About medical devices:
House Committee Introduces Five-Year Medical Device Tax Delay: I do not usually write about pending legislation or announcements about individuals making proposals. However, this article is a reminder that the medical device industry has a special place in the healthcare field. This sector was the only significant one that lobbied against passage of the ACA and has continue to challenge it. As a result, devices were hit with the highest taxes- 2.3%. By comparison, other sectors were assessed flat amounts lower than that percentage. The continued lobbying seems to have paid off. “The 2.3 percent tax has been subject to several moratoria since its passage in the Affordable Care Act in 2010, including a two-year delay extension as part of a continuing resolution in early 2018. The new bill would extend the delay until December 31, 2024.”
GE Files Confidentially for Health IPO, Buoying Stock: In its continuing effort to restructure after a significant slump in market value, the conglomerate seeks to shed its healthcare business in an IPO. The new enterprise value, including debt, could be about $65-70 billion.
Statement from FDA Commissioner Scott Gottlieb, M.D., and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on new steps to promote innovations in medical devices that help advance patient safety: The FDA has encouraged development of innovative devices that are significant improvements over those on the market or are new breakthroughs. Now, it finalized its guidance to promote devices that are not better per se, but improve safety. The initiative is called the Safer Technologies Program, or STeP.
Read the statement about this program
About pharma:
Pfizer, Glaxo to Create Over-the-Counter Drug Giant: Many pharma companies used to sell consumer products, like toothpaste, mouthwash and chewing gum. In more recent years, they have narrowed their focus to medications. Now companies are refining their offerings further to branded pharmaceuticals and vaccines. Continuing this trend, drug giants Pfizer and Glaxo are creating the world’s largest over-the-counter medicines business,, which last year had combined sales of $12.7 billion.
Read the article
Cleveland Clinic, Kaiser Permanente throw support behind proposal to require prices in TV drug ads: While transparency in healthcare costs is obviously beneficial, it ceases to have value when it obfuscates more than it enlightens. Drug prices vary widely due to factors such as insurance coverage, the pharmacy where the prescription is filled, and geography. Also, the price does not take into account the total cost of care. For example, some medications are more expensive but are less likely to require add-on drugs to achieve a therapeutic effect. Further, some drugs require less monitoring with office visits or lab tests and are thus cheaper overall than less costly alternatives. Adding a ”your costs may vary” statement to the ads is not honest or helpful. Let’s reveal true costs only when they are known.
Read the article
Embracing the future of work to unlock R&D productivity:This ninth annual study by the Deloitte Centre for Health Solutions has some bad news fo biopharma companies. Analysis of 12 large cap firms found that R&D returns " declined to 1.9 per cent, down from 10.1 per cent in 2010 - the lowest level in nine years.” Reasons for this decline are both reduced sales and higher expenses. It now costs $2.17 billion to bring a drug to market.
About hospitals:
Adverse Events and Patient Outcomes Among Hospitalized Children Cared for by General Pediatricians vs Hospitalists: Do hospitalists provide higher quality and more efficient care than the primary care physicians they replace in the inpatient setting? Many studies question the overall value of this relatively new specialty. But those studies were done looking at adult patients. If children are hospitalized, they can be much sicker than adults This study looks at pediatric hospitalists and comes to the conclusion that: “General pediatrician and hospitalist inpatient care had similar length of stay, total costs, and readmission rates. However, AEs [adverse events] differed between hospitalists and general pediatricians, with device-related AEs more common among hospitalists, which may be associated with hospitalists’ fewer years in practice.”
Read the study or
If you cannot connect to the above link, read a summary here
Medicare Program: Accrediting Organizations Conflict of Interest and Consulting Services; Request for Information: About a year after the Wall Street Journal reported that The Joint Commission did not remove accreditation from hospitals with significant quality problems, CMS has issued a request for information asking about conflicts of interest for accrediting organizations who also provide consulting services . “This request for information (RFI) seeks public comment regarding the appropriateness of the practices of some Medicare-approved Accrediting Organizations (AOs) to provide fee-based consultative services for Medicare-participating providers and suppliers as part of their business model. We wish to determine whether AO practices of consulting with the same facilities which they accredit under their CMS approval could create actual or perceived conflicts of interest between the accreditation and consultative entities.”
