regulation

‘The Waiver Program Is Tough’: Issues with the CMS Hospital-at-Home Program

The proliferation of hospital-at-home models has been one of the major home-based care trends during the COVID-19 crisis, and players on all sides are bullish that that trend will continue after the pandemic subsides. The U.S. Centers for Medicare & Medicaid Services’ (CMS) “Acute Hospital Care At Home” waiver program has allowed more health systems …

‘The Waiver Program Is Tough’: Issues with the CMS Hospital-at-Home Program Read More »

An overview of CDISC standards

Formedix has been strong advocates for the use of CDISC data standards in clinical and non-clinical research for decades, ever since we realized how it could transform our business by enabling the rapid design and build of clinical trials. We quickly focused our company around the use of CDISC standards, and are now industry leaders …

An overview of CDISC standards Read More »

‘We’ve Got to Have Set Standards’: Increased Standardization Likely Coming to Home Care

With more eyes than ever on the home care industry, experts are trying to read the tea leaves to determine if greater standardization will eventually follow. Once considered the “youngest kid” in the larger health care continuum, home care has been ushered into the spotlight over the past couple of years. A few things have …

‘We’ve Got to Have Set Standards’: Increased Standardization Likely Coming to Home Care Read More »

HHS Releases $25.5B in Provider Relief Funds, Promises Increased Audits Around M&A Activity

The U.S. Department of Health and Human Services (HHS) announced Friday that it is releasing another $25.5 billion under the Provider Relief Fund (PRF). Since a first round of $46 billion was sent to over 320,000 Medicare providers in April 2020, HHS has released tens of billions of follow-on dollars through a mix of general …

HHS Releases $25.5B in Provider Relief Funds, Promises Increased Audits Around M&A Activity Read More »

Impact of Certificate of Need on Health

An interesting paper from Kevin Chiu in the Journal of Health Economics looks at the relationship between certificate of need laws and health outcomes: Certificate of need (CON) regulations requires that health care providers obtain state approval before offering a new service or expanding existing facilities. The purported goal of CON regulations is to reduce …

Impact of Certificate of Need on Health Read More »

FDA: Why we approved Prograf based on real-world data

Recently, the Food and Drug Administration (FDA) approved Prograf (tacrolimus) in combination with other immunosuppressant drugs for the new indication of preventing organ rejection for patients who have received a lung transplant. While the FDA approving a new indication isn’t typically news, this is a noteworthy event because (i) it marks the first approval of …

FDA: Why we approved Prograf based on real-world data Read More »

FDA faces big questions as it takes a closer look at AI regulations

An action plan shared by the FDA earlier this year showed how the regulator is thinking about future regulations for AI and machine learning in healthcare. But the agency still has several big questions to address as it prepares to roll out new guidance.

FDA extends tie-up with CN Bio to test ‘lung-on-a-chip’ tech

The FDA has extended a collaboration with the UK firm CN Bio to investigate a “lung-on-a-chip” model to investigate inhaled drugs. In a statement the firm said the move follows the success of a pilot project to assess the performance of the technology. Based in Cambridge, UK, CN Bio has been working with the FDA …

FDA extends tie-up with CN Bio to test ‘lung-on-a-chip’ tech Read More »

Formedix Expedites Clinical Trial Build with New Cloud Clinical MDR Suite

Glasgow, UK – (March 29, 2021) – Formedix, a leading provider of clinical trial software solutions, announces the launch of ryze, an innovative all-in-one cloud-based clinical metadata repository (MDR) and study automation platform. ryze has been specifically developed to accelerate and streamline the design, build and submission of clinical trials, in compliance with the Clinical …

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EU starts rolling review of Sinovac’s COVID-19 vaccine

Europe’s regulator has begun a rolling review of Sinovac’s COVID-19 vaccine, known as Vero Cell. The vaccine is based on an inactivated SARS-CoV-2 virus, which has been killed and cannot cause COVID-19. In a statement, the European Medicines Agency said the rolling review is based on non-clinical and clinical studies suggesting the vaccine triggers production …

EU starts rolling review of Sinovac’s COVID-19 vaccine Read More »

Tecentriq can stay as therapy for triple-negative breast cancer, FDA experts say

Roche’s Tecentriq can stay on the US market as a therapy for triple negative breast cancer, advisers to the FDA have said as part of a review of several quickly-approved cancer drugs. Tecentriq was the first drug to be discussed in the review by the FDA’s Oncologic Drugs Advisory Committee (ODAC) of cancer drugs that …

Tecentriq can stay as therapy for triple-negative breast cancer, FDA experts say Read More »

HHS reverses previous administration’s push to deregulate more than 80 medical devices

In the final days of the Trump Administration, the Department of Health and Human Services sought to deregulate 83 different types of medical devices, citing a lack of reported adverse events. But the Food and Drug Administration put an end to the sudden reversal, saying the proposed exemptions were “flawed.” 

