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CMS 2020 Final Rules: Infection Control in Inpatient and Long-Term Acute Care
Antimicrobial resistance represents a serious risk for Medicare beneficiaries and for the public overall. CMS is finalizing an alternative new technology add-on payment pathway for antimicrobial products designated by the FDA as Qualified Infectious Disease Products (QIDPs). Under this policy, a QIDP will be considered new and will not need to demonstrate that it meets the substantial clinical improvement criterion; it will only need to meet the cost criterion. CMS also is increasing the new technology add-on payment to 75% for an antimicrobial designated as a QIDP.
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CMS Issues 2020 Final Rules for Inpatient and Long-Term Acute Care
The Centers for Medicare & Medicaid Services issued its final rule in August to update the Medicare payment policies for hospitals under the Inpatient Prospective Payment System and the Long-Term Care Hospital Prospective Payment System for fiscal year 2020. Changes were made to the rural hospital wage index, all-cause readmissions, and interoperability.
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Pharmacist Prescribing of Hormonal Contraceptives Available in Utah
Contraceptive access has expanded for adult women in Utah, as pharmacists have begun to prescribe hormonal contraceptives. As of September 2019, pharmacies in more than 75 Utah cities signed up to participate in the program. In 2018, the Utah legislature passed Senate Bill 184 to allow women aged 18 years and above to obtain hormonal contraceptives from a qualified pharmacist without a visit to a healthcare provider.
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Tips for Including Plain Language in Informed Consent Form
Many informed consent forms fail to communicate simply and clearly. They might use language prospective research participants may not process easily. While the new Common Rule provides some suggestions for making informed consent documents more readable, there are additional steps IRBs and researchers could take to improve the forms, including incorporating plain language.
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Sample Models of Post-Approval Monitoring Programs
There are many ways IRBs could conduct post-approval monitoring programs. These can range from simple email questions and answers to full reviews at the research site. These programs often are designed to be educational, as well as adding a layer of accountability in the human research protection process.
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In New Common Rule Era, There Is Role for Post-Approval Monitoring
Post-approval monitoring (PAM) is one method that IRBs could employ when keeping tabs on minimal-risk studies or studies that no longer have to go through the continuing review process. It also can be a way for a small IRB to improve office efficiency and enhance relationships with investigators. IRBs that would like additional information from studies, after continuing review ends, could use PAM to obtain that information.
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‘Re-Consent’ a Gray Area for IRBs
Wading into a thicket of ethical and legal issues, SACHRP is trying to clarify the concept of “re-consent” and when is it necessary.
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SACHRP Approves Participant Payment Guidelines
The Secretary’s Advisory Committee on Human Research Protections (SACHRP) recently approved guidelines on paying research participants, addressing a range of issues from “token” payments to frank coercion. After considerable discussion into the ethical implications of paying subjects too much or too little, SACHRP approved the guidelines, entitled “Addressing Ethical Concerns Regarding Offers of Payment to Research Participants.”
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Physician Not Liable for Alleged Complications After Gallbladder Removal
This successful defense case reveals potent methods for defeating medical malpractice claims. On the substance, the defendant physician successfully challenged one of the necessary elements that an injured patient must prove when alleging medical malpractice: causation. Causation includes factual and legal aspects, where the physician’s actions must have been a “substantial factor” in contributing to the patient’s harm, but there may be an intervening action or event that cuts off the physician’s liability. If the risk of injury exists, even when a procedure is performed correctly, then simply because an injury occurred does not mean that the physician was negligent.
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Negligent Thyroid Surgery Results in $2.2 Million Verdict
One of the primary lessons from the case for physicians and care providers is that assistant physicians, including residents, may be subject to liability for failing to provide services within the standard of care as well, and that standard does not change for a resident still in training.