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Archive for the ‘Health Care Reform’ Category

President Signs the 21st Century Cures Act

Wednesday, December 21st, 2016

21st Century Cures Act Signed by President Obama

21st Century Cures ActOn  December 13, 2016, signed the 21st Century Cures Act into law.  The Cures Act was perhaps the most significant piece of health care related legislation since the passage of the Affordable Care Act.  The Cures Act had strong bi-partisan support in both houses and included a wide variety of miscellaneous provisions that are intended to improve and modernize the health care system.  Perhaps the most forward looking provisions in the Cures Act relate to mental health and substance abuse treatment and advancement of biomedical research.  However, the Cures Act contains numerous subject area revisions that expand well beyond these two areas.  Just a few of the areas covered by the Cures Act include the following:

 

  • Mental Health and Substance Abuse
  • Funding of Opioid Addiction Services
  • Revising Documentation Related to the Delivery of Health Care Link
  • New OIG Civil Monetary Penalties for Grant Funding or Contracts
  • Revisions to the Site of Service Differential for Off-Campus Provider-Based Departments
  • Changes to Documentation Requirements to Facilitate Electronic Health Record Utilization

These are just of few of the new statutory provisions that were included in the Act.  We will continue to examine the legislation for items of significance, so be sure to check back to the Health Law Blog for more complete coverage of this important legislation.

 

Population Health Management and Clinical Integration

Monday, June 13th, 2016

Population Health ManagementPopulation Health Management and Clinical Integration – The Center of the Reformed Health Care System

Population health management is bigger than ever now that health reform has become ingrained in our health care system.  The concept of population health management is not necessarily new.  Related concepts emerged in the 1990s when capitated reimbursement gained some converts.  It was known then that in order to succeed under fixed levels of total compensation required systems to be developed to make people healthier while at the same time managing cost and resource utilization.  When a network took on capitation, it knew that it had to look at its patients as a population.  This was a change from the fee-for- service mindset that was previously and subsequently predominant in the health care system.  I think it is fair to say that there were very few organizations that successfully applied population management standards under alternative payment systems in the 1990s.  We very quickly saw capitation fall into the background because, with a few exceptions, the system just did not have it figured out yet how to view and manage population health.

Population health management has come a long way since those early efforts in the 1990s.  The concept is again front stage, but this time organizations have a head start building on what was learned in the past.  Technology and data analysis has become much more sophisticated and commonplace.  Technology is a necessary component of managing a population health and quality.  Evidence based medicine supports population management by collecting and applying baseline data, comparing data to other baselines, helping to structure evidence based care protocols based on current medical outcomes studies, and the ability to measure the success of an applied process or protocol.  This move toward technological support of population management was behind the move to virtually mandate electronic health records through legislation and regulations.  This technological infrastructure now serves as the backbone to permit data to be extracted in support of evidence-based population health management.

Population management is being embraced by forward looking organizations that have a vision of the future.  It can be quite an adjustment to make the changes that are necessary to indicate success under a population management system.  The old system rewarded providing more services that were reimbursed on a fee for service basis.  The old fee-for-service model is changing rapidly.  Overall population quality, outcomes and cost efficiency are now taking front seat.  Some providers who did very well under the old system can have difficulty adjusting their practice patterns to adjust to the new regimen.  More service led to more revenues under the old system.  Under population management, more is not always better.  Concepts of “more” are being replaced by concepts of “appropriate.”  Appropriate levels of service performed in appropriate service locations, by appropriate providers.

Hospitals, health care system, physician groups and others are finding it necessary to adapt to a new world in which providers are rewarded for meeting quality objectives for their entire patient population.   Where volume used to be king, efficiency and quality have now taken over the health care kingdom.

Our health care practice is normally a great indicator of trends in the industry.  In the 90’s we did a lot of provider integration work.  This work has now come full circle and is again a major part of our health care practice.  Our health law practice is involved creating clinically integrated organizations that are equipped to manage population health on several fronts.  This is an exciting process for our health law team as we are on the cutting edge of the hottest issues in health care.  We are creating new health care systems that include new collaborative relationships between providers.  We are applying these concepts in unique and creative ways.  This creative process results in a very exciting legal practice.

We will be posting a series on clinical integration in which we share some f our experience applying population management and evidence-based evidence standards to a number of specific types of organizations.  We will touch on some of the legal, business and operational challenges that we have encountered.

