regulation

Walgreens helped fuel San Francisco’s opioid crisis, judge finds

Court Battles, Healthcare, opioid crisis, Opioids, Policy, regulation / August 10, 2022

Walgreens helped fuel the opioid epidemic in San Francisco by dispensing hundreds of thousands of prescriptions without performing adequate due diligence, a federal judge ruled Wednesday. U.S. District Judge Charles Breyer found that over the course of a 15-year period, Walgreens pharmacists did not stop or flag suspicious orders, including tens of thousands from doctors …

Walgreens helped fuel San Francisco’s opioid crisis, judge finds Read More »

ODM standard for CRF design

Clinical Trials, Partner content, Pharma, Press releases, regulation / August 8, 2022

Over the last few years, our industry has become familiar with CDISC standards. This has largely been driven by regulation, with national regulators such as FDA and PMDA mandating the use of submission standards such as SEND, SDTM, and ADaM. This post shines a spotlight on the lesser-known Operational Data Model (ODM) standard, which is often overlooked as it’s …

ODM standard for CRF design Read More »

Minnesota jury rules that pharmacist who denied woman morning after pill didn’t violate her rights

Court Battles, Healthcare, Policy, regulation / August 5, 2022

A jury in Minnesota ruled on Friday that a pharmacist did not commit discrimination when he did not fill an emergency contraception prescription for a woman after her prior contraceptive method failed, according to the gender advocacy group Gender Justice. A jury in Aitkin County found that a pharmacist’s decision not to provide an emergency …

Minnesota jury rules that pharmacist who denied woman morning after pill didn’t violate her rights Read More »

Why Home Care Providers May Need to Rethink No-Hire Clauses 

Featured, HHCN+, Personal Home Care, Polsinelli, regulation, Staffing / July 25, 2022

Home care providers have always taken measures to ensure that they’re able to hold on to staff – especially amid labor shortages – through clauses in client services contracts prohibiting the direct hire of a caregiver.  Now, various government agencies are cracking down on these measures. “Government authorities, such as the Federal Trade Commission (FTC), …

Why Home Care Providers May Need to Rethink No-Hire Clauses  Read More »

Why An Active Public Health Emergency Is Beginning to Hurt, Not Help, Providers

Featured, HHCN+, Home Health Care, hospital at home, Kaiser Permanente, regulation / July 21, 2022

The public health emergency (PHE) was once considered an oasis of sorts, both for home health agencies and health systems looking to deliver hospital-level care in the home.  But after being active for two and a half years, the length of it – and the continued, but uncertain, prolonging of it – is causing problems …

Why An Active Public Health Emergency Is Beginning to Hurt, Not Help, Providers Read More »

CDC ends reporting of COVID cases on cruise ships

CDC, COVID-19, cruise ship, cruise ships, Healthcare, Policy, regulation, transportation / July 19, 2022

The Centers for Disease Control and Prevention (CDC) announced this week that it would be ending its monitoring program for COVID-19 cases on cruise ships. In a brief statement published on its COVID-19 guidance for cruise ship travel, the CDC said its “COVID-19 Program for Cruise Ships is no longer in effect.” “CDC will continue …

CDC ends reporting of COVID cases on cruise ships Read More »

Texas sues Biden administration over hospital abortion guidance

Abortion, Court Battles, Healthcare, hospital, News, Policy, regulation, Roe v. Wade, State Watch / July 14, 2022

Texas is suing the Biden administration over its recent guidance reminding hospitals and physicians that federal law requires them to provide abortions if there is a medical emergency and the health or life of the patient is at risk. According to the suit, filed in the Northern District of Texas, the Biden administration “seeks to …

Texas sues Biden administration over hospital abortion guidance Read More »

Judge allows abortions to resume in Louisiana

abortion access, abortion rights, Court Battles, Federal judge, Healthcare, Policy, regulation, trigger bans / July 12, 2022

A federal judge has ruled that abortion services can resume in the state of Louisiana, blocking the state from enforcing its so-called trigger ban.  Judge Donald Johnson granted a temporary restraining order to the Center for Reproductive Rights (CRR) and set a hearing on the case for July 18. CRR, along with ​​Boies Schiller Flexner …

Judge allows abortions to resume in Louisiana Read More »

DOJ creates new Reproductive Rights task force

abortion rights, Court Battles, Healthcare, regulation, Reproductive rights, task force / July 12, 2022

The Department of Justice (DOJ) on Tuesday announced the creation of a new Reproductive Rights Task Force aimed at protecting abortion access and enforcing federal laws on reproduction rights in the wake of the U.S. Supreme Court overturning Roe v. Wade. In a press release, the DOJ said the new task force will bring together …

DOJ creates new Reproductive Rights task force Read More »

FDA guidance on patient-focused drug development

FDA, Patient-centered drug development, Pharmaceuticals, regulation / July 5, 2022

FDA wants drugs to be more targeted to factors that impact patient’s lives in ways that they care about. To achieve this goal, last month FDA released a third guidance document on patient focused drug development generally applicable to a variety of clinical outcome assessments (COAs), including patient-reported outcome (PRO), observer-reported outcome (ObsRO), clinician-reported outcome …

FDA guidance on patient-focused drug development Read More »

Abortion providers challenge bans in Oklahoma

Court Battles, Healthcare, News, regulation, State Watch / July 1, 2022

Abortion providers in Oklahoma filed a lawsuit challenging the state’s two abortion bans on Friday, just a week after the Supreme Court overturned the constitutional right to an abortion. The lawsuit asks the Oklahoma Supreme Court to strike down two bans: one that was enacted in 1910 and revived when the Supreme Court overturned Roe …

Abortion providers challenge bans in Oklahoma Read More »

