Medicare CGM Access Act of 2014

S. 2689 & H.R. 5644 - Medicare CGM Access Act of 2014; Issues relating to health IT.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

**see addendum pageno specific bill - medicare coverage and reimbursement, continous glucose monitors PL 111-148 - The Patient Protection and Affordable Care Act, implementation issues related to diabetes care H.R. 2810 - Medicare Patient Access and Quality Improvement Act of 2013, SGR S. 1871 - SGR Repeal and Medicare Beneficiary Access Act of 2013, SDP renewal H.R. 4302 - Protecting Access to Medicare Act of 2014, SDP renewal H.R. 3710 - Medicare CGM Coverage Act S. 2689/H.R. 5644 - Medicare CGM Access Act of 2014

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. 2689/H.R. 5644, the Medicare CGM Access Act of 2014. Support entire bill; provides Medicare coverage for continuous glucose monitoring (CGM) devices to qualified individuals beginning January 1, 2015 and provides a pathway for the next generation of CGM-related technologies.

Client expense: $128,000 · Firm income: Not reported

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

- Issues related to Medicare reimbursement for Clinical Laboratory Services. - HR 8, "American Taxpayer Relief Act of 2012", regarding all provisions in Section 636. - HR 800, "To amend part B of title XVIII of the Social Security Act to exclude customary prompt pay discounts from manufacturers to wholesalers from the average sales price for drugs and biologicals under Medicare", regarding all provisions.- Issues related to physician-owned companies that manufacture or distribute medical devices. - Issues related to implantable medical devices. - Issues related to diabetes care products. - Issues related to competitive bidding of diabetes care products. - Issues related to health care pricing transparency. - Issues related to OIG study regarding competitive bidding. - Issues related to the CMS proposed rule regarding Medicare Part D and 6 protected classes. - S 1871, "SGR Repeal and Medicare Beneficiary Access Act of 2013", regarding all provisions. - PL 111-148, "Patient Protection and Affordable Care Act", regarding provisons related to the sustainable growth rate. - Issues related to 340B payments to hospitals. - HR 5644/ S 2689, "Medicare CGM Access Act of 2014", regarding all provisions. - HR 4302/ PL 113-93, "Protecting Access to Medicare Act of 2014", regarding implementation.

Client expense: $1,400,000 · Firm income: Not reported

H.R.1074/S.539 - National Diabetes Clinical Care Commission Act S.323/H.R. 1428 - Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act of 2013 S. 945/H.R. 1274 - Access to Quality Diabetes Education Act of 2013 S. 2689/H.R. 5644 - Medicare CGM Access Act of 2014

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

General healthcare and budget issues; General domestic and intl. tax issues; Access to medical device issues; S. 2689 (Collins); S. 2917 (Harkin); H.R. 83 (FY 2015 CR/Omnibus).

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE, Treasury, Dept of, White House Office

- PL 111-148 Patient Protection and Affordable Care Act Regulation: reposting requirements; benefits and payment parameters/reinsurance; 30 hr. full-time definition; excise tax - HR 3204 Drug Quality and Security Act regarding 3PL licensing and serialization standards - HR 2253 Health Care Fairness and Stability Act re: temporary delayed collection of the transitional reinsurance program payments- HR 3489 To amend Section 1341 of the PPACA to repeal the funding mechanism for the transitional reinsurance program in the individual market, and for other purposes: repeal funding source for the transitional reinsurance program - HR 4709 Ensuring Patient Access and Effective Drug Enforcement Act of 2014 to provide the opportunity for wholesalers or dispensers to remedy a situation before DEA closes a facility to ensure patients access to meds - HR 5644/S.2689 "Medicare Continuous Glucose Monitoring Access Act of 2014" to seek Medicaid reimbursement for seniors to obtain continuous glucose monitoring devices.

