Author: Peter

Centers for Medicare and Medicare Services is reportedly proposing to ban Theranos founder Elizabeth Holmes from owning or operating a laboratory for two years, along with revoking the license of Theranos' Newark, CA lab...Theranos had ten calendar days from receiving the notice to explain to CMS why the sanctions should not be imposed on Holmes and the company...The proposed sanctions stem from a number of key deficiencies CMS found in inspections last fall. Theranos had sent in a correction plan for the deficiencies but the regulator found it to be not credible.

Athletes who tested positive for meldonium before March 1 could have bans overturned less than four months before the Rio de Janeiro Olympics after WADA said it was unable to establish how quickly the drug...cleared the human body...The World Anti-Doping Agency's notice to national anti-doping bodies is expected to have a major impact on many of the 172 athletes who have tested positive for the performance-boosting drug since January...They include five-times grand slam tennis champion Maria Sharapova, who was among 40 Russian athletes to test positive for the drug after it was added to WADA's list of banned substances in January...In these circumstances, WADA considers that there may be grounds for no fault or negligence on the part of the athlete...adding that the presence of less than one microgram of meldonium in the samples was acceptable...The fact that WADA felt compelled to issue this unusual statement now is proof of how poorly they handled issues relating to meldonium...The Russian Sports Ministry supports and welcomes the decision made by WADA because it has shown a willingness to understand the situation, rather than stick to the rulebook...WADA has demonstrated impartiality and being objective in the fight against doping...

The Department of Health and Human Services has proposed allowing physicians to prescribe buprenorphine for twice as many opioid-addicted patients as they do now...Buprenorphine is a medication-assisted treatment for opioid use disorder, and certain physicians are permitted to prescribe or dispense the drug in their offices because it has low potential for abuse...Under current usage guidelines, physicians looking to prescribe and dispense buprenorphine must participate in training before receiving a special Drug Enforcement Administration number. Physicians certified to prescribe buprenorphine for opioid use disorder are currently permitted to prescribe it to up to 30 patients in their first year and then request authorization to prescribe it to up to 100 patients—a cap that HHS said "limits the ability of some physicians to prescribe to patients with opioid use disorder."...If the HHS proposal is adopted, then qualified and currently waived physicians will be able to prescribe buprenorphine for up to 200 patients.

Dr. John Alan Littleford, and three others were indicted by a federal grand jury in Denver last week on charges related to the illegal distribution of prescription medication and money laundering...Littleford...Dianna L Smithling...Stanley G. Callas and Scott Alan Eskanos were arrested this morning...defendants are alleged to have dispensed and distributed controlled substances to individuals in quantities and dosages that would enable the individuals to abuse, misuse, and develop or maintain dependencies or addictions to controlled substances. Littleford routinely wrote new prescriptions for opioids when the individuals for whom he was writing the prescriptions should have still had opioids left from a prior prescription...Callas and Eskanos knowingly filled these "early refill" prescriptions written by Littleford. The indictment specifically alleges unlawful distribution of controlled substances to seven individuals who presented as patients at the Pain & Injury Clinic and filled their prescriptions at Crown Point Pharmacy, Sky Ridge Pharmacy...The indictment alleges that Littleford’s unlawful distribution of Oxycodone to two of the individuals resulted in their respective deaths. Finally, the indictment alleges the defendants committed money laundering with the intent to promote the carrying on of their unlawful distribution of controlled substances.

Federal authorities have announced that they are reviewing the possibility of loosening the classification of marijuana, and if this happens, it could have a far-reaching impact on how the substance is used in medical settings...Marijuana is currently classified as a Schedule I drug, meaning it is listed alongside heroin and LSD as among the "most dangerous drugs" and has "no currently accepted medical use and a high potential for abuse."...The Drug Enforcement Administration announced last week that it is reviewing the possibility of reclassifying it as a Schedule II drug, which would put it in the same category as Ritalin, Adderal and oxycodone...There are thousands of people who are using medical marijuana for a whole host of medical conditions...where the efficacy has yet to be thoroughly studied...By changing the classification of the drug...researchers and doctors could find out how effective marijuana is in other conditions...We could move toward a more evidence-based use of medical marijuana... For too long schedule I status for marijuana has been a barrier for necessary research...

Biosimilar development in the U.S. appears to be gathering momentum, following the approval of Celltrion and Pfizer’s Remicade copy by the Food and Drug Administration in early April...The drug, marketed as Inflectra, is only the second biosimilar to clear regulatory review in the U.S., after Sandoz’s Zarxio in March 2015. But there are a number of other biosims entering late-stage development or with applications filed at the FDA... And with several blockbuster biologics nearing patent expiry, competition is likely to increase...Biosimilars promise to increase competition and lower prices across a number of other blockbuster biologics. They also represent new avenues of growth for companies seeking to enter previously protected markets...There is still a long way to go before biosimilars have anywhere near the market impact of generic drugs in the U.S...Biosimilars are still very much in early stages domestically...biosimilars look set to present a number of important opportunities and challenges to the U.S. biopharma landscape...

At the end of March, over 1,900 people convened in Atlanta, Georgia, at the National Prescription Drug Abuse and Heroin Summit, with attendees including advocates, clinicians, treatment providers, law enforcement officers and government officials…first time heroin was included in the conversation...The conference was put on by Operation UNITE…Of the many discussions held at the summit, the primary takeaways in continuing the fight against opioid addiction include:

1. Reduce Demand
2. Clinician Education
3. Holistic Approach
4. Collaboration

The Centers for Medicare and Medicaid Services has been letting patients grade their hospital experiences, and those "patient experience scores" may give some insight into a hospital’s health outcomes...Some people have been concerned that patient experience isn’t the most important factor to measure...Medicare has been putting a lot of data out for a long time, but the broad consensus has been it’s very hard for consumers to use this info...CMS responded by giving out star ratings that consumers can understand easily...The five-star rating system is based on patients’ answers to 27 questions about a recent hospital stay...If you use the star rating you’re more likely to end up at a high quality hospital...But I wouldn’t use only the star rating to choose a hospital...

...Office of the Actuary in the Centers for Medicare & Medicaid Services certified that the Diabetes Prevention Program reduces net Medicare spending and improves patient care...the Diabetes Prevention Program...enrolled Medicare beneficiaries at high risk of diabetes. The goal was to decrease the risk of developing serious diabetes-related illnesses...Over a 15-month period, Medicare estimated that participants in the program each saved $2,650...This program has been shown to reduce health care costs and help prevent diabetes, and is one that Medicare, employers and private insurers can use to help 86 million Americans live healthier...We are now working to determine the best strategies for incorporating the Diabetes Prevention Program into Medicare...

In the latest effort to push back against drug costs, the California legislature will hold a hearing on Wednesday to review a bill that would require companies to report any move to increase the list price of a medicine by more than 10 percent during any 12-month period. And drug makers would have to justify price hikes for medicines with a list price of more than $10,000 within 30 days of making such a move...The legislation, which would also require insurers to provide regulators with spending data on prescription medicines...The...bill "will bring prescription drugs in line with the rest of the health care sector by shedding light, for the first time, on those drugs that are having the greatest impact on our health care dollar," said state Senator Ed Hernandez...The Pharmaceutical Research and Manufacturers of America...in its own letter opposing the bill, argued that the reporting requirements are "extraordinarily broad" and would potentially apply to many drugs for which the impact of a price hike on insurance premiums would be "essentially" minimal and "would reflect an imperceptible change in the total cost of care."...BioCom maintained that the bill fails to require payers and pharmacy benefits to similarly disclose their reasons for increasing copayments, deductibles, and out-of-pocket expenses for consumers...