Medicare CGM Access Act of 2015

H.R. 1427 & S.804-Medicare CGM Access Act of 2015

Client expense: Not reported · Firm income: $20,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Medicare Part B Premium. (No bill.) Proposals to mitigate the expected increase in the 2017 Part B premium for beneficiaries not protected by the "hold harmless" provision. Medicare Part B Enrollment. Comments on the CMS/HHS Proposed Notice of Benefit and Payment Parameters for 2018. Medicare Supplemental Insurance. H.R. 6265, the Medigap Consumer Protection Act of 2016: proposal to improve access to and improve beneficiary information about Medigap for seniors and disabled individuals in the traditional Medicare program. Medicare Affordability. S. 3371, H.R. 6109, Medicare Affordability and Enrollment Act of 2016: proposals to improve Medicare for beneficiaries by capping out-of-pocket costs in traditional Medicare; increasing financial assistance for low-income beneficiaries; aligning the Medicare Savings Programs and Low-Income Subsidy; eliminating the 24- month waiting period for Medicare coverage for people receiving Social Security Disability Insurance benefits; making changes in the enrollment period for Medicare; eliminating gaps between enrollment and when actual coverage begins; limiting the Part B late enrollment penalty; and providing permanent funding for the State Health Insurance Assistance Programs (SHIPs), Area Agencies on Aging (AAAs), Aging and Disability Resource Centers ADRCs) and the National Center for Benefits Outreach and Enrollment. Medicare Part B Enrollment. S. 3236, H.R. 5772, the Beneficiary Enrollment Notification and Eligibility Simplification (BENES) Act: legislation to modernize and simplify Part B enrollment. Medicare Hearing Coverage. H.R. 1653, the Medicare Hearing Aid Coverage Act of 2015: proposal to provide Medicare coverage for the cost of hearing aids and examinations. Medicare Dental Coverage. S. 570, H.R. 1055, the Comprehensive Dental Reform Act of 2015: proposal to expand Medicare coverage to include dental care. Medicare Dental, Vision, and Hearing Coverage. H.R. 5396, H.R. 3308: Proposals to expand Medicare coverage to include comprehensive coverage of dental, vision, and hearing care. Home-based Primary Medical Care. S. 3130, Independence at Home Act of 2016: legislation to expand the Independence at Home Medicare demonstration project providing home-based primary medical care to elders with severe chronic illness and disability. Continuous Glucose Monitoring Devices. S. 804, Medicare CGM Access Act: legislation to provide Medicare coverage of continuous glucose monitoring (CGM) devices for beneficiaries with diabetes who meet specified medical criteria. Biologics Market Exclusivity Period. S. 3094, H.R. 5573, Price Relief, Innovation and Competition for Essential Drugs (PRICED) Act: legislation to reduce the market exclusivity period for biologics from its current 12 years to seven years. Drug Manufacture Transparency. S. 3335, H.R. 6043, Fair Accountability and Innovative Research Drug Pricing Act of 2016: proposal to require drug manufacturers to be more transparent about justification for increases in drug prices over ten percent, namely to report their spending on a drug's research and development as well as their profits on a drug each year since its approval. Drug Importation. H.R. 2623, the Personal Drug Importation Fairness Act: proposal to establish policies for the safe reimportation of pharmaceutical drugs by individuals for their personal use. Containment of Prescription Drug Costs. S. 2023, the Prescription Drug Affordability Act: proposals to require Medicare to negotiate drug prices under the Medicare Part D prescription drug program; allow for importation of prescription drugs from licensed Canadian pharmacies; require manufacturers to provide a rebate to the federal government for drugs covered under Medicare Part D for low-income Medicare beneficiaries; require generic drug manufacturers to pay an additional rebate to Medicaid if their drug prices rise faster than inflation; close the Medicare Part D donut hole for brand and generic drugs by 2017; and prohibit anti-competitive pay-for-delay arrangements between brand and generic drug makers. Medicare Prescription Drug Negotiation Authority. H.R. 4207, Medicare Fair Drug Pricing Act: proposal to allow the Secretary of Health and Human Services (HHS) to negotiate prices with pharmaceutical companies when drugs lack sufficient competition. Medicare Observation Status. S. 843, H.R. 1571, Improving Access to Medicare Coverage Act of 2015: proposal to count days in the hospital in observation status toward meeting the three-day prior hospitalization requirement for skilled nursing facility (SNF) care eligibility. Medicare Privatization. (No bill.) Proposals to transform traditional Medicare to a private insurance carrier program. Medicare Eligibility Age. (No bill.) Proposals to raise the eligibility age for Medicare from 65 to 67. Medicaid Restructuring. (No bill.) Proposals to change Medicaid from an entitlement program to block grants or per capita caps, forms of lump sum payments from the federal government. Affordable Care Act (ACA) repeal. (No bill.) Proposals to repeal the ACA affecting the closing of the Medicare Part D donut hole, Medicare coverage of ACA-mandated preventive services, and payment and delivery reforms that extend the life of the Medicare Part A Trust Fund. Childrens Health Insurance Program (CHIP) extension. (No bill.) Proposal to add an extension of the Medicare therapy cap exceptions process.

