Today's News and Commentary

About pharma

Trump set to nominate Stephen Hahn as FDA commissioner, pending vetting process: “Hahn, an oncologist, is the chief medical executive at MD Anderson Cancer Center in Houston…The Trump administration’s decision goes against the advice of four former FDA commissioners and an array of advocacy organizations, all of which had called for [acting director Dr. Ned] Sharpless to be named the permanent agency head.”

340B allies rally Congress to ensure Pelosi drug price plan doesn't imperil discounts: House Speaker Pelosi’s Lower Drug Costs Act calls for the Department of Health and Human Services to annually select the costliest 25 drugs and negotiate a lower price. However, language in the bill also says that any drug subject to a negotiated lower price will “not be considered a covered outpatient drug subject to an agreement under … 340B.” Covered entities such as hospitals and Federally Qualified Health Centers are concerned that this provision will cause large income losses because their acquisition costs for those drugs will go up. (Read about the 340b program in Chapter 7 of the text.)

OptumRx Drug Pipeline Insights Report: Q3 2019-Five drugs in the pharmaceutical pipeline anticipated to make the biggest impact: The headline is self-explanatory.

Drugmakers considering to use Purdue bankruptcy to settle opioid lawsuits: reportOther drug makers involved in the opioid suits want to limit their liability by piggy-backing onto the Purdue Pharma settlements.

Drugstores are pulling Zantac-like heartburn drugs off the shelves over potential cancer risk: In addition to the manufacturer’s withdrawal, now retail stores are also pulling these H2 blockers.

About the public’s health

Integrating Social Care into the Delivery of Health Care: Moving Upstream to Improve the Nation’s Health: The national Academies of Sciences, Engineering and Medicine issued this report, whose purpose is explained in the headline. The summary goals are:

  1. “Design health care delivery to integrate social care into health care, guided by the five health care system activities—awareness, adjustment, assistance, alignment, and advocacy…

  2. Build a workforce to integrate social care into health care delivery… 

  3. Develop a digital infrastructure that is interoperable between health care and social care organizations… 

  4. Finance the integration of health care and social care…

  5. Fund, conduct, and translate research and evaluation on the effectiveness and imple- mentation of social care practices in health care settings…”

Bloomberg Philanthropies Announces $120 Million Reinvestment to Expand its Data for Health Initiative: Without data, we don’t know what or where the problems are. Here is the issue we need to address: “Less than half of all deaths around the world are registered with a cause given, meaning that 29.4 million deaths go unrecorded each year. This lack of data disproportionately affects low- and middle-income countries with 60% of these countries—representing 2 billion people—not reporting any data. In addition, the births of nearly 40% of the 128 million children born each year are not officially recorded, potentially denying the child access to healthcare, education and government services.” The Data for Health Initiative was started to correct this lack of data. “With today’s announcement, the total amount committed to Data for Health comes to $220 million.”

Unprocessed Red Meat and Processed Meat Consumption: Dietary Guideline Recommendations From the Nutritional Recommendations (NutriRECS) Consortium: Many media outlets have carried the story about lack of randomized controlled experiments that would lead to recommendations to reduce unprocessed red meat consumption. The link is to the original article. “The panel suggests that adults continue current unprocessed red meat consumption (weak recommendation, low-certainty evidence). Similarly, the panel suggests adults continue current processed meat consumption (weak recommendation, low-certainty evidence).”

Opportunity for States to Participate in a Wellness Program Demonstration Project to Implement Health-Contingent Wellness Programs in the Individual Market: CMS issued this bulletin calling for applications for demonstration projects for wellness projects. The bulletin is also a great summary of what is and is not allowed vis-a-vis incentives for participation in wellness initiatives, i.e., they must be non-discriminatory.

Marine Omega‐3 Supplementation and Cardiovascular Disease: An Updated Meta‐Analysis of 13 Randomized Controlled Trials Involving 127 477 Participants: Use of omega -3 fish oil to prevent heart disease has been controversial. This meta-analysis combines research with the largest patient population yet. The authors conclude: “Marine omega‐3 supplementation lowers risk for myocardial infarction, CHD [coronary heart disease] death, total CHD, CVD [cardiovascular disease] death, and total CVD…” There is also a dose-response relationship for benefit. However, other factors that also improve health cannot be ruled out. (See Chapter 3 in the text and on the Book tab).

