Ensuring Access to Quality Complex Rehabilitation Technology Act of 2012

Issues pertaining to durable medical equipment including: bidding, power wheelchairs, oxygen, diabeti supplies, negative pressure wound therapy, Medicare audits, and fraud abuse; H.R. 1041 - Fairness in Medicare Bidding Act, all provisions; H.R. 3399/S. 1251 - Medicare and Medicaid FAST Act, all provisions; H.R. 452 - Medicare Decisions Accountability Act of 2011, all provisions; S.668 - Health Care Bureaucrats Elimination Act, all provisions; H.R. 3630 - Middle Class Tax Relief and Job Creation Act of 2012, all provisions; H.Con.Res. 112 - House Budget Resolution for Fiscal Year 2013, all provisions; S.3187 - Food and Drug Administration Safety and Innovation Act, all provisions; H.R. 4378 - Ensuring Access to Quality Complex Rehabilitation Technology Act of 2012, all provisions; H.R. 5652 - Sequester Replacement Reconciliation Act of 2012, issues pertaining to Medicare; CMS prior authorization demonstration for power mobility devices. H.R. 6490 - Medicare DMEPOS Market Pricing Program Act of 2012, all provisions. H.R. 6575 - Medicare Audit Improvement Act of 2012, all provisions. H.R. 8 - American Taxpayer Relief Act of 2012, all provisions.

Client expense: $160,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Natl Economic Council (NEC), Office of Management & Budget (OMB), SENATE, Treasury, Dept of, White House Office

HR 1040, Fairness in Medicare Bidding Act of 2011(FIMBA); HR 4378, Ensuring Access to Quality Complex Rehabilitation Technology Act of 2012 and HR 6490, Medicare DMEPOS Market Pricing Program Act of 2012

Client expense: $220,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), SENATE

H.R. 1546/S. 829-Medicare Access to Rehabilitation Services Act (Repeal of Therapy Caps) H.R. 560 Rural Representation and Transparency Improvement Act Payments to Physical Therapists under the Medicare Physician Fee Schedule Permanent Repeal of/alternatives to the Sustainable Growth Rate (SGR) Formula Opposition of Multiple Procedure Payment Reduction for PT Services Physician Quality Reporting System Opposition to Medicaid Funding Cuts Physician Self-Referral - elimination of PT exception Medicare Advanced Imaging Act Opt-Out Locum Tenens Prevention Initiatives for Fraud and Abuse in the Medicare program H.R. 2785 Opposition to Athletic Trainers' Equal Access to Medicare Act, all provisions Accountable Care Organizations Electronic Health Records/ Health Information Technology incentives for Physical Therapists Home Health PPS 2011/ 2012 Development of Alternatives to Medicare Therapy Cap Medicare Payment Reform H.R. 1700 Medicare Patient Empowerment Act, inclusion of physical therapists S. 668 Health Care Bureacrats Elmination Act (IPAB Repeal), all provisions H.R. 452 Medicare Decisions Accountability Act of 2011 (IPAB Repeal), all provisions Protecting Medicaid Caps or Block Grants SNF PPS FY 2012/MDS 3.0/RUG IV IRF PPS FY 2012 Quality Initiatives & Value Based Purchasing Local Coverage Determinations NCCI Edits H.R. 2863 Medicare Oral Health Rehabilitative Enhancement Act of 2011, all provisions H.R. 2499 Lymphedema Diagnosis and Treatment Cost-Saving Act of 2011, all provisions Protection of programs related to physical therapy in deficit reduction H.R. 1958 Medicare Orthotics and Prosthetics Improvement Act of 2011, all provisions OPPS CY 2012 H.R. 3000 Empowering Patients First Act, provisions pertaining to physical therapy H.R. 5 Protecting Access to Healthcare Act Medicare Advantage Mobile Health Technology Privacy/Security Meeting (HHS-ONC) Medicare Overpayment Proposed Rule Off-the-shelf Othotics Comments PCORI National Priority for Research and Research Agenda USPSTF peripheral arterial disease HR 3258 Medicare Equity Extension Act National Coverage Analysis for TENS comments Health Information Technology :EHR Comments EHR Incentive Program Stage 2 Comments Medicaid Eligibility Comments Medicare Physician Payment Innovation Act H.R. 4378- Ensuring Access to Quality Complex Rehabilitation Technology Act

