Today's News

About the public’s health:

Here’s How Trump’s Shutdown Fight With Democrats Could Play Out: What happens to federal healthcare programs if a budget agreement fails? Nothing. Six government departments, including HHS are funded through September 30, 2019, i.e., the end of the next fiscal year.

Read about what will be affected by a government shutdown

Sustainability of Blood Pressure Reduction in Black Barbershops: Sometimes the best solutions are the most obvious and not exorbitantly costly. Researchers from Cedars-Sinai Medical Center placed pharmacists in 52 barber shops in LA County that cater primarily to African American men. Coordinating care with their primary care physicians, the pharmacists were able to significantly and sustainably reduce blood pressure of hypertensive participants compared with a control group.

About hospitals:

Ratings agencies: No immediate impact on hospitals' credit from Texas ruling: The debt-rating agencies are not changing their evaluations based on Judge O’Connor’s ruling on the ACA (see Sunday’s posting). One rater speculated about the financial repercussions from an increase in the uninsured because of removal of Medicaid expansion.
Medicaid is NOT part of the discussion. The 2012 Supreme Court decision already clarified this issue- Medicaid expansion is voluntary. Further, Medicaid expansion has nothing to do with the individual mandate.

Read more about this issue

About pharma:

FDA Approves Celltrion and Teva's Trastuzumab Biosimilar, Herzuma: This post is not a product endorsement but I use the occasion to act as a reminder that many very expensive biotech drugs are ending their patent lives and face generic competition. This one is a variant of Herceptin, used to treat HER2-positive breast cancer.

Read the announcement

About health insurance:

Taking Surprise Medical Bills to Court: How much does a patient have to pay for care they receive for non-elective services from providers outside their insurance’s network? Hospitals claim that patients owe whatever they are charged, less any insurance company payments. Now some lawyers are using principles from contract law to claim that patients should not have to pay these inflated charges. “…contract law rests on the centuries-old concept of ‘mutual assent,’ in which both sides agree to a price before services are rendered… Thus, many states require, and consumers expect, written estimates for a range of services before the work is done — whether by mechanics and plumbers or lawyers and financial planners.”
Since insurance regulations are state-specific, this tactic for addressing “surprise medical bills” will need to be used in each locality. Of course, laws can be passed in each state to address this issue.
Read more about this novel approach

8 Medicare and Medicaid reforms that would have the biggest impact on federal spending: This article summarizes the Congressional Budget Office’s suggestions for reducing federal spending by changes to Medicare and Medicaid. Among these changes are capping Medicaid spending and reducing matching amounts, and increasing Medicare eligibility to age 67. None of the suggestions are new, and none are probably politically feasible given each of their stakeholders’ interests. However, it is still informative to see how much could be saved with some bold bipartisan action.

Read the analysis

Gallup: 29 percent of Americans delay healthcare because of cost: Out of pocket healthcare costs still present problems for patients- even if they have health insurance. According to this report, “Gallup's annual Health and Healthcare survey found 29 percent postponed treatment for the cost. It said more than half of them reported a serious or somewhat serious medical illness or condition -- a figure equivalent to 19 percent of all U.S. adults.” How much should patients pay to prevent unnecessary utilization and defray premium costs while not impeding access to necessary care? THAT is the question most plaguing insurers and public policy experts. Should we do what France does and link coinsurance with severity of diagnosis? (For example, patients will pay proportionately more for seeing a doctor for a “cold” than a heart attack.) The answer is as much a social solution as a financial one.

Read the announcement

Health insurance on demand? Some are betting on it: I am still trying to understand this article. Here’s how the concept is described: “People with health insurance often pay for coverage they never use… A startup wants to shake that up. It’s a radical idea: On-demand insurance that lets customers buy some of their coverage only if and when they need it, similar to how TV viewers might rent a new release from Amazon instead of paying every month for a pricey cable package they rarely use… Here’s how it works. Under Bind’s [the name of the product] plan, customers pay a base monthly premium that can be as much as 40 percent cheaper than other options their employer offers, the company says.
That covers most care, like doctor visits, hospital stays, maternity care, cancer treatment and prescriptions.
A patient can then buy additional coverage for some procedures that aren’t urgent like a knee surgery or hip replacement. In these cases, the patient has time to plan for the care and look at different options for who performs it.
The additional coverage comes with an extra premium and possibly a copayment, depending on the care provider and what is being purchased. In these cases, patients might get stuck paying more than $1,000 in additional costs.”