Medical Devices and IVD Conference

digital, digital health, Events, MDR, Medical Devices, patient centricity, regulation / July 1, 2022

SAE Media Group’s Inaugural Conference… Medical Devices and IVD 2022 14 – 15 November 2022 London, UK http://www.medicaldevices-ivd.com Navigating The MDR and IVDR and Best Strategies for Compliance SAE Media Group is proud to announce the launch of the Medical Devices and IVD Conference, taking place on 14 – 15 November 2022 in London, UK. …

Medical Devices and IVD Conference Read More »

Ohio abortion clinics challenge state ban

Court Battles, Healthcare, News, Policy, regulation, State Watch / June 29, 2022

A group of abortion clinics and abortion rights organizations filed a lawsuit in the Ohio Supreme Court on Wednesday seeking to block the state’s six-week abortion ban, which went into effect after the Supreme Court overturned Roe v. Wade. The American Civil Liberties Union (ACLU), Planned Parenthood and the WilmerHale law firm have filed a …

Ohio abortion clinics challenge state ban Read More »

New Oncology, Primary Care Models Could Offer Risk-Based Avenues for Home-Based Care Providers

CMS, CMS Innovation Center, HHS, innovation, regulation / June 28, 2022

The U.S. Department of Health and Human Services (HHS) and the Centers for Medicare & Medicaid Services (CMS) are taking steps to improve oncology care and primary care this week. While both are not directly related to home-based care, the federal government pushing this should pique providers’ interest. After all, both primary and oncology care …

New Oncology, Primary Care Models Could Offer Risk-Based Avenues for Home-Based Care Providers Read More »

Juul says FDA overlooked key data in e-cigarette application before banning sales

Court Battles, E-Cigarettes, FDA, Healthcare, Juul, nicotine, Policy, regulation, tobacco / June 28, 2022

E-cigarette giant Juul argued in court documents filed on Tuesday that the Food and Drug Administration (FDA) had overlooked a mountain of data that it had included in its application that demonstrated its products’ benefit to public health and said the decision to ban them was based on “deeply flawed reasons.” In the court documents, …

Juul says FDA overlooked key data in e-cigarette application before banning sales Read More »

Abortion rights proponents file wave of lawsuits challenging bans

Abortion, abortion rights, abortion ruling, Court Battles, Healthcare, Idaho, Kentucky, Louisiana, Mississippi, News, Policy, regulation, Roe v. Wade, State Watch, supreme court abortion ruling, Utah / June 27, 2022

Abortion rights activists have quickly filed a slew of lawsuits in states with trigger bans on abortions that went into effect following the Supreme Court’s decision to overturn Roe v. Wade last week. Lawsuits have so far been filed by organizations like Planned Parenthood and the American Civil Liberties Union (ACLU) in about half of …

Abortion rights proponents file wave of lawsuits challenging bans Read More »

Supreme Court sides with doctors convicted of over-prescribing pain medications

Court Battles, Healthcare, Policy, regulation / June 27, 2022

The Supreme Court on Monday sided with two doctors challenging their convictions on drug distribution charges for over-prescribing opioid medications in a decision that could make it harder for federal prosecutors to prove such cases against licensed physicians. The court was unanimous in ruling for the two doctors but split 6-3 on narrower legal issues …

Supreme Court sides with doctors convicted of over-prescribing pain medications Read More »

Supreme Court’s abortion ruling is watershed moment

Court Battles, Healthcare, Policy, regulation / June 24, 2022

The Supreme Court’s extraordinary decision to eliminate the universal right to abortion is a watershed moment in the American experiment, ending half a century when women were free to make their own reproductive decisions and immediately ushering in an era when states can make that choice for them. From a practical standpoint, the court’s decision …

Supreme Court’s abortion ruling is watershed moment Read More »

Next big fight looms over abortion pills

Court Battles, Healthcare, Policy, regulation / June 24, 2022

Abortion pills are likely to become the next major front of the fight over reproductive healthcare in the wake of the Supreme Court’s decision overturning Roe v. Wade. Republican-led states have been moving to limit or even completely ban access to the drugs, and advocates worry the Supreme Court’s decision will embolden even more states …

Next big fight looms over abortion pills Read More »

Biden administration plans to reduce nicotine levels in cigarettes

Administration, cigarettes, FDA, Healthcare, News, nicotine, Policy, regulation, tobacco / June 21, 2022

The Food and Drug Administration (FDA) is set to propose limits on the levels of nicotine tobacco companies can place in traditional cigarettes in an attempt to make them less addictive, according to a notice published in the agency’s biannual regulatory agenda. Proponents think the rule could save millions of lives from cancer and other …

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‘The Stability of Home Health Care Is at Risk’: CMS Proposes 4.2% Decrease to Provider Payments in 2023

Centers for Medicare & Medicaid Services (CMS), Featured, Home Health Care, National Association for Home Care & Hospice, regulation / June 17, 2022

The U.S. Centers for Medicare & Medicaid Services (CMS) released its FY 2023 home health proposed payment rule late Friday. It comes with a decrease to payment rates by 4.2%, or $810 million less compared to 2022 rates. Overall, the proposed rule looks to be one that will be disappointing to providers, and one they …

‘The Stability of Home Health Care Is at Risk’: CMS Proposes 4.2% Decrease to Provider Payments in 2023 Read More »

Home Health Providers in HHVBP Demo States Struggled to Achieve Financial Upside

3HC, EvergreenHealth Home Care, Featured, Home Health Care, regulation / June 15, 2022

Despite being a significant regulatory change to the home health care industry, some providers aren’t so sure whether the Home Health Value-Based Purchasing (HHVBP) Model will have that significant of a bottom-line impact. The model is constructed in such a way where the very best performers receive the largest payment boost, with a maximum adjustment …