Client expense: $200,000 · Firm income: Not reported

Government targets: Administration on Aging, Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), Labor, Dept of (DOL), Natl Economic Council (NEC), Office of Management & Budget (OMB), President of the U.S., SENATE, Social Security Administration (SSA), Treasury, Dept of, Vice President of the U.S.

Medicare Reimbursement issues for physician services and diabetes care; meaningful use; chronic care reform proposals; Evaluation & Management code reform. HR 1427/ S 804, Medicare CGM Access Act.

Client expense: Not reported · Firm income: $30,000

Government targets: Centers For Medicare and Medicaid Services (CMS), Environmental Protection Agency (EPA), HOUSE OF REPRESENTATIVES, Natl Institutes of Health (NIH), SENATE

S.804/HR.1427 MEDICARE CGM ACCESS ACT OF 2015, S.586/HR1192 NDCCA, S.1345/HR 1726 ACCESS TO QUALITY DIABETES EDUCATION ACT, S.1131/HR2102 MEDICARE NDPP, HR 771 PROTECTING ACCESS TO DIABETES SUPPLIES ACT, HR 1686 MEDICARE PREVENTION NUTRITION EDUCATION, MEDICARE COMPETITIVE BIDDING PROGRAM,

Client expense: Not reported · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

HR 1427 & S 804 - Medicare CGM Access Act of 2015

Client expense: Not reported · Firm income: $10,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to competitive bidding for DME products. H.R. 5210 and S. 2736- Patient Access to Durable Medical Equipment Act- provisions related to patient access. H.R. 1427/S.804- Medicare CGM Access Act of 2015- Provisions related to continuous glucose monitoring.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 1427/S.804 - Medicare CGM Access Act of 2015 - provisions related to continuous glucose monitoring. Issues related to competitive bidding for DME products. Issues related to physician-owned distributors. H.R. 5210/S. 2736 - Patient Access to Durable Medical Equipment Act - provisions related to patient access.

Client expense: $940,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 1427 and S.804, Medicare CGM Access Act of 2015; issues related to physician-owned distributorship; issues related to competitive bidding of DME; monitored issues related to Unique Device Identifier and Medicare claims.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 1427/S. 804 - Medicare CGM Access Act of 2015 H.R. 6 - 21st Century Cures Act S. 2700 - FDA and NIH Workforce Authorities Modernization Act H.R. 1192/S. 586 - National Diabetes Clinical Care Commission Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

- HR 1427/S 804, "Medicare CGM Access Act of 2015", regarding all provisions. - HR 284, "Medicare DMEPOS Competitive Bidding Improvement Act of 2015", regarding all provisions. - Issues regarding combination products. - Issues regarding Transferable Regulatory Exclusivity Incentive. - Issues related to Expanded Access. - S. 2736/ HR 5210, "Patient Access to Durable Medical Equipment Act of 2016", regarding all provisions. - Issues related to competitive bidding for DME products. - S. 2484, "Connect for Health Act", Provisions related to expanded use of RPM for certain patients with chronic conditions.

