary disclosure documents and support.  We also interact with governmental agencies to resolve issues through self-disclosure.

Compliance Team Subject Areas

  • Compliance Plan Structure and Operation
  • Compliance Auditing and Monitoring Programs
  • Compliance Work Plan and Task Prioritization
  • Risk Area identification, Scoring and Prioritization
  • Compliance Process Trainings
  • Compliance Risk Area Specific Training
  • Regulatory Interpretation and Guidance
  • Structuring Policies and Procedures
  • Governmental Investigations
  • Internal Investigations
  • Cooperation and Coordination With Governmental Investigators
  • Joint Defense Agreements and Cooperation With Joint Defendants
  • Civil Monetary Defense and Appeal
  • Foreign Corrupt Practices Act
  • International Anti-Bribery Law Compliance
  • Compliance Coordination with Subcontractors and Downstream Entities
  • Health Care Compliance Issues
  • Transportation and Global Relocation Compliance
  • Privacy Act and Health Information Compliance
  • False Claims Act Investigations and Enforcement Actions
  • Survey, Certification and Deficiency Citations
  • Breach Disclosure Assessment and Notification

 

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. 

Clinical Integration Readiness Analysis CINs

Tuesday, January 26th, 2016

 Are You Ready for Clinical Integration?

When we take on a nClinical Integration Attorneyew clinical integration project, one of the first activities we advise is the performance of a snapshot clinical integration readiness analysis.  The theory is that a future CIN needs to know where it is in the clinical integration process before it can plan where it needs to go and the steps that it needs to take.  The initial assessment gives indications of the existing lay of the land and helps the organization shape an integration business model with a more accurate context.

Through this initial assessment process, we can identify structural or governance issues that may hamper further integration.  The readiness assessment is only the beginning of a long road toward clinical integration.  However, time spent on this initial stage can save significant time and effort in the long term.

During early assessment and design stages, we attempt to encourage broad participation by providers.  We will normally recommend the creation of a governance and committee structure that is as inclusive as possible.  Clinical integration is primarily a process that physicians perform.  Mechanisms are created through which physicians collaborate across specialty, in an interdependent way toward the end goals of increasing quality and efficiencies.  Ideally, the process should be collaborative between physicians and institutional providers.  However, the dynamics between hospitals and physicians can sometimes adversely impact the working relationship.

Hospitals have been the center of the health care system through recent history.  Changes in the health care system are beginning to change that paradigm.  Health systems that recognize the realities of this shift will be at a competitive advantage in the future.  In order to meet the challenges of the changing health care system, physicians and facilities need to collaborate.  True change and collaboration cannot be forced on physicians.  Failure to recognize this will put some institutions behind in the creation of the collaborative organizations that are required to compete in the future.

This factor will often manifest itself in the form of governance and control issues.  A health care system may be reluctant to share governance and control with independent physicians.  Failing to create shared governance models will predictably make physicians reluctant to become adequately engaged in the creation or operation of the system.  Many projects shall cover governance and control issues and loose important momentum.

The degree of receptivity to joint governance and control is a significant indicator of potential success.  This is an important issue that must be considered early in the assessment process.  It is often difficult to “undo” the damage that can be inflicted over these issues early in the process.

John H. Fisher, CHC, CCEP is a health care attorney at the Ruder Ware law firm.  He has been involved in the creation and representation of provider networks since the early 1990s. John has followed legal issues impacting provider groups 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.  He is currently involved advising providers and their counsel on the development of clinically integrated provider groups in various locations around the country.

 

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.

Medicaid Reimbursement for Telehealth In Wisconsin Mental Health Programs

Tuesday, 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.

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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