EU safety regulators clear J&J COVID shot despite tiny clot risk

The benefits of Johnson & Johnson’s COVID-19 vaccine outweigh a tiny risk of unusual blood clots forming, Europe’s drugs regulator has said. In a decision that will allow the rollout of vaccines in certain EU states, the European Medicines Agency’s safety committee said there appears to be a link to unusual blood clots combined with …

EU safety regulators clear J&J COVID shot despite tiny clot risk Read More »

FDA worried about Pfizer/Lilly pain drug safety ahead of key meeting

After a long and troubled development the fate of Pfizer/Lilly’s tanezumab painkiller injection is in the balance ahead of a key meeting of advisers later this week.  Safety has been an issue throughout development and in 2012 the FDA put tanezumab on clinical hold because of a class-related issue with joint destruction, which was finally …

FDA worried about Pfizer/Lilly pain drug safety ahead of key meeting Read More »

Xavier Becerra Confirmed as HHS Secretary

The U.S. Senate on Thursday narrowly confirmed California Attorney General Xavier Becerra as the next secretary of the Department of Health and Human Services (HHS). It did so by a 50-49 margin, with the vote playing out almost entirely along party lines. Sen. Susan Collins of Maine was the only Republican who voted to confirm …

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What is the FTC’s stance on pharmaceutical mergers?

The answer to this question likely will be shaped in part by a new multilateral working group that will include not only representatives from the U.S. (U.S. Department of Justice Antitrust Division, and Offices of State Attorneys General), but also Canada (Canadian Competition Bureau), Europe (the European Commission Directorate General for Competition) and the United …

What is the FTC’s stance on pharmaceutical mergers? Read More »

CMS Could Target LUPAs, Functional Impairment in Future PDGM Adjustments

Despite the once-in-a-generation COVID-19 pandemic, the home health industry’s transition to the Patient-Driven Groupings Model (PDGM) was pretty seamless. Looking into the not-too-distant future, the U.S. Centers for Medicare & Medicaid Services (CMS) will now likely attempt to make modest tweaks to a handful of key areas, payment experts believe. The agency will do so …

CMS Could Target LUPAs, Functional Impairment in Future PDGM Adjustments Read More »

EU regulators probe safety of AstraZeneca vaccine batch after blood clot reports

European safety regulators have launched an investigation into the safety of a batch of the Oxford University/AstraZeneca COVID-19 vaccine, as countries including Denmark suspended its use as a precaution following reports of blood clots. Initial findings showed no issue with the shots suspended by Austrian authorities after a person was diagnosed with severe blood clotting …

EU regulators probe safety of AstraZeneca vaccine batch after blood clot reports Read More »

Budget 2021: Sunak focuses on vaccine development to restart economy

UK chancellor Rishi Sunak has announced a budget loaded with initiatives designed to kick-start the UK’s economy as it recovers from the coronavirus pandemic, with vaccine development, pharma and life sciences playing a key role. The ongoing fight against COVID-19 was a top-line feature of the budget announcement, with an extra £1.65bn to ensure the …

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How representative are clinical trials of the US population?

Diversity in clinical trials Recently, the FDA’s Center for Drug Evaluation and Research’s (CDER’s) released its 2020 Drug Trials Snapshots Summary Report. Part of the report examines the demographics of participants in clinical trials for the 53 drugs that FDA approved in 2020 either as new molecular entities (NMEs) under new drug applications (NDAs) or …

How representative are clinical trials of the US population? Read More »

Use of real-world evidence for regulatory decision-making

How do you evaluate treatment efficacy and safety outside of the clinical trial setting? This is not just a question of academic interest. In last week’s JAMA, Rubin 2021 writes about some of the challenges of evaluating COVID-19 vaccines outside of a clinical trial setting. In an interesting, two-day workshop last week, the Duke Margolis …

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China approves Sinovac’s coronavirus vaccine