Client expense: $890,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)

H.R. 1427 & S.804-Medicare CGM Access Act of 2015

Client expense: Not reported · Firm income: $20,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

no specific bill - medicare coverage and reimbursement, continuous glucose monitors, chronic care PL 111-148 - The Patient Protection and Affordable Care Act, implementation issues related to diabetes care H.R. 2 - Medicare Access and CHIP Reauthorization Act of 2015 H.R. 1470/S. 810 - SGR Repeal and Medicare Provider Payment Modernization Act of 2015 H.R. 1427/S. 804 - Medicare CGM Access Act of 2015

Client expense: Not reported · Firm income: $80,000

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

S. 804/H.R. 1427, the Medicare CGM Access Act. Support entire bill; provides Medicare coverage for continuous glucose monitoring (CGM) devices to qualified individuals.

Client expense: $108,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), HOUSE OF REPRESENTATIVES, Natl Institutes of Health (NIH), SENATE

Medicare Reimbursement issues for physician services and diabetes care; meaningful use; chronic care reform proposals; Evaluation & Management code reform. HR 1427/ S 804, Medicare CGM Access Act.

Client expense: Not reported · Firm income: $30,000

Government targets: Centers For Medicare and Medicaid Services (CMS), Environmental Protection Agency (EPA), HOUSE OF REPRESENTATIVES, Natl Institutes of Health (NIH), SENATE

- HR3204 Drug Quality & Security Act regarding 3PL licensing & serialization standards and federal licensing of 3PLs; support for Federal license for 3PL and wholesale distribution of medical devices in the U.S. - HR 1427/S804 Medicare CGM Access Act of 2015 to have Constant Glucose Monitoring Devices for diabetes therapies covered by private insurance to be covered by Medicare. - "Special Diabetes Program Funding" - assist healthcare clients & JDRF gain signatures for Senate support of $150M special program funding.

Client expense: $1,354,916 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Federal Aviation Administration (FAA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Homeland Security, Dept of (DHS), Labor, Dept of (DOL), Pension Benefit Guaranty Corporation (PBGC), SENATE, State, Dept of (DOS), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Customs & Border Protection, U.S. Trade Representative (USTR), White House Office

- HR3204 Drug Quality & Security Act regarding 3PL licensing & serialization standards and federal licensing of 3PLs; support for Federal license for 3PL and wholesale distribution of medical devices in the U.S. - HR 1427/S804 Medicare CGM Access Act of 2015 to have Constant Glucose Monitoring Devices for diabetes therapies covered by private insurance to be covered by Medicare. - "Special Diabetes Program Funding" - assist healthcare clients & JDRF gain signatures for Senate support of $150M special program funding.

Client expense: $1,354,916 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Federal Aviation Administration (FAA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Homeland Security, Dept of (DHS), Labor, Dept of (DOL), Pension Benefit Guaranty Corporation (PBGC), SENATE, State, Dept of (DOS), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Customs & Border Protection, U.S. Trade Representative (USTR), White House Office