Home Health Providers in HHVBP Demo States Struggled to Achieve Financial Upside Read More »

Data-driven policy and market access firm Avalere joins Fishawack Health

health economics outcomes research, Market Access, Partner content, Policy, Press releases, pricing, regulation / June 8, 2022

June 7, 2022, Washington DC – Fishawack Health (FH) announces the acquisition of leading healthcare consulting and advisory firm Avalere Health (Avalere) from Inovalon, which acquired the consultancy in 2015.    FH is a leading global commercialization partner for biopharmaceutical, medical technology, and wellness companies. A healthcare consulting firm for more than 20 years, Avalere partners …

Data-driven policy and market access firm Avalere joins Fishawack Health Read More »

Confusion Around Face-to-Face Documentation Remains for Home Health Providers

C3 Advisors, Home Health Care, regulation, WellSky / June 2, 2022

Face-to-face encounter documentation remains a pain point for home health providers. It makes sense why, too. The rules and regulations around it are often inconsistent, but there are also ways for providers to fight back against claim denials. Face-to-face documentation is already one of the top reasons for those claim denials in Medicare and Medicaid, …

Confusion Around Face-to-Face Documentation Remains for Home Health Providers Read More »

A ‘Persistence of Patient Harm’: Hospital Failures Highlight Need for Home-Based Care Investments

HHS, hospital at home, Medicare, Mount Sinai Health System, Moving Health Home, OIG, regulation / May 31, 2022

The traditional brick-and-mortar hospital system is broken, often leaving patients in a condition that’s worse than when they first arrived. That’s according to a May report from the U.S. Department of Health and Human Services Office of Inspector General (HHS-OIG). The findings throw further support for facility-based care alternatives, including the types of hospital-at-home models …

A ‘Persistence of Patient Harm’: Hospital Failures Highlight Need for Home-Based Care Investments Read More »

‘Medicare Advantage on Steroids’: Advocates Push Back on ACO REACH Model

Medicare, Medicare Advantage, Physicians for a National Health Program, regulation / May 23, 2022

Home health care providers and Medicare-for-all advocates certainly agree on their general disliking of Medicare Advantage (MA). The one problem is that these advocates are also fervently against direct contracting in traditional Medicare. And that is an area where many home-based care providers believed they could enter into new, value-based care arrangements either with the …

‘Medicare Advantage on Steroids’: Advocates Push Back on ACO REACH Model Read More »

What HHVBP Means for Managed Care, SNF Utilization

Arbor Research Collaborative for Health, CMS, Featured, HHCN+, Home Health Care, L&M Policy Research, Medicare Advantage, regulation / May 19, 2022

With the nationwide rollout of the Home Health Value-Based Purchasing (HHVBP) Model inching closer, home health agencies are feeling confident about their ability to adapt. Not only are operators confident, but some are even excited about what HHVBP might translate to in terms of improved managed care relationships and further diversion away from skilled nursing …

What HHVBP Means for Managed Care, SNF Utilization Read More »

FDA rolls out new import guidelines, manufacturer flexibilities to boost infant formula supply

baby formula, baby formula shortage, FDA, Healthcare, regulation, transportation / May 17, 2022

The Food and Drug Administration (FDA) on Monday announced a series of measures aimed at increasing the domestic U.S. supply of infant formula to counteract the current shortage, including temporary import guidelines and flexibilities for companies that don’t normally sell formula. The FDA said it will temporarily “not object” to the importation of certain infant …

FDA rolls out new import guidelines, manufacturer flexibilities to boost infant formula supply Read More »

Harris warns the ‘rights of all Americans are at risk’ if Roe overturned

Administration, Court Battles, Healthcare, News, Policy, regulation / May 3, 2022

Vice President Harris on Tuesday warned the rights of all Americans are at risk if the Supreme Court weakens the right to privacy by overturning Roe v. Wade. A draft opinion leaked Monday night showed the high court was poised to overturn Roe v. Wade, the landmark 1973 decision that guaranteed the right to an …

Harris warns the ‘rights of all Americans are at risk’ if Roe overturned Read More »

Biden: ‘Range of rights’ in question if abortion opinion in leaked draft is final

Administration, Court Battles, Healthcare, News, regulation / May 3, 2022

President Biden on Tuesday said that other rights, including same sex marriage and access to birth control, are in question if a leaked Supreme Court draft opinion which overturned Roe v. Wade becomes final. “It basically says all the decisions relating to your private life — who you marry, whether or not you decide to …

Biden: ‘Range of rights’ in question if abortion opinion in leaked draft is final Read More »

Ocasio-Cortez: Supreme Court ‘isn’t just coming for abortion’

Abortion, abortion access, Alexandria Ocasio-Cortez, Bernie Sanders, Clarence Thomas, Court Battles, Filibuster, Healthcare, House, joe manchin, News, Policy, regulation, Roe v. Wade, Samuel Alito, Supreme Court / May 3, 2022

Rep. Alexandria Ocasio-Cortez (D-N.Y.) on Monday warned progressives that the Supreme Court “isn’t just coming for abortion” after a leak of a Supreme Court draft ruling that would overturn Roe v. Wade. “As we’ve warned, SCOTUS isn’t just coming for abortion – they’re coming for the right to privacy Roe rests on which includes gay …

Ocasio-Cortez: Supreme Court ‘isn’t just coming for abortion’ Read More »

Planned Parenthood: Draft Supreme Court ruling striking down Roe v. Wade ‘devastating’

Court Battles, Healthcare, regulation / May 3, 2022

Planned Parenthood reacted with horror and dismay to the Monday publication of a draft Supreme Court ruling that would strike down Roe v. Wade, the landmark 1973 case that enshrined the right to an abortion. The draft decision, written by conservative Justice Samuel Alito and leaked to Politico, would, if it becomes official, hand the …