Client expense: $1,751,027 · Firm income: Not reported

Issues related to continuous glucose monitoring Issues related to competitive bidding for DME products including HR 2375 - the Transparency and Accountability in Medicare Bidding Act of 2013 Issues related to HHS office of Inspector General (OIG) and Senate Finance Committee investigations of Physician-Owned EntitiesIssues relating to remote patient management and telehealth S. 2689 & H.R. 5644 - Medicare CGM Access Act of 2014 - provisions related to continuous glucose monitoring H.R. 5380 - Medicare Telehealth Parity Act of 2014 - provisions that expand definition of telehealth into remote patient monitoring in chronic conditions

Client expense: $1,420,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 2689/H.R. 5644, the Medicare CGM Access Act of 2014. Support entire bill; provides Medicare coverage for continuous glucose monitoring (CGM) devices to qualified individuals beginning January 1, 2015 and provides a pathway for the next generation of CGM-related technologies

Client expense: $123,000 · Firm income: Not reported

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

**see addendum pageno specific bill - medicare coverage and reimbursement, continous glucose monitors PL 111-148 - The Patient Protection and Affordable Care Act, implementation issues related to diabetes care H.R. 2810 - Medicare Patient Access and Quality Improvement Act of 2013, SGR S. 1871 - SGR Repeal and Medicare Beneficiary Access Act of 2013, SDP renewal H.R. 4302 - Protecting Access to Medicare Act of 2014, SDP renewal H.R. 3710 - Medicare CGM Coverage Act S. 2689/H.R. 5644 - Medicare CGM Access Act of 2014

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

- PL 111-148 Patient Protection and Affordable Care Act Regulation: reposting requirements; benefits and payment parameters/reinsurance; 30 hr. full-time definition; excise tax - HR 3204 Drug Quality and Security Act regarding 3PL licensing and serialization standards - HR 2253 Health Care Fairness and Stability Act re: temporary delayed collection of the transitional reinsurance program payments- HR 3489 To amend Section 1341 of the PPACA to repeal the funding mechanism for the transitional reinsurance program in the individual market, and for other purposes: repeal funding source for the transitional reinsurance program - HR 4709 Ensuring Patient Access and Effective Drug Enforcement Act of 2014 to provide the opportunity for wholesalers or dispensers to remedy a situation before DEA closes a facility to ensure patients access to meds - HR 5644/S.2689 "Medicare Continuous Glucose Monitoring Access Act of 2014" to seek Medicaid reimbursement for seniors to obtain continuous glucose monitoring devices.

Client expense: $1,444,773 · Firm income: Not reported

- Issues related to Medicare reimbursement for Clinical Laboratory Services. - HR 8, "American Taxpayer Relief Act of 2012", regarding all provisions in Section 636. - HR 800, "To amend part B of title XVIII of the Social Security Act to exclude customary prompt pay discounts from manufacturers to wholesalers from the average sales price for drugs and biologicals under Medicare", regarding all provisions.- Issues related to physician-owned companies that manufacture or distribute medical devices. - Issues related to implantable medical devices. - Issues related to diabetes care products. - Issues related to competitive bidding of diabetes care products. - Issues related to health care pricing transparency. - Issues related to OIG study regarding competitive bidding. - Issues related to the CMS proposed rule regarding Medicare Part D and 6 protected classes. - S 1871, "SGR Repeal and Medicare Beneficiary Access Act of 2013", regarding all provisions. - PL 111-148, "Patient Protection and Affordable Care Act", regarding provisons related to the sustainable growth rate. - Issues related to 340B payments to hospitals. - HR 5644/ S 2689, "Medicare CGM Access Act of 2014", regarding all provisions. - HR 4302/ PL 113-93, "Protecting Access to Medicare Act of 2014", regarding implementation.

Client expense: $1,350,000 · Firm income: Not reported

S.1932 - Better Care, Lower Cost Act; S. 2689 & H.R. 5644 - Medicare CGM Access Act of 2014

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R.1074/S.539 - National Diabetes Clinical Care Commission Act S.323/H.R. 1428 - Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act of 2013 S. 945/H.R. 1274 - Access to Quality Diabetes Education Act of 2013 S. 2689/H.R. 5644 - Medicare CGM Access Act of 2014