Grab our rss feed and come along for the journey as we cover “clinical integration in the new millennium.”

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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!

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.

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.

Clinical Integration – Key Factors of Integrated Networks

Monday, May 19th, 2014

Key Clinical Integration Factors

Here are just a few of the key factors that are indicative of clinical integration.

  • Collaboration and Coordinated Care
  • Care Protocols
  • Provider Selection Criteria
  • Enforcement of Standards
  • Use of Shared Data
  • Robust Quality and Efficiency Standards
  • Provider Training
  • Continual Process

I am releasing a series of articles on various legal aspects of clinically integrated networks.  Sign up for our Newsletter or grab the RSS feed to receive notification when I publish articles in the series.

 

Mandatory Compliance Programs for Nursing Facilities and Skilled Nursing Facilities

Wednesday, July 18th, 2012

Mandatory Compliance Programs for Nursing Facilities and Skilled Nursing Facilities

SEC. 1128I. ACCOUNTABILITY REQUIREMENTS FOR FACILITIES.

  • (a) Definition of Facility- In this section, the term `facility’ means–
    • (1) a skilled nursing facility (as defined in section 1819(a)); or
    • (2) a nursing facility (as defined in section 1919(a)).
  • (b) Effective Compliance and Ethics Programs-
    • (1) REQUIREMENT- On or after the date that is 36 months after the date of the enactment of this section, a facility shall, with respect to the entity that operates the facility (in this subparagraph referred to as the `operating organization’ or `organization’), have in operation a compliance and ethics program that is effective in preventing and detecting criminal, civil, and administrative violations under this Act and in promoting quality of care consistent with regulations developed under paragraph (2).
    • (2) DEVELOPMENT OF REGULATIONS-
      • (A) IN GENERAL- Not later than the date that is 2 years after such date of the enactment, the Secretary, working jointly with the Inspector General of the Department of Health and Human Services, shall promulgate regulations for an effective compliance and ethics program for operating organizations, which may include a model compliance program.
      • (B) DESIGN OF REGULATIONS- Such regulations with respect to specific elements or formality of a program shall, in the case of an organization that operates 5 or more facilities, vary with the size of the organization, such that larger organizations should have a more formal program and include established written policies defining the standards and procedures to be followed by its employees. Such requirements may specifically apply to the corporate level management of multi unit nursing home chains.
      • (C) EVALUATION- Not later than 3 years after the date of the promulgation of regulations under this paragraph, the Secretary shall complete an evaluation of the compliance and ethics programs required to be established under this subsection. Such evaluation shall determine if such programs led to changes in deficiency citations, changes in quality performance, or changes in other metrics of patient quality of care. The Secretary shall submit to Congress a report on such evaluation and shall include in such report such recommendations regarding changes in the requirements for such programs as the Secretary determines appropriate.
    • (3) REQUIREMENTS FOR COMPLIANCE AND ETHICS PROGRAMS- In this subsection, the term `compliance and ethics program’ means, with respect to a facility, a program of the operating organization that–
      • (A) has been reasonably designed, implemented, and enforced so that it generally will be effective in preventing and detecting criminal, civil, and administrative violations under this Act and in promoting quality of care; and
      • (B) includes at least the required components specified in paragraph (4).
    • (4) REQUIRED COMPONENTS OF PROGRAM- The required components of a compliance and ethics program of an operating organization are the following:
      • (A) The organization must have established compliance standards and procedures to be followed by its employees and other agents that are reasonably capable of reducing the prospect of criminal, civil, and administrative violations under this Act.
      • (B) Specific individuals within high-level personnel of the organization must have been assigned overall responsibility to oversee compliance with such standards and procedures and have sufficient resources and authority to assure such compliance.
      • (C) The organization must have used due care not to delegate substantial discretionary authority to individuals whom the organization knew, or should have known through the exercise of due diligence, had a propensity to engage in criminal, civil, and administrative violations under this Act.
      • (D) The organization must have taken steps to communicate effectively its standards and procedures to all employees and other agents, such as by requiring participation in training programs or by disseminating publications that explain in a practical manner what is required.
      • (E) The organization must have taken reasonable steps to achieve compliance with its standards, such as by utilizing monitoring and auditing systems reasonably designed to detect criminal, civil, and administrative violations under this Act by its employees and other agents and by having in place and publicizing a reporting system whereby employees and other agents could report violations by others within the organization without fear of retribution.
      • (F) The standards must have been consistently enforced through appropriate disciplinary mechanisms, including, as appropriate, discipline of individuals responsible for the failure to detect an offense.
      • (G) After an offense has been detected, the organization must have taken all reasonable steps to respond appropriately to the offense and to prevent further similar offenses, including any necessary modification to its program to prevent and detect criminal, civil, and administrative violations under this Act.
      • (H) The organization must periodically undertake reassessment of its compliance program to identify changes necessary to reflect changes within the organization and its facilities.
  • (c) Quality Assurance and Performance Improvement Program-
    • (1) IN GENERAL- Not later than December 31, 2011, the Secretary shall establish and implement a quality assurance and performance improvement program (in this subparagraph referred to as the `QAPI program’) for facilities, including multi unit chains of facilities. Under the QAPI program, the Secretary shall establish standards relating to quality assurance and performance improvement with respect to facilities and provide technical assistance to facilities on the development of best practices in order to meet such standards. Not later than 1 year after the date on which the regulations are promulgated under paragraph (2), a facility must submit to the Secretary a plan for the facility to meet such standards and implement such best practices, including how to coordinate the implementation of such plan with quality assessment and assurance activities conducted under sections 1819(b)(1)(B) and 1919(b)(1)(B), as applicable.
    • (2) REGULATIONS- The Secretary shall promulgate regulations to carry out this subsection.’.