China’s national regulator has approved Sinovac Biotech’s COVID-19 vaccine for use by the general public. This is the second vaccine approved by China’s National Medical Products Administration (NMPA). Both of the vaccines, along with another experimental vaccine from Sinopharm, have been used in China’s vaccination programme. More than 31 million doses have been administered, mainly …

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Dilemma for Biden as Woodcock’s audition for FDA chief stumbles

The change of administration in the US has also seen a new leader at the FDA, with Dr Janet Woodcock appointed as interim commissioner by president Joe Biden’s new team. But there are doubts about her suitability for the permanent job because of her handling of the opioid crisis, says Richard Staines. Dr Janet Woodcock …

Dilemma for Biden as Woodcock’s audition for FDA chief stumbles Read More »

White paper reveals pathway for digital therapeutics use in Italy

A white paper has outlined a pathway that could allow Italy to realise the potential of digital therapeutics (DTx). The official journal of the Smith Kline Foundation, Tendenze Nuove, has published the paper entitled “Digital Therapeutics, an Opportunity for Italy” earlier this month. The book features insights and recommendations from 40 leading experts in the …

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Novavax’s COVID-19 shot effective against UK strain

Novavax’s COVID-19 vaccine could be added to the UK’s growing arsenal of shots against the disease after it showed 89.3% efficacy in a late-stage trial. The shot is the first to show efficacy against the new variant found in the UK which accounted for around half of cases in the phase 3 study. Efficacy against …

Novavax’s COVID-19 shot effective against UK strain Read More »

RxSource optimizes clinical labeling process with PRISYM 360 cloud-based solution

The Covid-19 pandemic has put further pressure on clinical trial suppliers to be fleet of foot in getting products dispatched when a new patient is recruited, as studies for vaccines have been set up and run at unprecedented speed.    For PRISYM ID client RxSource, a Global Clinical Trial Supplies Specialist, it means being ready to partner with sponsor …

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AZ has ‘constructive talks’ with EU leaders after vaccine row

AstraZeneca has said it has had “constructive talks” with European leaders in a bid to cool the row over vaccine supplies to the EU. The vaccine is expected to be approved by European regulators tomorrow, but this has been overshadowed by an announcement that the company will not be able to produce the 300 million …

AZ has ‘constructive talks’ with EU leaders after vaccine row Read More »

Biden likely to ditch Trump’s plans to relax digital health regulations

President Joe Biden looks likely to ditch the previous administration’s move to create a quicker route to market for digital health products and other devices following the pandemic emergency. After he took office on Wednesday, Biden quickly moved to freeze a raft of Trump policies, including the moves to loosen regulations on devices including digital …

Biden likely to ditch Trump’s plans to relax digital health regulations Read More »

Biden Administration Includes ‘Home Care Workforce Crisis’ in New Pandemic Plan

President Joe Biden focused on the ongoing COVID-19 pandemic during his first full day in office Thursday. In doing so, he once again drew attention to home-based care and getting the current “workforce crisis” under control. “Our national strategy is comprehensive,” Biden said during an address from the White House. “It’s based on science, not …

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In the final days of Trump administration, agencies clashed over how to regulate medical AI

The agency published its first action plan last week for how it plans to regulate machine learning-based software as a medical device. To start, the FDA said it will issue guidance on how changes to algorithms should be regulated as they “learn.”

Biden appoints veteran Woodcock as interim FDA commissioner

Agency veteran Dr Janet Woodcock is the new interim FDA commissioner appointed by president Joe Biden to replace outgoing Trump appointee Stephen Hahn. Woodcock has most recently been working with the Operation Warp Speed coronavirus vaccine and drug project started by the Trump administration. While this work will continue, the Operation Warp Speed name has …

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DOL Guidance Could Lead to More Home Care Companies Providing Live-In Services

The U.S. Department of Labor (DOL) recently issued an opinion letter allowing home care agencies to implement consistent shift rates that include pre-payment of overtime for caregivers who provide live-in services. In this case, a “live-in shift” is defined as being on the job for 24 hours or more at a time. Broadly, the DOL’s …

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Top Home Health, Home Care Legal Concerns for 2021

Wage-and-hour litigation, confusing state-level regulations and an increase in federal audits were among the biggest legal trends of 2020. While many of these issues will remain in the year ahead, 2021 will also bring several more legal hurdles for home-based care providers. The decision of whether to mandate COVID-19 vaccinations for home health and home …

Top Home Health, Home Care Legal Concerns for 2021 Read More »