Planned Parenthood: Draft Supreme Court ruling striking down Roe v. Wade ‘devastating’ Read More »

Rural Home-Based Care Remains Both Necessary and Extraordinarily Challenging

Androscoggin Home Care & Hospice, Featured, HHCN+, Home Health Care, NAHC, regulation, TruBlue Total House Care / April 29, 2022

Aging in place is difficult for many Americans, but it’s even more difficult for those living in rural areas. Things are additionally hard on in-home care providers in such parts of the country.. To ensure access to home health services, the Medicare program has historically provided a rural add-on payment to agencies, giving them slightly …

Rural Home-Based Care Remains Both Necessary and Extraordinarily Challenging Read More »

Questions Linger as Home-Based Care Shifts Toward Value-Based Care

Featured, HHCN+, Home Health Care, innovation, Personal Home Care, regulation, SCAN Health Plan / April 28, 2022

It would be silly to have an argument over whether value-based care is a good principle. That’s unless, of course, you had to parse out what exactly each individual or organization meant when they referred to value-based care. No one would argue – or should argue – that making the health care system more focused …

Questions Linger as Home-Based Care Shifts Toward Value-Based Care Read More »

When does FDA extrapolate clinical trial results to a broader indication

FDA, Pharmaceuticals, regulation / April 27, 2022

When new drugs are approved, FDA limits their on-label use to the treatment of specific diseases. A key question is whether the definition of a disease should be narrower or broader. Make the disease definition too broad, then there may not be strong evidence from the clinical trial to support its use among these types …

When does FDA extrapolate clinical trial results to a broader indication Read More »

Federal judge halts Kentucky’s restrictive new abortion law

Court Battles, Healthcare, Policy, regulation / April 21, 2022

A federal judge on Thursday temporarily blocked a restrictive new abortion law in Kentucky, handing a win to abortion providers challenging the measure. In a 21-page ruling, Louisville-based U.S. District Judge Rebecca Grady Jennings, a Trump appointee, sided with Planned Parenthood’s request to block Kentucky officials from enforcing the sweeping new law, which providers say …

Federal judge halts Kentucky’s restrictive new abortion law Read More »

HHS Renews Public Health Emergency, Keeping Key Home Health Waivers in Place

CMS, HHS, Home Health Care, regulation, U.S. Medical Management LLC / April 14, 2022

The U.S. Department of Health and Human Services (HHS) on Wednesday opted to renew the COVID-19 public health emergency (PHE), keeping in place several regulatory waivers that have been critical lifelines for home health and hospice operators since the start of 2020. While the extension itself is not surprising, it offers further stability as operators …

HHS Renews Public Health Emergency, Keeping Key Home Health Waivers in Place Read More »

Federal appeals court upholds Biden admin vaccine mandate for federal workers

Court Battles, Healthcare, regulation / April 7, 2022

A federal appeals court on Thursday ruled to uphold the Biden administration’s vaccine mandate for federal workers, ordering that a preliminary injunction issued against the requirement be eliminated. The 5th Circuit Court of Appeals’s 2-1 ruling reversed a ruling by U.S. District Judge Jeffrey Brown in Texas, a Trump appointee, who in January blocked the …

Federal appeals court upholds Biden admin vaccine mandate for federal workers Read More »

NASEM Report Slams ‘Ineffective’ Nursing Home System, Highlights Post-Acute Care Utilization Shifts

innovation, John A. Hartford Foundation, LeadingAge, NASEM, National Academies of Sciences Engineering and Medicine, regulation, Staffing / April 6, 2022

The National Academies of Sciences, Engineering and Medicine (NASEM) on Wednesday released its long-anticipated report on how to improve nursing home care in the U.S. In doing so, NASEM reinforced what so many long-term and post-acute care stakeholders have learned over the past two years: that, for multiple reasons – both within and beyond their …

NASEM Report Slams ‘Ineffective’ Nursing Home System, Highlights Post-Acute Care Utilization Shifts Read More »

Making Sense of a Unified Post-Acute Value-Incentive Program

Featured, HHCN+, Home Health Care, Humana, JAMA Network Open, Medicare, Medicare Payment Advisory Commission, MedPAC, regulation / March 24, 2022

Home health agencies have had to navigate several changes since 2020, from the payment mechanics of the Patient-Driven Groupings Model (PDGM) to the new policies of the public health emergency (PHE). Yet there’s another change on the distant horizon that forward-thinking operators can’t afford to forget about: a unified payment system for post-acute care providers, …

Making Sense of a Unified Post-Acute Value-Incentive Program Read More »

How the PE Nursing Home Crackdown Could Affect the Home Health Industry

Featured, Home Health Care, Intrepid USA Healthcare Services, Mertz Taggart, Polsinelli, Private Equity, regulation, white house / March 14, 2022

Pushed by the White House, federal watchdogs have a new directive – cracking down on private equity in health care. While they’ll largely be targeting nursing homes and PE investment as part of a recently unveiled senior care initiative from the Biden administration, there will likely be ripple effects in the home-based care space. In …

How the PE Nursing Home Crackdown Could Affect the Home Health Industry Read More »

Key Barriers Could Limit Adoption of Home-Based Care Models

Ascension Health, DispatchHealth, innovation, Landmark Health, Moving Health Home, regulation / March 9, 2022

Over the past few years, the U.S. health care system has learned that home-based care companies are well-positioned to respond to unique challenges, with at-home care approaches often boosting patient satisfaction, lowering costs and improving quality of care. Despite that positive movement in the home-based care market, a few key barriers could limit broader adoption …

Key Barriers Could Limit Adoption of Home-Based Care Models Read More »

Government Watchdogs Looking to Ding Home-Based Care Providers

Baker Donelson, Featured, HHCN+, Home Health Care, Personal Home Care, regulation / March 9, 2022

This article is an exclusive feature available as a part of your subscription to HHCN + With the light at the end of the COVID-19 tunnel finally visible, home-based care agencies will now have to worry about checking their peripherals once they reach the other side. Government watchdog agencies are expected to come hard for …

Government Watchdogs Looking to Ding Home-Based Care Providers Read More »

New bill moves to tighten accelerated approval regulation in US

FDA, FDA approval, Healthcare, Market Access, News, patients, regulation / March 9, 2022

US House Energy & Commerce Committee Chair Frank Pallone (D-NJ) has introduced a new bill to enhance the Food and Drug Administration’s (FDA) authority to ensure products that receive accelerated approval are providing a clinical benefit to patients. Under the proposed Accelerated Approval Integrity Act, the FDA would be granted power to expedite the withdrawal …

New bill moves to tighten accelerated approval regulation in US Read More »

FDA Guidance: Methods for identifying what is important to patients

FDA, Patient-centered, Quality, regulation / March 7, 2022

What disease components are most burdensome to patients? How do researchers find this information out? To answer this question, the Food and Drug Administration (FDA) recently put out its second guidance document on Patient-Focused Drug Development: Methods to Identify What Is Important to Patients. A few qualitative approaches they recommend to collect this information include: …

FDA Guidance: Methods for identifying what is important to patients Read More »

Why Political Roadblocks Threaten Home Health Care’s Biggest Policy Objectives in 2022

Featured, Home Health Care, Legislation, Moving Health Home, National Association for Home Care & Hospice, regulation, VNA Health Group / February 22, 2022

Policy concerns in home-based care are considered timely and critical for those in the industry. The issue is, unfortunately, they aren’t always viewed in that light by outsiders and lawmakers in Washington, D.C. Among those concerns are the extension of the Acute Hospital Care at Home waiver, adequate reimbursement for telehealth and the Choose Home …

Why Political Roadblocks Threaten Home Health Care’s Biggest Policy Objectives in 2022 Read More »

Several Government Agencies are Increasingly Targeting Home Care Agencies

Home Care Association of America, Home Care Pulse, Legislation, Personal Home Care, Polsinelli, regulation / February 17, 2022

The next year will be a big one for home care. There will be increased opportunities for agencies with a larger national spotlight shone on them. Meanwhile, there are both legal threats and advocacy efforts that should be top of everyone’s mind, Home Care Association of America (HCAOA) CEO Vicki Hoak said during Home Care …

Several Government Agencies are Increasingly Targeting Home Care Agencies Read More »

The future of regulatory labeling compliance depends on technology adoption

Artificial Intelligence, Compliance, Daily, Health Tech, Life Sciences, Machine Learning, MedCity Influencers, regulation, SYN, Top Story / February 11, 2022

The life sciences industry is more quickly adapting to new methods, standards and requirements. The focus is now on how to drive greater data governance and quality through a unified framework.  The challenge comes in instituting a framework that will meet regulatory and labeling requirements.

Home-Based Care Can Help Turn Around CMS’ Investment Portfolio, Former Administrator Says

Centers for Medicare & Medicaid Services, Home Health Care, hospital at home, Personal Home Care, regulation / February 9, 2022

Former U.S. Centers for Medicare & Medicaid Services (CMS) Administrator Seema Verma is bullish on a lot. Speaking at the Home Care 100 conference Tuesday, she expressed enthusiasm for a new era of data-tracking and technology, as well as value-based care, Medicare Advantage and hospital at home. Most noteworthy to the attendees, however, was her …

Home-Based Care Can Help Turn Around CMS’ Investment Portfolio, Former Administrator Says Read More »

Home-Based Care Workers ‘More Comfortable’ Bringing Lawsuits Against Current, Former Employers

Featured, Home Health Care, Littler Mendelson, Personal Home Care, regulation, U.S. Department of Justice / January 31, 2022

Four home care operators in Portland, Maine, were indicted on counts of wage fixing and labor market allocation charges, the U.S. Department of Justice (DOJ) announced Friday. And there could be a lot more where that came from. On a webinar last week, Littler Mendelson lawyers covered five legal trends to watch in 2022. Three …

Home-Based Care Workers ‘More Comfortable’ Bringing Lawsuits Against Current, Former Employers Read More »

HHCN+ Report: The Pros and Cons of Certificate of Need Regulations in Home Health Care

Featured, HHCN + Report, HHCN+, Home Health Care, McBee Associates, regulation, Visiting Nurse Health System / January 25, 2022

This article is an exclusive feature available as a part of your subscription to HHCN + Certificate of Need (CON) laws for home health agencies vary by state. In some states, there are no restrictions. In others, there are strict restrictions on how many home health and hospice providers are allowed to operate. There are …

HHCN+ Report: The Pros and Cons of Certificate of Need Regulations in Home Health Care Read More »

Japan approves Pfizer COVID vaccine for children aged 5 to 11

BioNTech, COVID-19, Market Access, News, Pfizer, Pharma, regulation, Vaccine / January 21, 2022

Japan’s health ministry has authorised the use of Pfizer and BioNTech COVID-19 vaccine in children aged between five and 11. The vaccine, Comirnaty, is claimed to be the first in Japan to be approved for use in this age group. Once the Ministry of Health, Labor and Welfare grants special approval, Japan will join the …

Japan approves Pfizer COVID vaccine for children aged 5 to 11 Read More »

Scotland backs AstraZeneca drug as first-line treatment for NSCLC

AstraZeneca, cancer, News, Oncology, Pharma, regulation / January 18, 2022

Scotland has approved AstraZeneca’s Tagrisso (osimertinib) as a monotherapy for the for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) mutations. Lung cancer is linked to a quarter of all cancer deaths in the country, with almost half of lung …

Scotland backs AstraZeneca drug as first-line treatment for NSCLC Read More »

Two new drugs added to WHO list of COVID-19 therapies

COVID-19, Eli Lilly, GlaxoSmithKline, Market Access, News, Pharma, regulation, WHO / January 17, 2022

A World Health Organization (WHO) panel has given the green light to two new drugs to treat COVID-19. US-based Eli Lilly’s baricitinib (Olumiant), a Janus kinase inhibitor, and GlaxoSmithKline and Vir Biotechnology’s sotrovimab, a monoclonal antibody, were recommended in new WHO guidelines, published in the British Medical Journal.  Baricitinib, administered with corticosteroids, was strongly recommended as …

Two new drugs added to WHO list of COVID-19 therapies Read More »

Positive Reimbursement Environment, Diverse Payer Mix Creating Tailwinds for Aveanna

Aveanna Healthcare, Home Health Care, regulation / January 12, 2022

Aveanna Healthcare Holdings (Nasdaq: AVAH) has been bullish on its plans to expand into a leading provider of senior home health services since it went public in April. Prior to its IPO, the company had been more of a pediatric provider, but it has aggressively acquired new assets since, realizing the vision it laid out …

Positive Reimbursement Environment, Diverse Payer Mix Creating Tailwinds for Aveanna Read More »

Overview of FDA Drugs Approved in 2021

HC Statistics, Pharmaceuticals, regulation / January 10, 2022

In 2021, the Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) approved 50 new drugs, either as new molecular entities (NMEs) under New Drug Applications (NDAs), or as new therapeutic biologics under Biologics License Applications (BLAs). FDA summarizes these approvals in their recently released report titled: Advancing Health Through Innovation: New Drug …

Overview of FDA Drugs Approved in 2021 Read More »

Supreme Court Seems Skeptical on OSHA Rule, More Receptive to CMS Mandate

regulation, U.S. Supreme Court / January 7, 2022

The U.S. Supreme Court on Friday listened to arguments regarding the issue that has been top of mind for most home-based care providers for the past several months: vaccine mandates. No decision has been made on whether the Occupational Safety and Health Administration (OSHA) rule, nor the Centers for Medicare & Medicaid Services’ (CMS) mandate, …

Supreme Court Seems Skeptical on OSHA Rule, More Receptive to CMS Mandate Read More »

Nine for 2022: International issues that are compelling, new or changed in 2022

COVID vaccine, COVID-19, Market Access, patients, R&D, regulation, Vaccine, Views & Analysis, Views and analysis / January 5, 2022

The year 2020 ended on a note of hope, with the 8th December vaccination of 91-year-old Margaret Keenan, the world’s first person to receive a COVID-19 vaccine outside clinical trials. Despite an estimated 9.25 billion doses administered globally by 4th January, with 25 different vaccines either approved for use or under emergency use authorisation, 2022 …

Nine for 2022: International issues that are compelling, new or changed in 2022 Read More »

Insights from the WHO’s Global Strategy on Digital Health event

digital, digital health, patients, Pharma, regulation, Views & Analysis, Views and analysis / December 24, 2021

The World Health Organization (WHO) recently held a virtual panel discussion during Digital Health Week with speakers from around the world to talk about global strategy on digital health and collective opportunities for catalysing collaborative action. The panel focused on the objectives of the WHO’s Global Strategy on Digital Health 2020-2025, which aims to develop …

Insights from the WHO’s Global Strategy on Digital Health event Read More »

OSHA Mandate Reinstated, Noncompliance Penalties to Begin in January

OSHA, regulation / December 20, 2021

The U.S. Occupational Safety and Health Administration (OSHA) regulation requiring workers at companies with 100 or more employees to be vaccinated against COVID-19 or undergo weekly testing has been revived. The 6th Circuit Court of Appeals lifted a stay on the OSHA vaccine mandate late Friday. The mandate had been paused since Nov. 6, challenged …

OSHA Mandate Reinstated, Noncompliance Penalties to Begin in January Read More »

Majority of US States Again Subject to CMS Vaccine Mandate After New Court Ruling

Centers for Medicare & Medicaid Services, regulation / December 15, 2021

On the last day of November, a nationwide injunction was issued by a federal judge in Louisiana to freeze the COVID-19 vaccine mandate from the Centers for Medicare & Medicaid Services (CMS). On Wednesday, the 5th U.S. Circuit Court of Appeals in New Orleans ruled that the injunction should not have been applied nationwide. Instead, …

Majority of US States Again Subject to CMS Vaccine Mandate After New Court Ruling Read More »

Supreme Court Keeps NY Vaccine Mandate Alive. Here’s What Home Health Providers Should Know.

Hall Estill, Polsinelli, Poricanin Law, regulation / December 14, 2021

On Monday, the Supreme Court refused to block New York state’s requirement that health care workers must be vaccinated against COVID-19. For home-based care providers, the move is unlikely to change much for now – either in New York or elsewhere. A similar challenge in the state of Maine had previously reached the Supreme Court, …

Supreme Court Keeps NY Vaccine Mandate Alive. Here’s What Home Health Providers Should Know. Read More »

‘It’s Now for the Wealthy’: Regulation Creating Cost Barriers for Live-In Home Care Services

Baker Donelson, Featured, Georgetown Home Care, HHCN+, Personal Home Care, Polsinelli, regulation / December 7, 2021

This article is an exclusive feature available as a part of your subscription to HHCN + In 2013, the Obama administration included live-in caregivers in U.S. wage and overtime law. Previously, those caregivers – along with salaried workers – had been exempt from overtime provisions. The administration’s goal at the time was to raise caregiver …

‘It’s Now for the Wealthy’: Regulation Creating Cost Barriers for Live-In Home Care Services Read More »

Federal Judge Halts Health Care Worker Vaccine Mandate Nationwide

CMS, Home Health Care, regulation / December 1, 2021

The health care worker vaccine mandate is now on ice. A federal judge on Tuesday issued a preliminary injunction to stop the start of the national vaccine mandate for all providers covered by the Medicare and Medicaid Conditions of Participation (CoPs), a group that includes home health agencies. The move comes just one day after …

Federal Judge Halts Health Care Worker Vaccine Mandate Nationwide Read More »

CMS Vaccine Mandate Blocked in 10 States

CMS, Medicaid, Medicare, OSHA, regulation / November 29, 2021

First it was the COVID-19 vaccination mandate from the U.S. Occupational Safety and Health Administration (OSHA). Now, it’s the one from the Centers for Medicare & Medicaid Services (CMS). Since OSHA and CMS released their interim emergency regulations requiring COVID-19 vaccinations for certain individuals, each has been challenged in court. On Monday, a federal judge …

CMS Vaccine Mandate Blocked in 10 States Read More »

‘We Will Hold You Accountable’: New York Home Health Agencies to Pay $18.5 Million

Amazing Home Care Services LLC, Department of Consumer and Worker Protection, Home Health Care, Intergen Health LLC, Personal Home Care, regulation / November 18, 2021

One of the largest home health groups in New York has agreed to pay millions of dollars to resolve wage-and-hour violations. The home health group is made up of Intergen Health LLC and Amazing Home Care Services LLC, which share ownership and employees. Both Intergen and Amazing Home Care primarily serve New York’s Medicaid population, …

‘We Will Hold You Accountable’: New York Home Health Agencies to Pay $18.5 Million Read More »

OSHA Cracking Down on Workplace Violence Against Home-Based Care Workers

regulation, The Occupational Safety and Health Administration / October 25, 2021

Due to the nature of the job, home-based care workers face the risk of experiencing workplace violence. It’s paramount for providers to enact measures that will protect these workers and avoid liability for negligence, legal experts caution. Workplace violence is defined as an act or threat of violence. This ranges from verbal abuse to physical …

OSHA Cracking Down on Workplace Violence Against Home-Based Care Workers Read More »

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

DispatchHealth, Featured, innovation, MultiCare Health System, regulation / October 11, 2021

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

cdisc, Clinical Trials, formedix, Partner content, Pharma, Press releases, regulation / October 6, 2021

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

Caring Senior Service, Family & Nursing Care, Featured, HCAOA, Home Care Association of America, Personal Home Care, regulation / September 29, 2021

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

Boumil Law Office, CMS, HHS, Home Health Care, HRSA, regulation / September 10, 2021

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

Certificate of Need, CON, hospitals, regulation, Supply of Medical Services / August 19, 2021

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

FDA, Pharmaceuticals, real world data, regulation, RWD / August 11, 2021

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

AI, Artificial Intelligence, Clinical Decision Support, Daily, ethics, FDA, Health Tech, Healthcare, Legal, Machine Learning, Policy, regulation, SYN, Top Story / May 31, 2021

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

CN Bio, digital, FDA, News, regulation, Respiratory / May 5, 2021

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

Clinical Trials, COVID-19, FDA, Partner content, Pharma, Press releases, regulation / May 4, 2021

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 …

Formedix Expedites Clinical Trial Build with New Cloud Clinical MDR Suite Read More »

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

COVID-19, News, R&D, regulation, Sinovac, Vaccine / May 4, 2021

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

breast cancer, cancer, News, Oncology, regulation, Tecentriq / April 28, 2021

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

AI in radiology, Daily, digital health, Digital Therapeutics, FDA, Health Tech, HHS, Legal, Medical Devices, Policy, regulation, SYN, Top Story / April 22, 2021

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

COVID-19, Johnson & Johnson, Market Access, News, PRAC, regulation, safety, Vaccine / April 21, 2021

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

Eli Lilly, News, Osteoarthritis, pain, Pfizer, R&D, regulation / March 23, 2021

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

Better Medicare Alliance, BMA, National Hospice and Palliative Care Organization, NHPCO, Partnership for Medicaid Home-Based Care, PMHC, regulation / March 18, 2021

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 …

Xavier Becerra Confirmed as HHS Secretary Read More »

What is the FTC’s stance on pharmaceutical mergers?

FTC, Industrial Organization, Pharmaceuticals, Public Policy, regulation / March 18, 2021

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

BlackTree Healthcare Consulting, EvergreenHealth Home Care, Featured, Home Health Care, Medicare, regulation / March 15, 2021

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

AstraZeneca, EMA, News, patients, regulation, safety / March 11, 2021

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

Budget 2021, News, R&D, regulation, Rishi Sunak, Vaccine / March 4, 2021

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 …

Budget 2021: Sunak focuses on vaccine development to restart economy Read More »

How representative are clinical trials of the US population?

CDER, FDA, Pharmaceuticals, regulation / February 25, 2021

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

data, Econometrics, Epidemiology, Pharmaceuticals, regulation, RWE / February 21, 2021

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 …

Use of real-world evidence for regulatory decision-making Read More »

China approves Sinovac’s coronavirus vaccine

COVID-19, Infectious Diseases, News, R&D, regulation, Sinovac, Vaccine / February 8, 2021

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 …

China approves Sinovac’s coronavirus vaccine Read More »

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

FDA, Joe Biden, News, R&D, regulation, Views and analysis / February 5, 2021

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

digital, digital health, Digital Therapeutics, Healthware, Italy, News, regulation, reimbursement / February 4, 2021

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 …

White paper reveals pathway for digital therapeutics use in Italy Read More »

Novavax’s COVID-19 shot effective against UK strain

COVID-19, Infectious Diseases, News, Novavax, R&D, regulation, Vaccines / January 29, 2021

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

Clinical Trials, COVID-19, Medical Devices, Partner content, Pharma, Press releases, regulation / January 28, 2021

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 …

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

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

AstraZeneca, Market Access, News, regulation, Vaccine / January 28, 2021

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

digital, digital health, FDA, Joe Biden, News, regulation / January 22, 2021

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

Biden Administration, CMS, HHS, Home Health Care, LeadingAge, Personal Home Care, regulation, Staffing / January 21, 2021

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 …

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

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

AI, Artificial Intelligence, Caption Health, clinical decision support software, Daily, FDA, health software, HHS, Legal, Policy, regulation, SYN, Top Story / January 21, 2021

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

FDA, Janet Woodcock, Joe Biden, News, R&D, regulation / January 21, 2021

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 …

Biden appoints veteran Woodcock as interim FDA commissioner Read More »

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

Littler Mendelson, Personal Home Care, regulation / January 14, 2021

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 …

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

Top Home Health, Home Care Legal Concerns for 2021

Home Health Care, Littler Mendelson, Nixon Gwilt Law, Parker Poe, Personal Home Care, Poricanin Law, regulation / January 13, 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

AstraZeneca, BioNTech, coronavirus, COVID-19, Infectious Diseases, Market Access, Moderna, News, Pfizer, regulation / January 7, 2021

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

Gene Therapies, HTA, regulation / December 23, 2020

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, News, Pfizer, R&D, regulation, Vaccine / December 22, 2020

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

Elder-Well Franchising System, Featured, Franchises, Home Health Care, LeadingAge, Legislation, Personal Home Care, regulation / December 10, 2020

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 …

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

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

BioNTech, COVID-19, FDA, Infectious Diseases, News, Pfizer, R&D, regulation, Vaccine / December 9, 2020

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

HHS, regulation / December 7, 2020

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. …

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

Latin America: How pharma can navigate a complex market

Brazil, Colombia, country focus, COVID-19, Latin America, Market Access, Masters Speciality Pharma, pricing, regulation, Views & Analysis, Views and analysis / December 7, 2020

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 …

Latin America: How pharma can navigate a complex market Read More »

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

FDA, innovation, Pharmaceuticals, Public Policy, regulation, Uncategorized / December 3, 2020

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

BioNTech, COVID-19, Market Access, News, Pfizer, regulation, Vaccine / December 2, 2020

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 …

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

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

CMS, Featured, Home Health Care, regulation, the American Academy of PAs, the American Association of Nurse Practitioners, The National Association for Home Care & Hospice / November 30, 2020

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 …

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

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

Bass Berry & Sims, CMS, Home Health Care, Parker Poe, regulation, The Centers for Medicare and Medicaid Services / November 29, 2020

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, …

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

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

CMS, Contessa, Featured, Johns Hopkins University, Legislation, regulation, The Centers for Medicare and Medicaid Services / November 25, 2020

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

Alnylam, Dicerna, Market Access, News, pricing, Rare diseases, regulation / November 24, 2020

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?

Clinical Trials, regulation, vaccinations / November 11, 2020

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

AstraZeneca, COVID-19, Infectious Diseases, Moderna, News, R&D, regulation / November 2, 2020

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

CMS, Home Health Care, Intrepid USA Healthcare Services, LeadingAge, Medicare, regulation / November 2, 2020

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

CMS, Home Health Care, Parker Poe, regulation, The Department of Health and Human Services / October 27, 2020

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

Cures Act, Pharmaceuticals, regulation, RWD, RWE / October 22, 2020

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 …

FDA’s use of real-world data Read More »

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

AstraZeneca, BioNTech, COVID-19, FDA, Moderna, News, Pfizer, R&D, regulation, Vaccine / October 16, 2020

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 …

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Accelerating the digital approval process

approval processes, asset approval, digital, regulation, Sales and Marketing, Views & Analysis, Views and analysis / October 15, 2020

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

Accenture, automation, digital, Market Access, regulation, Views & Analysis, Views and analysis / October 6, 2020

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 …

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

AstraZeneca, AZD1222, coronavirus, COVID-19, News, R&D, regulation, Top Stories, Vaccine / October 2, 2020

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. …

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Exclusive interview with ForwardVue Pharma released for Ophthalmic Drugs 2020

Drugs, ForwardVue Pharma, ophthalmic, Partner content, Pharma, Press releases, regulation / August 24, 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

BioMarin, FDA, News, R&D, Rare diseases, regulation / August 20, 2020

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

Duchenne muscular dystrophy, Market Access, News, NS Pharma, Rare diseases, regulation, Sarepta / August 13, 2020

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 …

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CMS: True Telehealth Change Will Require Congressional Action

Home Health Care, innovation, Medicare, National Association for Home Care & Hospice, Nixon Law Group, regulation / August 4, 2020

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 …

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Dombi: Regulatory Flexibilities Mean More Competition for Home Health Providers

Featured, Home Health Care, LeadingAge, National Association for Home Care & Hospice, National Council on Aging, regulation / July 29, 2020

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

Home Health Care, Parker Poe, Personal Home Care, regulation / July 28, 2020

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

Featured, Home Health Care, Personal Home Care, regulation, Staffing / July 22, 2020

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

Featured, Home Health Care, Personal Home Care, Polsinelli, regulation, Sequoia Financial Group / July 17, 2020

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 — …

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

Alnylam, Market Access, MHRA, News, PH1, regulation, ultra-rare diseases / July 16, 2020

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 …

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

clinical data, drug development, EMA, FAIR, FAIR data, FDA, guidance, Pharma R&D, Pharmacovigilance, real world data, real world evidence, regulation, regulatory, RWD, RWE / June 15, 2020

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 …

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