Medicare Part B Premium. (No bill.) Proposals to mitigate the expected increase in the 2017 Part B premium for beneficiaries not protected by the hold harmless provision. Medigap. H.R. 6265, the Medigap Consumer Protection Act of 2016: proposal to improve access to and improve beneficiary information about Medigap for seniors and disabled individuals in the traditional Medicare program. Medicare Affordability. S. 3371, H.R. 6109, Medicare Affordability and Enrollment Act of 2016: proposals to improve Medicare for beneficiaries by capping out-of-pocket costs in traditional Medicare; increasing financial assistance for low-income beneficiaries; aligning the Medicare Savings Programs and Low-Income Subsidy; eliminating the 24-month waiting period for Medicare coverage for people receiving Social Security Disability Insurance benefits; making commonsense changes in the enrollment period for Medicare; eliminating gaps between enrollment and when actual coverage begins; limiting the Part B late enrollment penalty; and providing permanent funding for the State Health Insurance Assistance Programs (SHIPs), Area Agencies on Aging (AAAs), Aging and Disability Resource Centers (ADRCs) and the National Center for Benefits Outreach and Enrollment. Medicare Part B Enrollment. S. 3236, H.R. 5772, the Beneficiary Enrollment Notification and Eligibility Simplification (BENES) Act: legislation to modernize and simplify Part B enrollment. Medicare Observation Status. Public Law 114-42, Notice of Observation Treatment and Implication for Care Eligibility Act (NOTICE Act): comments on the CMS/HHS proposed rule to strengthen protections for Medicare beneficiaries who are hospitalized in observation status. Medicare Hearing Coverage. H.R. 1653, the Medicare Hearing Aid Coverage Act of 2015: proposal to provide Medicare coverage for the cost of hearing aids and examinations. Expanding Drug Monopolies. H.R. 6, 21st Century Cures Act. Proposal to extend orphan drug market exclusivity for existing drugs to new indications. Medicare Part B Drug Payments. H.R. 5122: legislation to prohibit the Department of Health and Human Services from taking any further action on a proposed rule to change how Medicare pays for certain drugs that are typically not self-administered (such as some intravenous medications and chemotherapy drugs). Drug Manufacture Transparency. S. 3335, H.R. 6043, Fair Accountability and Innovative Research Drug Pricing Act of 2016: proposal to require drug manufacturers to be more transparent about justification for increases in drug prices over ten percent, namely to report their spending on a drugs research and development as well as their profits on a drug each year since its approval. Biologics Market Exclusivity Period. S. 3094, H.R. 5573, Price Relief, Innovation and Competition for Essential Drugs (PRICED) Act: legislation to reduce the market exclusivity period for biologics from its current 12 years to seven years. Continuous Glucose Monitoring Devices. S. 804, Medicare CGM Access Act: legislation to provide Medicare coverage of continuous glucose monitoring (CGM) devices for beneficiaries with diabetes who meet specified medical criteria. Home-based Primary Medical Care. S. 3130, Independence at Home Act of 2016: legislation to expand the Independence at Home Medicare demonstration project providing home-based primary medical care to elders with severe chronic illness and disability. Alzheimers Beneficiary and Caregiver Assistance. S. 3137, H.R. 5681, Alzheimers Beneficiary and Caregiver Support Act: proposals to improve the quality of life for people living with Alzheimers disease and other forms of dementia, support family care partners, and reduce costs to federal and state health programs. Alzheimers Caregiver Support. S. 3113, H.R. 3039, Alzheimers Caregiver Support Act: legislation to provide vital support and training to people living with Alzheimers disease and other forms of dementia and to their caregivers. Medicare Payment Policy. Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2017 (CMS-16545-P): comments to CMS/HHS pertaining to the proposed rule for Sec. II. E. 5, Assessment and Care Planning for Patients with Cognitive Impairment, which recognizes the value of assessment and care planning services for patients with cognitive impairment, including people living with Alzheimers disease and other forms of dementia. Medicare End-Stage Renal Disease Prospective Payment System. End-Stage Renal Disease Prospective Payment System, Coverage and Payment for Renal Dialysis Services Furnished to Individuals with Acute Kidney Injury, End-Stage Renal Disease Quality Incentive Program, Durable Medical Equipment, Prosthetics, Orthotics and Supplies Competitive Bidding Program Bid Surety Bonds, State Licensure and Appeals Process for Breach of Contract Actions, Durable Medical Equipment, Prosthetics, Orthotics and Supplies Competitive Bidding Program and Fee Schedule Adjustments, Access to Care Issues for Durable Medical Equipment; and the Comprehensive End-Stage Renal Disease Care Model (CMS-1651-P): comments to CMS/HHS regarding obstacles in many states to obtaining DME among people with Medicaid and Medicare benefits (dual eligibles).

Client expense: $180,000 · Firm income: Not reported

Government targets: Administration on Aging, Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), Labor, Dept of (DOL), Natl Economic Council (NEC), Office of Management & Budget (OMB), President of the U.S., SENATE, Social Security Administration (SSA), Treasury, Dept of, Vice President of the U.S.

