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Glossary terms about United States law and regulation. 58 records carry it: 51 terms, 4 collections, 2 technologies, 1 institution.
| Cancers | Other tags | ||||
|---|---|---|---|---|---|
21st Century Cures Act A 2016 US law that funded the Cancer Moonshot, created the RMAT designation for cell and gene therapies, told the FDA to work out how real-world data could support approvals, and made companies publish how patients can request unapproved drugs. | none | none | law | ||
Abigail Alliance v. von Eschenbach (2007) A 2007 US appeals court ruling that terminally ill patients have no constitutional right to buy unapproved drugs after phase 1, which pushed the access movement toward legislation and eventually the Right to Try Act. | none | none | law | ||
Academy of Oncology Nurse & Patient Navigators (AONN+) Academy of Oncology Nurse & Patient Navigators AONN+ is the professional society for cancer nurse navigators and patient navigators in the US; it trains and certifies the people who guide patients through care. | none | none | none | ||
After treatment in the United States: the survivorship care plan, and what the trial found The United States answer to life after treatment was a written survivorship care plan, made an accreditation requirement for cancer centres. The randomised trial of it found no benefit on any patient-reported outcome, and the requirement was later replaced with a broader survivorship programme standard. | HR-positive / HER2-negative breast cancer, Colorectal cancer, Prostate cancer | rejuvenation, survivorship, access | |||
Alliance for Fertility Preservation Alliance for Fertility Preservation The Alliance for Fertility Preservation helps people with cancer in the US understand how treatment can affect fertility, what preservation costs, and whether their state's law makes insurers pay for it. | none | none | patient-org | ||
American Cancer Society National Navigation Roundtable American Cancer Society The National Navigation Roundtable is a coalition led by the American Cancer Society that sets standards for patient navigation programmes so more people get help through cancer care. | none | none | none | ||
Association for Molecular Pathology v. Myriad Genetics (2013) The 2013 US Supreme Court ruling that human genes as they occur in nature cannot be patented, which ended one company's monopoly on BRCA testing and let hereditary cancer testing become cheap and widely available. | none | none | law | ||
Biologics Price Competition and Innovation Act 2010 The 2010 US law that created a route for copies of biologic drugs such as trastuzumab and rituximab, while giving the original twelve years of protection from those copies. | Approved1998🇺🇸🇪🇺🇬🇧🇯🇵+3 | none | none | law | |
California End of Life Option Act (2015) California's End of Life Option Act allows an adult diagnosed with a terminal disease who meets the Act's conditions to request aid-in-dying drugs from their attending physician. | none | none | law | ||
Centers for Medicare & Medicaid Services (CMS) Baltimore, US The US federal agency that runs Medicare, Medicaid and the Children's Health Insurance Program. Its national coverage decisions set what Medicare pays for in cancer care, from screening scans to tumour marker tests and cell therapies. | none | none | none | ||
Expanded access (compassionate use) The regulated way a seriously ill patient who cannot join a trial can get an unapproved drug: the doctor asks the company, the company agrees, and the regulator reviews the request, usually within days for a single patient. | none | none | law | ||
Family Smoking Prevention and Tobacco Control Act 2009 The 2009 US law that finally gave the FDA power over tobacco products, the cause of roughly a third of cancer deaths, including authority to ban flavours, restrict marketing and set nicotine levels, though it may not ban cigarettes or nicotine outright. | none | none | law, prevention | ||
FDASIA 2012 and the origins of the expedited programmes The 2012 US law that created Breakthrough Therapy designation and made the paediatric study laws permanent, sitting on top of the 1992 user-fee law that gave the FDA review deadlines and the 1997 law that created Fast Track. | none | none | law | ||
FDORA 2022 accelerated approval reforms A December 2022 US law that lets the FDA insist the confirmatory trial for an accelerated approval is already running before the drug is approved, and gives it a quicker way to withdraw a drug when confirmation fails. | none | none | law | ||
Federal Food, Drug, and Cosmetic Act and the Kefauver-Harris Amendments The 1938 US law that makes a company prove a medicine is safe before selling it, and the 1962 amendments that added the requirement to prove it works, which is why every cancer drug approval rests on controlled trials. | none | none | law | ||
