Trinity Health regularly provides comments to policymakers to help inform their work toward enacting a people-centered national health care system. We are dedicated to providing services that place the people we serve at the center of very behavior, action and decision. This work is also dedicated to supporting better health, better care and lower costs to ensure affordable, high quality, people-centered care for all.
Trinity Health comments include:
Statement from Mike Slubowski, President and CEO of Trinity Health, Regarding President Joe Biden's National COVID-19 Response Strategy, January 21, 2021
Improving 340B Drug Savings Program Request for Input, October 2020
Trinity Health submitted comments to Congressional leaders on improving the 340B drug savings program. Trinity Health does not believe legislation to change the 340B program is needed. However, the program could be strengthened if Congress were to use its oversight powers to ensure that the Department of Health and Human Services (HHS) enforce the 340B statute and use its existing authority to penalize manufacturers that are not meeting their 340B statutory obligations. Specifically, Trinity Health recommends:
- The 340B program is not scaled back. Savings from the 340B program allow hospitals to offer vital services despite challenges created by poor reimbursement and a weak payer-mix. If the 340B program were scaled back, reduced or saddled with costly administrative burdens, 340B hospitals would lose their ability to provide the same services and benefits that the communities currently rely to meet the needs of the vulnerable.
- Congress should ensure HHS is requiring drug manufacturers comply with the law and prevent them from denying 340B pricing to hospitals for drugs dispensed through community pharmacy arrangements. Drug manufactures should also be curtailed from moving forward with any rebate model without prior approval or, at the very least, until guidance has been issued, subject to public notice and comment.
Establishing a Fixed Time Period of Admission & an Extension of Stay Procedure for Nonimmigrant Academic Students, Exchange Visitors & Representatives of Foreign Information Media, October 2020
U.S. Immigration and Customs Enforcement is proposing to change the way that holders of certain nonimmigrant Verified International Stay Approval (VISA) classifications, including J-1 visas, extend their period of authorized stay in the United States.
Specifically, the change would eliminate “duration of status” as an authorized period of stay, replacing it with a specific end date. If finalized, this rule would negatively impact the provision of health care, particularly at a time in which the country is already facing a nation-wide physician shortage while responding to the ongoing COVID-19 pandemic. Trinity Health urges the Department of Homeland Security (DHS) not to finalize this policy.
Outpatient Prospective Payment System (OPPS) for Calendar Year (CY) 2021, October 2020
Trinity Health appreciates the ongoing efforts from the Centers for Medicare and Medicaid Services (CMS) to improve payment processes across the delivery system. However, Trinity Health has significant concerns with many of the policies proposed. Trinity Health comments include:
- 340B Drug Pricing Program cuts: CMS proposes to pay for drugs acquired under the 340B Drug Saving Program at average sales price (ASP) minus 28.7 percent. This represents deeper cuts than those proposed in prior years. Trinity Health strongly opposes any cuts to the 340B program as they are inconsistent with Congressional intent, represent a further assault on safety-net institutions, and continue to strain the ability of providers to better serve patients and communities.
- Site neutrality: CMS proposes to continue its site-neutrality policy. Trinity Health continues to strongly oppose this policy and outlines why continuing this payment cut jeopardizes the ability of hospitals to support hospital-level care in an outpatient setting.
- Hospital Inpatient Only List (IPO): CMS proposes to eliminate the IPO list over a three-year period, beginning in calendar year 2021 with the removal of 266 musculoskeletal-related services. Trinity Health is concerned this proposal may create inconsistencies and barriers to care, if not implemented correctly, this policy may lead to delayed care and unintended consequences. Trinity Health recommend CMS:
- Provide more clarity around appropriate settings.
- Create ambulatory surgery center (ASC) exclusion criteria for services removed from the IPO list and national guidelines for screening patients to determine appropriate setting.
- Develop national guidelines outlining patients who are appropriate candidates for inpatient vs outpatient authorization as well as for patients who are reasonable candidates for same-day discharge.
- Supervision of Outpatient Therapeutic Services—Trinity Health supports CMS' proposal to change the minimum default level of supervision for non-surgical extended duration therapeutic services to general supervision for the entire service and urges CMS to also allow for general supervision for pulmonary rehabilitation, cardiac rehabilitation, and intensive cardiac rehabilitation services.
Medicare Physician Fee Schedule and Quality Payment Program CY2021 Proposed Rule, October 2020
Trinity Health appreciates the ongoing efforts of the Centers for Medicare and Medicaid Services (CMS) to improve the Medicare program through the delivery of high-value care and burden reduction during COVID-19. Trinity Health offers several recommendations for improving policies to further reduce barriers to necessary care, simplify the program, and reduce administrative burden:
- Telehealth expansions: Trinity Health supports the codification of many of the telehealth flexibilities provided during the COVID-19 public health emergency and encourages CMS to maintain flexibilities for nursing homes, audio-only telehealth, and expand flexibility for critical care services.
- Medicare Shared Savings Program: Trinity Health urges CMS to delay the significant restructuring of the quality program through the alternative payment model (APM) Performance Pathway (APP), a new—and undefined—reporting process, and changes to the quality threshold for the Medicare Shared Saving Program (MSSP). It is not appropriate to make such far sweeping changes during the COVID-19 pandemic. Trinity Health encourages CMS to engage stakeholders to determine appropriate measures and implementation timeline.
- Quality Payment Program: similar to MSSP comments, Trinity Health opposes implementation of the APP for the Merit-Based Incentive Payment System (MIPS). Trinity Health urges CMS to maintain the current existing APM scoring standard and scoring rules. In addition, Trinity Health requests that CMS commit to pay the Advanced Alternative Payment Model incentive payment no later than June 30 in future.
- Professional scope of practice: CMS proposes several policies that would reduce supervision requirements and make permanent flexibility provided during the COVID-19 Public Health Emergency (PHE), including allowing nurse practitioners, clinical nurse specialists and physician assistants to supervise diagnostic tests consistent with state law and scope of practice requirements. Trinity Health is supportive of the increased flexibility and applauds CMS for reducing burden.
- One-year delay of electronic prescribing requirements required under the SUPPORT Act: Trinity Health is committed to the use of Electronic Prescribing for both non-controlled and controlled medications. The COVID pandemic required Trinity Health to reprioritize work and resources – both human and financial – to properly support both employees caring for, and the patients and families impacted by the pandemic. Trinity Health strongly supports the one-year delay in implementation for the electronic prescribing requirements and appreciates that CMS has acted to reduce burdens for this requirement at this time.
Treatment of Medicare Part C Days in the Calculation of a Hospital's Medicare Disproportionate Share Percentage, October 2020
This proposed rule would alter the treatment of Medicare Advantage patient days in the calculation of a hospital's disproportionate patient percentage (DPP); and, thereby, modify the disproportionate share hospital (DSH) payments. This rule was issued in response to the Department of Health and Human Services (HHS) and the Centers for Medicare and Medicaid Services (CMS) loss in the U.S. Supreme Court in the Allina case. It is an attempt by CMS to use retroactive rulemaking to implement the same policy that was vacated by the court. This is the second attempt by CMS to apply this policy retroactively prior to fiscal year 2014. Trinity Health vigorously opposes the proposal by CMS to apply the rule retroactively and its attempt to avoid the impact of the Supreme Court’s decision that determined prior attempts at the policy were invalid. Through this proposed rule, CMS is exceeding its authority in attempting to codify a policy already decided by the Supreme Court that would take away funds owed to hospitals.
Request for Information: Electronic Prescribing of Controlled Substances (EPCS), October 2020
Trinity Health is committed to the use of Electronic Prescribing for both non-controlled and controlled medications. The COVID-19 pandemic has delayed the implementation of this requirement established by the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) Act. Trinity Health has had to reprioritize work and resources – both human and financial – to properly support both employees caring for, and the patients and families impacted by COVID-19. Through comments on this request for information, Trinity Health recommendations to the Centers for Medicare and Medicaid Services (CMS) on targeted programmatic components for implementing the EPCS requirement, including penalties and appeals. Further, Trinity Health recommend CMS review processes, lessons learned and best practices in those states that have already mandated a similar requirement.
Department of Labor Proposed Rule Regarding Use of Environmental, Social & Governance (ESG) Factors in Benefit Plans, July 2020
Trinity Health opposes the proposed rule by the Department of Labor (DOL) entitled “Financial Factors in Selecting Plan Investments”. The proposed rule would impose significant analytical and documentation burdens on fiduciaries of benefit plans governed by the Employee Retirement Income Security Act (ERISA) wishing to select--or allow individual account holders to select--investments that use environmental, social and governance (ESG) factors in investment analysis or that provide ESG benefits. Consideration of ESG factors in investing has achieved widespread acceptance globally. Academic studies have demonstrated that an ESG perspective can improve performance and reduce earnings-per-share volatility. The proposed rule is lacking in its quantification of any benefits from its implementation. Trinity Health ardently opposes this rule.
HHS Must Provide Additional Flexibilities to Help Providers Respond to the COVID Pandemic, July 2020
Trinity Health appreciates the efforts of the Department of Health and Human Services (HHS) to help providers respond to the ongoing COVID-19 pandemic. There remain significant policy levers that HHS can use to help Trinity Health and other providers continue to be able to respond to the needs of communities during the pandemic. Recommendations to reduce burden include:
- Disburse remaining money in the Provider Relief Fund quickly and transparently.