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Duty suspension bills: H.R. 5452/S. 2689- To suspend temporarily the duty on 11-Aminoundecanoic Acid (Note: bill numbers from 112th Cong.) H.R. 4689/S. 2693- To extend the temporary duty on orgasol polyamide powders (Note: bill numbers from 112th Cong.) H.R. 4688/S. 2696- To extend the temporary duty on dry adhesive copolyamide pellets (Note: bill numbers from 112th Cong.)H.R. 5451/S. 2714- To suspend temporarily the duty on methane sulfonic acid (Note: bill numbers from 112th Cong.) H.R. 5450/S. 2717- To suspend temporarily the duty on methane sulfonyl chloride (Note: bill numbers from 112th Cong.) H.R. 4690/S. 2711- To suspend temporarily the duty on dicumyl peroxide (Note: bill numbers from 112th Cong.) H.R. 5377/S. 2685- To suspend temporarily the duty on 2,5-dimethyl-2,5 hexanediol (Note: bill numbers from 112th Cong.) H.R. 5378/S. 2687- To suspend temporarily the duty on dimethylisopropylamine (Note: bill numbers from 112th Cong.) H.R. 2708, omnibus bill to amend the Harmonized Tariff Schedule of the United States to modify temporarily certain rates of duty (includes above provisions)

Client expense: $110,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Defense, Dept of (DOD), Energy, Dept of, Environmental Protection Agency (EPA), HOUSE OF REPRESENTATIVES, Homeland Security, Dept of (DHS), Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), Surface Transportation Board (STB), Transportation, Dept of (DOT), U.S. International Trade Commission (ITC), U.S. Trade Representative (USTR)

Duty suspension bills: H.R. 5452/S. 2689- To suspend temporarily the duty on 11-Aminoundecanoic Acid (Note: bill numbers from 112th Cong.) H.R. 4689/S. 2693- To extend the temporary duty on orgasol polyamide powders (Note: bill numbers from 112th Cong.) H.R. 4688/S. 2696- To extend the temporary duty on dry adhesive copolyamide pellets (Note: bill numbers from 112th Cong.)H.R. 5451/S. 2714- To suspend temporarily the duty on methane sulfonic acid (Note: bill numbers from 112th Cong.) H.R. 5450/S. 2717- To suspend temporarily the duty on methane sulfonyl chloride (Note: bill numbers from 112th Cong.) H.R. 4690/S. 2711- To suspend temporarily the duty on dicumyl peroxide (Note: bill numbers from 112th Cong.) H.R. 5377/S. 2685- To suspend temporarily the duty on 2,5-dimethyl-2,5 hexanediol (Note: bill numbers from 112th Cong.) H.R. 5378/S. 2687- To suspend temporarily the duty on dimethylisopropylamine (Note: bill numbers from 112th Cong.) H.R. 5376/S. 2690, S. 2689- To suspend temporarily the duty on BS 100 beads, BS 110 beads and BS 130 beads (Note: bill numbers from 112th Cong.) H.R. 2708, omnibus bill to amend the Harmonized Tariff Schedule of the United States to modify temporarily certain rates of duty (includes above provisions)

Client expense: $110,000 · Firm income: Not reported

Duty suspension bills: H.R. 5452/S. 2689- To suspend temporarily the duty on 11-Aminoundecanoic Acid (Note: bill numbers from 112th Cong.) H.R. 4689/S. 2693- To extend the temporary duty on orgasol polyamide powders (Note: bill numbers from 112th Cong.) H.R. 4688/S. 2696- To extend the temporary duty on dry adhesive copolyamide pellets (Note: bill numbers from 112th Cong.)H.R. 5451/S. 2714- To suspend temporarily the duty on methane sulfonic acid (Note: bill numbers from 112th Cong.) H.R. 5450/S. 2717- To suspend temporarily the duty on methane sulfonyl chloride (Note: bill numbers from 112th Cong.) H.R. 4690/S. 2711- To suspend temporarily the duty on dicumyl peroxide (Note: bill numbers from 112th Cong.) H.R. 5377/S. 2685- To suspend temporarily the duty on 2,5-dimethyl-2,5 hexanediol (Note: bill numbers from 112th Cong.) H.R. 5378/S. 2687- To suspend temporarily the duty on dimethylisopropylamine (Note: bill numbers from 112th Cong.) H.R. 5376/S. 2690, S. 2689- To suspend temporarily the duty on BS 100 beads, BS 110 beads and BS 130 beads (Note: bill numbers from 112th Cong.) H.R. 6727, omnibus bill to amend the Harmonized Tariff Schedule of the United States to modify temporarily certain rates of duty (includes above provisions) (Note: bill numbers from 112th Cong.) Note: above bills are from 112th Cong. (new legislation not yet introduced)

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