IRS Proposed Regulations Defining Section 501(r) Responsibilities

Tuesday, July 10th, 2012

In the week before the Supreme Court decided the landmark case upholding the Affordable Care Act, the Treasury Department issued proposed regulations providing regulatory detail on the aspects of new Code Section 501(r) that regulates a non‑profit hospital’s financial assistance programs.  We have previously covered the requirement that a 501(c)(3) organization conduct a Community Health Needs Assessment (CHNA) but have not previously covered some of the other requirements of Section 501(r).

 The Supreme Court’s recent affirmation of the Affordable Care Act means that the requirements of Section 501(r), including the financial assistance portions of that provision, will go forward as planned.

 The Treasury Department’s new proposed regulations provide guidance on the requirements for complying with Code Sections 501(r)(4)-(6) which require hospitals to establish financial assistance policies, limit certain charges to financial assistance eligible individuals, and regulates billing and collection methods.

 Financial Assistance Policy

 Section 501(r)(4) requires a hospital organization to establish a written financial assistance policy (“FAP”) and a written policy relating to emergency medical care.  Both policies are required to include specific information. 

 The proposed regulation further identifies the information that a hospital facility is required to include in its FAP and the methods a hospital facility must use to publicize its FAP.  What a hospital facility must include in its emergency medical care policy is also clarified.

 Limitation on Charges to FAP-eligible Persons

 Section 501(r)(5) requires a hospital organization to limit amounts charged for medically necessary care provided to FAP-eligible persons to not more than the amount that would be billed to individuals who have insurance covering such care (“AGB”).  

 What does AGB Stand for?

 The proposed regulation describes how a hospital facility determines the AGB it can charge a FAP-eligible individual for medically necessary care.  A hospital facility will not fail to satisfy this requirement if it charges an individual more than AGB, as long the hospital facility is complying with all requirements regarding notifying individuals about the FAP, responding to submitted applications, and correcting the amount charged if the individual is later found to be FAP-eligible.

 Extraordinary Collection Efforts

 Section 501(r)(6) requires a hospital organization to make reasonable efforts to determine whether an individual is FAP-eligible before engaging in extraordinary collection actions against the person.

 The proposed regulation clarifies what actions are “extraordinary collections actions” and the “reasonable efforts” that a hospital facility must make to determine FAP-eligibility before engaging in such actions.

 What Entities Does Section 501(r) Apply To?

 Finally, the proposed regulations also provide guidance on which entities are required to meet the requirements of the above-mentioned sections.  Specifically, a definitions section defines “hospital organization,” “hospital facility,” and other key terms used in the regulation.

 Hospital facilities are encouraged to review their policies regarding FAP and consider how these proposed regulations may impose new requirements for maintaining their tax-exempt status.  In addition, the Department of Treasury invites comments and requests for a public hearing until September 24, 2012.

 For further information, please contact Mary Ellen Schill, John H. Fisher, CHC or your regular Ruder Ware attorney contact.