- Forgive the Medicare Accelerated and Advance Payment loans.
- Increase adoption and expansion of telehealth.
- Modify the new laboratory reporting to reduce burden.
- Create national supply chain certainty.
Monitoring Health Care System Resilience Request for Information (RFI), July 2020
The Office of the Assistance Secretary (OASH) within the Department of Health and Human Services released an RFI seeking to gain a better understanding of how organizations, networks, non-federal government agencies, and other relevant stakeholders have operationally defined “resilience” in their respective components of the health system; including their use of data, analytic approaches and proven indicators. OASH also sought comments identifying opportunities to strengthen the U.S. health care system, including through public-private partnerships in data sharing and comprehensive analytics. In robust comments, Trinity Health outlined:
- The need for the federal government to better communicate and collaborate to ensure consistent guidance during a public health crisis.
- Recommendations to make permanent key telehealth flexibilities provided to-date in response to COVID-19.
- Recommendations to improve the efficiency and strength of the supply chain.
- Identification of and recommendations for gaps in IT infrastructure and data that have resulted in a less successful national response to the COVID-19 pandemic.
- Examples of how the infrastructure built into the existing alternative payment models helped Trinity Health respond to COVID-19 in communities; and recommendations for accelerating the pace at which the nation's health system moves away from reliance on fee-for-service.
- Recommendations to reduce administrative waste and increased costs related to payer denials.
- Examples of ways that public and private partnerships can make the U.S. health system more resilient.
FY2021 Hospital Inpatient Prospective Payment System (IPPS) Proposed Rule, July 2020
On May 11, 2020, the Centers for Medicare and Medicaid Services (CMS) released the proposed fiscal year (FY) 2021 IPPS rule. Significant policies proposed include: requiring hospitals to report the median charge negotiated with Medicare Advantage (MA) organizations and third-party payers in efforts to reduce reliance on hospital chargemasters for pricing; a continuation of the wage index changes finalized in the FY2020 IPPS rule, which increases the wage index for hospitals below the 25th percentile while reducing the wage index for other hospitals; and the codification in regulation of what CMS considers to be existing bad dept policies. Comments submitted by Trinity Health include:
- Delaying the implementation date of final hospital price transparency regulation by at least one year, to January 2021, due to the complexity of the requirement and a need to focus on the COVID-19 pandemic response.
- Requesting CMS not finalize the proposal requiring hospitals to provide the median charge for third-party organizations (including MA) to avoid increasing burden as work continues toward compliance of the requirements of the final price transparency rule.
- Urging CMS to consider the impact of the COVID-19 pandemic on Medicaid enrollment, uncompensated care, and uninsured patients as they calculate disproportionate share hospital payments.
- Recommending the Department of Health and Human Services work with Congress to create a new designated pool of funding for low-wage hospitals that would not be subject to Medicare budget neutrality requirements.
- Identifying concerns with the bad debt proposals.
CMS will finalize the rule 30 days prior to the effective date (September 1) rather than standard 60 days (August 1), citing flexibility under the Congressional Review Act and the existing public health emergency.
Food and Nutrition Proposed Rule Regarding National School Lunch and Breakfast Programs, April 2020
Trinity Health is very concerned with the Food and Nutrition Service (FNS) proposed rule, Simplifying Meal Service and Monitoring Requirements in the National School Lunch and School Breakfast Programs. Trinity Health comments and recommendations reflect a strong interest in advancing the health of all communities of which food and nutrition is an integral component. Trinity Health is concerned that this rule will weaken school nutrition standards that serve millions of American children and jeopardize the progress schools have made to provide healthier food to children.
Proposed Procedural Requirements and Resubmission: U.S. Securities and Exchange Commission, February 2020
Trinity Health is very concerned about rulemaking that will undermine the existing shareholder resolution process proposed by the U.S. Securities and Exchange Commission’s (SEC) in its Procedural Requirements and Resubmission Thresholds Under Exchange Act Rule and Amendments to Exemptions from the Proxy Rules for Proxy Voting Advice.
Trinity Health advances our mission and core values through a robust shareholder advocacy program that harnesses influence as shareowners in Fortune 500 companies to improve corporate decision-making on tobacco, food/nutrition, health/medications, climate change and violence.
The work of Trinity Health is more successful when done in collaboration with partners including Interfaith Center for Corporate Responsibility (ICCR) and Ceres Investor Network on Climate Risk and Sustainability (INCRS). Trinity Health was a co-signer on the INCRS letter to the SEC and also submitted separate comments and recommendations. These comments reflect a strong interest in advancing the stated mission of the SEC: “to protect investors, maintain fair, orderly, and efficient markets, and facilitate capital formation.” Trinity Health feedback also offered the following arguments with supportive examples:
- Misleading/fraudulent letters used by SEC to support rulemaking.
- Insufficient economic evidence to support need for change to shareholder proposal process.
- Existing process supports a more efficient and transparent market.
Medicaid Program: Medicaid Fiscal Accountability Regulation Proposed Rule, January 2020
The Medicaid Fiscal Accountability Rule (MFAR), proposed by the Centers for Medicare and Medicaid Services (CMS), would make significant changes to hospital supplemental payments and state Medicaid program financing. If finalized, the rule would limit provider taxes, intergovernmental transfers, and bona fide provider donations, thereby decreasing state flexibility in financing the state share of their Medicaid programs—likely leading to a reduction in services, coverage, and provider payments. Notably, the proposed rule does not include a robust impact analysis on beneficiaries, states or providers.
Trinity Health is deeply concerned that the implications of the MFAR rule extend well beyond its stated goal of increased transparency and will negatively impact access to care for low-income Medicaid beneficiaries, and place significant new burdens on states.
Trinity Health strongly opposes this rule as it is bad public policy for those with whom we hold near and dear—the poor and underserved—those who are at the heart of our mission. Therefore, Trinity Health recommends that CMS maintain current policy. If instead CMS chooses to move forward with the proposed policies, CMS should:
- Collect additional data and perform further state-by-state analyses on the impact prior to finalizing any of the proposed policies.
- Work with the Office of the Actuary to develop a robust regulatory impact analysis (RIA) and release an interim final rule containing the RIA for additional public comment before implementation of any current proposals.
- Narrow the scope of the proposed policies based on the analyses of state-level data and push back the effective date of the proposed policies to allow states at least five years to come into compliance.
- Phase-in any changes to payment, financing and reporting while working closely with states to ensure these changes do not negatively impact access to care.
Revisions to Safe Harbors Under the Anti-Kickback Statute, December 2019
Trinity Health appreciates the attempts by the Office of the Inspector General's (OIG) to reduce provider burden and provide additional protections for value-based care arrangements. Trinity Health further supports the direction the agency is headed in the proposed Anti-Kickback rule. In comments to the OIG, Trinity Health offers recommendations to further improve the rule, and:
- Strongly suggests Safe harbors should more closely mirror the exceptions being proposed in the Centers for Medicare and Medicaid Services (CMS) Stark rule to reduce confusion and complexity.
- Urges the OIG to increase the financial limit the new patient engagement safe harbor.
- Recommends that the OIG review the reporting and record keeping requirements associated with transportation authority through the lens of the Department of Health and Human Services’ Patients Over Paperwork Initiative, and identify ways to streamline requirements.
Modernizing and Clarifying the Physician Self-Referral (Stark) Regulations, December 2019
Trinity Health appreciates the work of the Centers for Medicare and Medicaid Services (CMS) to appropriately balance program integrity and compliance with the physician self-referral law, while providing the flexibility required for successful participation in value-based care arrangements. Trinity Health strongly support the direction CMS is heading with the proposed rule—the agency listened to many recommendations submitted in the August 2018 Physician Self-Referral Law Request for Information. Trinity Health makes recommendations that would further improve the Stark regulations, including modifying the new exceptions proposed for value-based arrangements to further reduce burden for providers and increase flexibility.
Affirmative Action and Nondiscrimination Obligations of Federal Contractors and Subcontractors, December 2019
Trinity Health appreciates the opportunity to respond to the proposed rule by the Office of Federal Contract Compliance Programs (OFCCP) to amend regulations pertaining to its authority over “TRICARE and certain other health care providers”.
- Trinity Health agrees that changing the OFCCP’s definition of “subcontract” in the E.O. 11246, VEVRAAA, and Section 503 regulations to exclude “agreements to furnish medical services and supplies to beneficiaries of TRICARE” would ultimately provide the desired outcome, whether it is done under the rationale of “lack of authority” or “exemption from that authority”.
- As proposed, the rule will provide clarity surrounding the jurisdiction of OFCCP over TRICARE participants—particularly given the decade-long confusion as it relates to the OFCCP’s moratoria on this topic—create alignment of TRICARE participation with other federal health care payers, and will ultimately increase or improve access to medical care for uniformed service members and veterans.
Substance Abuse and Mental Health Administration (SAMHSA) Proposed Rule for Substance Use Disorder (SUD) Records, October 2019
Trinity Health applauds the Administration for taking steps to provide greater clarity and flexibility for regulations governing the confidentiality of SUD patient's records. While recognizing the importance of balanced regulations that respect the privacy of patients and promote improved quality of care, Trinity Health acknowledges that SAMHSA is statutorily constrained from making additional changes to the guiding regulation.
