Medical policy and regulation
Medical policy and regulation in healthcare ensure the safety, efficacy and quality of medical treatments and services by setting standards and guidelines for medical practices, drug development and healthcare delivery. Continuous updates and oversight in medical policy and regulation help guide clinical innovation and refine current approaches to healthcare.
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18 Dec 2024
AMA's top 10 health recommendations for 2025
As the new year approaches, the AMA has released 10 recommendations aimed at helping individuals achieve meaningful and lasting health improvements in 2025 and beyond. Continue Reading
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12 Dec 2024
USPSTF proposes guidelines for cervical cancer screening
With the advent of new self-collection methods for HPV testing, the USPSTF has proposed draft guidelines for cervical cancer screening that include patient-collected HPV tests. Continue Reading
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29 Sep 2020
Gilead to Pay $97M to Resolve Healthcare Fraud Allegations
The healthcare fraud allegations claimed that Gilead used a foundation as a conduit to pay the copays of thousands of Medicare patients taking its pulmonary arterial hypertension drug. Continue Reading
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28 Sep 2020
FDA Finalizes Rule on Prescription Drug Importation from Canada
The final rule fulfills President Trump’s July 2020 Executive Order on drug pricing, which called for prescription drug importation from Canada in certain FDA-authorized programs. Continue Reading
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28 Sep 2020
Bristol Myers Squibb Gets FDA Priority Review for T-Cell Therapy
The FDA priority review for the T-cell therapy comes four months after the company received a Refusal to File letter regarding the Biologics License Application for the same therapy. Continue Reading
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25 Sep 2020
Exploring the Most Favored Nation Approach for Drug Pricing
President Trump’s latest favored nation executive order is an attempt to lower prescription drug costs in the US by relying on international price competition. Continue Reading
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24 Sep 2020
FDA Seeks to Clarify Evidence for Intended Use Determinations
A proposed rule from the agency will help to provide better clarity on the types of evidence used to determine intended use of products regulated by the agency. Continue Reading
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21 Sep 2020
HHS, DoD Release COVID-19 Vaccine Distribution Strategy
The two documents provide an overview for state, tribal, territorial, and local public health programs on how to plan and operationalize a COVID-19 vaccine distribution strategy. Continue Reading
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15 Sep 2020
HHS Issues Guidance to Expand Access to COVID-19 Vaccines
The guidance authorizes state-licensed pharmacists to order and administer COVID-19 vaccinations to individuals, subject to specific requirements under the Public Health Service Act. Continue Reading
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14 Sep 2020
Trump Pursues Most Favored Nation Strategy for Lower Drug Prices
A new executive order aims to lower prescription drug prices by expanding the drugs covered under the “most-favored-nations” pricing scheme, which includes both Medicare Part B and D. Continue Reading
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11 Sep 2020
Steps to Implement a Successful COVID-19 Vaccination Program
According to Premier, there are four considerations for a successful COVID-19 vaccination program, including prioritization, allocation, distribution, and accurate patient tracking. Continue Reading
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09 Sep 2020
FDA Authorizes Faster COVID-19 Antigen Test from Abbott
The COVID-19 antigen test does not need the use of an analyzer and is authorized for use at point-of-care settings, such as doctor’s offices, emergency rooms, and some schools. Continue Reading
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03 Sep 2020
National Academy of Medicine Presents COVID-19 Vaccine Framework
A National Academy of Medicine committee issued a draft framework advising equitable allocation of potential COVID-19 vaccines for public comment. Continue Reading
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01 Sep 2020
FDA Expands Remdesivir Use to All Hospitalized COVID-19 Patients
The agency expanded a previous emergency use authorization to allow for the use of remdesivir in all hospitalized COVID-19 patients, not just the severely ill. Continue Reading
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31 Aug 2020
CMS Seeks Faster Medicare Coverage for Newly Approved Devices
The proposed rule would create a new, accelerate Medicare coverage process for products the FDA deems “breakthrough.” Continue Reading
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27 Aug 2020
BioMarin Receives FDA Complete Response Letter for Gene Therapy
Other recent FDA complete response letters went out to Gilead for its rheumatoid arthritis drug and Tricida for veverimer, a metabolic acidosis treatment. Continue Reading
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24 Aug 2020
FDA Authorizes Use of Convalescent Plasma as COVID-19 Treatment
The emergency use authorization allows the distribution of investigational convalescent plasma as a COVID-19 treatment despite scant evidence on its effectiveness. Continue Reading
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18 Aug 2020
FDA Grants Emergency Use Authorization to Yale for COVID-19 Test
Yale’s COVID-19 test processes saliva samples when testing for COVID-19 infection, eliminating the need for nasopharyngeal swabs, which have been prone to shortages in the past. Continue Reading
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13 Aug 2020
FDA Approves New Opioid For Intravenous Use in Hospitals
Other recent FDA approvals include Roche’s spinal muscular atrophy drug, GSK’s multiple myeloma drug, a liquid biopsy sequencing companion diagnostic test, and a muscular dystrophy mutation therapy. Continue Reading
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10 Aug 2020
AGs Lead Charge to Increase Access, Affordability of Remdesivir
In an official letter, the multistate coalition urges FDA, HHS, and NIH to scale up production and distribution of remdesivir to ensure the drug is made available for COVID-19 patients at an affordable price. Continue Reading
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07 Aug 2020
President Requires Government to Only Buy US-Made Essential Drugs
The executive order recently signed by President Trump aims to safeguard the medical supply chain by limiting competition of government procurement of essential drugs. Continue Reading
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06 Aug 2020
Coalition Calls on FDA to Ban Music in Certain Pharmaceutical Ads
The 22-page citizen’s petition asks FDA to ban music in any ads on TV, radio, or social media advertisements for pharmaceuticals that address side effects and risks. Continue Reading
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04 Aug 2020
FDA Requires Drug Manufacturers to Update Opioid Labels
Labels for opioid and OUD medicines will need to discuss the availability of naloxone, a drug used to reduce opioid overdose deaths, the FDA announced. Continue Reading
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30 Jul 2020
Disagreements Within FDA About Novel Drug Approvals Common
Disagreements highlight differing points of view on a novel drug approval, but frequency of these disagreements may have implications for the FDA’s latest push to publish only integrated reviews. Continue Reading
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28 Jul 2020
Members of Congress Demand Transparency of Operation Warp Speed
In an official letter, members of Congress demanded answers about Operation Warp Speed, including vaccine candidates, scientific review, clinical trials, and how funding will support future COVID-19 vaccines. Continue Reading
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27 Jul 2020
Trump Aims to Lower Drug Prices Via PBM Reform, Drug Importation
Executive orders signed by the president last week aim to lower drug prices by eliminating kickbacks to middlemen and increasing drug importation. Continue Reading
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22 Jul 2020
States Sue Mallinckrodt Over Underpaid Medicaid Drug Rebates
The states claim that Mallinckrodt violated the False Claims Act and underpaid hundreds of millions of dollars in Medicaid drug rebates at the expense of taxpayers. Continue Reading
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21 Jul 2020
Emergency Use Authorization Issued for COVID-19 Pooled Testing
The FDA signed off on COVID-19 pooled testing from Quest Diagnostics for a second time in order to boost coronavirus testing while preserving testing supplies. Continue Reading
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15 Jul 2020
Pfizer, BioNTech Gain FDA Fast Track for COVID-19 Vaccine Candidates
BNT162b1 and BNT162b3 are the two most advanced COVID-19 vaccine candidates from Pfizer and BioNTech’s vaccine program and are being evaluated in ongoing clinical studies in the US and Germany. Continue Reading
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10 Jul 2020
Invoice-Based Drug Reimbursement Did Not Cut Medicaid Spending
In the period after switching from price-based payment, there was less than a 0.1 percent reduction in per unit Medicaid spending used invoice-based drug reimbursement, according to a study. Continue Reading
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09 Jul 2020
Is Germany’s Drug Pricing Strategy An Option for the US?
A recent Health Affairs study found that the US’ drug pricing strategy can be designed to better align prices with clinical benefit without delaying patient access like in Germany. Continue Reading
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09 Jul 2020
Novartis to Pay $642M to Resolve Healthcare Fraud Allegations
The two healthcare fraud allegations claim that Novartis illegally paid the copays for patients taking its drugs and paid kickbacks to doctors prescribing its drugs. Continue Reading
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08 Jul 2020
FDA Grants EUA for Becton Dickinson’s Rapid COVID-19 Antigen Test
The rapid COVID-19 antigen test can be used in certain patient care settings to scale up and test millions of Americans quickly and efficiently, Becton Dickinson says. Continue Reading
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07 Jul 2020
FDA Releases Guidance on COVID-19 Vaccine Development
The COVID-19 vaccine development guidance includes recommendations on chemistry, manufacturing, non-clinical data, clinical trials, safety, assays, and emergency use authorizations. Continue Reading
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06 Jul 2020
Remdesivir’s $2,340 Price Tag Well Below Value, Gilead CEO Says
Daniel O’ Day said the price for remdesivir as a COVID-19 treatment will ensure access to the drug which has shown to reduce hospitalized days among infected patients. Continue Reading
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02 Jul 2020
DOJ Charges Another Generic Drug Company with Price Setting
Glenmark pharmaceuticals Inc is the fifth company to be charged for its role in antitrust violations that raised and maintained the prices for various generic drugs. Continue Reading
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29 Jun 2020
FDA Backs New Effort to Repurpose Drugs As COVID-19 Treatments
The initiative will leverage FDA-NCATS CURE ID platform to enhance drug repurposing for COVID-19 treatments and inform future clinical trials for diseases with high unmet medical need. Continue Reading
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25 Jun 2020
FDA Oks Botox As a Biologic for Pediatric Urology Patients
FDA accepted the biologics license application for BOTOX due to promising Phase 3 trial results in pediatric patients with neurogenic detrusor activity. Continue Reading
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18 Jun 2020
FDA Rescinds Emergency Use Authorization for COVID-19 Antibody Test
The COVID-19 antibody test from Chembio Diagnostic System no longer meets the criteria for emergency use authorization created during the pandemic, FDA says. Continue Reading
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17 Jun 2020
Coalition of AGs Accuse 26 Generic Drug Companies of Price Fixing
The generic drug manufacturers allegedly also took part in antitrust violations, market allocating, and the rigging of bids for more than 80 products, over 50 attorneys general say in a new lawsuit. Continue Reading
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16 Jun 2020
Merck Earns Approval for Drug Targeting Hospital-Acquired Infection
FDA’s approval of Recarbrio advances treatment for hospital-acquired infections, like ventilator-associated bacterial pneumonia, caused by difficult to treat Gram-negative organisms. Continue Reading
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15 Jun 2020
FDA Reverses Emergency Use Authorization for Hydroxychloroquine
After issuing the emergency use authorization of hydroxychloroquine in March, FDA acquired clinical trial results that showed the drug may not be effective against COVID-19. Continue Reading
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11 Jun 2020
FDA Issues Guidance on Patient Access Requests During COVID-19
The FDA guidance will give IBRs clarity on key factors and procedures they should consider when reviewing individual patient expanded access requests during COVID-19. Continue Reading
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05 Jun 2020
FDA Approves Eli Lilly’s Tau Pathology Drug For Alzheimer’s
Other recent FDA news includes the approval of Eli Lilly and Bristol Myers Squibb’s individual non-small cell lung cancer drugs and the approval of Roche’s liver cancer drug. Continue Reading
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04 Jun 2020
$628M HHS Task Order to Advance Manufacturing of COVID-19 Vaccines
HHS’s task order with Emergent BioSolutions will allow the company to commit to manufacturing COVID-19 vaccine candidates and therapeutics through 2021. Continue Reading
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01 Jun 2020
Robust Biosimilars Market Promotes High Savings, Affordability
A stronger biosimilars market can save the healthcare system billions, but employers and the government must eliminate any marketing that discourages biosimilar use. Continue Reading
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26 May 2020
Teva Walks Away from Negotiations Over Healthcare Fraud Charges
As one of the largest generic drug supplies in the US, Teva doesn’t believe it will be charged for an alleged healthcare fraud scheme during the COVID-19 pandemic. Continue Reading
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21 May 2020
FDA OKs Roche’s First-Line Treatment for Some Lung Cancers
The FDA approval was based on Roche’s study that found atezolizumab boosted overall survival rate in patients with high PD-L1 expression compared with chemotherapy. Continue Reading
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19 May 2020
6 Pharmacy Owners, Marketers Charged in $14M Healthcare Fraud Case
The charges in the indictment include conspiracy to commit healthcare fraud, pay and receive kickbacks, and engage in monetary transactions in criminally derived property. Continue Reading
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19 May 2020
FDA Rejects Bristol Myers Cell Squibb’s CAR T-Cell Therapy
The refusal to file for the CAR T-cell therapy application spells trouble for the merger Bristol Myers Squibb completed last year with Celgene. Continue Reading
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18 May 2020
FDA Approves Lilly’s Advanced Lung, Thyroid Cancer Drug
Other recent FDA moves include the acceptance of Agenus Inc.’s IND application for an allogeneic iNKT therapy and fast track designation for Amgen’s omecamtiv mecarbil for heart failure. Continue Reading
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15 May 2020
FDA Grants Emergency Use Authorization for COVID-19 Serology Test
The COVID-19 serology test is Abbott’s fourth test to receive FDA emergency use authorization and accelerates the supply of reliable antibody testing during the pandemic. Continue Reading
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14 May 2020
Generic Drug Company Pays $24.1M to Resolve Antitrust Violations
Apotex Corp agreed to pay a $24.1 million criminal penalty for its role in an antitrust scheme that fixed the price of the generic drug pravastatin. Continue Reading
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13 May 2020
FDA Issues Emergency Use Authorization for COVID-19 Antigen Test
The COVID-19 antigen test can produce results in minutes and its simple structure allows for millions of Americans to be tested for the novel coronavirus per day. Continue Reading
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20 Apr 2020
NIH Ties Up with Top Pharma Companies for COVID-19 Drug Discovery
NIH and 16 other companies including J&J, Bristol Myers, GSK, and Roche, will develop a framework to advance clinical trials and boost COVID-19 drug discovery. Continue Reading
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16 Apr 2020
FDA Approves Selumetinib for Rare Pediatric Neurofibromatosis
Other recent FDA approvals include a generic albuterol inhaler, a blood purification device for COVID-19, and emergency use of N95 mask decontaminators. Continue Reading
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16 Mar 2020
FDA Authorizes Additional COVID-19 Testing in New York
Last week, the FDA took two significant steps to address the outbreak by giving New York COVID-19 testing flexibility. Continue Reading
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10 Mar 2020
Gene Therapy, Regenerative Medicine Markets Booming Worldwide
Gene therapy, cell therapy, and other regenerative medicines raised millions in 2019, and experts expect dollars to increase as adoption soars. Continue Reading
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09 Mar 2020
FDA Approves First Generic Drug Version of Daraprim
To increase patient access and boost market competition, the FDA approved the first generic drug version of the drug at the center of Martin Shkreli’s drug price gouging case. Continue Reading
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05 Mar 2020
Sanofi to Pay $11.85M to Resolve Medicare Fraud Allegations
The settlement will put to rest accusations that Sanofi paid kickbacks to patients in an alleged Medicare scheme fraud involving its charitable foundation, The Assistance Fund. Continue Reading
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28 Feb 2020
FDA Boosts Affordable Access to Insulin and Biological Products
The FDA’s new finalized rule will increase patient access to insulin products and other biological products, provide resources, and potentially lower drug prices. Continue Reading
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27 Feb 2020
Esperion Earns FDA Approval for Cholesterol Lowering Drug Nexletol
The FDA approval is the first in nearly 20 years for an oral, once-daily, non-statin LDL-cholesterol lowering drug for patient who cannot tolerate statin pills. Continue Reading
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13 Feb 2020
Congress’ Think Tank Digs Into Drug Patenting Practices
The Congressional Research Service reports on drug patenting practices as these “take place against a backdrop of a broader public policy debate over drug pricing.” Continue Reading
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12 Feb 2020
Industry Backs FDA Guidance on Patient-Focused Drug Development
With the forthcoming FDA guidance on patient-focused drug development, BIO and PhRMA argued for clarity on what patient experience data informs FDA decision-making. Continue Reading
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07 Feb 2020
CMS Moves to Foster Access to Generics, Biosimilars in New Rule
The administration is proposing to increase Medicare Part D drug pricing transparency via requirements to create more competition against specialty drugs. Continue Reading
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03 Feb 2020
FDA Breaks Down Barriers to Prioritizing Generic Drug Approvals
An update to the US Food and Drug Administration's policy on prioritization of generic drug applications enables the agency to prioritize submissions more likely to receive approval. Continue Reading
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03 Feb 2020
FDA Aims to Bolster Gene Therapy Development with New Guidance
With more than 900 INDs for gene therapies currently in development, a new deluge of FDA final and draft guidances aim to accelerate gene therapy development. Continue Reading
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30 Jan 2020
FTC, NY Sue to Ban Martin Shkreli From Pharmaceutical Industry
FTC and the state of New York filed a lawsuit seeking to permanently ban Martin Shkreli and another former Vyera Pharmaceuticals executive from the pharmaceutical industry over Daraprim’s price. Continue Reading
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24 Jan 2020
Improving Vaccination Efforts Requires Renewed Commitment
Authors of a recent op-ed call for a renewed commitment to eliminating known diseases through robust vaccination efforts. Continue Reading
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17 Jan 2020
FDA Proposes Policies for Pediatric Studies
FDA addressed a new pediatric requirement on submissions for pediatric studies. Continue Reading
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17 Jan 2020
Study: FDA Should Simplify Drug Approval Programs
Researchers claim regulatory innovations have resulted in drug approvals based on weaker data, and a former top FDA official has suggestions. Continue Reading
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15 Jan 2020
Industry Supports FDA’s Reorganization of Office of New Drugs
Industry feedback sought to inform the direction of FDA reorganization efforts for its Office of New Drugs. Continue Reading
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13 Jan 2020
CA Proposes Single Market for Drug Pricing, Manufacturing Hub
California is looking to establish a single market for drug pricing within the state and a new contracting program for generic drugs. Continue Reading
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09 Jan 2020
Drug Price Hikes Undeterred Despite Legislative Proposals
Hundreds of drug prices have increased to begin the year against a backdrop of Congressional efforts to curb spending on prescription drugs. Continue Reading
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16 Dec 2019
Senate Confirms Hahn as FDA Commissioner in Bipartisan Vote
Stephen Hahn, MD, received a 72-18 vote into his new role as FDA commissioner. Continue Reading
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20 Nov 2019
How Could Drug Price Proposals Impact Pharma Company Profits?
Proposals to curb drug price increases will limit but not eliminate the profitability of pharmaceutical companies. Continue Reading
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15 Nov 2019
Exploring International Reference Pricing for Pharmaceuticals
Policymakers are considering an international reference pricing model to reduce prescription drug costs, but will this model succeed in the US? Continue Reading