My first comment is that it is insurance, not pay per view. Insurance’s purpose is to indemnify against catastrophic loss not provide on-demand entertainment. Second, how will they control for moral hazard- the principle that behavior changes in the presence of insurance coverage?

Read this article and make sense of it- if you can

Today's News

About insurance:

Health Law Could Be Hard to Knock Down Despite Judge’s Ruling: Comments are coming quickly about the ACA ruling discussed yesterday in my special weekend posting. Many legal commentators think Judge O’Connor erred in his logic in arriving at his decision declaring the ACA unconstitutional. I am concerned, however that inaccuracies are clouding these analyses. Two are noteworthy in this NY Times article. First, the article states that the “tax penalty was effectively eliminated when Congress reduced its amount to zero in the tax legislation enacted last year. “ This statement is factually incorrect. As my quotation yesterday notes, the penalty was not reduced to zero it was eliminated. This distinction is important since if a penalty amount (even zero) were still on the books it could be raised in the future and thus still linked to a mandate. The second error concerns Congressional intent when it repealed the penalty. Critics say that Congress did not intend to invalidate the whole law by this repeal. Two facts should give pause to this conclusion. First are the strong efforts by Congress in 2017 to repeal the ACA (remember Senator McCain’s thumbs down gesture that saved the law?) Second is the fact that the repeal of the penalty was part of a reconciliation bill- which can only change funding/tax provisions, NOT policy issues.
We will need to see where the inevitable appeal of the decision goes, For now, it is business as usual.

Read this NY Times article

CMS Report: Retail Drug Spending Slowed in 2017: The Office of the Actuary of CMS reported that drug spending grew by 0.4 percent in 2017 to $333.4 billion. Drug costs are about 10% of total healthcare spending. Recall that total costs are a function of price, volume and intensity (such as new technology-which can be either more or less expensive). The reasons for this slow growth are reduced volumes and increasing number of generics- both in the face of higher prices for branded drugs.
Read the announcement

Novartis weighs reinsurance tie-up to fund ultra-expensive drugs: Novartis is exploring a novel way to help customers pay for expensive new therapies- through purchasing reinsurance for the excess costs. While interesting, recall that insurance coverage is one reason healthcare expenses are so high. This problem was pointed out several decades ago by Professor Burt Weisbrod in his classic article The Healthcare Quadrilemma. We need solutions that decrease costs, not ones that provide a clever way to allow increasing them.

Read about this exploration in the Financial Times
Also read about it here (if you can’t access the Financial Times)

About pharma:

IFPMA Updates Ethics Code to Ban Gifts from Drugmakers: The International Federation of Pharmaceutical Manufacturers & Association called for a ban on gifts and promotional aids for prescription drugs in any country where its members operate. The strictness is exemplified by the fact that: “Providers can accept pens and notepads in the context of company organized events, but only as necessary to take notes during the meeting and without the names of any specific medicines.” It appears the rest of the world is catching up to American standards.

Read the announcement
Read the code

Centene wants its PBM to move from rebates to net pricing. That could be the new normal: Centene is now joining CVS and possibly other Pharmaceutical Benefit Managers to change its financial model. Insurers contract with PBMs to provide and manage their pharma benefits. PBMs make money in two ways: administrative charges and rebates/discounts from pharma manufacturers. These companies are now offering their customers predictable “net pricing, “ which means the customer (including patients) receive the benefits of the discounts and rebates the PBMs receive. This new method should enhance transparency- assuming the process is audited accurately and the results are made available.

Read about this change in pricing

About healthcare IT:

Docs don’t routinely report patient symptoms in EHRs: The title of this article was only one finding of the original study, but is very important. Many people with whom I have spoken who study this issue have pointed out that lack of symptom recording in medical records is a key reason for diagnostic errors. It is commonly held wisdom in medicine that if you ask the right questions, patients will tell you what is wrong with them about 80% of the time. We really need to talk to patients more and develop aids to recording their symptoms.

Read the report

Special Sunday Edition

US District Court Finds Affordable Care Act Unconstitutional

On Friday evening, Judge Reed O’Connor of the US District for Northern Texas issued a partial summary judgement and declared the personal mandate of the Affordable Are Act (ACA) unconstitutional. While the 55 page ruling has detailed legal reasoning, it is, on the whole very readable for non-lawyers. Here is the essence of the case and its decision:

The ACA was passed in 2010 with plans for most of its features (like the insurance exchanges and Medicaid expansion) to start in 2014. After passage, the National Federation of Independent Businesses filed a lawsuit against the federal government [NFIB v. Sebelius, 567 U.S. 519, 530–38 (2012)] claiming the law was unconstitutional. Two parts to the law were challenged- the Medicaid expansion requirement and the mandatory insurance requirement that was part of the creation of insurance exchanges. The case reached the Supreme Court in 2012.

The Medicaid provision required states to expand Medicaid or face withholding of all Medicaid funds. Regarding this provision , the Supreme Court found that it was coercive and thus struck it down. Medicaid expansion provisions remain but are not mandatory.

The insurance provision was the more contentious and ambiguous, and is the subject of the current decision. The focus was on the constitutionality of the mandate as it related to the Commerce Clause of the Constitution. This clause gives Congress the authority to regulate interstate commerce. However, it does not give Congress the right to compel commerce. Therefore, the plaintiffs claimed the mandate requiring everyone to heave health insurance was unconstitutional and not covered by the Commerce Clause. Chief Justice Roberts, in writing for the majority, issued an opinion that took many by surprise:
An individual who did not have health insurance was compelled to pay a fine to the US Treasury, the amount of which was linked to the offender’s income. The Internal Revenue Service was charged with collecting this fine as part of annual income tax payments. Therefore, this fine behaved like a tax. Because Congress has the right to levy taxes, the mandate was constitutional. Thus, the mandate and its “tax penalty” provision became linked.

On 12/22/2017, Congress passed Public Law No: 115-97.P- called the Tax Cuts and Jobs Act (TCJA) of 2017. Article VIII (Sec. 11081)--Individual Mandate states: “This section repeals the penalty for individuals who fail to maintain minimum essential health coverage as required by the Patient Protection and Affordable Care Act (commonly referred to as the individual mandate).” The idea thus arose that if the penalty (tax) is eliminated and the penalty was the reason for the constitutionality of the mandate (which still exists), then the law is now unconstitutional.

As a result of the TCJA repeal, attorneys general from the states of Alabama, Arizona, Arkansas, Florida, Georgia, Indiana, Kansas, Louisiana, Mississippi, Missouri, Nebraska, North Dakota, South Carolina, South Dakota, Tennessee, Texas, Utah, West Virginia, Wisconsin, as well as Governor Paul LePage of Maine and individuals Neill Hurley and John Nantz sued the federal government to invalidate the ACA. Joining the federal government as “Intervenor Defendants” were the attorneys general for the states of of California, Connecticut, Delaware, Hawaii, Illinois, Kentucky, Massachusetts, Minnesota, New Jersey, New York, North Carolina, Oregon, Rhode Island, Vermont, Virginia, and Washington, and the District of Columbia. Practically speaking it was a group of Republican states against a group of Democratic states and the federal government.

Three stances were put forth:
1. The plaintiffs claimed that because the penalty was inextricably linked to the mandate (which still exists) and because the mandate is an essential element of the insurance provisions, the whole law should be ruled unconstitutional.

2. The federal government agrees that the mandate is unconstitutional but claims that the rest of the provisions still apply. In other words, it is severable form the rest of the law. Recall that many Republicans ran on platforms promising that the preexisting condition exclusion in the ACA would be protected. If the Republican plaintiffs won their case, these protections would vanish.

3. The Democratic attorneys general disagreed with all the plaintiffs’ claims.

Judge O’Connor decided that the penalty was, indeed, inextricably linked to the mandate and that a ruling on the mandate could not be severed from its integral role in the law. Therefore:
”For the reasons stated above, the Court grants Plaintiffs partial summary judgment and declares the Individual Mandate, 26 U.S.C. § 5000A(a), UNCONSTITUTIONAL. Further, the Court declares the remaining provisions of the ACA, Pub. L. 111-148, are INSEVERABLEand therefore INVALID. The Court GRANTS Plaintiffs’ claim for declaratory relief in Count I of the Amended Complaint.” [Emphases and caps are the court’s.]

What happens now? Nothing as far as the insurance exchanges. This ruling will undoubtedly be appealed, at least by the Democratic attorneys general. Barring unforeseen circumstances, it is also likely bound for the Supreme Court- where two Trump appointees will add a new dimension to its proceedings. What about restoring the penalty? Highly unlikely with a Republican-controlled Senate and White House.

Stay tuned….

Today's News

About public health:

H.R.1318 - Preventing Maternal Deaths Act of 2018: Finally, Congress agrees about one issue. Today it passed this law, which amends the Public Health Service Act. Its purpose is “to develop surveillance systems at the local, State, and national level to better understand the burden of maternal complications and mortality and to decrease the disparities among population at risk of death and complications from pregnancy.” The bill goes to the president for signature.

Read the Act
Read commentary

About insurance:

Federal court blocks Trump administration's exceptions to birth control rule in five states: California, Delaware, Virginia, Maryland and New York sued the federal government to stop implementation of a religious conscience exemption for providing coverage of birth control. The US Court of Appeals for the Ninth Circuit found in the states’ favor to block the rule.

Read the news report
Read the decision

Average outpatient visit in US approaching $500: For once, we are not first in healthcare costs. The US ranked second between #! Switzerland and #3 Norway for the world’ highest average outpatient costs. But inpatient care is by far the highest here. At $22,500 it is about $7000 higher than #2 Switzerland. Why are our insurance costs so high? As many economists have said before: “It’s the process, stupid.”

Read more about this issue

Appeals court rules BCBS must face antitrust claims: Is the Blue Cross/Blue Shield Association guilty of anticompetitive behavior based on actions by member organizations in overlapping territories and excluding non-Blues plans? Not yet…but the “11th Circuit United States Court of Appeals denied an appeal from the insurance giant after a lower court ruled in April that BCBS must defend itself against allegations it engaged in anticompetitive behavior that violates the Sherman Antitrust Act of 1890.” Stay tuned.

Read more about this decision

About pharma:

Statement from FDA Commissioner Scott Gottlieb, M.D. and Director of FDA’s Center for Drug Evaluation and Research Janet Woodcock, M.D., on efforts to modernize generic drug labels while maintaining the efficiency of generic development: In the past, generic drug manufacturers could rely on the accuracy of the approved labeling (the “package insert” explaining uses and potential harms) of comparable branded drugs. However, due to successful litigation five years ago, these companies were held to be independently liable if the brand drug labeling was not sufficient to prevent adverse outcomes. The problem was that generic companies were not allowed to change the labeling- a “Catch-22.” So the FDA proposed a rule to allow them to do so. The FDA just withdrew the rule- citing potential increased costs that would be passed on to consumers and confusion if different generic versions of the same chemical entity had different labeling. The FDA claims that this change will allow generic companies to retain their legal shield against patient lawsuits.

Read the FDA announcement

Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s new strategic framework to advance use of real-world evidence to support development of drugs and biologics: The FDA has been moving to include “real world” data in decisions on both new drug approvals and modification of indications. This statement explains the latest program update.

Read the FDA announcement

Johnson & Johnson knew for decades that asbestos lurked in its Baby Powder: Starting about twenty years ago, lawsuits started appearing that claimed J&J’s Baby Powder cause mesothelioma- a rare cancer most often associated with asbestos. But the company denied that the talc-based product had any such toxic ingredients. Today, Reuter’s investigative reporting revealed that the powder did, indeed, contain asbestos and J&J covered up its knowledge of this contamination.. The stock price dropped about 10% at the close of trading.

Read the Reuters article

5 convicted in meningitis outbreak case; 1 acquitted:
Most medications come from highly regulated pharmaceutical facilities which must adhere to rules termed “Good Manufacturing Practices” or GMPs. Sometimes, however, physicians need specially formulated drugs. These products are created in what are called “compounding pharmacies.” Unfortunately, these pharmacies were not subject to GMP.
In 2014, a Massachusetts compounder sent steroid solutions to physician customers that was contaminated with fungus. These solutions were used to inject patients with back pain. The result was 76 patients died from meningitis and many hundreds were sickened. As a result of this case, regulations on compounding pharmacies were implemented. It was only yesterday, however that these convictions were handed down.

The story doesn’t end there, however. The real problem is that steroid injections for back pain do not meet criteria for evidence-based care. In other words, a contaminated drug was injected into patients for whom the treatment was not proven effective.

Read the announcement

About healthcare IT:

The 15 largest health data breaches of 2018: Breaches continue to plague healthcare companies as they strive for more interoperability, Here is the top 15 list for this year. The #1 spot goes to Charlotte, NC- based Atrium Health, affecting 2.6 million patients.

Read the full list

Eli Lilly and Evidation expand digital biomarker collaboration to data from smartphones and wearables: Data gathered from smartphones, wearable devices and voice data are to be used (with patient consent) to gather biodata that the drug company can use to modify and extend it products. For example, “Evidation's platform is being used by Lilly to analyze data from continuous glucose monitors, insulin pumps and real-world information to improve its diabetes offerings, toward the Big Pharma’s goal of building a connected ecosystem that includes an automated insulin delivery device and connected insulin pen.”

Read more about this collaboration

Report on Non-Device Software Functions: Impact to Health and Best Practices-December 2018; Submitted Pursuant to Section 3060(b) of the 21st Century Cures Act: When is software a device that the FDA regulates and when is it exempt? This issue was addressed by Section 3060(a) of the 21st Century Cures Act of December 13, 2016 (Pub. L. 114-255). This section specified that certain software functions were to be excluded from FDA review, but also mandated reporting about this issue every two years. This report is the first update. In general, such software falls into five categories: “(1) administrative support of a health care facility; (2) maintaining or encouraging a healthy lifestyle and unrelated to the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition; (3) serving as electronic patient records when not intended to interpret or analyze patient records; (4) transferring, storing, converting formats, or displaying data; or (5) providing certain types of clinical decision support to a health care provider unless interpreting or analyzing a clinical test or other device data.”

The “bottom line” on this report is that:  “In general, the analysis found more benefits than risks to patient safety and health related to these software functions.”

Read the full report

Today's News

About safety:
Physical and verbal violence against health care workers: When we talk about healthcare safety we most often refer to error prevention in patient care. But are healthcare workers safe? I came across this article and it has some astounding statistics about this problem, among them: “According to the Occupational Safety and Health Administration (OSHA), approximately 75 percent of nearly 25,000 workplace assaults reported annually occurred in health care and social service settings and workers in health care settings are four times more likely to be victimized than workers in private industry.”
Before we ask healthcare workers to assure patient safety we must make sure they are safe themselves.

Read more about this issue

About quality:

Framework for Effective Board Governance of Health System Quality: As the Institute for Healthcare Improvement (IHI) wraps up its annual meeting, it issued this report outlining how hospitals boards can be more involved with quality efforts. The document IHI issued states:
”Health system leaders and trustees are looking for greater depth and clarity on what they should do to fulfill their oversight of quality.” While the framework provides useful guidelines for what the board should do, its premise is flawed. Quality of care is the only subject that should ultimately matter when all other issues are considered. As such, quality efforts should start with the board; in other words, it should be a top down process with buy-in at all levels of the organization. In addition to board activities, the role of leadership is to create a culture that is conducive to quality improvement activities.

Read the framework

About pharma:

Warning, investors: Way too many drugs will be vying for market share in 15 diseases: Competition in pharma is great for patients and payers, but not so much for pharma companies. Biotech companies understand the large profits from successful drug launches; but what happens if many are coming up with solutions in the same disease categories? According to research by Leerink, “15 disease areas will become dangerously overcrowded over the next five years.” What are companies doing to prospectively target these categories to maximize their chances of coming out with unique products?

Read more about this category crowding issue

FTC Submits Comment on FDA Guidance Aimed at Deterring Abuse of Citizen Petition Process:
One technique pharma companies have used to delay generic competition is soliciting consumer comments against such introductions. The FDA has modified its approach to weighing these complaints and the Federal Trade Commission (FTC) concurs.

Read more about this issue

About insurance:

Social determinants of health pose challenges for most Americans, survey shows: As previous posts have mentioned, the healthcare field is finally realizing that addressing social determinants is necessary to improving health and controlling costs. The classic stereotype of someone whose needs require addressing is a poor or homeless person. But as this article points out, a new Waystar survey reveals “that 68 percent of Americans identified having challenges in at least one SDoH [social determinants of health] risk category. Of all patients in the ‘high risk’ segment, 60 percent have never discussed their issues with a provider or their insurance company.” The magnitude of this issue should now be apparent and represents a business opportunity to “do well by doing good.”

Read more about these findings

Measuring Progress: Adoption of Alternative Payment Models in Commercial, Medicaid, Medicare Advantage, and Fee-for-Service Medicare Programs: Policy makers and insurers tout their support for changing payments from volume-based to value-based. Despite some progress, this transition has been very slow. One way to encourage this change is through Alternative Payment Models (APMs), such as bundled payments or capitation. A recent survey of 226M Americans revealed that about 34% of payments were based on APMs- up from 23% two years previously. But the implementation of these methods is very uneven and range from about half of Medicare Advantage plans to about a quarter of Medicaid plans (commercial plans are at about 28%). What can we do to speed the change when many providers are lobbying against taking on risk arrangements?

Read more about this survey

ObamaCare sign-ups surge in final weeks but lag last year's numbers:
Updating yesterday’s post on this topic, enrollment is now down 12% from last year with two more days to sign up. There are many reasons for this decrease- some good (like many more people are employed and getting insurance from employers or are covered by expanded Medicaid programs) others not so good (like people opting out entirely because the penalty for not being insured was eliminated or choosing a “short term” policy instead).

Read more about the update on this issue

Study highlights long wait times in Canada under single-payer system. Does that make it a bad idea for U.S.?
The first comment about this article is that CANADA DOES NOT HAVE A SINGLE PAYER SYSTEM! This misconception is probably the single greatest mistake people make when comparing the US to our northern neighbor. Medicare is a single payer system- the federal government comes up with the money to pay for beneficiaries no matter where they reside. Canada’s system (called medicare- not capitalized) is structured closer to our Medicaid. Canadian provinces and territories receive, on average, only about 25% of their budgets from federal support. Further, those entities operate their own healthcare systems with coverage parameters set according to loose guidelines mandated by the federal law under Health Canada.

Now that this error has been corrected, we can move to the subject of the article. Each year the Fraser Institute conducts a survey on, among other items, health-related waiting times for Canadians. Results: they are longer than desired and longer than in the U.S. Why?
Recall that cost, quality and access are the three levers we can use to structure healthcare systems. Canadian provinces and territories, like other governments around the world, have budgets to which they adhere. Canada also has a culture of equity, e.g., the rich cannot buy their way to faster care in the Canadian system (though they can travel to the US and pay). Limits on cost and maintenance of quality mean access suffers; in this case, longer waits. In the US, we have mainly rationed care by presence, absence, or type of insurance coverage.
Now the big question: Are American’s ready, from a cultural standpoint, to adopt an egalitarian system with cost controls- regardless of how many payers there are?

Read more about this analysis

About information technology:

Draft Guidance Document - Pre-market Requirements for Medical Device Cybersecurity: Health Canada just issued this draft guidance on cybersecurity for medical devices. In view of many recent international “hacks” (such as the alleged Chinese action against Marriott) this problem has global dimensions. The problem is nicely framed in the announcement: “Medical devices have evolved from largely analogue, non-networked and isolated hardware to networked devices incorporating remote access, wireless technology and complex software. Increasing levels of interconnectedness and data exchange between medical devices can have significant benefits to both patients and the healthcare system but can also leave devices vulnerable to unauthorized access. These vulnerabilities can negatively impact safety by causing diagnostic or therapeutic errors, or by affecting clinical operations.” A multi-national approach to cyber safety will be required for connected devices to be truly safe.