UK left trailing as EU quickly approves Moderna’s COVID-19 vaccine

The European Union has approved the coronavirus vaccine from Moderna, leaving the UK trailing because of changes to post-Brexit drug approval rules. With the UK reeling from one of the worst outbreaks of the disease, it’s a worrying situation for one of the countries worst hit by the pandemic that is relying on vaccines to …

UK left trailing as EU quickly approves Moderna’s COVID-19 vaccine Read More »

Getting gene therapies to market faster

The FDA approval process is slow. Even for COVID-19 vaccines, the process can be time consuming. However, regulators around the world do have some expedited programs. However, a number of countries have programs that expedite review, particularly for the diseases with unmet need, orphan drugs, or when new treatments represent a significant advance over the …

Getting gene therapies to market faster Read More »

‘Highly likely’ BioNTech vaccine will work against new strain, says CEO

BioNTech CEO Ugur Sahin has said that it is “highly likely” the company’s COVID-19 vaccine will work against the more infectious strain circulating in the south east of England, although further studies will be needed. Sahin was addressing a news conference after the vaccine was approved by the European Union, three weeks after the shot …

‘Highly likely’ BioNTech vaccine will work against new strain, says CEO Read More »

No Funding, Closures and Limited Capacity: Adult Day Providers in Dire Need of Help

In late November, the aging-focused advocacy organization LeadingAge wrote a note to Congress, calling for relief on behalf of the 5,500 adult day service providers across the country and the vulnerable patients they serve. “Adult day services providers across the country urgently need dedicated federal funding to ensure they are able to continue providing services …

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FDA reviewers back Pfizer/BioNTech COVID-19 vaccine ahead of panel

Reviewers from the FDA have given their blessing to the Pfizer/BioNTech COVID-19 vaccine ahead of a key meeting tomorrow – but the regulator noted that there are still uncertainties about whether the shot can stop the disease from spreading. The gist of a briefing document published from FDA reviewers ahead of an expert advisory board …

FDA reviewers back Pfizer/BioNTech COVID-19 vaccine ahead of panel Read More »

Biden Picks California Attorney General Becerra to Lead HHS, COVID-19 Response

President-elect Joe Biden has picked Xavier Becerra, the current attorney general of California, to lead the U.S. Department of Health and Human Services (HHS), according to several news reports. Prior to serving as California’s top prosecutor, Becerra represented the Los Angeles area in Congress for 12 years. HHS is currently headed by Secretary Alex Azar. …

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Latin America: How pharma can navigate a complex market

Bureaucracy, political upheaval, and lack of regulations continue to make Latin America a difficult market for European and North American pharma to enter – and COVID-19 has only worsened these issues. Developing market specialist Dr Zulf Masters OBE takes us through the nuances of being successful in this region. Having worked all around the world …

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What is the impact of FDA review time on pharmaceutical R&D investments?

This is the question that a recent paper by Chorniy et al. (2020) attempt to answer. This issue is clearly very relevant as the UK recently has approved the Pfizer/BioNTech vaccine for COVID-19 before the US. Unlike most studies that attempt to examine the relationship between FDA review time and R&D investment dollars, the authors …

What is the impact of FDA review time on pharmaceutical R&D investments? Read More »

Pfizer/BioNTech to deliver COVID-19 vaccine to UK after approval

Pfizer and BioNTech are preparing to deliver their COVID-19 vaccine to the UK after the country’s drugs regulator became the first authority in the world to approve it. As predicted by pharmaphorum, the regulator was able to move faster than its counterparts from the European Medicines Agency, who are also conducting a separate review of …

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Non-Physician Certification in Home Health Care Blocked by State-Level Barriers

Over the past several years, it seems as though the home health industry has been inching closer and closer toward the elimination of Medicare’s strict physician-certification policy. Now — thanks to the CARES Act — nurse practitioners (NPs), physician assistants (PAs) and clinical nurse specialists (CNSs) are able to certify eligibility for home health. While …

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CMS’s Stark Law Changes Could Mean More Value-Based Business for Home Health Operators

In an effort to boost value-based care, the U.S. Centers for Medicare & Medicaid Services (CMS) recently announced that it has finalized changes to the Physician Self-Referral Law — often referred to as the Stark Law. For home health providers, the changes could mean more opportunities for value-based care arrangements moving forward, experts believe. Broadly, …

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CMS Launches ‘Unprecedented’ Hospital-at-Home Strategy to Manage Latest COVID-19 Surge