Continues to educate Congress on HR 4378 - Ensuring Access to Quality Complex Rehabilitation Technology Act of 2012. This legislation creates a separate benefit for complex rehab technology under Medicare for individuals with significant disabilities and functional limitations. Discussed possible solutions for improving access to Medicaid for military families who have children with disabilities. Discussed concerns and possible solutions to prior authorization and physician documentation matters regarding the submission of medical claims for Medicare beneficiaries and people with disabilities. Discussed concerns with the dual-eligible population regarding those who are individuals with disabilities and the avaialability of home and community-base services and supports. Discussed our concerns and possible solutions around Medicare caps on rehabilitation therapy for individuals with disabilities. Supports HR 3613, Part D Beneficiary Appeal Fairness Act of 2011. This legislation resolves some of the concerns surrounding high-cost prescription drug coverage in the following ways: It would permit requests from beneficiaries for exceptions and appeals for all tiers in Medicare Part D tiers, including specialty tier drugs. It would prohibit insurance companies from blocking a more favorable cost-sharing structure as an outcome of the exceptions and appeals process decision. This legislation ensures that all Part D beneficiaries have access to an exceptions and appeals process if they find their medications unaffordable and prevents anyone from being at a disadvantage or subject to discrimination due to a specific condition. Supports HR 1546 and S. 829 - the Medicare Access to Rehabilitation Services Act. This legislation would repeal the arbitrary Medicare Part B outpatient therapy caps now affecting an estimated 640,000 Medicare beneficiaries who depend on outpatient rehabiliation therapy. Under Medicaid: Expand managed care where feasible to higher risk, higher cost beneficiaries and those dually eligible for Medicare with strict oversight and patient protections to improve care coordination and achieve efficiencies for these patients. Restore Medicaids discount prescription drug pricing to those dually eligible for Medicare.

Issues pertaining to durable medical equipment including: bidding, power wheelchairs, oxygen, diabeti supplies, negative pressure wound therapy, Medicare audits, and fraud abuse; H.R. 1041 - Fairness in Medicare Bidding Act, all provisions; H.R. 3399/S. 1251 - Medicare and Medicaid FAST Act, all provisions; H.R. 452 - Medicare Decisions Accountability Act of 2011, all provisions; S.668 - Health Care Bureaucrats Elimination Act, all provisions; H.R. 3630 - Middle Class Tax Relief and Job Creation Act of 2012, all provisions; H.Con.Res. 112 - House Budget Resolution for Fiscal Year 2013, all provisions; S.3187 - Food and Drug Administration Safety and Innovation Act, all provisions; H.R. 4378 - Ensuring Access to Quality Complex Rehabilitation Technology Act of 2012, all provisions; H.R. 5652 - Sequester Replacement Reconciliation Act of 2012, issues pertaining to Medicare; CMS prior authorization demonstration for power mobility devices. H.R. 6490 - Medicare DMEPOS Market Pricing Program Act of 2012, all provisions.

Client expense: $170,000 · Firm income: Not reported

Issues pertaining to durable medical equipment including: competitive bidding, power wheelchairs, oxygen, diabetic supplies, negative pressure wound therapy, Medicare audits, and fraud and abuse. H.R. 1041, Fairness in Medicare Bidding Act--all provisions. H.R. 6490, The Medicare DMEPOS Market Pricing Program Act. See continuation on next page. S. 1251 and H.R. 3399, Medicare and Medicaid FAST Act--all provisions. H.R. 452, Medicare Decisions Accountability Act of 2011--all provisions. S. 668, Health Care Bureaucrats Elimination Act--all provisions. H.R. 3399, Medicare and Medicaid FAST Act, all provisions. S. 3187, The Food and Drug Administration Safety and Innovation Act, all provisions. H.R. 4378, Ensuring Access to Quality Complex Rehabilitation Technology Act of 2012, all provisions. H.R. 5652, Sequester Replacement Reconciliation Act of 2012, all provisions. CMS prior authorization demonstration for power mobility devices. H.R. 6490, Medicare DMEPOS Market Pricing Program Act of 2012, all provisions.

