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China said...it was relaxing drug laws to give greater leniency to people who import small amounts of medicines unapproved in China but sold legally overseas...Under the previous law, such drugs were classified as “fake drugs”. Those caught importing unapproved medicines were considered drug smugglers and faced heavy penalties...The change is part of wider revisions to drugs laws and authorities said it recognized how some Chinese, unable to afford expensive foreign-made, brand-name drugs, were turning to the grey market to buy cheaper generic versions that had not been approved by local regulators...READ MORE

The Trump administration released a final rule...that boosts Medicare payments to rural hospitals in a bid to address major inequalities...The rules included an increase to the wage index for certain low-wage hospitals such as those in rural areas..."The changes we’re finalizing in today’s rule are long overdue and improve the way Medicare pays hospitals, which will help many rural hospitals maintain their healthcare labor force," CMS Administrator Seema Verma...READ MORE

A Canadian advisory council studying prescription drug coverage said...the federal government should create a C$15.3 billion ($11.5 billion) universal, single-payer public pharmacare system, and warned that the current system requires a major overhaul...Canada is the only country with a universal health care system that does not include universal coverage for prescription drugs. Most prescriptions are paid for through employer-funded drug plans, while some are covered by government programs for the elderly, or people with low incomes or very high costs...If implemented in full, the plan would likely cut into profits of insurers and drugmakers in Canada, while saving employers and patients money...READ MORE

In a cut-throat, protectionist sort of way, it makes sense that Nevada’s existing medical providers want to handicap new competitors. But that doesn’t mean elected officials should be doing their bidding...Elite Medical Center provides hospital and emergency room services near the Strip. It’s a small facility trying to fill an overlooked niche in the market — tourists. It treats an average of 30 patients a day. It boasts that patients see a doctor within minutes of arrival...Most Las Vegas residents would likely have never heard of it, except its competitors keep attacking the facility. Other hospitals are upset that Elite Medical Center doesn’t accept Medicaid and Medicare as payment methods...But why would hospitals care if a competitor didn’t accept certain payment methods? That would seem like an opportunity to lure those customers...The medical field needs innovation. Nevada won’t get it by stifling providers who dare to do things differently...READ MORE

Medicare and Medicaid will cover CAR-T cell therapies...a decision that helps address, but doesn't fully solve, the reimbursement challenges that have hampered uptake of the pricey cancer drugs...One major hang-up is reimbursement. Kymriah costs $475,000 for pediatric and young adult patients with leukemia and both therapies are priced at $373,000 to treat lymphoma in adults...Under regulations published this month, Medicare will reimburse at least 65% of the treatment's cost, or about $242,000, through Part B...That will give hospitals surety they will receive payment for the drug, yet doesn't necessarily make whole the full cost of treating a patient with CAR-T. The cell therapies are also still reimbursed via billing codes for bone marrow and stem cell transplants, rather than using a separate identifier...READ MORE

The White House will withdraw a controversial plan to ban drugmaker rebates to pharmacy benefit managers in Medicare and Medicaid, stepping back from what the administration had once billed as "the most significant change in how Americans' drugs are priced at the pharmacy counter."..."Based on careful analysis and thorough consideration, the President has decided to withdraw the rebate rule...noting ongoing discussions about potential legislation around drug pricing...Drugmakers had supported the proposed rule, which fit with pharma's public relations campaign attacking the role played by PBMs in keeping drug costs high...READ MORE

Illicit chemical knock-offs of the extremely potent opioid fentanyl would be put permanently in the same legal class as heroin to boost prosecutions of traffickers and makers of the drugs, under a proposal to be unveiled...by the U.S. Drug Enforcement Administration...The new classification is meant to help fight a proliferation of chemical look-alikes of fentanyl, known as analogues...DEA Acting Chief Operations Officer Greg Cherundolo is set to go before a Senate committee...to propose that Congress make the measure permanent so that cases against various analogues will not be undercut when the temporary ban lapses...READ MORE

...Centers for Medicare and Medicaid Services...said it has finalized a decision to cover expensive cancer cell therapies sold by Gilead Sciences Inc and Novartis AG...CMS...said it will cover the U.S. Food and Drug Administration-approved therapies when provided in healthcare facilities that have programs in place to track patient outcomes...The nationwide decision clears up “a lot of confusion” about coverage and will help patients get access to the novel therapies...CMS Administrator Seema Verma said...READ MORE

The FDA has tied the contamination of blood pressure drugs by probable carcinogens to an approved switch in manufacturing to a process that uses certain solvents. Now an online pharmacy says it has discovered the solvents are as bad as the impurities they have been creating and has criticized the FDA for not taking steps to limit their use...In a citizen petition...Valisure says the FDA has established acceptable limits for impurities such as those commonly known as NDMA and NDEA after they were discovered in heart drugs last year, leading to massive global recalls...But it claims the FDA has not lowered the acceptable level for the solvent DMF, although it “has become apparent that the switch in the manufacturing industry to the use of the DMF solvent may be largely responsible” for the appearance of the impurities in the U.S. drug supply...The petition says the FDA needs to investigate the use of the solvent N,N-Dimethylformamide in drug manufacturing since it is classified as a Class 2 carcinogen...READ MORE

The Canadian government has assured the pharmaceutical industry that new features of its plan to cut drug costs would apply only to new medicines, Health Canada said…The new features of the government’s proposed regulations, which would take into account cost-effectiveness of medicines and their likely impact on government budgets, would be limited to new drugs, Health Canada told Innovative Medicines Canada and BIOTECanada, the patented drug industry’s main lobby groups...The original cost-benefit analysis estimated the new regulations would cost drugmakers C$8.6 billion ($6.4 billion) over 10 years. As an alternative to the proposed changes, drugmakers offered to voluntarily give up C$8.6 billion in revenue over the same period...Exactly how much the new rules will reduce prices depends on implementation details that have not yet been decided...READ MORE