S.804/HR.1427 MEDICARE CGM ACCESS ACT OF 2015, S.586/HR1192 NDCCA, S.1345/HR 1726 ACCESS TO QUALITY DIABETES EDUCATION ACT, S.1131/HR2102 MEDICARE NDPP, HR 771 PROTECTING ACCESS TO DIABETES SUPPLIES ACT, HR 1686 MEDICARE PREVENTION NUTRITION EDUCATION, MEDICARE COMPETITIVE BIDDING PROGRAM, Docket No. FDA-2016-N-0400 FDA LANCET DEVICES GUIDANCE DOCKET, Docket No. FDA-2016-N-0001 FDA DIABETES DEXCOM G5 LABELING CHANGE

Client expense: Not reported · 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), SENATE

HR 1427 & S 804 - Medicare CGM Access Act of 2015

Client expense: Not reported · Firm income: $10,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 1427/S. 804 Medicare CGM Access Act H.R. 3081/ S. 1778 TELEmedicine for MEDicare (TELE-MED) Act H.R. 1190/S. 141 Protecting Seniors' Access to Medicare Act H.R. 2446 To amend title XIX of the Social Security Act to require the use of electronic visit verification for personal care services furnished under the Medicaid program, and for other purposes. H.R. 3821 Medicaid Directory of Caregivers Act S.2104 Preserving Medicare Advantage for all Medicare Beneficiaries Act

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

- HR 1427/S 804, "Medicare CGM Access Act of 2015", regarding all provisions. - HR 284, "Medicare DMEPOS Competitive Bidding Improvement Act of 2015", regarding all provisions. - Issues regarding combination products. - Issues regarding Transferable Regulatory Exclusivity Incentive. - Issues related to Expanded Access. - S. 2736, "Patient Access to Durable Medical Equipment Act of 2016", regarding all provisions.

Client expense: $2,040,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)

H.R. 1427/S.804 - Medicare CGM Access Act of 2015 - provisions related to continuous glucose monitoring. Issues related to competitive bidding for DME products. Issues related to physician-owned distributors. H.R. 5210/S. 2736 - Patient Access to Durable Medical Equipment Act - provisions related to patient access.

Client expense: $920,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

no specific bill - medicare coverage and reimbursement, continuous glucose monitors, chronic care PL 111-148 - The Patient Protection and Affordable Care Act, implementation issues related to diabetes care H.R. 2 - Medicare Access and CHIP Reauthorization Act of 2015 H.R. 1470/S. 810 - SGR Repeal and Medicare Provider Payment Modernization Act of 2015 H.R. 1427/S. 804 - Medicare CGM Access Act of 2015

Client expense: Not reported · Firm income: $80,000

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

HR 1427 & S 804 - Medicare CGM Access Act of 2015

Client expense: Not reported · Firm income: $10,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

- HR3204 Drug Quality & Security Act regarding 3PL licensing & serialization standards and federal licensing of 3PLs; support for Federal license for 3PL and wholesale distribution of medical devices in the U.S. - HR 1427/S804 Medicare CGM Access Act of 2015 to have Constant Glucose Monitoring Devices for diabetes therapies covered by private insurance to be covered by Medicare.

Client expense: $1,680,927 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Federal Aviation Administration (FAA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Labor, Dept of (DOL), Postal Regulatory Commission, SENATE, State, Dept of (DOS), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Customs & Border Protection, U.S. Postal Service (USPS), U.S. Trade Representative (USTR), White House Office

S. 1131/H.R. 2102, the Medicare Diabetes Prevention Act. Support entire bill; provides Medicare coverage for the National Diabetes Prevention Program to individuals with prediabetes. Also support regulatory pathway to achieve Medicare coverage of National DPP announced in March. S. 804/H.R. 1427, the Medicare CGM Access Act. Support entire bill; provides Medicare coverage for continuous glucose monitoring (CGM) devices to qualified individuals. H.R. 1686, the Preventing Diabetes in Medicare Act of 2015. Support entire bill; extends Medicare coverage of medical nutrition therapy services to people with prediabetes and other risk factors for developing type 2 diabetes.