Mandatory Compliance Programs – CMS Regulatory Requirements

Monday, July 9th, 2012

Supreme Court Says “Game On” for Mandatory Compliance Programs

Compliance programs were made mandatory for all providers as a condition of participation in the Medicare program under the patient protection and affordable care act of 2010. With the recent Supreme Court decision upholding the affordable care act,  any uncertainty as to whether the mandatory compliance programs will become a reality has been lifted.

The affordable care act also required the CMS to promulgate regulations that establish the core elements for providers and suppliers to meet with respect to the mandatory compliance programs. CMS is authorized to determine the timing and core elements of the required compliance programs. The first industry segment that are required to adopt compliance programs are nursing facilities which must comply with mandatory compliance program requirements by March 23, 2013. However, CMS missed it statutory deadline (March 23, 2012) for promulgating detailed regulations to guide nursing facilities in the creation of compliance programs. It is expected that these regulations as well as the requirements for other providers will be forthcoming soon now that the Supreme Court has upheld the Affordable Care Act.

The Office of Inspector General has in the past issue compliance program guidance for various industry segments.  We can expect at least some of these requirements to be part of the regulatory clarification coming from CMS under its authority to enforce mandatory compliance programs. We can also expect additional requirements to be added based upon a parallel recent promulgation from CMS that is applicable to Medicare advantage managed-care plans and prescription drug part D plan entities. Although not directly applicable to organizations other than Medicare Advantage Programs and Part D prescription drug programs, the regulatory proposals are instructive of the current thinking of CMS with respect to required elements of compliance programs.

Some key elements of the recent regulatory proposal which were not included in previous OIG compliance program guidance include:

  •  A strong recommendation that there be standardized process for the governing body to review the compliance program documents at least annually. Current guidance is much more permissive and only suggests periodic reviews. The new regulations would require a complete effectiveness review and a detailed “gap analysis” to the Board of Directors on an at least an annual basis.
  • More details concerning distribution of standards of conduct and policies and procedures to new employees. The new proposed regulations required distribution of these materials within 90 days of initial hire and at least annually thereafter.  Distribution of policies and procedures will be an “obligation” rather than simply a “suggestion” once the new proposed regulations are finalized.
  •  The proposed regulations contain the clearest statement to date from CMS that “dual role” compliance officers, where the compliance officer is also the CFO, CEO or General Counsel, present a built-in conflict of interest and are not permitted. This has been a controversial topic in the past as many organizations still maintain their general counsel as their compliance officer. If the recent proposed regulations are any indication, many “dual role” compliance officers will be the way of the past. It appears that it will still be permissible for divisional  managers, such as quality assurance managers, to act in a dual role. However, operational management will not be permitted to act in his rules. This clearly includes CFOs, COOs and General Counsel who are specifically mentioned in the proposed regulations

There are many additional details that are contained in the most recent proposed regulations. There’s every indication that these proposed regulations are a foreshadowing of the eventual requirements that CMS will release under the mandatory compliance program authority that will be applicable to other providers such as nursing homes, physician groups, hospice, DME providers and other health care providers.

In view of these pending requirements and in light of the apparent expansion of compliance program requirements that is being hinted at by CMS,  providers should conduct an effectiveness review of their compliance programs now and begin the ongoing process of conducting such reviews on an at least an annual basis.  Reviews should be conducted with the requirements of the new proposed regulations in mind.

Small organizations, such as physician practices and smaller healthcare organizations should begin immediately to implement scalable compliance program structures that are focused on the specific risk areas that affect their organizations and begin to create an infrastructure for an effective compliance program.

 Organizations who still have their General Counsel, CFO, or COO acting as their compliance officer should begin to set the stage to undo that structure.  A separate office of Chief Compliance Officer should be created and separately budgeted.  The CCO should have autonomy from other operational offices and should have direct access to the Board of Directors, a Compliance Committee and the CEO.  This issue can be politically difficult within an organization and should be addressed soon rather than later.  Ultimately, this is an issue that must be firmly addressed by the Board of Directors under its responsibility to oversee the compliance program.

Supreme Court Upholds PPACA Except Medicaid Expansion To States

Thursday, June 28th, 2012

The United states supreme court today released the long awaited decision regarding the constitutionality of the affordable care act. We will be blogging more on this issue and are preparing a variety of e-Alerts.

That bottom line is that the court upheld the individual mandate and all other aspects of ppaca. The only exception is that the court held that penalizing states for failing to expand Medicaid is unconstitutional.

Stay tuned for more details on what this means for the health care industry.

Blogged from iPad.

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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