In comments, Trinity Health urges the Department of Health and Human Services (HHS) to work with Congress to align 42 CFR Part 2 and the Health Insurance Portability and Accountability Act (HIPAA)—this is critical to providing more effective treatment and care coordination for substance use disorders patients. In addition, the comment letter highlights the challenges that the existing regulations create for value-based care and interoperability—both of which are priorities for Trinity Health and the Administration.
Medicare Physician Fee Schedule and Quality Payment Program CY2020 Proposed Rule, September 2019
Trinity Health appreciates the ongoing efforts of the Centers for Medicare and Medicaid Services (CMS) to improve the Medicare program through the delivery of high-value care. Supporting many of the proposals in the rule, Trinity Health offers several recommendations for improving other policies to further reduce barriers to necessary care, simplify the program, and reduce administrative burden:
- Payment for Opioid Use Disorder (OUD) Treatment Services—Trinity Health strongly supports the efforts of CMS to expand Medicare coverage of and payment for OUD services. However, several recommendations are offered for how CMS can strengthen and simplify the two proposed bundle payments for OUD—one for services furnished at opioid treatment programs and the other under the physician fee schedule—to maximize their impact.
- Office/Outpatient E/M Coding—Trinity Health applauds the decision by CMS to maintain five levels of evaluation/management (E/M) visits in place of its proposal last year to create a blended rate for levels two through four. Trinity Health further supports the proposal to increase valuations for all E/M codes and the new prolonged services add-on code. These proposed changes will further incentivize physicians to spend the appropriate amount of time and resources with patients based on their health and care needs.
- MIPS Value Pathways—Trinity Health agrees that there is a need to simplify the Merit-Based Incentive Payment System (MIPS) program. However, it is strongly recommended that a MIPS Value Pathways (MVP) framework develop population health focused MVPs rather than specialty- or condition-focused MVPs as proposed. In its comments, Trinity Health further outlines how a new MVP could support population health.
- MIPS Quality Measures—in these comments, CMS is urged to continue to align the quality measure set available for providers under MIPS with the set included in the Medicare Shared Savings program (MSSP) accountable care organization (ACO) program and to align the quality measure reporting domains currently used in MSSP across both programs. Changes to the MSSP quality measures or scoring methodology to align with MIPS are not supported as this could impede the evolution of meaningful quality measurement in the ACO program. Trinity Health further recommend CMS maintain the current quality measures and scoring methodology for ACOs.
Outpatient Prospective Payment System (OPPS) for Calendar Year (CY) 2020, September 2019
Trinity Health appreciates the ongoing efforts from the Centers for Medicare and Medicaid Services (CMS) to improve payment systems across the delivery system. However, significant concerns with many of the policies proposed in this rule have been identified. Trinity Health comments include:
- Price transparency—As drafted, the proposed policy would not help patients understand their out-of-pocket obligation and would increase administrative burden/cost. Instead, Trinity Health urges CMS to require providers and payers deliver an estimate based on up-to-date coverage information.
- 340 B Drug Pricing Program cuts—Despite defeat in federal court, CMS continues to propose payment cuts for drugs paid for under the 340B program. Trinity Health urges CMS to immediately follow the direction of the federal judge and determine a remedy that will pay back 340B hospitals.
- Site neutrality—CMS proposes to implement the second phase of their site-neutrality policy. However, consistent with Trinity Health comments in 2018, this rule was recently overturned by a judge as being outside of the scope of CMS. Trinity Health believes CMS should immediately reimburse hospitals for withheld payments and not implement the second phase of these cuts.
- Wage index—CMS proposes to implement wage index adjustments finalized in the CY20 Inpatient Prospective Payment System final rule, including increasing the wage index for low wage index hospitals while reducing the wage index for all other hospitals and removing wage index data from hospitals that undergo urban-to-rural reclassification from the calculation of the rural floor. Trinity Health continues to recommend that the Department of Health and Human Services work with Congress to create a new designated pool of funding for low wage index hospitals that is not subject to budget neutrality as part of a comprehensive, long-term approach to help rural facilities.
USDA Revision of Categorical Eligibility in the Supplemental Nutrition Assistance, September 2019
Trinity Health is deeply concerned with the proposed rule by the U.S. Department of Agriculture's (USDA) for the Supplemental Nutrition Assistance Program (SNAP) that would remove significant flexibility used by more than 40 states. The rule would negatively impact access to necessary food and nutrition assistance for more than 3 million people by the Administration's own estimates, including near-poor working families, seniors, people with disabilities, and children.
In its comments, Trinity Health outlines the critical role SNAP plays in communities, provides data illustrating the connection between food security and health—including health spending, and strongly urges the USDA to not finalize the proposed rule.
Methods to Insuring Access to Covered Medicaid Services, August 2019
By law, states must assure Medicaid provider payments are sufficient to allow access to care for beneficiaries. The Center for Medicare and Medicaid Services (CMS) is proposing to rescind regulation that requires states to submit to them an access monitoring review plan as well as certain access analysis when proposing to reduce or restructure Medicaid provider payment rates. Trinity Health supports efforts to reduce burden and increased state flexibility. However, to ensure adequate access to services for the vulnerable Medicaid population along with state adherence to the law, Trinity Health:
- Urges CMS to maintain the requirement that any changes to payment rates that could affect access be subject to a public comment opportunity.
- Recommends states be required to maintain a process though which stakeholders can offer feedback on access to care, and CMS should maintain minimum standards—such as timeline and potential approaches—for addressing access to care issues.
- Urges CMS to require states maintain a process for continued monitoring of access to care.
- Recommends CMS maintain baseline standards for ensuring access to care.
- Expresses that it is critical to ensure beneficiaries, providers and other essential stakeholders are included in any technical expert panels and workgroups CMS plans to develop to support its strategy to monitor access, noting that Trinity Health welcomes the opportunity to be a resource and participate.
Reducing Administrative Burden Request for Information (RFI), August 2019
Trinity Health applauds the continued interest of the Centers for Medicare and Medicaid Services (CMS) to reduce burdens for hospitals, physicians and patients. The complexity and redundancy of the existing regulatory process has become overly intrusive and is distorting the practice of medicine. In addition, many providers and health systems, such as Trinity Health, are seriously committed to value-based care and have invested greatly in developing the infrastructure for alternative payment models and managing total cost of care for patients. As we work to provide people-centered care, commercial insurers create administrative burden and waste through arbitrary denials and downgrades of care—all of which interfere with appropriate care delivery.
Trinity Health believes the old framework of overregulation can be modified to instead rely on transparency, database monitoring, and selective focus where abuse has been detected. Highlights from comments on this RFI include recommendations to:
- Measure outcomes and not process, to generate meaningful care improvement data.
- Increase the ability of qualified provider Accountable Care Organizations and Clinically Integrated Networks to function as full-risk recipients for Medicare Advantage and other alternative payment models.
- Advance policies that provide additional flexibility for alternative payment models and align payment rules in order to provide the most efficient and high-quality care to beneficiaries.
- Create an advisory panel that includes hospital and health system participants to discuss impending regulations and assist in developing more realistic timelines and solutions.
- Expand Medicare coverage of telehealth services.
- Update fraud and abuse laws, safe harbors and exceptions to support continued accountability of providers and improved quality.
- Align the Health Insurance Portability and Accountability (HIPPA) Act and 42 CFR part 2 to improve the quality and safety of clinical care.
Section 1332 State Relief and Empowerment Waivers Request for Information (RFI), July 2019
Trinity Health appreciates the opportunity to respond to the RFI for 1332 waivers. Trinity Health is committed to public policies that support better health, better care and lower costs to ensure affordable, high quality, people-centered care for all. As such, Trinity Health submitted comments that aim to ensure comprehensive and affordable coverage for all, which can in part be achieved by stabilizing the health insurance marketplaces. Specifically, Trinity Health comments:
- Urge the Department of Health and Human Services and the Treasury Department (The Departments) to work with states to use 1332 waivers to fortify the existing marketplaces and qualified health plans (QHP) and to ensure that consumers maintain access to comprehensive coverage that includes the 10 essential health benefits.
- Urge the Departments to continue to work with states to use 1332 waivers to implement reinsurance programs, given the growing evidence on the positive impacts of reinsurance programs on lowering premiums, maintaining issuer participation in the marketplaces, and supporting access to coverage.
- Support policies that foster personal engagement and promote self-management and shared decision-making. Urge the Departments to ensure that Section 1332 waiver programs include affordable coverage and a cost-sharing structure that supports access to and appropriate utilization of services and does not result in delayed or avoided care.
- Recommend the Centers for Medicare and Medicaid Services (CMS) guarantee that all plan options offered under a 1332 waiver provide coverage at least as generous as current bronze level qualified health plan (QHP) standards and that marketplace plans continue to align with QHP metal levels.
- Emphasize states and CMS must ensure transparency as they develop waiver applications, including sufficient opportunity for stakeholder input, public review and comment. In addition, evaluations of Section 1332 waivers should be robust, transparent and grounded in data.
Inpatient Prospective Payment System (IPPS) for Fiscal Year (FY) 2020, June 2019
Trinity Health appreciates the opportunity to comment on the proposed FY20 IPPS rule. In comments Trinity Health:
- Recognizes the need to address sustainability of rural and low-wage index hospitals. However, the Department of Health and Human Services (HHS) and Congress should develop policies to help these facilities through a comprehensive, long-term approach. Trinity Health opposes proposed arbitrary changes to the wage index and calculation of rural floor that harm high-wage index hospitals.