In an effort to increase hospital capacity amid the current COVID-19 surge, the U.S. Centers for Medicare & Medicaid Services (CMS) on Wednesday announced “unprecedented” flexibilities around providing hospital-level care for patients in their homes. Similar to CMS’s recent allowances surrounding telehealth, the agency’s latest efforts are focused on lifting barriers that could potentially hinder …

CMS Launches ‘Unprecedented’ Hospital-at-Home Strategy to Manage Latest COVID-19 Surge Read More »

FDA approves Alnylam’s ultra-rare disease drug Oxlumo

The FDA has approved Alnylam’s gene silencing drug Oxlumo, the first treatment for primary hyperoxaluria type 1 (PH1), an ultra-rare and life-threatening genetic disorder. Oxlumo (lumasiran) was also approved in the European Union last week, making it the third from Alnylam’s pipeline of RNA interference therapeutics to make it to market. The approval will mean …

FDA approves Alnylam’s ultra-rare disease drug Oxlumo Read More »

How long does it take to bring a vaccine to market?

Given the incredible speed in which vaccine development for COVID-19 is occurring, it merits thinking back on the typical development and approval time of previous vaccines. Puthumana et al. (2020) reviews 21 vaccines approvals since 2010. They find that: …most novel vaccines approved by the FDA required about 8 years of clinical development and were …

How long does it take to bring a vaccine to market? Read More »

UK could get COVID-19 vaccines early next year, ahead of European countries

COVID-19 vaccines could be approved and available early next year in the UK ahead of European countries, after its national regulator began its own rolling reviews of shots from AstraZeneca and Moderna. AstraZeneca has confirmed that the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has begun a fast-track rolling review of its AZD1222, the …

UK could get COVID-19 vaccines early next year, ahead of European countries Read More »

Late RAPs Could Trigger Immediate 20% Payment Reduction in 2021

The U.S. Centers for Medicare & Medicaid Services (CMS) released its final home health payment rule for CY 2021 on Thursday, with essentially no changes to the Patient-Driven Groupings Model (PDGM) or its controversial behavioral adjustment.  In addition to doubling down on PDGM, boosting the home health base payment rate by 1.9% and making minor …

Late RAPs Could Trigger Immediate 20% Payment Reduction in 2021 Read More »

HHS Loosens Provider Relief Fund Restrictions, Allows Agencies to Cover Lost Revenue

In response to ongoing opposition from both lawmakers and providers, the Department of Health and Human Services (HHS) recently announced it has made changes to its rules surrounding COVID-19 relief funding. The department’s amended rules now allow providers to use Provider Relief Fund (PRF) money toward lost revenue that’s potentially unrelated to COVID-19. “After reimbursing …

HHS Loosens Provider Relief Fund Restrictions, Allows Agencies to Cover Lost Revenue Read More »

FDA’s use of real-world data

The 21st Century Cures Act required the Food and Drug Administration (FDA) establish a program for evaluating the use of real-world data (RWD) to support the approval of new indications for drugs. Real-world data is typically data from either health insurance claims, electronic health records (EHRs), patient registries, or mobile devices. But how has FDA …

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Pfizer to wait until after election to file COVID-19 vaccine in US

Pfizer said it will wait until after the US election to file its COVID-19 vaccine with the US regulator, as it waits for important safety data to become available. The vaccine is being developed by Pfizer and development partner BioNTech and will wait until late November to make its application with the FDA. In a …

Pfizer to wait until after election to file COVID-19 vaccine in US Read More »

Accelerating the digital approval process

The boom in digital tech over COVID means that pharma can move faster than ever – but the industry’s traditional processes for asset approval are still holding timelines back. David Reily examines how pharma companies are responding to the increased burden of asset approval with new ways of working. The coronavirus pandemic has forced a …

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Why intelligent automation is the future for regulation

There are a host of new, previously unimaginable tools and techniques – from analytics to robotic process automation (RPA) and artificial intelligence (AI) – available to help speed up processes and increase data accuracy. But for many life sciences organisations, these tools are either not yet fully adopted or are not being put to good …

Why intelligent automation is the future for regulation Read More »

European regulators begin rolling review of AZ’s COVID-19 vaccine

European regulators have started a first ‘rolling review’ of a COVID-19 vaccine, which is being developed by AstraZeneca in collaboration with the University of Oxford. It’s an historic announcement, bringing hope that the vaccine could be approved in the near future, although the European Medicines Agency did not say how long the process will take. …