Client expense: Not reported · Firm income: $70,000

HR 1040, Fairness in Medicare Bidding Act of 2011(FIMBA); HR 4378, Ensuring Access to Quality Complex Rehabilitation Technology Act of 2012 and HR 6490, Medicare DMEPOS Market Pricing Program Act of 2012

Client expense: $320,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), SENATE

HR 4378 - Ensuring Access to Quality Complex Rehabiliation Technology Act of 2012. Throughout the second quarter, 2012, United Spinal has been advocating on this legislation to create a separate benefit category in Medicare for coverage of complex rehabilitation technology such as highly sophisticated, customized power mobility devices. The bill entails a broader baseline of services than those that are currently referred to under the Medicare program as durable medical equipment. HR 4378 ensures access to appropriate prodcuts and technology based on a person's functional needs in addition to their diagnosis and the severity of their injury or disorder; allows individuals to access devices that can be used outside of the home and in the community, allows individuals to work and participate in community life; and, ensuring access to local CRT suppliers equipped to make repairs and maintenance for specialized devices. United Spinal Association wrote a letter in April to Secretary Sebelius applauding the newly created Administration for Community Living (ACL) in support of the focus on community living and urged the agency to lift the outdated rule that ties Medicare coverage of wheelchairs and other mobility assistive equipment to in-the-home use. United Spinal also met with the ACL to discuss complex rehab technology and Medicaid managed care and there will be a continuing dialogue between the Association and the ACL on these and other matters. In April, United Spinal submitted comments to the Centers for Medicare and Medicaid Services in response to the proposed information collection requirements for the Medicare prior authorization demonstration applied to coverage claims for power mobility devices. We insisted that CMS be proactive in providing guidance, in the form of guides or templates, to assist physicians and treating practitioners in filing claims and documenting medical necessity and functional limitations from the outset. In June comments to the Office of Management and Budget, we continue to urge the creation of an electronic template under this demonstration to help accelerate the delivery of necessary equipment that will enhance mobility-related activities of daily living and support the independendce of individuals with disabilities. In April, United Spinal signed onto a letter to the Food and Drug Administration's Center for Devices and Radiological Health on the Medical Device User Fee and Modernization Act (MDUFA) agreement in principle between industry and FDA (Docket No. FDA-2010-N-0389). The letter supports the agency-industry agreements intent to do the following: significantly improve FDA review times to help speed up safe and effective treatments to patients; vastly enhance the consistency and timeliness of the approval process, helping to provide patients more information and certainty about the process; offer greater accountability and improved transparency resulting in more data points on FDAs performance; provide enhanced resources to give FDA the necessary tools for meeting new performance goals. Medicaid Eligibility Rules United Spinal co-signed a Consortium for Citizens with Disabilities letter to HHS Secretary Kathleen Sebelius, spearheaded by the Healthcare for America Now coalition urging the Centers for Medicare & Medicaid Services (CMS) to reconsider the provision of the final Medicaid rule (CMS-2349-F) that permits important eligibility determination functions to be contracted to private entities. Public accountability for Medicaid eligibility determinations is essential. The best way to ensure accountability is if governmental staff carries out these functions in the best interest of the public, free of bias or conflicts of interest. This has been the policy in Medicaid for decades: to change it without a process for notice and comment would be highly unusual and set a bad precedent. Congressional Hearing on Competitive Acquisition United Spinal Association submitted a statement for the record to the United States House Committee on Ways and Means Subcommittee on Health. United Spinal urged the committee to look closely at how the Centers for Medicare and Medicaid Services is gathering data on the impact this program has on all consumers, including people with disabilities. United Spinal Association will continue to monitor how the program is impacting consumers. United Spinal signed onto a Coalition for Disability Health Equity letter to CMS in response to the agencys proposed rules on the agency's electronic health record incentive program. Health information technology and electronic health records have the power to collect aggregated data on people with disabilities to provide information to improve the quality of care of all people with disabilities. The incentive program offers an important opportunity to reduce health disparities and improve equity in the U.S. health care system. Reducing disparities is included in the first of the five pillars of meaningful use health outcomes policy priorities and health disparities among those with disabilities are included in HHS policies to reduce health disparities, including Healthy People 2020 and the Affordable Care Act. Supported reauthorization of the Traumatic Brain Injury Act. This is the only federal legislation that specifically assists states and other entities to develop and expand service delivery systems, and provide needed advocacy to meet the needs and protect the rights of individuals who have sustained a TBI and their families. HR 3613: Part D Beneficairy Appeal Fairness Act which supports implementation of a fair and reasonable exceptions and appeals process under Medicare Part D coverage for seniors and people with disabilities that depend on 'specialty tier' drugs to improve or maintain their health status and function. Support making the Medicaid Buy In program mandatory nationwide. To maintain their capacity for employment that keeps them off the Medicaid rolls, workers with disabilities often need long-term services and supports. In many states, they are able to purchase affordable Medicaid coverage for this purpose but the benefits vary. To promote the productivity and independence of workers with disabilities, Medicaid buy-in coverage should be made consistent in scope, remain affordable and offered for purchase in all states. Request that DOL issue the Rehab Act Section 503 Final Rules governing Federal Contractor compliance with measurable affirmative action goals for recruiting, hiring and advancing workers with disabilities. Federal contractors and subcontractors account for one-fifth of all jobs in the employment marketplace. It is critical that they be held accountable to the law. HR 1546 and S 829, the Medicare Access to Rehabilitation Services Act which eliminates Medicare Part Bs arbitrary and unfair outpatient rehab therapy payment caps. Advance the use of home and community-based services and supports as mandatory long-term care benefits (currently optional to the states) which are far less costly than nursing home and other facility-based care for such purposes and are currently mandatory under Medicaid. Expand managed care where feasible to higher risk, higher cost beneficiaries and those dually eligible for Medicare as well with strict oversight and patient protections to improve care coordination and achieve efficiencies for these patients. Restore Medicaids discount prescription drug pricing to those dually eligible for Medicare. Intensify efforts to reduce fraud and abuse which accounted for $12.9 billion in Medicaid improper payments in FY 2007. Insist that Medicare restore its pre-2008 catheter policy language around individual consideration that enabled physicians to diagnose and prescribe the proper treatment based on their patients specific needs, circumstances and risk factors. Add a new criterion for Medicare eligibility for a closed system catheter that allows automatic qualification for patients with permanent severe bladder impairments, reducing their risk of bacterial contamination which can lead to life-threatening UTIs.