Five Wishes advance directive Five Wishes is a plain-language US advance directive in which you name who decides for you and write down the medical care, comfort and spiritual support you want, and what you want your family to know. | none | none | supportive | ||
GINA (Genetic Information Nondiscrimination Act 2008) A 2008 US law that stops health insurers and employers using your genetic test results against you, so a BRCA or Lynch syndrome result cannot raise your premiums or cost you a job; it does not cover life, disability or long-term care insurance. | none | none | law | ||
Hatch-Waxman Act 1984 The 1984 US law that created the modern generic drug: copies are approved on bioequivalence alone, brands get patent time restored for years lost in review, and the two sides fight it out through patent challenges with a 30-month pause. | Approved2001🇺🇸🇪🇺🇬🇧🇯🇵+3 | none | none | law | |
HIPAA (Health Insurance Portability and Accountability Act) The 1996 US law whose privacy rules govern how hospitals, insurers and their contractors may use and share a patient's health records, including tumour genomics, and what must be stripped out before data can be used for research without consent. | none | none | law | ||
Inflation Reduction Act 2022: Medicare drug price negotiation The 2022 US law that for the first time lets Medicare negotiate prices for top-selling drugs, capped what older patients pay for prescriptions at 2,000 dollars a year, and exempted drugs approved only for rare diseases, an exemption widened in 2025. | Approved2013🇺🇸🇪🇺🇬🇧🇯🇵+2 | none | none | law | |
Livestrong Fertility Livestrong Foundation Livestrong Fertility helps eligible people with cancer in the US get fertility preservation at a discount, with free medicines from partner companies and a case manager to guide them. Apply before treatment starts. | none | none | patient-org | ||
Mammography Quality Standards Act (MQSA) and the breast density notice A US federal law sets quality standards for mammography facilities. Its rules require each woman's results letter to say in plain words whether her breast tissue is dense, because dense tissue makes cancer harder to see on a mammogram and raises the risk of breast cancer. | none | none | law | ||
Medicare coverage with evidence development Medicare's way of paying for a promising but uncertain test or treatment only for patients enrolled in a registry or study, used for PET scans in cancer from 2006 and now the frame for how Medicare covers gene panels and cell therapies. | none | none | law | ||
Medicare drug price negotiation for 2028: apalutamide, ribociclib, abemaciclib and lenvatinib Four cancer medicines are among the drugs selected for the third round of Medicare price negotiation, with prices due from 1 January 2028: Erleada (apalutamide), Kisqali (ribociclib), Verzenio (abemaciclib) and Lenvima (lenvatinib). The negotiated prices had not been published in CMS's data file by November 2026. | Approved2018🇺🇸🇪🇺🇬🇧🇯🇵+2 | none | none | law | |
Medicare hospice benefit (United States) In the US, Medicare pays for hospice care with nothing to pay for covered services when a doctor certifies a life expectancy of six months or less and the person chooses comfort care instead of treatment aimed at cure. Care can continue beyond six months if the doctor recertifies. | none | none | supportive | ||
Medicare NCD 110.1: hyperthermia for cancer Medicare pays for local heat treatment of a tumour only when it is given with radiotherapy for cancers in or just under the skin, not on its own or with chemotherapy. | none | none | none | ||
Medicare NCD 110.18: aprepitant for chemotherapy-induced vomiting Medicare Part B pays for an all-oral three-drug anti-sickness regimen, aprepitant with a 5-HT3 blocker and dexamethasone, for people receiving one of 20 listed chemotherapy drugs. It does not pay for aprepitant on its own. | Approved2003🇪🇺 | none | none | none | |
Medicare NCD 110.20: blood-brain barrier osmotic disruption for brain tumours Medicare does not pay for opening the blood-brain barrier with an osmotic infusion as part of chemotherapy for brain tumours. Chemotherapy itself remains covered. | Brain and spinal cord tumours | none | none | ||
Medicare NCD 110.21: erythropoiesis-stimulating agents in cancer Medicare pays for epoetin or darbepoetin to treat anaemia caused by chemotherapy only when haemoglobin is below 10 g/dL, at the label starting dose, and stops paying if the blood count does not respond within 8 weeks. It does not pay for these drugs to prevent anaemia, for anaemia from radiotherapy alone, or in leukaemias such as AML and CML. | Approved2007🇪🇺 | Multiple myeloma, Chronic lymphocytic leukaemia | none | none | |