Read the RFI and
More background about the request
About insurance:
I read 1,182 emergency room bills this year. Here’s what I learned: Sarah Kliff has been writing on Vox about the crazy emergency room bills that readers have sent and she has investigated. [She was a guest speaker at Northwestern recently and I had a chance to meet her. Hear her if you can.] This article summarizes her findings and is well-worth reading. It epitomizes many of the problems with our healthcare system and should make you angry. Think about what you can do about them. For starters, if you think the bill is outrageous or erroneous and cannot get a resolution form the providers of care, file a complaint with a state agency, such as the department of insurance. That action also gets the insurance company involved and often leads to accomodations.
A Path to Incremental Health Care Reform: Improving Affordability, Expanding Coverage, and Containing Costs: This Urban Institute policy study recommends four “scenarios” to achieve the article title’s goals.:
“Scenario 1: Restore 2016 ACA policies. Reinstate the ACA’s individual mandate penalties and cost-sharing reductions and prohibit the expanded availability of short- term, limited-duration (STLD) plans.
Scenario 2: Expand Medicaid eligibility in all remaining states….
Scenario 3: Improve marketplace financial assistance…
Scenario 4: Reduce nongroup market premiums and out- of-pocket costs. Cap provider payment rates paid by insurers in nongroup insurance markets at levels somewhat above Medicare levels.”
However, these measure are not all cost-saving. Implementing Scenario 1 will reduce the number of uninsured by 2.2 million and reduce federal spending by $11.4 billion. If all four measures are put in place 12.2 million more people would be insured, but at an increased federal cost of $119.2billion.
Read the policy statement
Characteristics of Physicians Excluded From US Medicare and State Public Insurance Programs for Fraud, Health Crimes, or Unlawful Prescribing of Controlled Substances: One of the major causes of waste and diminished quality is the category of “fraud and abuse.” This study examines the prevalence among physicians and identifies characteristics of those more likely to engage in these activities:
” In this cross-sectional study assessing all physician exclusions from 2007 to 2017, the number of physician exclusions grew by 20% per year (equivalent to 48 additional exclusions per year) to encompass approximately 0.3% of US physicians in 2017. Exclusions were more common in the West and Southeast census regions, and male physicians, physicians with osteopathic training, older physicians, and physicians in specific specialties (eg, family medicine, psychiatry, internal medicine, anesthesiology, surgery, and obstetrics/gynecology) were more likely to be excluded.” Despite these findings, claims reviews, not physician characteristics will be the principle way these problems are discovered.
Read the study.
If you cannot access this study, read more about it here.
December 2018 Health Sector Economic Indicators Briefs: The Healthcare Price Index growth has finally dipped below the inflation rate: 1.5% versus 2.0%, respectively. The study by Altarum also showed that the national health spending growth estimate for 2017 was down from 4.7% to 3.9%.
Read the report
The public’s health:
Christmas, national holidays, sport events, and time factors as triggers of acute myocardial infarction: SWEDEHEART observational study 1998-2013: Relax, it’s Christmas! In this multi-year Swedish study, researchers found the highest risk for heart attack was at Christmas- even greater than major sporting events like the World Cup. Maybe the Swedes are not so “chill” after all. Happy Holidays!
Advance Care Planning in Older Adults With Multiple Chronic Conditions Undergoing High-Risk: Years after recognition of this problem, advanced directives are still underutilized. This study is one of many updating the need for this important documentation. I am quoting some conclusions since this article may only be available to subscribers of the journal. “Among a cohort of 393 older adults with multiple chronic conditions who are undergoing high-risk surgery, 101 (25.7%) had preoperative ACP documentation, including only 17 of 55 decedents (30.9%). Yet in a prior study, 52% of surgeons self-reported having had preoperative ACP discussions. High-risk populations in this study, including patients 85 years and older, those with dementia, and those with greater health care use, were more likely to have ACP documentation.”
Read the study
Nearly 40,000 People Died From Guns in U.S. Last Year, Highest in 50 Years: Res ipsa loquitur.