Category:

Requiring patients to visit a hospital, clinic or medical office to get an abortion pill is needlessly risking their health during the COVID-19 pandemic, a group of physicians allege in a lawsuit that seeks to suspend the federal rule...The federal lawsuit, which the American Civil Liberties Union filed...in Maryland, questions why patients can’t fill a prescription for mifepristone by mail. The U.S. Food and Drug Administration approved mifepristone to be used in combination with a second drug, misoprostol, to end an early pregnancy or manage a miscarriage...“Of the more than 20,000 drugs regulated by the FDA, mifepristone is the only one that patients must receive in person at a hospital, clinic, or medical office, yet may self-administer, unsupervised, at a location of their choosing,” the lawsuit says...READ MORE

Drug manufacturers, distributors, and dispensers oppose Buy American policies as likely to reduce reliable supplies and raise product costs...Efforts to shift more production of pharmaceuticals and APIs to the United States as a strategy for reducing drug shortages and ensuring access to needed medicines...The recent $2-trillion COVID economic stimulus legislation...supports exploration of federal “Buy American” policies, ostensibly to reduce US dependence on drugs and medical products imported from overseas...READ MORE

The HHS Office for Civil Rights announced... that during the coronavirus pandemic it will use discretion when enforcing HIPAA-compliance for telehealth communications tools...Even though some of those technologies may not fully comply with HIPAA requirements, OCR says it "will not impose penalties for noncompliance with the regulatory requirements under the HIPAA Rules against covered health care providers in connection with the good faith provision of telehealth during the COVID-19 nationwide public health emergency."...Covered entities seeking to use audio or video communication tech to reach patients where they live "can use any non-public facing remote communication product that is available to communicate with patients," said the agency. "This exercise of discretion applies to telehealth provided for any reason, regardless of whether the telehealth service is related to the diagnosis and treatment of health conditions related to COVID-19."...READ MORE

China has expanded a pilot drug bulk-buying program to almost the entire country in an attempt to negotiate lower prices from drug manufacturers, heaping fresh pressure on multinational pharmaceutical companies and their domestic rivals...The program rolled out last year saw 11 Chinese cities...band together behind a tender process to bulk-buy 25 types of drugs. This caused the price of some medicines to plunge over 90%…The scheme will be expanded to 25 provinces and regions, who will form a league to look for suppliers for these drugs that will be stocked at public hospitals as well as some military and private medical institutions...READ MORE

Last week, the Centers for Medicare and Medicaid Services released its final Notice of Benefit and Payment Parameters for the 2021 benefit year...This final rule permits insurers to exclude the value of a pharmaceutical manufacturer’s copay support program from a patient’s annual deductible and out-of-pocket maximum obligations...Translation: CMS has confirmed that insurers have the option to use copay accumulator adjustment for their pharmacy benefit programs...Patients on specialty drugs lose big from accumulators, while plans profit from the lower spending that results. Consequently, copay maximizers have emerged as a more patient-friendly alternative to accumulators...Plan sponsors are publicly denouncing copay support programs—while they’re privately embracing them. CMS’s final rule ignores the troubling reality behind maximizers and accumulators: They encourage plans to use pharmacy benefit deductibles as a scheme that allows payers—not patients—to reap the greatest benefits from a manufacturer’s patient support program...READ MORE

...in the letter, Abramowitz explained that, although ASHP is grateful for the action the Administration has taken to provide hospitals with necessary personal protective equipment and ventilators, they “will be rendered useless without an adequate supply of the medications…that must administered concomitantly with mechanical ventilation in critically ill patients…to ensure the successful use of this life-saving supportive care.”...Medications used in conjunction with ventilator include opioids, sedatives, and paralytics...This week, the Drug Enforcement Administration announced it will take additional steps to allow for the increased production of controlled substances used in COVID-19 care...READ MORE

China’s National Healthcare Security Administration has announced it has agreed an average 61% cut in prices of 70 top-selling drugs with large pharma manufacturers in exchange for inclusion on a state-run insurance scheme list...the 70 drugs include Roche’s Perjeta, Novartis’ Xolair and the top selling drug in the world AbbVie’s Humira, as well as Eli Lilly and China-based Innovent Biologics’ Tyvyt...The NHSA claims this makes the prices of these drugs the lowest in the world. Also, this agreements means big pharma and their drugs will have greater access to the world’s second largest pharma market because more Chinese citizens in smaller, more remote cities will be able to afford the drugs through their state medical insurance system...READ MORE

On Tuesday, May 12, Governor Gavin Newsom granted California’s 47,000 pharmacists the ability to order and administer coronavirus disease 2019 (COVID-19) tests throughout the state. His current objective is to test 60,000 California residents per day. After receiving a request for this expanded authority for pharmacists from the California Pharmacists Association, Newsom recognized that granting pharmacists the ability to test in the state would make that objective possible...READ MORE

Following the first approved Medicaid section 1135 waiver for Florida, the Centers for Medicare and Medicaid Services has approved 33 more waiver requests in the last 2 weeks....The waivers are intended to provide the states with relief during the coronavirus disease 2019 pandemic by providing states the flexibility to focus resources on managing the outbreak. Some waivers available under Section 1135 of the Social Security Act include temporary suspension of prior authorization requirements; extension of existing authorizations; modified timeline requirements for state fair hearings and appeals; and relaxed provider enrollment requirements to allow states to quickly enroll out-of-state or other new providers...READ MORE

The Trump administration issued a new rule that aims to prevent payments to Medicare and Medicaid fraudsters by boosting revocation powers and extending the time before troublesome organizations can rejoin the programs...The Centers for Medicare & Medicaid Services said that the final rule...marks a major turnaround from the agency’s normal approach of attempting to recoup fraudulent payments after the fact...“For too many years, we have played an expensive and inefficient game of ‘whack-a-mole’ with criminals⁠—going after them one at a time⁠—as they steal from our programs,”...READ MORE