HR 3248/S 1283: Lifespan Respite Care Act of 2005; HR 4281: Small Business Health Fairness Act; PL 109-365: Older Americans Act Amendments of 2006; Older Americans Act Reauthorization; HR 3267/S 1760: Healthy Start Reauthorization Act of 2007; HR 6111: Tax Relief and Health Care Act of 2006; PL 111-148: The Patient Protection and Affordable Care Act; PL 111-152: Affordable Health Care for America Act; HR 4872: Health Care and Education Reconciliation Act of 2010; HR 4213 American Jobs and Closing Tax Loopholes Act; PL 111-192: Preservation of Access to Care for Medicare Beneficiaries and Pension Relief Act; S 829/HR 1546: Medicare Access to Rehabilitation Services Act; HR 452: Medicare Decisions Accountability Act; HR 3765: Temporary Payroll Tax Cut Contribution Act of 2011; HR 3630: Middle Class Tax Relief & Job Creation Act of 2011; HR 5: Protecting Access to Health Care Act; HR 1700: Medicare Decision Accountability Act; HR 3497: MODDERN (Modernize Our Drug and Diagnostics Evaluation and Regulatory Network) Cures Act of 2011; HR 4378: Ensuring Access to Quality Complex Rehabilitation Technology Act of 2012; and S 3289: Children's Mental Health Accessibility Act of 2012.