Medicare NCD 110.6: scalp hypothermia during chemotherapy Medicare's national payment rule for scalp hypothermia given with chemotherapy: the ice packs or devices may count as supplies, but Medicare recognises no separate charge for them. | none | none | none | ||
Medicare NCD 190.28: CA 125 tumour marker test Medicare pays for the CA 125 blood test to follow ovarian and related cancers after diagnosis, to check for recurrence and response to treatment, but not to diagnose a pelvic mass or to investigate symptoms. | Ovarian cancer, Endometrial cancer, Mesothelioma | none | none | ||
Medicare NCD 190.30: CA 19-9 tumour marker test Medicare pays for the CA 19-9 blood test to follow people already diagnosed with pancreatic or bile duct cancer, not to diagnose them. | Pancreatic ductal adenocarcinoma, Biliary tract cancer | none | none | ||
Medicare NCD 190.7: human tumour stem cell drug sensitivity assays Medicare treats laboratory tests that grow a patient's tumour cells and expose them to cancer drugs to pick a treatment as experimental, and does not pay for them. | none | none | none | ||
Medicare NCD 210.1: prostate cancer screening tests Medicare pays for one screening PSA blood test and one screening digital rectal examination a year for men aged 50 and over. | Prostate cancer | none | none | ||
Medicare NCD 210.14: lung cancer screening with low-dose CT Medicare in the United States pays for a yearly low-dose CT scan of the chest for people aged 50 to 77 with no symptoms who have smoked at least 20 pack-years and still smoke or quit within the last 15 years. A conversation about the benefits and harms comes first, and the patient pays no coinsurance or deductible. | Lung cancer | none | none | ||
Medicare NCD 210.2: screening Pap smears and pelvic examinations Medicare pays for a Pap smear and pelvic examination every two years, or every year for women at high risk of cervical or vaginal cancer or of childbearing age with a recent abnormal result. | Cervical cancer, Vaginal cancer | none | none | ||
Medicare NCD 210.2.1: cervical cancer screening with HPV testing Medicare pays for an HPV test once every five years for women aged 30 to 65 with no symptoms, given together with a Pap test. | Cervical cancer | none | none | ||
Medicare NCD 220.4: mammograms Medicare pays for a diagnostic mammogram when a doctor orders one, and for screening mammograms on a set schedule: none under 35, one between 35 and 39, and then one every year (at least 11 months apart) from age 40. | Breast cancer | none | none | ||
Medicare NCD 220.6.17: FDG PET for cancer Medicare pays for one FDG PET scan to plan the first treatment of most cancers, and for three more scans after the first treatment is finished; a local contractor decides on any further scans. A few uses are excluded, such as planning first treatment for prostate cancer. | Breast cancer, Melanoma, Cervical cancer | none | none | ||
Medicare NCD 220.6.19: NaF-18 PET for bone metastases Medicare no longer pays nationally for sodium fluoride (NaF-18) PET scans to look for cancer in the bones; local contractors may cover other PET tracers used as their FDA labels allow. | none | none | none | ||
Medicare NCD 230.9: cryosurgery of the prostate Medicare pays for freezing treatment of the prostate as a first treatment for prostate cancer confined to the gland area (stages T1 to T3), and as a second treatment only after radiotherapy has failed and the cancer still meets set limits. | Prostate cancer | none | none | ||
Medicare negotiated price for ibrutinib (Imbruvica), first cycle The first ten drugs with a Medicare-negotiated price, in effect from 1 January 2026, included one cancer medicine, ibrutinib (Imbruvica). Its price is set per 30-day supply and rose with inflation from 2027. | Approved2013🇺🇸🇪🇺🇬🇧🇯🇵+2 | none | none | law | |
Medicare negotiated prices from 2027: enzalutamide, pomalidomide, palbociclib and acalabrutinib Of the fifteen drugs whose Medicare-negotiated prices start on 1 January 2027, four are cancer medicines: Xtandi (enzalutamide), Pomalyst (pomalidomide), Ibrance (palbociclib) and Calquence (acalabrutinib). | Approved2012🇺🇸🇪🇺🇬🇧🇯🇵+2 | none | none | law | |
Medicare Principal Illness Navigation services (G0023, G0024) In the US, Medicare can pay for a trained navigator to help people with serious illnesses including cancer coordinate care, find support services and speak up for themselves. Your doctor has to set it up at a visit, with your consent, and cost sharing may apply. | none | none | supportive | ||