Draft Recommendation Statement: Illicit Drug Use in Children, Adolescents, and Young Adults: Primary Care–Based Interventions: Does primary care counseling work to prevent illicit drug use in children, adolescents and young adults? Here is the draft recommendation for comment: “The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of primary care–based behavioral counseling interventions to prevent or reduce illicit drug use, including nonmedical use of prescription drugs, in children, adolescents, and young adults.” Perhaps the way it is done needs to be changed or we may also need a different combination of strategies.

The FDA approves a breakthrough treatment for the world's deadliest infectious disease — now what?: The FDA approved a breakthrough drug to treat TB. More money needs to be raised for the treatment, but even if available, there is still the problem of distribution (access). How can we get the drug where it is needed at a reasonable cost? What parts of the access equation need to be addressed (see Chapter 1 in the text and Book tab)?

About healthcare quality and safety

New round of Medicare Readmission Penalties Hits 2583 Hospitals: CMS announced the recent results of readmission bonuses or penalties. In summary:

  • “1,177 hospitals received a higher penalty than they did last year.

  • 1,148 hospitals received a lower one than last year.

  • 64 hospitals received the same penalty as last year.

  • 194 hospitals that had not been penalized last year are being punished this year.

  • The maximum penalty — a 3% reduction in payments — was assessed against 56 hospitals.

  • 372 hospitals avoided penalties in both years.

These figures do not include 2,142 hospitals that Medicare exempted from the program this year, either because they had too few cases to judge; served veterans, children or psychiatric patients; or were critical-access hospitals, which are the only hospitals within reach of some patients.”

CMS estimates the penalties will cost hospitals $563 million for the year.

About healthcare IT

VA bolsters medical info sharing with community care providers: Recognizing that many veterans receive care outside the VA system, the VA is adopting an “opt-in” policy of sending information (including electronically) to other providers. Veterans will now need to “opt out” if they do not want to share information. The problem of electronic interoperability still needs to be addressed.

Novartis, Microsoft ink deal to use AI to accelerate drug development : One of the latest partnerships in the field of using Artificial Intelligence to speed drug development.

RGENT/11 Cybersecurity Vulnerabilities in a Widely-Used Third-Party Software Component May Introduce Risks During Use of Certain Medical Devices: FDA Safety Communication: This article was perhaps the most cited by media outlets today. According to the FDA: “A security firm has identified 11 vulnerabilities, named ‘URGENT/11.’ These vulnerabilities may allow anyone to remotely take control of the medical device and change its function, cause denial of service, or cause information leaks or logical flaws, which may prevent device function.” Read the announcement for more information about the threats and appropriate actions.

About health insurance

Democratic chairman proposes new fix for surprise medical bills: Proposed methods for solving the problem of surprise medical bills have generated lots of controversy among affected stakeholders. Now, the Chair of the House Ways and Means Committee, Richard Neal (D-Mass) is proposing to
”essentially punt the details of the fix to a committee consisting of stakeholder groups and the departments of Health and Human Services, Labor, and Treasury. The committee would come up with recommendations that would then be issued in a regulation from the administration.
Neal's letter was first reported by Politico.”

CIGNA Expands Its Medicare Advantage [MA] Offerings and benefits While Minimizing Costs : This article is a press announcement, but there are three newsworthy items in it. First, is the cost: “plans in every market that feature a $0 premium and 89 percent of plans that have a $0 copay for primary care physician office visits. In addition, Cigna is maintaining or reducing premiums in 86 percent of its plans nationally compared to last year, and is offering plans that have no out-of-pocket costs for specialist care.” Second, is an expansion of benefits in line with what CMS has recently allowed. Finally, is plan design: “Cigna is launching its first-ever MA PPO plans in 43 counties…” Most MA plans are HMOs. It is likely other big players in this market, like United and Humana will match some of these initiatives.

About hospitals

The largest healthcare real estate projects announced in 2019: In the past few years, the number of large hospital construction projects decreased significantly compared to the first decade of the 2000s. The list of projects announced this year, amounting to about $700 billion, is a significant rebound for this sector.