Client expense: $68,819 · Firm income: Not reported

Implementation of the Community First Choice Option for Medicaid. Allignment of Medicare and Medicaid for dually eligible recipients. Preservation of Medicaid as an entitlement program. Medicaid eligibility changes in the Affordable Care Act. Implementation of the Olmstead decision regarding community integration. Achieving a Better Life Experience Act draft legislation. Implementation of the Affordable Care Act, P.L. 111-148 and P.L. 111-192, including Medicaid Health and Long Term Services and Supports provisions. Implementation of the Budget Control Act (P.L. 112-25). S. 3271, a bill to help Medicare beneficiaries with disabilities have access to Medigap policies and H.R. 4378, a bill to improve access to complex rehabilitation. Quality measures for long term services and supports in Medicaid Managed Care. Proposed rules pertaining to State Plan Home and Community-Based Services Option.

Client expense: $40,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Education, Dept of, Equal Employment Opportunity Commission (EEOC), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Housing & Urban Development, Dept of (HUD), Justice, Dept of (DOJ), Office of Management & Budget (OMB), SENATE, Social Security Administration (SSA), White House Office

Issues pertaining to durable medical equipment including: competitive bidding, power wheelchairs, oxygen, diabetic supplies, negative pressure wound therapy, Medicare audits, and fraud and abuse; H.R. 1041 - Fairness in Medicare Bidding Act, all provisions; S.1251 - Medicare and Medicaid FAST Act, all provisions; H.R. 452 - Medicare Decisions Accountability Act of 2011, all provisions; S.668 - Health Care Bureaucrats Elimination Act, all provisions; H.R. 3399 - Medicare and Medicaid FAST Act, all provisions; H.R. 3630 - Middle Class Tax Relief and Job Creation Act of 2012, all provisions; H.Con.Res. 112 - House Budget Resolution for Fiscal Year 2013, all provisions; S.3187 - Food and Drug Administration Safety and Innovation Act, all provisions; H.R. 4378 - Ensuring Access to Quality Complex Rehabilitation Technology Act of 2012, all provisions; H.R. 5652 - Sequester Replacement Reconciliation Act of 2012, all provisions; CMS prior authorization demonstration for power mobility devices.

Client expense: $190,000 · Firm income: Not reported

Issues pertaining to durable medical equipment including: competitive bidding, power wheelchairs, oxygen, diabetic supplies, negative pressure wound therapy, Medicare audits, and fraud and abuse. H.R. 1041, Fairness in Medicare Bidding Act--all provisions. See continuation on next page. S. 1251 and H.R. 3399, Medicare and Medicaid FAST Act--all provisions. H.R. 452, Medicare Decisions Accountability Act of 2011--all provisions. S. 668, Health Care Bureaucrats Elimination Act--all provisions. H.R. 3399, Medicare and Medicaid FAST Act, all provisions. S. 3187, The Food and Drug Administration Safety and Innovation Act, all provisions. H.R. 4378, Ensuring Access to Quality Complex Rehabilitation Technology Act of 2012, all provisions. H.R. 5652, Sequester Replacement Reconciliation Act of 2012, all provisions. CMS prior authorization demonstration for power mobility devices.

Client expense: Not reported · Firm income: $60,000

HR 1040, Fairness in Medicare Bidding Act of 2011(FIMBA) and HR 4378, Ensuring Access to Quality Complex Rehabilitation Technology Act of 2012

Client expense: $210,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), SENATE

HR 1040, Fairness in Medicare Bidding Act of 2011(FIMBA) and HR 4378, Ensuring Access to Quality Complex Rehabilitation Technology Act of 2012

Client expense: $210,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), SENATE