Accelerating Access to Critical Therapies for ALS Act

Health care issues affecting individuals with neuromuscular disease including therapy development, newborn screening, screening and diagnosis, adequate insurance coverage, and access to care. Advocated for passage of H.R. 4393, the Advancing Access to Precision Medicine Act, provide for a State option under the State Medicaid plan to provide DNA sequencing clinical services for certain children. Advocated for funding for the FDA Orphan Products Grants Program. Advocated for passage of H.R. 3235, the Access to Genetic Counselor Services Act of 2019, to provide for expanded coverage of services provided by genetic counselors. Advocated for the passage of the Newborn Screening Saves Lives Reauthorization Act, H.R. 2507 / S. 2158, to encourage investment in the national newborn screening program in order to detect more neuromuscular conditions early to speed appropriate interventions for patients. Advocated for robust funding of the national newborn screening program. Advocated for increased funding for National Institutes of Health, Food and Drug Administration, Health Resources and Services Administration, and other health agencies that conduct research on neuromuscular disease and provide services to those with these conditions. Advocated for adequate, affordable, accessible health coverage for individuals with neuromuscular conditions. Issues related to surprise medical billing, including HR 3630, the No Surprises Act; S 1895, the Lower Health Care Costs Act; S 1531, the Stopping the Outrageous Practice of Surprise Medical Bills Act of 2019. Advocated for maintaining strong incentives for rare disease drug development included within the Orphan Drug Act (PL 97-414) Advocated on the Promising Pathway Act (S.3872) and the ACT for ALS Act (H.R.7071). Advocated for access to healthcare via telemedicine/telehealth throughout and after the COVID-19 public health emergency. H.R. 6800, HEROES Act and related COVID-19 packages, support various provisions relevant to people with NMDs including increased federal support for state Medicaid programs; Medicaid maintenance of effort provisions; nationwide reopening of Marketplace special enrollment period; expansion of paid sick leave and paid family and medical leave; making permanent flexibilities to allow Medicare beneficiaries to continue accessing healthcare through telehealth; more resources to enhance testing and contact tracing in underserved communities; opposing waivers from IDEA and the Rehab Act; and better data collection on the impact of COVID-19 on people with disabilities. Continuing to support passage of legislation and proposals to protect patients from surprise medical billing and hold patients harmless.

Client expense: $100,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Federal Aviation Administration (FAA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE, Transportation, Dept of (DOT)

Matters affecting access to and pricing of pharmaceuticals; matters affecting the Orphan Drug Act and therapies for rare diseases; legislation and regulatory activity relating to importation of prescription drugs, including S. 61 and H.R. 478, Safe and Affordable Drugs from Canada Act of 2019; S. 97 and H.R. 447, Affordable and Safe Prescription Drug Importation Act; S. 2543, Prescription Drug Pricing Reduction Act (PDPRA) of 2019 and H.R. 3; Lower Drug Costs Now Act of 2019; Policies impacting the U.S. response to the COVID-19 pandemic including H.R. 604, the Coronavirus Preparedness and Response Supplemental Appropriations Act, Public Law No. 116-123; H.R. 6201, Families First Coronavirus Response Act, Public Law No. 116-127; H.R. 748, the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), Public Law No. 116-136; and H.R. 6800, the Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES Act"). Education regarding Executive Orders impacting drug pricing including Medicare rebate reform, the 340B drug discount program, Buy America requirements, drug importation, and imposition of most favored nation pricing on drugs under Medicare Parts B and D. H.R. 1407/S.578, ALS Disability Insurance Access Act; and H.R. 7071, Accelerate Access to Critical Therapies for ALS Act.

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

ALS Disability Insurance Access Act (S.578/H.R.1407) to waive the five-month waiting period before people with ALS receive benefits under Social Security Disability Insurance. The Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act (S. 2741/ H.R. 4932) would expand access to telemedicine and telehealth for people with ALS through a legal and regulatory environment where providers are permitted to deliver safe, high quality care using telehealth and telemedicine regardless of care delivery location or technological method. Additionally, all changes made to expand access to telehealth during the COVID-19 public health emergency should be permanently extended. Promising Pathway Act (H.R. 7269/ S. 3872) to establish a new time-limited provisional approval path at the FDA for drug sponsors to market drugs that show promise while additional testing takes place and before full FDA approval is achieved. Accelerating Critical Therapies for ALS Act (H.R. 7071) to establish a grant program to provide access to experimental drugs to people with ALS and other rapidly progressing neurological diseases for which effective therapies do not currently exist and create a Center of Excellence for Neurodegenerative Diseases at the FDA to speed the development and approval of therapies for neurodegenerative diseases.

Client expense: $24,945 · Firm income: Not reported

Health care issues affecting individuals with neuromuscular disease including therapy development, newborn screening, screening and diagnosis, adequate insurance coverage, and access to care. Advocated for passage of H.R. 4393, the Advancing Access to Precision Medicine Act, provide for a State option under the State Medicaid plan to provide DNA sequencing clinical services for certain children. Advocated for funding for the FDA Orphan Products Grants Program. Advocated for passage of H.R. 3235, the Access to Genetic Counselor Services Act of 2019, to provide for expanded coverage of services provided by genetic counselors. Advocated for the passage of the Newborn Screening Saves Lives Reauthorization Act, H.R. 2507 / S. 2158, to encourage investment in the national newborn screening program in order to detect more neuromuscular conditions early to speed appropriate interventions for patients. Advocated for increased funding for National Institutes of Health, Food and Drug Administration, Health Resources and Services Administration, and other health agencies that conduct research on neuromuscular disease and provide services to those with these conditions. Advocated for adequate, affordable, accessible health coverage for individuals with neuromuscular conditions. Issues related to surprise medical billing, including HR 3630, the No Surprises Act; S 1895, the Lower Health Care Costs Act; S 1531, the Stopping the Outrageous Practice of Surprise Medical Bills Act of 2019. Advocated for maintaining strong incentives for rare disease drug development included within the Orphan Drug Act (PL 97-414) Advocated on the Promising Pathway Act (S.3872) and the ACT for ALS Act (H.R.7071). Advocated for access to healthcare via telemedicine/telehealth throughout and after the COVID-19 public health emergency. H.R. 6800, HEROES Act and Senate-led COVID-19 package, support various provisions relevant to people with NMDs including increased federal support for state Medicaid programs; Medicaid maintenance of effort provisions; nationwide reopening of Marketplace special enrollment period; expansion of paid sick leave and paid family and medical leave; making permanent flexibilities to allow Medicare beneficiaries to continue accessing healthcare through telehealth; more resources to enhance testing and contact tracing in underserved communities; opposing waivers from IDEA and the Rehab Act; and better data collection on the impact of COVID-19 on people with disabilities. H.R. 6420/S. 3652 All Dependents Count Act, support passage. H.R. 3630, No Surprises Act; S. 1895, Lower Health Care Costs Act; S. 1531, the Stopping the Outrageous Practice of Surprise Medical Bills Act of 2019; H.R. 5800, Ban Surprise Billing Act; H.R. 5826 Consumer Protections Against Surprise Medical Bills Act, support passage of legislation to protect patients from surprise medical billing that holds patients harmless H.R. 127, Compassionate Access, Research Expansion and Respect States (CARERS) Act, support passage