Results for

This bill provides for approval of the application submitted by Jaci Hermstad to the Food and Drug Administration for compassionate use of the gene therapy antisense oligonucleotides.

Generating Effective and Novel Evidence for Therapy Payment Act or the GENE Therapy Payment Act This bill allows state Medicaid programs to pay for certain gene therapy drugs through risk-sharing value-based payment agreements with drug manufacturers. The bill applies to covered outpatient drugs that provide potentially curative treatment for serious or life-threatening rare diseases or conditions after not more than three administrations.

Accelerating Access to Critical Therapies for ALS Act This bill establishes a grant program, as well as a new center within the Food and Drug Administration (FDA), to facilitate access to investigational therapies for neurodegenerative diseases such as amyotrophic lateral sclerosis (i.e., ALS, also known as Lou Gehrig's disease, a progressive and fatal disease). Specifically, the Department of Health and Human Services (HHS) must award grants for the provision of investigational drugs for ALS and other rapidly progressing neurodegenerative diseases through an expanded access (i.e., compassionate use) program. HHS may award these grants to (1) a small business that is the sponsor of an investigational new drug application, or (2) a participating clinical trial site for such a sponsor. Additionally, HHS must establish within the FDA a Center of Excellence for Neurodegenerative Diseases. The center shall have duties and authorities similar to those of the FDA's Oncology Center of Excellence, which helps expedite the development of medical products and assists providers in requesting access to investigational drugs.

Accelerating Access to Critical Therapies for ALS Act This bill establishes grant programs to address neurodegenerative diseases, such as amyotrophic lateral sclerosis (also known as ALS or Lou Gehrig's disease), and contains other related provisions. The Department of Health and Human Services (HHS) shall award grants to eligible entities to support research on and facilitate access to investigational drugs that diagnose or treat ALS. The Food and Drug Administration shall award grants to public and private entities to cover the costs of research and development of drugs that diagnose or treat ALS and other severely debilitating neurodegenerative diseases. HHS shall also establish the Collaborative for Neurodegenerative Diseases, which shall support the development and regulatory approval of drugs that address ALS and other rare neurodegenerative diseases.

Accelerating Access to Critical Therapies for ALS Act This bill establishes grant programs to address neurodegenerative diseases, such as amyotrophic lateral sclerosis (also known as ALS or Lou Gehrig's disease), and contains other related provisions. The Department of Health and Human Services (HHS) shall award grants to eligible entities to support research on and facilitate access to investigational drugs that diagnose or treat ALS. The Food and Drug Administration shall award grants to public and private entities to cover the costs of research and development of drugs that diagnose or treat ALS and other severely debilitating neurodegenerative diseases. HHS shall also establish the Collaborative for Neurodegenerative Diseases, which shall support the development and regulatory approval of drugs that address ALS and other rare neurodegenerative diseases.

This resolution applauds the growth in research and development into new therapies for rare diseases and recognizes that significant research and development efforts and related investments are needed to develop therapies to treat and cure thousands of rare diseases for which no treatment options are currently available.

This concurrent resolution expresses the sense of Congress that the Centers for Medicare & Medicaid Services should issue regulations that require Medicare coverage of home infusion therapy services regardless of whether or not a skilled professional is present in the beneficiary's home on the day on which a home infusion drug physically enters the beneficiary's body.

Treat and Reduce Obesity Act of2019 This bill expands Medicare coverage of intensive behavioral therapy for obesity. Specifically, the bill allows coverage for therapy that is provided by (1) a physician who is not a primary care physician; or (2) other health care providers (e.g., physician assistants and nurse practitioners) and approved counseling programs, if provided upon a referral from, and in coordination with, a physician or primary care practitioner. Currently, such therapy is covered only if provided by a primary care practitioner. The bill also allows coverage under Medicare's prescription drug benefit of drugs used for the treatment of obesity or for weight loss management for individuals who are overweight.

Treat and Reduce Obesity Act of2019 This bill expands Medicare coverage of intensive behavioral therapy for obesity. Specifically, the bill allows coverage for therapy that is provided by (1) a physician who is not a primary care physician; or (2) other health care providers (e.g., physician assistants and nurse practitioners) and approved counseling programs, if provided upon a referral from, and in coordination with, a physician or primary care practitioner. Currently, such therapy is covered only if provided by a primary care practitioner. The bill also allows coverage under Medicare's prescription drug benefit of drugs used for the treatment of obesity or for weight loss management for individuals who are overweight.

Preserving Patient Access to Home Infusion Act This bill specifically includes pharmacy services and certain self-administered drugs as part of covered home infusion therapy under Medicare, and specifies that certain payment components still apply regardless of whether or not a qualified supplier is physically present in the beneficiary's home.

Preserving Patient Access to Home Infusion Act This bill specifically includes pharmacy services and certain self-administered drugs as part of covered home infusion therapy under Medicare, and specifies that certain payment components still apply regardless of whether or not a qualified supplier is physically present in the beneficiary's home.

Prohibition of Medicaid Funding for Conversion Therapy Act This bill prohibits state Medicaid programs from covering conversion therapy. The bill definesconversion therapyas any practice or treatment that seeks to change a person's sexual orientation or gender identity in exchange for monetary compensation.

Puppies Assisting Wounded Servicemembers for Veterans Therapy Act or the PAWS for Veterans Therapy Act This bill requires the Department of Veterans Affairs to implement a pilot program to assess the effectiveness of addressing post-deployment mental health and post-traumatic stress disorder through a method where veterans train service dogs for veterans with disabilities.

Safe Step Act This bill requires a group health plan to establish an exception to medication step-therapy protocol in specified cases. A medication step-therapy protocol establishes a specific sequence in which prescription drugs are covered by a group health plan or a health insurance issuer.  A request for such an exception to the protocol must be granted if (1) an otherwise required treatment has been ineffective, (2) such treatment is expected to be ineffective and delaying effective treatment would lead to irreversible consequences, (3) such treatment will cause or is likely to cause an adverse reaction to the individual, (4) such treatment is expected to prevent the individual from performing daily activities or occupational responsibilities, (5) the individual is stable based on the prescription drugs already selected, or (6) there are other circumstances as determined by the Employee Benefits Security Administration. The bill requires a group health plan to implement and make readily available a clear process for an individual to request an exception to the protocol, including required information and criteria for granting an exception. The bill further specifies timelines under which plans must respond to such requests.

Safe Step Act This bill requires a group health plan to establish an exception to medication step-therapy protocol in specified cases. A medication step-therapy protocol establishes a specific sequence in which prescription drugs are covered by a group health plan or a health insurance issuer.  A request for such an exception to the protocol must be granted if (1) the treatment is expected to be ineffective, (2) the treatment will cause or is likely to cause an adverse reaction to the individual, (3) the treatment is expected to decrease the individual's ability either to perform daily activities or occupational responsibilities or adhere to the treatment plan, (4) the individual is stable based on the prescription drugs already selected, or (5) there are other medical reasons that warrant withholding the treatment. The bill requires a group health plan to implement and make readily available a clear process for an individual to request an exception to the protocol. Requests must be granted no later than three days after receipt of the request. In certain cases where the life, health, and ability of the individual are jeopardized by the protocol, the request shall be granted no later than 24 hours after receipt of the request.

Medicare Drug Price Negotiation Act This bill makes a series of changes relating to the prices of prescription drugs under the Medicare prescription drug benefit and Medicare Advantage (MA) prescription drug plans (PDPs). Under current law, the Centers for Medicare & Medicaid Services (CMS) may neither negotiate the prices of covered drugs nor establish a formulary. The bill repeals these restrictions and instead specifically requires the CMS to (1) negotiate the prices of covered drugs; and (2) either establish a formulary for covered drugs, or require changes to PDP formularies that take into account CMS negotiations. If the CMS is unable to negotiate an appropriate price for a drug in accordance with certain criteria, the price must be the lowest of three specified options (e.g., the average price in other countries). The CMS must identify drugs that are subject to negotiation, with priority given to certain categories of drugs based on usage and cost. Additionally, drug manufacturers must issue rebates to the CMS for drugs dispensed to eligible low-income individuals. Subject to civil monetary penalties, a Medicare or MA PDP sponsor must report, both to drug manufacturers and to the CMS, specified information related to the determination and payment of such rebates.

Medicare Drug Price Negotiation Act This bill makes a series of changes relating to the prices of prescription drugs under the Medicare prescription drug benefit and Medicare Advantage (MA) prescription drug plans (PDPs). Under current law, the Centers for Medicare & Medicaid Services (CMS) may neither negotiate the prices of covered drugs nor establish a formulary. The bill repeals these restrictions and instead specifically requires the CMS to (1) negotiate the prices of covered drugs; and (2) either establish a formulary for covered drugs, or require changes to PDP formularies that take into account CMS negotiations. If the CMS is unable to negotiate an appropriate price for a drug in accordance with certain criteria, the price must be the lowest of three specified options (e.g., the average price in other countries). The CMS must identify drugs that are subject to negotiation, with priority given to certain categories of drugs based on usage and cost. Additionally, drug manufacturers must issue rebates to the CMS for drugs dispensed to eligible low-income individuals. Subject to civil monetary penalties, a Medicare or MA PDP sponsor must report, both to drug manufacturers and to the CMS, specified information related to the determination and payment of such rebates.

Prescription Drug Price Relief Act of 2019 This bill establishes a series of oversight and disclosure requirements relating to the prices of brand-name drugs. Specifically, the bill requires the Department of Health and Human Services (HHS) to review at least annually all brand-name drugs for excessive pricing; HHS must also review prices upon petition. If any such drugs are found to be excessively priced, HHS must (1) void any government-granted exclusivity; (2) issue open, nonexclusive licenses for the drugs; and (3) expedite the review of corresponding applications for generic drugs and biosimilar biological products. HHS must also create a public database with its determinations for each drug. Under the bill, a price is considered excessive if the domestic average manufacturing price exceeds the median price for the drug in Canada, the United Kingdom, Germany, France, and Japan. If a price does not meet this criteria, or if pricing information is unavailable in at least three of the aforementioned countries, the price is still considered excessive if it is higher than reasonable in light of specified factors, including cost, revenue, and the size of the affected patient population. The bill also requires drug manufacturers to report specified financial information for brand-name drugs, including research and advertising expenditures.

Prescription Drug Price Relief Act of 2019 This bill establishes a series of oversight and disclosure requirements relating to the prices of brand-name drugs. Specifically, the bill requires the Department of Health and Human Services (HHS) to review at least annually all brand-name drugs for excessive pricing; HHS must also review prices upon petition. If any such drugs are found to be excessively priced, HHS must (1) void any government-granted exclusivity; (2) issue open, nonexclusive licenses for the drugs; and (3) expedite the review of corresponding applications for generic drugs and biosimilar biological products. HHS must also create a public database with its determinations for each drug. Under the bill, a price is considered excessive if the domestic average manufacturing price exceeds the median price for the drug in Canada, the United Kingdom, Germany, France, and Japan. If a price does not meet this criteria, or if pricing information is unavailable in at least three of the aforementioned countries, the price is still considered excessive if it is higher than reasonable in light of specified factors, including cost, revenue, and the size of the affected patient population. The bill also requires drug manufacturers to report specified financial information for brand-name drugs, including research and advertising expenditures.

New Opportunities for Value that Extend Lives Act of 2019 or the NOVEL Act of 2019 This bill establishes a process for expediting the assignment of Healthcare Common Procedure Coding System (HCPCS) codes to medical products that have been designated as a breakthrough product or regenerative advanced therapy by the Food and Drug Administration; it also establishes a process for determining coverage under Medicare of such breakthrough products that have been assigned HCPCS codes.

Outpatient Therapy Modernization and Stabilization Act This bill modifies payment and funding for certain outpatient therapy services under Medicare. Among other things, the bill specifically includes physicians, physical therapists, occupational therapists, and other specified practitioners who are enrolled as Medicare suppliers as eligible suppliers who may receive COVID-19 (i.e., coronavirus disease 2019) relief funds under the Public Health and Social Services Emergency Fund. The bill also permanently allows physical therapists, occupational therapists, and speech-language pathologists to provide telehealth services under Medicare, and includes specified therapy services as eligible Medicare telehealth services. (Currently, the Centers for Medicare & Medicaid Services is authorized to waive requirements for Medicare telehealth services during the public health emergency relating to COVID-19, and it has done so to allow all providers that are otherwise eligible to furnish in-person services under Medicare to also furnish telehealth services.)

Drug-price Transparency in Communications (DTC) Act This bill provides statutory authority for the Centers for Medicare & Medicaid Services rule titledMedicare and Medicaid Programs; Regulation to Require Drug Pricing Transparency, published on May 10, 2019. The rule requires direct-to-consumer television advertisements for covered drugs and biologics under Medicare and Medicaid to include the list price of a 30-day supply or for a typical course of treatment, if the list price is at least $35 per month. The rule takes effect July 9, 2019.

Medical Nutrition Therapy Act of 2020 This bill expands Medicare coverage of medical nutrition therapy services. Currently, Medicare covers such services for individuals with diabetes or kidney disease under certain circumstances; such services must also be provided by a registered dietitian or nutrition professional pursuant to a physician referral. The bill extends coverage to individuals with other diseases and conditions, including obesity, eating disorders, cancer, and HIV/AIDS; such services may also be referred by a physician assistant, nurse practitioner, clinical nurse specialist, or (for eating disorders) a clinical psychologist.

Medical Nutrition Therapy Act of 2020 This bill expands Medicare coverage of medical nutrition therapy services. Currently, Medicare covers such services for individuals with diabetes or kidney disease under certain circumstances; such services must also be provided by a registered dietitian or nutrition professional pursuant to a physician referral. The bill extends coverage to individuals with other diseases and conditions, including obesity, eating disorders, cancer, and HIV/AIDS; such services may also be referred by a physician assistant, nurse practitioner, clinical nurse specialist, or (for eating disorders) a clinical psychologist.

Improving Low-Income Access to Prescription Drugs Act of 2019 This bill requires the Centers for Medicare & Medicaid Services to establish a transition program under the Medicare prescription drug benefit for limited-income, newly eligible individuals (i.e., individuals who are eligible for subsidies and have not yet enrolled in, or whose coverage has not yet taken effect under, a Medicare or Medicare Advantage prescription drug plan). Such coverage must provide immediate access to covered drugs at the point of sale as soon as the individual becomes eligible for subsidies; coverage also applies retroactively for dual eligible individuals and for individuals who receive benefits under the Supplemental Security Income program.