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

Government targets: Centers For Disease Control & Prevention (CDC), HOUSE OF REPRESENTATIVES, Natl Institutes of Health (NIH), SENATE

H.R. 1427/S. 804 - Medicare CGM Access Act of 2015 H.R. 6 - 21st Century Cures Act S. 2700 - FDA and NIH Workforce Authorities Modernization Act S. 2689/H.R. 4762 - Reliable and Effective Growth for Regenerative Health Options that Improve Wellness Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 1427 & S 804 - Medicare CGM Access Act of 2015; HR 5210 - Patient Access to Durable Medical Equipment Act of 2016

Client expense: Not reported · Firm income: $20,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 1427 and S.804, Medicare CGM Access Act of 2015; issues related to physician-owned distributorship; issues related to competitive bidding of DME; issues related to Unique Device Identifier and Medicare claims.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Research in Endocrinology; HR 6 House 21st Century Cures bill; Senate Innovations for Healthier Americans bill, S. 2745; HR 2101 Research for All act of 2015; inclusion in research; S. 1101 MEDTECH Act, HR 1427/ S 804, Medicare CGM Access Act.

Client expense: Not reported · Firm income: $30,000

Government targets: Centers For Medicare and Medicaid Services (CMS), Environmental Protection Agency (EPA), HOUSE OF REPRESENTATIVES, Natl Institutes of Health (NIH), SENATE

S.804/HR.1427 MEDICARE CGM ACCESS ACT OF 2015, S.586/HR1192 NDCCA, S.1345/HR 1726 ACCESS TO QUALITY DIABETES EDUCATION ACT, S.1131/HR2102 MEDICARE NDPP, HR 771 PROTECTING ACCESS TO DIABETES SUPPLIES ACT, HR 1686 MEDICARE PREVENTION NUTRITION EDUCATION, MEDICARE COMPETITIVE BIDDING PROGRAM, Docket No. FDA-2016-N-0400 FDA LANCET DEVICES GUIDANCE DOCKET, Docket No. FDA-2016-N-0001 FDA DIABETES DEXCOM G5 LABELING CHANGE

Client expense: Not reported · 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), SENATE

S.804/HR.1427 - MEDICARE CGM ACCESS ACT OF 2015, S.586/HR.1192 - NDCCA, S.1345/HR 1726 ACCESS TO DIABETES QUALITY EDUCATION ACT, S.1131/HR.2102 MEDICARE NDPP, HR.771 PROTECTING ACCESS TO DIABETES SUPPLIES ACT, HR 1686 MEDICARE PREVENTION NUTRITION EDUCATION, SPECIAL DIABETES FUNDING PROGRAM, CMS COMPETITIVE BIDDING PROGRAMS FOR DIABETES SUPPLIES, RESTRICTION OF ACCESS TO DIABETES TREATMENTS BY INSURANCE PROVIDERS

Client expense: Not reported · Firm income: Not reported

S.804/HR.1427 - MEDICARE CGM ACCESS ACT OF 2015, S.586/HR.1192 - NDCCA, S.1345/HR 1726 ACCESS TO DIABETES QUALITY EDUCATION ACT, S.1131/HR.2102 MEDICARE NDPP, HR.771 PROTECTING ACCESS TO DIABETES SUPPLIES ACT, HR 1686 MEDICARE PREVENTION NUTRITION EDUCATION, SPECIAL DIABETES FUNDING PROGRAM, CMS COMPETITIVE BIDDING PROGRAMS FOR DIABETES SUPPLIES, RESTRICTION OF ACCESS TO DIABETES TREATMENTS BY INSURANCE PROVIDERS

Client expense: Not reported · Firm income: Not reported

S.804/HR.1427 - MEDICARE CGM ACCESS ACT OF 2015, S.586/HR.1192 - NDCCA, S.1345/HR 1726 ACCESS TO DIABETES QUALITY EDUCATION ACT, S.1131/HR.2102 MEDICARE NDPP, HR.771 PROTECTING ACCESS TO DIABETES SUPPLIES ACT, HR 1686 MEDICARE PREVENTION NUTRITION EDUCATION, SPECIAL DIABETES FUNDING PROGRAM, CMS COMPETITIVE BIDDING PROGRAMS FOR DIABETES SUPPLIES, RESTRICTION OF ACCESS TO DIABETES TREATMENTS BY INSURANCE PROVIDERS