European regulators begin rolling review of AZ’s COVID-19 vaccine Read More »

Exclusive interview with ForwardVue Pharma released for Ophthalmic Drugs 2020

SMi reports: Alan Franklin, CEO, ForwardVue Pharma will be presenting at the Ophthalmic Drugs conference The 4th Annual Ophthalmic Drugs Conference taking place on the 23rd -24th November 2020, will explore new discoveries in the treatment of ocular disease, innovations in combination technologies, and the utterly unique challenges that are faced in the treatment of …

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BioMarin files achondroplasia drug after rejection for haemophilia therapy

US biotech BioMarin has hit back with a filing for a rare disease drug, after suffering what was described by analysts as a “major setback” when the FDA rejected its gene therapy for haemophilia A. California-based BioMarin said the US filing for vosoritide in achondroplasia could lead to the first treatment for children with achondroplasia, …

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NS Pharma takes on Sarepta as FDA approves DMD drug

The FDA has approved a new therapy for the rare muscle wasting disease Duchenne muscular dystrophy (DMD) as Japan’s NS Pharma takes on Sarepta and its controversially approved rival. NS Pharma’s Viltepso (viltolarsen) has been approved in patients who have confirmed mutation of the DMD gene that is amenable to exon 53 skipping. The DMD …

NS Pharma takes on Sarepta as FDA approves DMD drug Read More »

CMS: True Telehealth Change Will Require Congressional Action

The Centers for Medicare & Medicaid Services (CMS) has proposed a new rule that would make certain COVID-19-related telehealth flexibilities introduced over the past few months permanent for Medicare beneficiaries. The move comes in conjunction with an executive order from President Trump to improve rural and telehealth access.  While CMS’s proposed rule potentially paves the …

CMS: True Telehealth Change Will Require Congressional Action Read More »

Dombi: Regulatory Flexibilities Mean More Competition for Home Health Providers

Home-based care providers are at the forefront of the nation’s fight against the coronavirus; yet they still lack the full federal help they need to succeed.  Meanwhile, regulatory flexibilities for hospitals and other health care providers are creating newfound competition for home health and home care agencies. “So far, it has been difficult to measure …

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August to Usher in Onslaught of Home Health Audits

For months now, home health providers have had to worry about an onslaught of new issues, from volume disruptions and personal protective equipment (PPE) shortages, to cash flow problems and lack of telehealth reimbursement. One long-time stressor they haven’t had to fret about, though, is being audited by the Centers for Medicare & Medicaid Services …

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PPP Loans Have Helped Save More Than 160K US Home-Based Care Jobs

The Paycheck Protection Program (PPP) has helped home-based care providers who received less than $150,000 in loans save more than 160,000 jobs nationwide, according to data from the Small Business Administration (SBA). States such as Texas, California and Florida saw the highest number of home-based care jobs retained as a result of the program. Meanwhile, …

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PPP Tax Debate Could Cost Home-Based Care Agencies in the Long Run

Home-based care providers who received loans under the Paycheck Protection Program (PPP) could face unexpected expenses when it comes time to file their 2020 taxes. That is, unless the government intervenes. “Congress clearly intended that PPP funds would be nontaxable,” Leon LaBrecque — a lawyer, accountant and chief growth officer at Sequoia Financial Group — …

PPP Tax Debate Could Cost Home-Based Care Agencies in the Long Run Read More »

UK patients get early access to Alnylam’s ultra-rare disease drug lumasiran

The UK’s regulator has granted early access to Alnylam’s ultra-rare disease drug lumasiran, allowing patients with primary hyperoxaluria type 1 to gain access ahead of a regulatory decision by the European Commission.  The Medicines and Healthcare products Regulatory Agency (MHRA) gave a positive opinion for lumasiran through its Early Access to Medicines Scheme (EAMS).  Eligible patients in the …

UK patients get early access to Alnylam’s ultra-rare disease drug lumasiran Read More »

How Are Regulatory Agencies Reacting to the Use of Real-World Evidence?

As we have discussed here previously, real-world data (RWD) and real-world evidence (RWE) offer many potential benefits in every stage of the drug discovery and development process, continuing on into post-market surveillance. With drug developers and other researchers becoming more interested in using RWD and the RWE that results from analyzing it, regulatory agencies have …

How Are Regulatory Agencies Reacting to the Use of Real-World Evidence? Read More »