Oregon Death with Dignity Act (1997) Oregon's 1997 law allows a capable adult with a terminal disease expected to cause death within six months to request medication they take themselves to end their life, after a voluntary written request confirmed by two physicians. | none | none | law | ||
Orphan Drug Act 1983 The 1983 US law that pays companies to develop drugs for rare diseases with seven years of market exclusivity, tax credits and fee waivers, which is why so many cancer drugs are first approved for a rare subtype. | none | none | law | ||
PACT Act 2022: cancers presumed service-connected for US veterans exposed to burn pits and other toxins A 2022 US law means a veteran who served where burn pits and other toxins were used, and later develops one of a listed set of cancers, does not have to prove the service caused it to receive veterans' benefits. The list covers head, neck, respiratory, digestive, reproductive, kidney and brain cancers, lymphomas, melanoma, pancreatic cancer and glioblastoma. | Head and neck squamous cell carcinoma, Glioma & glioblastoma, Melanoma | none | law | ||
Paediatric drug laws: BPCA and PREA Two US laws, one a carrot and one a stick, that get new drugs studied in children: BPCA gives six extra months of exclusivity for doing requested paediatric studies, and PREA requires paediatric assessments, though until 2020 cancer drugs mostly escaped it. | none | none | law | ||
POLST (Portable Medical Orders for Life-Sustaining Treatment) In the US, a POLST form turns the wishes of someone who is seriously ill or very frail into signed medical orders, so emergency teams know which treatments to give or not give. It is optional and is different from an advance directive. | none | none | supportive | ||
Right to Try Act 2018 and state right-to-try laws A 2018 US law letting patients with life-threatening illnesses ask a company directly for a drug that has passed phase 1 without going through the FDA; companies still decide, and in practice most access happens through the older expanded access route. | none | none | law | ||
State biomarker testing coverage laws A wave of US state laws, starting in 2021, that require insurers regulated by the state and often Medicaid to pay for the tumour and inherited gene tests that decide which targeted drug a patient should get. | none | none | law | ||
The Common Rule (45 CFR 46) The US rules that require an ethics committee to approve research on people and require informed consent, written in 1991 and rewritten in 2018 so that a single committee can oversee a multi-site cancer trial and patients can give broad consent for future use of their samples. | none | none | law | ||
Tobacco 21 Since December 2019 it has been illegal across the United States to sell tobacco or vaping products to anyone under 21, a rule that started in one Massachusetts town and spread state by state, aimed at the years when most smokers start. | none | none | law, prevention | ||
US regulatory exclusivity periods Separate from patents, US law gives an approved drug fixed periods during which the FDA will not approve a copy: five years for a new chemical, three for new clinical studies, seven for an orphan indication, twelve for a biologic, plus six months for paediatric studies. | none | none | law | ||
US state fertility preservation coverage laws Some US states have laws that require certain health insurers to pay for fertility preservation, such as egg or sperm freezing, for people whose cancer treatment may cause infertility. Check your state on the Alliance for Fertility Preservation map before treatment starts. | none | none | law | ||
Washington Death with Dignity Act (Initiative 1000, 2008) Washington's law, passed by public vote in 2008, allows some terminally ill adult residents expected to die within six months to request medication to end their life as part of end-of-life care. | none | none | law | ||
What recovery costs in the United States More than half of United States survivors in a comparative survey reported financial difficulty, against a third in the UK. What a person pays for rehabilitation, psychological care, fertility preservation and a wig depends on their insurance, their state and their employer rather than on their cancer. | HR-positive / HER2-negative breast cancer, Colorectal cancer, Multiple myeloma | none | rejuvenation, survivorship, measurement | ||
World Trade Center Health Program and the cancers it covers (Zadroga Act) Responders and survivors of the 11 September 2001 attacks in New York who later develop one of a long list of cancers can have their care paid for by a US federal programme. The list covers most solid cancers and all blood cancers, plus any cancer in someone under 20 and any rare cancer. | Mesothelioma, Thyroid cancer, Prostate cancer | none | law |