Client expense: Not reported · Firm income: Not reported

S.804/HR.1427 - MEDICARE CGM ACCESS ACT OF 2015, S.586/HR.1192 - NDCCA, S.1345/HR 1726 ACCESS TO DIABETES QUALITY EDUCATION ACT, S.1131/HR.2102 MEDICARE NDPP, HR.771 PROTECTING ACCESS TO DIABETES SUPPLIES ACT, HR 1686 MEDICARE PREVENTION NUTRITION EDUCATION, SPECIAL DIABETES FUNDING PROGRAM, CMS COMPETITIVE BIDDING PROGRAMS FOR DIABETES SUPPLIES, RESTRICTION OF ACCESS TO DIABETES TREATMENTS BY INSURANCE PROVIDERS

Client expense: Not reported · Firm income: Not reported

S.804/HR.1427 - MEDICARE CGM ACCESS ACT OF 2015, S.586/HR.1192 - NDCCA, S.1345/HR 1726 ACCESS TO DIABETES QUALITY EDUCATION ACT, S.1131/HR.2102 MEDICARE NDPP, HR.771 PROTECTING ACCESS TO DIABETES SUPPLIES ACT, HR 1686 MEDICARE PREVENTION NUTRITION EDUCATION, SPECIAL DIABETES FUNDING PROGRAM, CMS COMPETITIVE BIDDING PROGRAMS FOR DIABETES SUPPLIES, RESTRICTION OF ACCESS TO DIABETES TREATMENTS BY INSURANCE PROVIDERS

Client expense: Not reported · Firm income: Not reported

HR 1427 & S 804 - Medicare CGM Access Act of 2015

Client expense: Not reported · Firm income: $10,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Lobbied for support of H.R. 1427 and S. 804.

Client expense: Not reported · Firm income: $36,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 1131/H.R. 2102, the Medicare Diabetes Prevention Act. Support entire bill; provides Medicare coverage for the National Diabetes Prevention Program to individuals with prediabetes. S. 804/H.R. 1427, the Medicare CGM Access Act. Support entire bill; provides Medicare coverage for continuous glucose monitoring (CGM) devices to qualified individuals. H.R. 1686, the Preventing Diabetes in Medicare Act of 2015. Support entire bill; extends Medicare coverage of medical nutrition therapy services to people with prediabetes and other risk factors for developing type 2 diabetes.

Client expense: $179,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 1427 and S.804, Medicare CGM Access Act of 2015; issues related to physician-owned distributorship; issues related to competitive bidding of DME.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 1427 - Medicare CGM Access Act of 2015 - provisions related to continuous glucose monitoring. S. 804 - Medicare CGM Access Act of 2015 - provisions related to continuous glucose monitoring. Issues related to competitive bidding for DME products. Issues related to physician-owned distributors.

Client expense: $1,000,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

- HR 1427/S 804, "Medicare CGM Access Act of 2015", regarding all provisions. - HR 284, "Medicare DMEPOS Competitive Bidding Improvement Act of 2015", regarding all provisions. - Issues regarding combination products. - Issues regarding Transferable Regulatory Exclusivity Incentive. - Issues related to Expanded Access. - S. 2736, "Patient Access to Durable Medical Equipment Act of 2016", regarding all provisions.

Client expense: $1,140,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)

We plan to lobby for support of H.R.1427 - Medicare CGM Access Act of 2015 and S. 804 Medicare CGM Access Act of 2015.

Client expense: Not reported · Firm income: Not reported

H.R. 1427 - Medicare CGM Access Act of 2015 - provisions related to continuous glucose monitoring. S. 804 - Medicare CGM Access Act of 2015 - provisions related to continuous glucose monitoring. Issues related to competitive bidding for DME products. Issues related to physician-owned distributors.

Client expense: $996,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE