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House Republicans have shown an interest in overhauling Medicare’s policies so that makers of health devices can get paid more easily and earlier in the development process than they now do.
The draft proposal from the House Energy and Commerce Committee’s so-called 21st Century Cures initiative includes a provision regarding coverage of newer devices. Offered by John Shimkus, R-Ill., it would support an industry push toward streamlining the process through which Medicare decides which devices to cover and how much it will pay. The provision also would aid in allowing coverage for products still in testing through clinical trials, building on existing “coverage with evidence” policies now in place at the Centers for Medicare and Medicaid Services, Shimkus told CQ HealthBeat (subscription).
“This provision would allow more Medicare beneficiaries to participate in covered clinical trials,” he said. “Sharing the data from those trials, CMS and device manufacturers can more effectively and efficiently reach a determination on whether a new technology should be covered, and what cost, under Medicare.”
The House Energy and Commerce Committee on Tuesday unveiled a discussion draft (view summary) of a long-awaited plan (view accompanying white paper) to spur medical breakthroughs. The early version of the measure — dubbed the 21st Century Cures Act — seeks to promote the development of new medical advances for drugs and medical devices through an overhaul of the product and federal agency regulatory process and modernizing the development and examination of new treatments in clinical trials.
The discussion draft is billed as a starting point and the committee release noted that the inclusion of a policy should not be considered an endorsement. Democrats on the committee did not immediately endorse the draft proposal and rallied around a separate effort initiated this week (HR 531) to ramp up funding additional basic research at the National Institutes of Health.
President Barack Obama, in the annual State of the Union address this week, laid out his agenda for 2015. Republican lawmakers applauded 31 times but are unlikely to accept all of the president’s prescriptions. A prominent proposal in the address featured a “precision medicine initiative” that would advance efforts to address cures for diseases like cancer and diabetes. The president offered no details on the initiative and Republican lawmakers largely accepted the concept as an endorsement of ongoing development of a medical research and drug product approval process overhaul package.
Separately, on Thursday, in a vote timed to coincide with an annual anti-abortion rally in Washington, DC, the House approved – in a 242-179 roll call vote – a measure (HR 7) seeking to permanently block federal funding for abortion services. Lawmakers originally planned on voting on a bill that seeks to prohibit abortions in cases where the probable age of the fetus is 20 weeks or later (HR 36). However, the funding restriction bill was substituted instead after a group of GOP lawmakers objected to abortion ban exception language included in the abortion ban measure.
President Obama, in his State of the Union address on Tuesday evening urged a “precision medicine initiative” that would advance efforts to address cures for diseases like cancer and diabetes. While the president offered no specific details on the initiative, congressional reaction to the speech interpreted a likely intersection with ongoing development in the House Energy and Commerce Committee of a medical research and drug product approval process overhaul package.
Committee chairman, Michigan Republican Fred Upton touted the work on a looming legislative measure, dubbed “21st Century Cures“, which seeks to speed the discovery, development, and delivery cycle of medical advances. Senate Health, Education, Labor and Pensions Committee Chairman Lamar Alexander of Tennessee immediately tied the president’s initiative suggestion with the looming “21st Century Cures” effort.
State of the Union excerpt (view transcript):
21st century businesses will rely on American science and technology, research and development. I want the country that eliminated polio and mapped the human genome to lead a new era of medicine: one that delivers the right treatment at the right time.
In some patients with cystic fibrosis, this approach has reversed a disease once thought unstoppable. Tonight, I’m launching a new Precision Medicine Initiative to bring us closer to curing diseases like cancer and diabetes and to give all of us access to the personalized information we need to keep ourselves and our families healthier.
An advocacy group for enhancing medical research on Wednesday unveiled its top congressional priorities for the first 100 days of the new Congress. The group, Research!America, seeks action on ending the budgetary sequestration process, an increase funding for medical research agencies, plus votes on the 21st Century Cures initiative, a repeal the medical device tax, and a permanent research and development tax credit. It is unlikely that the entire suite of objectives will be met over the next three months. However, some progress can be noted.
The White House announced on Wednesday that a fiscal 2016 budget plan will be unveiled on-time this year — on Feb. 2, which could entice a timely congressional appropriations process that could address sequestration and additional medical research funding. Details are expected as early as this month on the House Energy and Commerce Committee’s 21st Century Cures plan, which seeks to streamline federal supervision of medical advances. Also, several hundred lawmakers this week signed on to the re-introduction of a bill (HR 160) that seeks to repeal the medical device tax. Separate action on making the R&D tax credit permanent awaits the much longer process of assembling on overhaul of the entire federal tax structure.
The House Energy and Commerce Committee has spent the last year developing a bipartisan proposal to eliminate federal rule roadblocks and entice research to speed medical breakthroughs. The committee is expected to unveil the proposal, dubbed “21st Century Cures,” later this month after a dozen hearings last year on various possible elements of the bill.
CQ Roll Call’s Melissa Attias reports (subscription) that the package could include a new approval pathway for antibiotics to fight drug-resistant bacteria. The antibiotic provisions would establish a new approval process for anti-bacterial and anti-fungal drugs that are aimed at treating a serious or life-threatening disease in a limited group of patients to fill an unmet medical need. The process would allow the treatments to be studied in smaller clinical trials, addressing concerns that large-scale trials are often impossible given the limited number of people with those infections. However, opponents of the bill worry about the safety risks of compromising the Food and Drug Administration drug approval process.
Medical journal articles are a primary source of information on new medical advances and studies but they are usually laden with very detailed caveats and scientific jargon. The process of disseminating the new information to the public takes a circuitous pathway from the journal to media reports. However, an online or newspaper news article about the research study may offer misinformation, which in turn affects the behavior of the public and even other scientists and doctors. Over time, the cumulative effect of contradictory reports can confuse the public.
A study from the BMJ (formerly the British Medical Journal) examines the process on how health information included studies can be exaggerated in media reports. The report highlights the major role of the press release written to tout a new study to the media, which can also be the original source for erroneous information. The pressures of a fast-paced news cycle, combined university competition and self-promotion largely accounts for any exaggeration of health issues presented to the public.
New projects sponsored by the National Institutes of Health sound more like the plot in a sci-fi thriller, but the agency is hoping that extra funding will help make “co-robotics” – robots that work cooperatively with people in movement and rehabilitation – a reality.
For the third year in a row, NIH is participating in the Interagency National Robotics Initiative, which supports innovative research on assistive robotic technology. Researchers have maintained that the robots could assist patients who have suffered strokes, use wheelchairs or have been diagnosed with autism.
The National Science Foundation, the National Aeronautics and Space Administration and the Agriculture Department are also participating in the initiative, which will receive $2.3 million for the projects over the next five years.
“Technology is becoming more and more adaptable in all areas of our life, from GPS in cars to speech recognition technology on smart phones,” said Grace Peng, program director of rehabilitation engineering at the National Institute of Biomedical Imaging and Bioengineering, in a press release. “With these awards, we hope to encourage robotics researchers to think of new ways to apply their technology in the realm of health care.”
One of the projects is designed to help stroke patients regain movement by wearing an exoskeleton robot that can therapeutically move their affected limb. Another project is geared toward children with autism spectrum disorder and would develop a music-based robot to interact with the child in an effort to stimulate their emotional and social activities.
Money for the projects, however, remains contingent upon an availability of funds. The NIH budget has tightened in recent years, and lawmakers continue to seek additional money for biomedical research, CQ Roll Call’s Emily Ethridge reports (subscription).
A federal moratorium on some research into the transmission of influenza, Middle East Respiratory Syndrome and the SARS virus could delay results and drive researchers from the narrow field, the Congressional Research Service concluded in an analysis.
The unusual decision to pause research came in October after a series of safety and security breaches at the Centers for Disease Control and Prevention involving samples of anthrax and a deadly flu virus. The moratorium addresses so-called gain-of-function research aimed at making viruses more contagious – work that is primarily carried out at the National Institute of Allergies and Infectious Diseases at the National Institutes of Health.
Beyond the immediate pause in research, the biggest ramifications lie in whether the government opts to use moratoria in other scientific areas, CRS stated in its analysis. The government since 2001 has used guidelines to address the risks and benefits and whether existing biosafety requirements do enough to reduce the risk of accidental infection or releases of superbugs.
“The use of a federal funding moratorium may indicate an increased willingness to restrict such research at the federal level rather than relying on a case-by-case analysis of projects at the institutional level,” according to the analysis.
Critics of gain-of-function research question whether enough safeguards are in place, and whether broad dissemination of findings could prompt findings to fall into the wrong hands.
The Department of Health and Human Services today published a notice of proposed rules on reporting requirements for clinical trials on new drug products. The rules clarify requirements on posting clinical trial results on the federal website – ClinicalTrials.gov. The site contains information on more than 178,000 clinical trials and seeks to prevent duplication of trials and can quickly signal concerns about unsafe or ineffective drugs.
The website is a joint project of the Food and Drug Administration and the National Institutes of Health. However, a public watchdog group this week questioned continuing role of the NIH in the development broader looming rules on human medical research protections. The group, Public Citizen, claims that NIH is the largest federal sponsor and conductor medical research on human subjects and involvement in rule revisions poses a conflict of interest.
The Ebola crisis is ravaging the economies of the Ebola stricken West African countries of Liberia, Sierra Leone and Guinea. The Economist magazine this week reports that the World Bank estimates the cost to the region at $33 billion over the next 18 months. Prices of food and some basic products have doubled but some commodity-based businesses have been able to continue to export products.
The Economist also reports on drug manufacturers redoubling efforts to produce an Ebola vaccine. The World Health Organization has partnered with GlaxoSmithKline and a U.S. firm, NewLink Genetics, to expedite work on a vaccine. The drugs will be ready for testing in Africa by the end of the year. Also, Johnson & Johnson announced announced last week that it will begin human trials in January on a separate vaccine.
In July, a massive research project by Thomson Reuters scoured all scientific and patent databases and culled a list of 10 possible medical advances possible by 2025. The list included improved detection and prevention of dementia and Alzheimer’s Disease and genomic engineering to prevent Type 1 Diabetes.
This week, the Cleveland Clinic simply asked its experts on medical innovations expected in 2015. The clinic’s scientists suggested ten advances, including a new speedy and cost-effective blood testing process, single dose radiation therapy for breast cancer and a dengue fever vaccine.
Federal spending on medical research produces results and the National Institutes of Health periodically seeks to license patents on new discoveries and novel medical research techniques. Today, NIH issued a notice of an exclusive license on cancer targeting compounds and a separate request seeking to license a variety of techniques for HIV research and x-ray imaging, plus a new surgical tool for eye surgery.
Many developing technologies and techniques stem from research funding at NIH or through federal grants. Disseminating the fruits of federally funded research is governed by a law enacted in 1980, which allows for licensing of federal patents to industry. The law (view Congressional Research Service description) gives the title to inventions made with government support to small business, universities or other non-profit organizations and is credited with forging a vibrant biotechnology industry. Federal researchers retain the right to use the new innovations and the licensees are responsible for the often-arduous process of perfecting and developing the new technology.
Earlier this year, (@CQHealthTweet) HealthBeat’s Kerry Young’s monitored the various licensing missives from NIH and reported on the licensing of a technique that uses a rabies virus to develop a vaccine against the Ebola virus.
Amid congressional wrangling this week over spending bills and pre-election posturing, a bipartisan group of House Energy and Commerce Committee lawmakers were busy examining options for improving the process for developing and regulating new medical technologies and treatments. The committee on Tuesday hosted a roundtable discussion (view video) with HHS Secretary Sylvia Burwell, top agency chiefs and leaders from several medical research organizations.
National Institutes of Health Director Francis Collins reminded lawmakers that the U.S. took the lead in mapping the human genome, which has led to new technologies. However, China now provides largest current investment in genomics research. Separately, Food and Drug Administration Commissioner Margaret Hamburg and researchers on the panel stressed the need for regulatory improvements to foster the development of personalized medicine, which uses genetic analysis to tailor medical treatments specifically to an individual patient.
The largest discretionary spending component of the budget of the Department of Health and Human Services funds the National Institutes of Health, the primary federal medical research agency. The sprawling NIH campus in Bethesda, Md., belies the fact that 85 percent of the agency’s $31 billion annual budget goes to fund medical research off campus in all 50 states.
A medical research advocacy group, United for Medical Research, this week updated its state-by-state map of NIH research funding flowing to each state and supporting an estimated 400,000 jobs. California and Massachusetts lead in receipt of NIH research grants and the larger states dwarf the totals for Idaho, Wyoming and Alaska. NIH has established an award program that seeks to ship research dollars to 23 states with a poor track record of competing for NIH grant money. However, parsing out medical research outside of the NIH also amplifies the nationwide impact of any reductions in the NIH budget.