- Urges the Centers for Medicare and Medicaid Services (CMS) to continue existing policy of using a three year average of data for allocating disproportionate share hospital uncompensated care pool.
- Applauds policy changes that will allow Critical Access Hospitals be reimbursed for training residents.
Office of Management and Budget (OMB) Request for Comment on the Consumer Inflation Measures Produced by Federal Statistical Agencies, June 2019
Trinity Health is committed to public policies that support better health, better care, and lower costs to ensure affordable, high quality and people-centered care for all. As such, Trinity Health has concerns with OMB’s consideration of updating the inflation measure used to adjust the Official Poverty Measure (OPM). A change in the OPM would result in individuals losing access to or seeing a reduction in essential health care or other vital benefits. Trinity Health comments:
- Urge OMB to ensure that any update to the inflation measure does not result in fewer individuals being eligible for health care programs – including Medicaid and the Children's Health Insurance Program (CHIP), the Medicare Low Income Subsidy program, and marketplace premium tax credits and cost-sharing assistance – or other programs such as the Supplemental Nutrition Assistance Program that use the federal poverty guidelines to determine eligibility.
- Caution OMB that the loss of eligibility or reduced benefits as a result of a change in the annual estimation of the OPM would have a negative impact on health status, outcomes, and access to necessary care and supportive services.
- Highlight that decreased eligibility for health care and other essential safety net programs will lead to increased costs and burden on individuals and the health care system.
CMS Interoperability Proposed Rule, June 2019
Interoperability is essential to a People-Centered Health System and Trinity Health is committed to helping consumers easily and securely access their electronic health data, direct it to any desired location, and be assured that their health information will be effectively and safely used to benefit their care. Trinity Health applauds the commitment of the Centers for Medicare and Medicaid Services (CMS) to interoperability. The comments on the proposed CMS-9115 interoperability and access rule and imbedded requests for information reflect a shared goal to improve care coordination; specific comments include:
- Acknowledge requiring providers to transmit admissions, discharges, and transfer (ADT) data is important. However, Trinity Health urges CMS to require this as an attestation rather than as a condition of participation. In addition, it is recommended the use of Fast Healthcare Interoperability Resources (FHIR) standard to share this information.
- Support requiring hospitals to attest they are promoting interoperability.
- Agree patients should have access to all of their information, free of charge, and incorporate it into any tool they wish to use.
- Recommend CMS clarify how they will address security concerns that may arise as a result of open application programming interfaces (APIs), including the need for patient education and consent prior to APIs using personally identifiable information.
- Advance interoperability across the continuum of care.
- Suggest CMS use Center for Medicare and Medicaid Innovation (CMMI) models to evaluate interoperability.
- Highlight consistency in patient data matching is foundational to interoperability and support use of a unique patient identifier (UPI). However, Trinity Health cautions relying solely on UPI will not address the patient matching issue alone.
ONC Information Blocking Proposed Rule, June 2019
Trinity Health is fiercely committed to interoperability as a mechanism to improve the efficiency of care delivery, reduce the cost of care, and improve the health of patient. Trinity Health comments to the Office of the National Coordinator for Health Information Technology (ONC) regarding the 21st Century Cures Act: Interoperability, Information Blocking and the National Health IT Certification Program offers recommendations that reflect a strong interest in improving interoperability and patient access to data to improve care coordination across a people-centered health system. Trinity Health comments:
- Require that no information blocking occurs.
- Highlight existing challenges resulting from the lack of alignment between the Health Information Portability and Accountability Act (HIPAA) and 42 C.F.R. Part 2, and how that will affect the compliance and implementation of the proposed rule; while strongly advocate for better correlation between the two policies.
- Request that ONC acknowledge problems with patient data matching and how they could impact the effectiveness of the proposed rule.
- Support using Fast Healthcare Interoperability Resources (FHIR) as the interoperability standard, but recommend extending the timeline two additional years to allow providers and vendors to implement.
- Urge ONC to work with the Centers for Medicare and Medicaid Services (CMS) to ensure security of open application programming interfaces (APIs).
- Promote patient access to meaningful information about price and quality of care.
- Recommend price transparency efforts that provide patients with accurate cost information that takes into account copays, coinsurance, deductible met and in/out of network nuances, and stress health plans must fully participate for this information to be meaningful.
Direct Contacting Geographic Population-Based Payment Model RFI, May 2019
The Centers for Medicare and Medicaid Innovation (CMMI) issued a Request for Information (RFI) seeking feedback on a potential new model that would allow entities to assume full risk for Medicare fee-for-service beneficiaries in a defined target region. Trinity Health commends the interest of the Centers for Medicare and Medicaid Services (CMS) in models that aim to increase investment in primary care, which has historically been undervalued. Trinity Health also encourage CMS to continue to pursue models that promote flexibility and support providers in delivering high-quality, people-centered care. Trinity Health comments:
- Urge CMS to make the Next Generation accountable care organization (ACO) program permanent.
- Require entities to implement alternative payment models (APMs) with downstream provider participants and meet the quality and performance requirements for advanced APMs.
- Request CMS target regions with low APM uptake and provide preference to existing APMs if overlap occurs.
- Recommend using this opportunity to move to a national benchmark over a five-year period to eliminate unjustified disparities in utilization and unit cost.
- Propose streamlined waiver flexibility across all APMs, and allow providers who are in down-side risk arrangements the ability to use all waiver flexibility afforded by Medicare.
- Encourage CMS use CMMI models to test screening and referrals for social influencers of health and serve as a convener for conversations/initiatives occurring in this space.
Increasing Consumer Choice Through the Sale of Individual Health Insurance Coverage Across State Lines, April 2019
The Centers for Medicare and Medicaid Services (CMS) issued an RFI seeking feedback on how to eliminate barriers to and enhance the ability of health insurance issuers to sell individual health insurance coverage across state lines. Trinity Health fully supports access to affordable health care coverage and is committed to the success of the health insurance marketplace. In response to the RFI, Trinity Health outlines why the sale of insurance coverage across state lines is not a viable long-term strategy to reduce average market premiums or provide meaningful choice to consumers. Trinity Health affirms:
- Issuers are unlikely to be able to construct provider networks that will support competitive premiums.
- This policy would likely destabilize existing risk pools and result in increased premiums for domestic plans in states with additional coverage mandates.
- Access issues tend to be focused in rural areas within states; those counties are not likely to be a high priority for issuers looking to sell policies across state lines.
- There is little evidence that issuers are interested in pursuing sales across state lines. A number of states have enacted legislation allowing out-of-state issuers to pursue sales within their states and to-date, not one issuer has been documented as having pursued this option.
Letter to CMS regarding a Change to an ACO Tobacco Screening and Cessation Quality Measure, April 2019
Trinity health sent a letter to the Centers for Medicare and Medicaid Services (CMS) urging leadership to address the unintended consequences from the recently revised accountable care organization (ACO) quality measure on Preventive Care and Screening, Tobacco Use Screening and Cessation Intervention. The measure does not accurately reflect the commitment – by Trinity Health and/or other ACOs – to tobacco cessation and may lead to a loss of shared savings for ACOs. Trinity Health strongly advises that the measure revert to the prior specifications for 2019 and be treated as a new measure for 2018—specifically that it is captured as a reporting-only status.
Supplemental Nutrition Assistance Program (SNAP) Proposed Rule, April 2019
Trinity Health appreciates the opportunity to provide comments to the United States Department of Agriculture Food and Nutrition Service (USDA) on SNAP Requirements and Services for Able-Bodied Adults Without Dependents (ABAWDs) Proposed Rule. This proposed rule would modify state waiver flexibility for SNAP and result in hundreds of thousands of able-bodied adults without dependents losing benefits. Trinity Health is deeply concerned the proposed rule would negatively affect access to necessary food and nutrition assistance while doing little to support access to programs that promote self-sufficiency. Further, access to food and proper nutrition is a major factor in determining health outcomes, and the proposed rule will adversely affect the health of those who stand to lose SNAP coverage.
In these comments, Trinity Health urges the USDA to withdraw or modify the rule so that it protects access to necessary food and nutrition programs and adheres to the bipartisan policies implemented in the recently passed 2018 Farm Bill. Specifically, Trinity Health recommends:
- Prioritization of communities designated as having a “lack of sufficient jobs” for inclusion in other federal and state economic improvement and business development zone designations.
- The USDA should strengthen state education and training programs.
- States should be encouraged to coordinate economic and community development to prioritize employment access and training for low-income communities. In addition, states should be incentivized to develop policies that link social services and private employers hiring practices through entities like social enterprises, transitional hiring partnerships, and case management in order to encourage employment and job retention.
- States should be encouraged to provide SNAP case management as individuals are engaged in a job training program, supportive social enterprise employment, or as they transition back into the workforce with a private employer.
- The USDA and states should also place greater priority in providing access to transportation and continued use of flexible waivers in places were employment and education and training initiatives require long-distance transportation.
Department of Veterans Affairs Community Care Program Proposed Rule, March 2019
Trinity Health appreciates the opportunity to comment on the Department of Veterans Affairs' (VA) proposed rule that would allow eligible veterans to receive hospital care, medical services and extended care service from non-VA entities or providers in the community. In these comments, Trinity Health:
- Supports allowing eligible veterans to receive services from a non-VA provider and looks forward to partnering with the VA to fill medical service performance gaps.
- Concurs with the process by which the VA will identify medical service lines that are not able to furnish care or services in a manner that complies with VA’s standards for quality, and commends the VA's commitment to quality care and transparency of this data.
- Supports authorizing emergency care for veterans within 72 hours of care being provided, and remains committed to providing high quality, safe and reliable emergency services for eligible veterans.
- Recommends reducing the proposed threshold for veterans to access community care from a non-VA provider to 14 days for a primary care appointment and under 20 days for specialty care. Trinity Health is committed to serving this population and will see veterans within 48 hours when possible.
Department of Veterans Affair's (VA) Proposed Rule, March 2019
Trinity Health appreciates the opportunity comment on the proposed rule related to the Department of Veterans Affairs (VA) that would grant eligible veterans more convenient access to urgent care—through qualifying non-VA entities or providers—without prior approval from the VA. In these comments, Trinity Health:
- Strongly concurs—for the purposes of the regulation—with the proposed rule's definition of qualifying non-VA providers as including any non-VA provider that has entered into a contract, agreement, or other arrangement with the VA to provide services allowing for the greatest flexibility for both the VA and for non-VA providers.
- Agrees with excluding general preventive services—with the exception of certain appropriate preventive services such as flu shots—and longitudinal care from this policy. Such provisions will ensure the VA's health care partners have the flexibility to deliver appropriate preventive services in conjunction with an urgent care visit, but do not attempt to provide care as a substitute for the VA's preventive and primary care.
- Recommends allowing eligible veterans the ability to access additional entities that have "urgent care" capability, such as primary care clinics and emergency departments with co-located "fast track" or urgent care capabilities. These types of clinics often meet the Centers for Medicare and Medicaid Services intent and guidelines for urgent care clinics, without being called urgent care clinics or walk-in retail health clinics. More important, they fill care gaps while avoiding the unnecessary expense associated with receiving care in hospital emergency departments.
Steps to Address Rising Health Care Costs Request for Information (RFI), March 2019
Trinity Health appreciates the opportunity to provide recommendations to the U.S. Senate Committee on Health, Education, Labor & Pensions (HELP). The recommendations proposed in the letter are designed help lower health care costs, improve the health and outcomes of patients, and increase the ability for patients to access information about their care. Trinity Health recommends:
- The Department of Health and Human Services (HHS) and the Congress continue to push for all payers—public and private—to move toward value-based care. This push should include implementing financially sustainable models, ensuring multi-payer engagement, increasing up-side opportunity for providers, aligning accountable care organization (ACO) and Medicare Advantage rules, providing additional waivers to ACOs, and simplifying quality measurement while ensuring measures are outcomes based.
- The Center for Medicare and Medicaid Innovation incorporate social influencers of health into new delivery and payment models for all payers. As new models are developed and tested, the Centers for Medicare and Medicaid Services (CMS) and other federal agencies should continue to work with state, regional and local stakeholders to find innovative ways to integrate social services into care management programs and foster payment models that support such integration.
- HHS establish an effective national strategy for accurately matching patients to their data, and a common national standard for privacy and security.
- CMS incentivize inclusion of behavioral health integration in alternative payment models. Additionally, Congress and HHS must expand the pipeline of behavioral health professionals, and support increased behavioral health training for primary care physicians.
- Congress and HHS should work to strengthen, not weaken, policies for access to comprehensive and affordable health care.
- The Senate HELP Committee convenes hearings to understand the affects the administrative and financial complexity of the existing health care system has on patients, and to think more broadly about alternative approaches.
Health Insurance Portability and Accountability Act (HIPAA), Request for Information, February 2019
Trinity Health appreciates the opportunity to identify recommendations to promote care coordination and remove barriers to value-based health care associated with HIPAA. Trinity Health urges the Department of Health and Human Services to:
- Align HIPAA and 42 CFR Part 2 to improve care coordination and the quality and safety of clinical care.
- Educate providers and patients on information sharing requirements and the benefits of robust data sharing.
- Develop a single standard of privacy regulations at the federal level to provide relief from navigating more restrictive state laws.
- Promote rulemaking to support seamless and secure access by patients to their electronic health information.
- Streamline data sharing between providers without compromising privacy protections for non-clinical disclosures.
- Eliminate requirement to physically distribute and receive written acknowledgment of provider's Notice of Privacy Practices.
Healthy People 2030 Objectives, Request for Comments, January 2019
In comments submitted to the Department of Health and Human Services (HHS), Trinity Health reflects its appreciation for the addition of new core Healthy People 2030 (HP 2030) Objectives around social determinants of health. Trinity Health also acknowledges that to allow for more comprehensive monitoring, HP 2030 reflects a reduction in the total number of objectives while at the same time enhancing categorization; and that the addition of the opioid category is appropriate. Trinity Health urges additional recommendations, requesting that HP 2030 objectives:
- Be better aligned with public health, prevention, and quality initiatives as well as HHS priorities.
- Include the Centers for Medicare and Medicaid Services priorities that, among others, measure improvements in care coordination across providers, reduction in all-cause readmissions, and addressing social determinants of health.
- Are expanded to include Pneumococcal vaccine and shingles vaccine.
- Distinguish between type 1 and type 2 in the multiple diabetes objectives.
Environmental Protection Agency (EPA) Mercury and Air Toxics Standards, January 2019
Trinity Health – in collaboration with Health Care Without Harm and other national health care providers – is calling on the EPA to protect current Mercury and Air Toxics Standards (MATS), which limit mercury and other air toxics emitted from power plants.
Mercury is a potent neurotoxin that causes brain damage, learning disabilities and birth defects in children. As a result of MATS, according to EPA’s own analysis, the value of the air quality improvements to people’s health totals $37 billion to $90 billion each year. Because of the continued dangers posed by mercury pollution, and based on the tremendous progress made in reducing mercury pollution, Trinity Health urges the EPA to maintain the standards currently in place.
Medicaid and Children’s Health Insurance Plan (CHIP) Managed Care, January 2019
Trinity Health appreciates the ongoing efforts of the Centers for Medicare and Medicaid Services (CMS) to support the delivery of value-based care and reduce administrative burden. With a strong belief that Medicaid makes people-centered care possible, Trinity Health urges CMS to:
- Support provider-led Medicaid innovation and value-based payment and care that gives greater flexibility for providers to continue to work with CMS, states, managed care plans, and community-based providers to develop models that advance whole-person care across physical, behavioral and social determinant of health needs.
- Reduce administrative burden for providers and health systems by limiting the variation across states for managed care network adequacy standards and in the definition of "specialists".
- Strengthen beneficiary protections to ensure appropriate access to care as well as information about coverage.
International Pricing Index (IPI) Model for Medicare Part B Drugs, December 2018
Trinity Health shares the Administration's interest in addressing the rising cost of drugs, but has great concerns with the immediate and unintended ramifications that this proposed IPI Model would have on the safety-net currently provided by hospitals to vulnerable patients and communities. Trinity Health's recommendations to the Centers for Medicare and Medicaid Services (CMS) include:
- Scaling back the proposed scope and size of the demonstration by engaging in a few small pilots rather than a large scale mandatory model and pursuing a more reasonable implementation time frame.
- Exempting 340B Drug Pricing Program hospitals from the model, because including these hospitals is inconsistent with the Congressional intent of the 340B Program.
- Ensuring appropriate, additional payments—particularly for hospital outpatient departments—to address administrative and operational burdens as well as the likely shift of infusion volume and other drug administration services to the hospital setting.
- Exploring the agency's authority to implement a capping mechanism for drug price increases with respect to drugs purchased by model participants.
Inadmissibility on Public Charge Grounds, December 2018
Trinity Health expressed significant concern to the Department of Homeland Security (DHS) over the proposed Inadmissibility on Public Charge Grounds rule and urges the DHS to immediately rescind and not finalize the proposed rule. This proposal would impose harsh and punitive new rules on legal immigrants seeking to better their lives in our nation and to become productive residents and citizens. The proposed regulation would have a detrimental effect on the health and wellness of individuals, the health and wellness of communities, and the economies of communities across the country. Specifically, Trinity Health is extremely concerned by the negative impact of the proposed policies on:
- Coverage and care for legal immigrants and family members and the likely “chilling effect” of the proposed rule as people forego participation in programs that support their long-term self-sufficiency.
- Public health and social determinants of health, including access to health insurance coverage, essential and preventive services and healthy food and housing.
- Economic well-being of individuals and families, the health care system, states and our communities.
340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties (CMP), November 2018
Trinity Health urges the Health Resources and Services Administration (HRSA) to swiftly implement and enforce the long-delayed 340B Ceiling Price and Manufacturer CMP final rule to ensure that 340B covered entities are receiving the correct 340B price; and, thereby, that the program is best able to meet its intended objective. Trinity Health was pleased to see HRSA propose to make January 1, 2019 the compliance effective date—after repeated and lengthy previous delays—and urges HRSA to stick by the commitment to this date and to publish the final rule in time to meet this January 1 deadline. Trinity Health also encourages the agency to promptly publish the website, which will make ceiling prices available to covered entities, as soon as possible after January 1, 2019. Adequate enforcement of manufacturers' pricing obligations is key to the success of the 340B Program.
Anti-Kickback Statute (AKS) and Beneficiary Inducement Civil Monetary Penalty (CMP) Request for Information (RFI), October 2018
Trinity Health offers recommendations to the Office of the Inspector General on regulatory safe harbors and exceptions for the AKS and beneficiary inducement CMP. In the letter, Trinity Health urges for the creation of two new AKS safe harbors: one for value-based payment arrangements, and the other for assistance to patients for better health. These new safe harbors are critical to ensuring better care coordination and advancing the delivery of value-based care. These safe harbor recommendations are consistent with those that Trinity Health offered in August 2018 on the Physician Self-Referral "Stark" Law.
Medicare Shared Savings Program (MSSP); Accountable Care Organizations (ACOs)—Pathways to Success, October 2018
Trinity Health believes the Centers for Medicare and Medicaid Services (CMS) MSSP proposed rule would be enhanced by increasing upside risk opportunity and leveling the playing field with Medicare Advantage. Committed to working with CMS to promote innovative model designs and testing, including total cost of care risk models, Trinity Health's strong dedication to population-based models and the MSSP is demonstrated by six years of participation across multiple markets. Serving more than 200,000 Medicare beneficiaries across the MSSP and Next Generation ACO models, Trinity Health uses shared savings earned to recoup some of the initial investments, and make new ones to generate additional savings and deliver high-quality care. However, other providers have not made sufficient investments because of uncertainties in the program, inadequate upside opportunity, and continued concerns around fee-for-service (FFS) utilization. This proposed rule will work to further chill the movement toward population-based models. Therefore, Trinity Health recommends:
- 80 percent upside potential be made available at all levels of the BASIC and ENHANCED Tracks. Based on experience, Trinity Health believes that if CMS wants ACOs to assume downside risk more quickly, than—under the current MSSP program—there must be sufficient opportunity for shared savings to support early investments in infrastructure.
- Alignment of Medicare Advantage (MA) and ACO program rules. The comments applaud CMS for moving toward aligned waiver opportunities and beneficiary assignment methodology and offer a number of additional suggestions to create a level playing field.
- Reduction of regulatory burden on participating providers by offering greater flexibility or waivers to support the delivery of patient-centered care and services in the home, and greater flexibility around the mandatory first, face-to-face visit, beneficiary notification provision.
Outpatient Prospective Payment System (OPPS) for Calendar Year (CY) 2019, September 2018
Trinity Health is deeply concerned and disappointed by the site-neutral proposals put forth by the Centers for Medicare and Medicaid Services (CMS) in the proposed CY 2019 OPPS rule. These proposed changes are outside the scope and intent of Congress and are misdirected policy that relies on inadequate data analyses and policy rationales. Specifically, Trinity Health opposes the following policy changes, and urges CMS to not finalize the proposed:
- Reduction in payment for the hospital outpatient clinic visit in excepted off-campus hospital outpatient departments.
- Reduction in payment for services from expanded clinical families furnished in excepted off-campus hospital outpatient departments.
- Continuation of the current policy that pays for separately payable drugs acquired through the 340B program at the rate of average sales price (ASP) minus 22.5 percent and expansion of this payment reduction to non-excepted hospital outpatient departments.
Medicare Physician Fee Schedule (MPFS) for Calendar Year 2019, September 2018
Trinity Health urges the Centers for Medicare and Medicaid Services (CMS) to improve the efficiency and outcomes driven by the Medicare program. Trinity Health also offered suggested revisions to payment policies under the physician fee schedule and other revisions to Part B for CY 2019; the Medicare shared savings program requirements; quality payment program; and Medicaid Promoting Interoperability program. Following specific suggestions offered include:
- Support for the CMS proposal to expand the list of Medicare telehealth codes covered under the physician fee schedule.
- Rationale for why the proposed changes to documentation, coding and billing could negatively impact quality of care, coordination across providers as well as physician payment.
- Support for the CMS proposal to eliminate the prohibition on billing for same-day visits.
- Concern regarding the potential impact of the proposed requirements on the furnishing professional and the performing facility as well as offers comments, suggestions and requests for clear guidance on any implemented requirements.
- Concern regarding proposals on the Medicaid Promoting Interoperability program.
Reducing Regulatory Burden of the Physician Self-Referral ("Stark") Law, August 2018
Trinity Health applauds the Centers for Medicare and Medicaid Services (CMS) for engaging in a critical examination of ways to reduce regulatory burden of the Stark Law and appreciates the opportunity to make recommendations in response to the agency's request for information (RFI). Simplifying this regulatory scheme will provide tremendous benefit to the overall health care system by reducing the expenditure of limited resources on technical compliance issues that do not actually impact the Medicare program or its beneficiaries. Furthermore, removing obstacles that the Stark Law creates on development of alternative payment models (APMs) and coordinated care initiatives will go a long way in transforming the health care system and advancing the movement to value-based payment models.
To this end, Trinity Health's primary and overarching recommendation is that CMS develop a simple, verifiable and objective regulatory exception under the Stark Law that specifically addresses new population-based/APM arrangements. This exception should apply to all arrangements that are reasonably necessary to achieve the purposes of the APM and facilitate a team approach to patient care delivery among hospitals, physicians and post-acute providers.
Notice of Request for Information Regarding Health Care Access Standards, July 2018
Trinity Health provided feedback to the Veterans Administration (VA) in response to the Notice of Request for Information (RFI) Regarding Health Care Access Standards in development of the access standards required by Section 104(a) of the VA Maintaining Internal Systems and Strengthening Integrated Outside Networks (MISSION) Act of 2018. Trinity Health comments addressed the importance of a team-based care model, referenced work on national benchmarks, and shared access standards for primary and specialty care.
Accelerating Transformation with the Congressional Health Care Innovation Caucus, July 2018
Trinity Health believes that the Center for Medicare and Medicaid Innovation (CMMI) at the Centers for Medicare and Medicaid Services (CMS) holds great promise in promoting transparent model design across all payers; supporting evaluation and measurement of model impacts; and developing market-based innovations that build on promising practices. In comments to the recently launched Health Care Innovation Caucus in Congress, Trinity Health urges Congress to work with CMS to continue to evolve existing models and programs that drive value-based care, promote population health and engage beneficiaries. CMMI has been a leader in this work, but significant difficulties exist with data, systems and policy changes. Policymakers should take a strategic approach that lays out an attractive, sustainable path for health care organizations to transition to a value-based approach. Recommendations on this approach include:
- Convening a group of integrated systems and physician organizations to discuss directly with the Administration a path that would take—those willing—to full capitation in five years.
- Ensuring multi-payer engagement with Medicare, Medicaid, commercial payers, employers and federal and state agencies.
- Increasing up-side opportunity to engage providers by offering programs that are attractive, predictable and rewarding from inception.
- Recognizing that transformation will take time by building on and fostering greater sustainability of models that are comprehensive and have demonstrated success in improving quality and reducing costs, while also reducing fragmentation.
340B Program in the HHS Blueprint to Lower Drug Prices, July 2018
The Department of Health and Human Services (HHS) on May 16 released a request for information (RFI) on ways to lower drug prices and reduce out-of-pocket costs for consumers. Trinity Health appreciates the Administration's focus on lowering drug prices, but focusing on the 340B Program as part of a plan to lower drug prices is misplaced. Instead, the issue of unsustainable increases in the costs of drugs must be addressed. 340B hospitals are committed to the stated purpose of the 340B Program: to "stretch scarce Federal resources as far as possible, reaching more eligible patients and providing more comprehensive services." Trinity Health offers the following recommendations with respect to the 340B Program:
- Support continuation of a strong 340B Program and the essential role it plays in ensuring safety-net hospitals can continue to serve the most vulnerable uninsured and underinsured patients and improve health in communities.
- Advance important exceptions and flexibilities to the Group Purchasing Organization (GPO) prohibition policy, including for drug shortages or other situations where there is a disruption in availability.
- Ensure the 340B definition of patient continues to recognize the varying arrangements between an individual and a covered entity that may create a provider-to-patient relationship and recognize that any narrowing of this definition of patient would do significant harm to 340B hospitals and the patients served.
- Deem as 340B-eligible those locations of a hospital that are determined by the Centers for Medicare and Medicaid Services to be part of the hospital for purposes of the hospital’s Medicare certification.
United States Munitions List Proposed Rule, July 2018
Trinity Health values the opportunity to comment on the proposed rule to address the Control of Firearms, Guns, Ammunition and Related Articles that the President Determines No Longer Warrant Control Under the United States Munitions List (USML). Trinity Health is specifically concerned about the shift of weapon sale regulation from the U.S. Department of State to the U.S. Department of Commerce. Because the State Department is required and organized to consider the probable impacts of importing nations on stability, human security, conflict and human rights, Trinity Health believes that shifting gun exportation licensing to the Commerce Department, whose principle mission is to stimulate trade, has the potential to increase the sales of weapons around the world without consideration of the impacts historically reviewed by the State Department. Trinity Health strongly urges the Departments of Commerce and State to rescind this proposed rule.
Inpatient Prospective Payment System (IPPS) for Fiscal Year (FY) 2019 including Price Transparency and Interoperability Requests for Information (RFIs), June 2018
In comments to the Centers for Medicare and Medicaid Services (CMS) proposed FY 2019 IPPS rule, which includes RFIs on price transparency and interoperability, Trinity Health makes several recommendations in support of better health, better care and lower costs to ensure affordable, high quality, and people-centered care for all. Specifically, Trinity Health encourages CMS to:
- Convene hospitals, physicians, payers, consumers and employers to explore ways to increase health care literacy of consumers, especially around their health plan benefit design; and to develop a framework in which payers provide key information to providers so that providers can better assist patients in receiving an accurate estimate of out-of-pocket costs. Charge data is not helpful to consumers, does not solve the price transparency challenge; and, therefore, is not meaningful information for consumers.
- Advance the widespread exchange of health information through interoperable technology requiring all acute care, post-acute care and skilled nursing facilities to attest that they are regularly transmitting admit, discharge and transfer (ADT) transactions to established community-wide, regional or state-wide health information exchanges.
- Develop a long-term quality strategy that focuses on outcomes-based measures that are meaningful to patients, that are risk-adjusted for sociodemographic factors, and reflect successful performance toward improving care and outcomes and reducing costs.
Direct Provider Contracting (DPC) Request for Information, May 2018
The Center for Medicare and Medicaid Innovation (Innovation Center) issued a Request For Information (RFI) to seek input on Direct Provider Contracting Models (DPC) between payers and practices to inform the potential testing of an approach in Medicare fee-for-service (FFS), Medicare Advantage (MA) and Medicaid. The Center for Medicare and Medicaid (CMS) identities that the goal of a DPC model is to enhance the beneficiary-physician relationship by providing a platform for physician group practices to provide flexible, accessible and high quality care. Trinity Health commends CMS for its interest in a model that aims to increase investment in primary care, which has historically been undervalued, and encourages CMS to pursue models that promote flexibility, and support providers in delivering high-quality, people-centered care. Trinity Health offered the following recommendations:
- Embed the DPC model within a total cost of care model—similar to partial or full-risk provider arrangements with Medicare accountable care organization (ACO) and Medicare Advantage models—as these models support better care coordination across settings and providers, encourage more appropriate use of primary care providers and specialists, support more opportunities for patient engagement, and offer financial and infrastructure support to participating providers.
- Improve existing payment and delivery reform models such as ACOs; and, by developing and testing new total cost of care models to foster beneficiary engagement, reduce burdens on participating providers as well as support greater market-based innovations. Improving the existing models will also achieve the stated goal of the DPC model.
Trinity Health Joins Others In Urging for Language in Appropriations Bill That Advances Efforts to Improve Patient Matching in Electronic Health Records (EHRs), May 2018
Trinity Health recently submitted a joint letter to key appropriators urging inclusion of report language in the fiscal year 2019 Labor-Health and Human Services (HHS) appropriations. This letter works to clarify that the current unique patient identifier ban does not preclude HHS from examining issues related to patient matching. It also encourages the Office of the National Coordinator for Health Information Technology (ONC) and the Centers for Medicare and Medicaid Services (CMS) to provide technical assistance to private-sector led initiatives in support of a coordinated national strategy allowing industry and the federal government to promote patient safety by accurately identifying patients and matching them to their health information.
Opioid Comments to House Ways and Means Committee, March 2018
In comments to the House Ways and Means Committee, Trinity Health urges Congress to prioritize a coordinated, comprehensive strategy on opioids that ensures appropriation of federal funding for programs that support the collaborative, community-based opioid efforts of state and local governments, hospitals and community-based organizations. Recommendations for key congressional action include:
- Advancing responsible, evidence-based prescribing guidelines that do not simultaneously create access barriers to pain management for patients for whom opioids are medically indicated and who are benefiting from such treatment.
- Expanding and ensuring coverage and access to non-opioid and non-pharmacological alternative approaches to pain management.
- Aligning the confidentiality of substance use records with Health Insurance Portability and Accountability Act (HIPAA) requirements thereby granting health care providers access to information to diagnose and effectively treat patients who use opioids and other controlled substances and better ensure integrated care across providers and settings.
- Enhancing prescription drug monitoring programs (PDMPs) to achieve interoperability with health system electronic health records (EHRs) as well as interstate data sharing and cross-state information exchange.
- Providing appropriate reimbursement and financial incentives for supporting a collaborative, team-based workforce.
- Ensuring meaningful insurance coverage of and access to evidence-based medication-assisted treatment (MAT), including limiting prior authorization requirements, no lifetime limits, no arbitrarily low dose and time limits, expanding MAT training, and providing financial incentives for prescribers willing to secure waivers to prescribe Buprenorphine, for example.
FDA Opioid Policy Steering Committee Request for Comment, March 2018
Trinity Health appreciates the ongoing work of the Food and Drug Administration (FDA) Opioid Policy Steering Committee to identify ways the agency can address this crisis. Important considerations that Trinity Health brings to the attention of the committee, include:
- Urging the FDA to work with other agencies within the Department of Health and Human Services (HHS) to ensure that government mitigation measures—including provider education requirements—are not duplicative in nature and are as consistent as possible across all states.
- Recognizing that public policies intended to reduce inappropriate use of opioids must not simultaneously create access barriers to pain management for patients for whom opioids are medically indicated and who are benefiting from such treatment.
- Ensuring that any database efforts advanced by the agency—including related requirements on providers—not be overly burdensome, and are integrated into existing databases, systems and workflow.
- Exploring how the agency could support an increase in the number of and access to permanent prescription take-back programs and drop-off sites as well as broadening access to disposal options such as drug deactivation systems.
- Expanding options for non-opioid and non-pharmacological alternative approaches to pain management as the FDA has an important role in supporting this research and speeding these alternatives to market.
Medicare Part D Opioid Overutilization Strategies, March 2018
As a national leader in community palliative care, Trinity Health's comments to the Centers for Medicare and Medicaid Services (CMS) on proposed opioid overutilization strategies urge the agency to explicitly exclude end-of-life care and palliative care in addition to the current exceptions for hospice care and cancer diagnoses. It is critical that public policies intended to reduce inappropriate use of opioids do not simultaneously create access barriers to pain management for palliative care patients for whom opioids are medically indicated and who are benefiting from such treatment.
Confidentiality Requirements for Substance Use Disorder Records, February 2018
Trinity Health provided comments to the Substance Abuse and Mental Health Services Administration (SAMHSA) concerning the effect of regulations on the confidentiality of substance use disorder patient records (known as 42 CFR Part 2) on patient care, health outcomes, and patient privacy.
Trinity Health's recommendations urge that SAMHSA align 42 CFR Part 2 confidentiality requirements for sharing a patient's substance use disorder records with the requirements in the Health Insurance Portability and Accountability Act (HIPAA) so that opioid and substance use disorders can be treated like other medical conditions and result in improved patient safety and continuity of care while at the same time maintaining the privacy and dignity of the individuals we serve.
Trinity Health Opioid Comments to Senate Finance Committee, February 2018
Trinity Health strongly believes that health systems and hospitals must play a critical role in addressing opioid use and addiction. Trinity Health is committed to developing and implementing important opioid utilization reduction strategies, ensuring comprehensive education and awareness programs, engaging in robust advocacy, and measuring impact to ensure continuous improvement for all populations that we serve. In comments to the Senate Finance Committee, Trinity Health urged that federal and state mitigation measures and provider
education requirements and initiatives are as consistent as possible across all states to avoid duplication, confusion, and undue burden on providers. Recommendations for action include several areas in which Medicare and Medicaid can support critical prevention, intervention, treatment and recovery initiatives, including:
- Ensuring meaningful insurance coverage of and access to evidence-based medication-assisted treatment (MAT).
- Providing appropriate reimbursement and financial incentives for supporting a collaborative, team-based workforce.
- Aligning the confidentiality of substance use records with HIPAA requirements thereby granting health care providers access to information to diagnose and effectively treat patients who use opioids and other controlled substances and better ensure integrated care across providers and settings.
- Ensuring prescription drug monitoring programs (PDMPs) achieve interoperability with health system electronic health records (EHRs) as well as interstate data sharing and cross-state information exchange.
CMS Innovation Center: New Direction Request for Information (RFI), November 2017
The Center for Medicare and Medicaid Services (CMS) issued a RFI to seek input on shaping a new direction for the Center for Medicare and Medicaid Innovation (CMMI). Trinity Health collaborated with the Health Care Transformation Task Force (HCTTF) to develop recommendations, including:
- Improve return on Investment (ROI) of models to entice more participants in alternative payment models (APMs).
- Refine mechanisms (waivers, quality measures, benchmarks, etc) in existing models to improve their ability to deliver a return to CMS and participants.
- Adjust definition of Advanced APM to include upside only models, lower thresholds, and the Program of All Inclusive Care for the Elderly (PACE) model to expand participation.
- Allow ACOs to assume more risk.
- Increase opportunities for state-based innovation (multi-payer, duals, etc).
Preliminary 2018 Clinical Laboratory Fee Schedule, October 2017
In comments to the Centers for Medicare and Medicaid Services (CMS), Trinity Health urges the agency to swiftly suspend implementation of the draft Clinical Laboratory Fee Schedule (CLFS) payment rates until significant data deficiencies can be addressed. Instead, CMS should engage stakeholders in ways to improve the data process and calculation thereby establishing a clear path forward for the clinical laboratory community and the Medicare beneficiaries who rely on its services. Specifically, Trinity Health urges CMS to:
- Modify the regulation to address data integrity concerns and market exclusion through a statistically valid process that is least burdensome on providers.
- Ensure that the private payer data CMS collects accurately represents all segments of the clinical laboratory market.
- Provide a transparent process to allow for the validation of the data collected by CMS.
Outpatient Prospective Payment System (OPPS) for Calendar Year (CY) 2018, September 2017
Trinity Health urges the Centers for Medicare and Medicaid Services (CMS) to consider how several of the proposed changes for outpatient services and payments in 2018 would create significant regulatory burden and inefficiency – including those related to 340B, appropriate use criteria, the inpatient-only list, and drug administration add-on codes – at a time when the agency is promoting regulatory flexibility and efficiency. Of most significant concern, Trinity Health strongly urges CMS to:
- Rescind in its entirety the proposed cut in payments for 340B drugs as the proposed payment cut is inconsistent with the Congressional intent of the 340B Program, represents a further assault on safety-net institutions, and will have a devastating impact on patients and communities.
- Retain total knee arthroplasty (TKA) or total knee replacement on the inpatient-only list as clinicians across Trinity Health do not believe it is clinically appropriate to remove, and are concerned about risks for vulnerable Medicare patients.
Medicare Physician Fee Schedule (MPFS) for Calendar Year 2018, September 2017
Trinity Health urges the Centers for Medicare and Medicaid Services (CMS) to improve the efficiency and outcomes driven by the Medicare Physician Fee Schedule Rule (MPFS) and offered specific suggestions in its comments including:
- Ways to streamline the evaluation and management (E/M) coding process.
- Rationale for why the proposed payment reduction for non-grandfathered provider-based departments is flawed.
- Explanations for why ordering professionals – not furnishing providers and facilities – should be accountable for Appropriate Use Criteria.
- Ideas to improve the Medicare Shared Savings Program (MSSP).
- Support for changes to Diabetes Prevention Program and expansion of reimbursable telehealth services.
Reducing Regulatory Burdens Imposed by the Affordable Care Act & Improving Healthcare Choices to Empower Patients, July 2017
Trinity Health believes that stabilizing the Health Insurance Marketplaces, under the Affordable Care Act (ACA), through 2018 and beyond is critical for payers, providers and, most importantly, for the consumers who rely on them. As part of its commitment to ensure coverage for all, Trinity Health has become a national leader in advancing sustainable and fair Marketplace policy and maximizing enrollment. Recommendations to the Centers for Medicare and Medicaid Services (CMS), in response to this request for information (RFI), include:
- Providing full funding for cost-sharing reductions (CSRs), which are critical to increasing plan participation and making plans affordable for individuals and families.
- Implementing and funding reinsurance and wrap-around risk adjustment policies that promote affordable coverage incentivizing people to purchase insurance and responsibly use health care services.
- Incentivizing the inclusion of clinically integrated networks that drive value-based payment arrangements and care.
- Funding outreach and enrollment—particularly outreach and enrollment focused on young adults—including public service announcements (PSAs), advertising, and the use of enrollment navigators, among other mechanisms.
- Ensuring consistency in the development and enforcement of standards across states in order to reduce unnecessary regulatory and administrative burden.
Hospital Inpatient Prospective Payment Systems (IPPS) for Fiscal Year (FY) 2018, June 2017
Highlights from Trinity Health’s comments on the Traditional FY 2018 IPPS rule to the Center for Medicaid and Medicare Services (CMS) include:
- Adopting a five-year transition period in use of the hospital S-10 worksheet, engaging in education and auditing of the S-10 to ensure consistency and compliance, and including the unreimbursed costs of public health care programs, including Medicaid, in the uncompensated care calculation.
- Eliminating the 96-hour certification requirement for critical access hospitals (CAHs) on a permanent basis.
- Removing redundancy when selecting measures across quality reporting programs and evolving all quality reporting to focus on patient-reported outcomes that can be derived from the electronic medical record.
- Accounting for socioeconomic risk adjustment in quality reporting and payment programs by utilizing significant factors that demonstrate an impact on a person's health outcomes, such as census tract data on poverty and income for example.
Highlights from Trinity Health’s comments to CMS on Request for Information (RFI) on Regulatory Flexibilities and Efficiencies include:
- The complexity and redundancy of the existing regulatory process has become overly intrusive and is distorting the practice of medicine. Trinity Health believes the old framework of overregulation can be modified and instead regulation can rely on transparency, database monitoring, and selective focus where abuse has been detected.
Highlights from Trinity Health’s comments to CMS on RFI on Physician-owned hospitals include:
Trinity Health discourages CMS from diluting current restrictions on physician self-referrals for hospital services because financial self-interest leads to increased utilization and over building. Both of these contribute to unnecessary cost for the health care system.
Support for Continued U.S. Role in Paris Climate Agreement, May 2017
Trinity Health President and CEO, Richard Gilfillan, along with his counterparts at Catholic Health Initiatives, Kevin E. Lofton; and Dignity Health, Lloyd Dean sent a letter to President Trump supporting a continued role for the United States in the Paris Climate Agreement. Our support of the Paris agreement is one way in which we live out our core value of justice, which includes our commitment to foster right relationships in promoting the common good, including sustainability of the Earth. We also recognize that the impacts of climate change show up in the health of those we serve, particularly the most vulnerable communities.
Advancing Care Coordination through Episode Payment Models (EPMs); Cardiac Rehabilitation Incentive Payment Model; and Changes to the Comprehensive Care for Joint Replacement Model, April 2017
Trinity Health is firmly committed to transforming our delivery system into a People-Centered Health System and views bundled payments as an important part of this journey. In comments to the Centers for Medicare and Medicaid Services (CMS), Trinity Health expressed support for several policy matters, including:
- Flexibility in time frames pertaining to EPM programs to ensure providers can continue, without barriers, on their individual paths toward Alternative Payment Models (APMs).
- Exclusion of the Medicare Shared Savings Program (MSSP) Track 3 participants from EPMs, thus leaving the savings in the population-based model.
- Shared-decision making using tools such as a patient-decision aid, which provides balanced, evidence-based sources of information about treatment options.
Programs of All-Inclusive Care for the Elderly (PACE) Innovation Act Request for Information (RFI), February 2017
As the largest sponsor of PACE organizations in the country, Trinity Health understands the role this program plays in helping frail, elderly individuals remain in the community by meeting their needs through individualized and comprehensive care, and looks forward to working with the Centers for Medicare and Medicaid Services (CMS) on how this model might be expanded to a broader range of high-need populations. Providing a learning laboratory to test a wide-variety of value-based care models is critical, but it also takes significant time and investment to see sustainable success. Providers need a viable path to develop the capabilities needed to manage this risk and the assumption of such risk requires early success to maintain sustainability of continued participation. Therefore, Trinity Health's recommendations for this PACE RFI include:
- Ensuring that all stakeholders – providers, CMS and states – have enough time for learning what payment mechanisms, including benchmarking methodologies, will best support the needed redesigns in care delivery.
- Encouraging CMS to support the significant investment of capital that is required to redesign care delivery to improve beneficiary health.
- Keeping core strengths and competencies of PACE services in mind and including full waiver authority in any pilots.
- Urging that risk be phased-in, down-side risk be limited, and that CMS maintain any risk stabilization programs, such as stop-loss and risk corridors, for the full duration of the pilot.
Healthcare Leaders to Congress and Administration: Improve the Value-Based Care Movement, January 2017
Trinity Health joined with the Health Care Transformation Task Force, Premier Inc., and a broad coalition of others urging President Donald Trump and Congressional leaders to accelerate the movement toward value-based care. One hundred twenty organizations representing a broad coalition of patients, clinicians, employers, labor unions, hospitals, pharmacists, consumer groups, biopharmaceutical companies and insurance carriers signed the letter expressing the need to drive legislative reforms, new and improved alternative payment models, and creation of better outcomes measures.
Recommendations on Interoperability and Improving Patient Access to Data, January 2017
Trinity Health was invited to join an in-person conversation with Vice President Joe Biden in Washington, D.C. on January 6, 2017 to discuss leveraging health information technology (health IT) to advance progress against the scourge of cancer and improve patient access to electronic health data. Trinity Health offered specific recommendations—to be approached in concert with the private section—on which the Department of Health and Human Services can lead and advance progress toward interoperability. Those recommendations include:
- Accelerate public and private sector efforts toward the consistent implementation of uniform national standards for health IT.
- Align Meaningful Use and Advancing Care Information requirements for physicians and hospitals; or, preferably, cancel Stage 3 of the Meaningful Use program and suspend all regulatory requirements that mandate submission of electronic clinical quality measures, which presently are unable to accurately measure the quality of care provided.
- Promote an effective national strategy for accurately matching patients to their data.
- Establish common national standards for privacy and security.
- Require consumer interoperability standards so that it is easy for consumers to access all their information, free of charge, and incorporate it into any certified tool they wish to use.
Letter to President-elect Trump and Congressional Leadership, December 23, 2016
To help President-elect Trump and Congressional leadership better understand the implications of any repeal to the Affordable Care Act (ACA), Trinity Health sent a letter outlining two important aspects that must continue for successful transformation: comprehensive, affordable coverage and value-based payment. Trinity Health is committed to ensuring that all Americans have affordable, continuous and high-quality health care coverage. The letter outlines Trinity Health's desire to press forward both public and private initiatives to evolve a payment and care delivery system that provides high-value, affordable care while reducing health care costs.