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Centers for Medicaid & Medicare Services just released data on 2016's Medicare Part D plans…analysis reveals that 85% of Medicare Part D regional prescription drug plans will have a preferred cost sharing network in 2016…Preferred network plans are controversial (and generally disliked) by pharmacy owners. That’s because reduced pharmacy profits are the biggest source of cost savings from these networks. Despite ongoing complaints, it's still full speed ahead for preferred networks.

Senate passed legislation…intended to protect small and midsize businesses from increases in health insurance premiums…The bill,…eliminates a provision of the law that would have imposed tough, potentially costly new requirements on businesses with 51 to 100 employees…"This bill will make a helpful adjustment to the Affordable Care Act for small and midsize businesses by limiting potential premium increases and letting states determine what’s best for their market,"…

Pharmaceutical companies that make minor tweaks to brand-name drugs in order to blunt competition from cheaper generic treatments may be violating antitrust laws, the Federal Trade Commission said…known as "product-hopping," harms consumers who save billions of dollars each year through generic competition and undermines laws that allow pharmacists to automatically substitute brand-name drugs with low-cost copycats, …"Such conduct could deprive generic companies of their most efficient means of distribution -- automatic substitution at the pharmacy -- and, as a result, maintain the brand’s monopoly through illegal means,"

At its September meeting, the IACP Board of Directors unanimously voted to support a bipartisan Congressional letter,…demanding that the FDA withdraw its Guidance for Industry #230: Compounding Animal Drugs from Bulk Substances…. the letter points out that the agency does not have statutory authority to interfere with the state-regulated practice of veterinary medicine…the guidance attempts to create new regulatory authority without legislation to support that effort.

Senator Lamar Alexander…called on the government to delay Stage 3 final rules – and offered five reasons why…"The whole purpose of this program is to benefit patients, so that they and their health care providers have quicker and better access to their health histories and their doctors and hospitals and pharmacists can provide them with better care,"…"There is no reason not to take time to do it right."

1. Stage 2 is so onerous, in fact, that just 12 percent of physicians and 40 percent of hospitals have managed to successfully attest.
2. Penalties and bonus payouts under the new Medicare payment system are inextricably tied with meaningful use compliance.
3. Many leading medical institutions with the best electronic health records systems also recommend proceeding with caution.
4. A recent GAO report that shows that, in many cases, MU mandates are actually hindering electronic health record interoperability.
5. The HELP Committee has worked to develop seven areas for legislation to drive interoperability:

• Decreasing unnecessary physician documentation;
• Enabling patients to have easier access to their own health records;
• Making electronic health records more accessible to the entire health care team, such as nurses;
• Stopping information blocking
• Ensuring that EHR certification "means what it says it does"
• Improving standards
• Ensuring the security and privacy of patient records.

…changeover to ICD-10 medical diagnosis codes could complicate tasks in emergency departments…researchers...looked at more than 24,000 clinical encounters in the emergency room, they found that nearly a quarter could be assigned incorrect ICD-10 codes…also…27% of 1830 ICD-9 indicator codes commonly used by emergency physicians had convoluted mappings to ICD-10 codes that could pose problems for clinical documentation, reimbursement, disease reporting, and justifying hospital admissions…Depending on the analytic programs that the pharmacies use to predict how much medications to store and how complex the transition to ICD-10 is, pharmacies might have shortages of medications due to inaccurate reports and algorithms..

Millennium Health LLC is struggling to wrangle enough support for a debt restructuring plan that would allow it to settle a federal billing probe by a deadline this week,… Millennium is negotiating the terms for a bankruptcy filing at the same time that it’s finalizing a $275 million settlement of a federal investigation into its billing practices,..The Department of Justice has said it must have a plan to pay the sum by the end of this week…

We recently announced…Patient Engagement Advisory Committee …The Committee will provide advice to the FDA Commissioner on…issues relating to medical devices, the regulation of devices, and their use by patients…PEAC will bring patients, patient advocacy groups, and experts together for a broader discussion of important patient-related issues, to increase integration of patient perspectives into the regulatory process, and to help drive more patient-centric medical device innovation, development, evaluation, and access.

FDA is considering approval for an intranasal formulation of the opioid overdose antidote naloxone (Narcan). Naloxone has been the standard of emergency treatment for opioid overdose …only injectable formulations of naloxone are currently approved for use…FDA has granted priority review to Adapt Pharma’s naloxone...nasal spray, which was previously given a fast track designation…

In a letter to Health Secretary Jeremy Hunt on Thursday, the Coalition for Affordable T-DM1 said the government should grant a compulsory license for patents covering Kadcyla, or T-DMI (ado-trastuzumab emtansine)…allowing other companies to supply so-called biosimilar versions…As well as being rejected by NICE, from next month Kadcyla will also not be covered by the Cancer Drugs Fund…prompting Roche Chief Executive…to call Britain's drug system "stupid"…Issuing a compulsory license would put Britain on a collision course with the pharmaceuticals industry, something the government is unlikely to want given its desire to encourage life sciences.