Read the draft guidance

Trump administration seeks public feedback on how to fix HIPAA privacy rules: The Health Insurance Portability and Accountability Act (HIPAA) IT provisions deal with data standardization, privacy and security. The first aids interoperability while the latter two present potential obstacles. Further, healthcare providers claim (often incorrectly) that they cannot release information to aid care because of HIPAA concerns. In order to address these issues, the Office of Civil Rights (the federal agency responsible for enforcing HIPAA provisions) is now seeking public comments about problems that HIPAA is causing.

Read about this initiative

Today's News

Today is International Universal Health Coverage Day

About information technology:

Twelve States File First Multistate Healthcare Data Breach Lawsuit: The article title says it all. This case is the first time multiple states’ attorneys general are suing IT companies for HIPAA breaches. The case was filed in U.S. District Court for the Northern District of Indiana and involves four companies and 3.9million individuals.

Read more about this lawsuit

In overhaul of Healthcare.gov webpage, information about ways to apply is gone Much has been written about various attempts by the current federal administration to sabotage the ACA. This action is a new one. Two of the previously listed options — to enroll by phone and by mail — have been completely removed from the site. “These removals occurring well into the Open Enrollment period, after consumers may have already visited HealthCare.gov and decided to use one of these methods.”
Read more about this latest effort to make ACA enrollment more difficult

National Coordinator for HIT gives country C- grade on interoperability: National Coordinator for HIT Donald Rucker, MD gave the country a C- for interoperability, though he states some places earned an A while others flunked. The problem with this statement is that until everyone “gets an A” our healthcare system is not seamless and interoperable. In other words, in the larger scheme it doesn’t matter if I can talk to you without any problems, but can’t communicate well with half the other people in the country.

Read more on this statement

An Educational Intervention to Improve HPV Vaccination: A Cluster Randomized Trial: Sometimes low tech solutions prove to be the most effective. In an effort to increase HPV immunizations, parents in the exam rooms were given a tablet to watch a video outlining the risks and benefits of the vaccine. “Adolescents whose parents watched the video had a 3-times greater odds of receiving a dose of the HPV vaccine.”

Read more about this study

FDA clears Pear’s smartphone app therapy for opioid use disorder: More and more, apps are being used as adjuncts for treatment. If they are truly treatment applications and not just informational, they require FDA approval. According to this article: “The FDA has cleared its first prescription digital therapeutic for patients suffering from opioid abuse: a smartphone app designed by Pear Therapeutics to be used alongside standard-of-care medication-assisted treatments. Commercialization of the reSET-O app will be led by Novartis’ Sandoz unit and is expected to launch by the end of the year.”

Read more about this app 


About quality:

NCQA Launches New Population Health Management Programs: The National Committee for Quality Assurance (NCQA) released two new programs. “Population Health Program Accreditation assesses how an organization applies population health concepts to programs for a defined population. Population Health Management Prevalidation reviews health IT solutions to determine their ability to support population health management functions.”

Read the NCQA announcement for more details.

Screening for Ovarian Cancer-US Preventive Services Task Force Recommendation Statement: Screening tests for ovarian cancer have very high false positive rates. The good news is that if tests are negative, cancer can be ruled out with a high degree of certainty. So should we screen for ovarian cancer? The answer is still NO- at least in asymptomatic women without evidence of hereditary syndromes know to increase the disease.

Read more about the recommendation

IHI 2018: How to demonstrate the ROI on quality improvement projects: This week was the annual Institute for Healthcare Improvement annual conference.  
One constant question about quality is “how do you show its ROI?” This issue was addressed at this meeting drawing from experience from Britain’s National Health Service.

Read more about this issue.

About insurance:

Some Americans ditch Obamacare for cheaper alternatives: So-called short-term plans are becoming more popular for those who cannot receive premium support for Exchange plans. The reason these plans have lower premiums is that they may exclude benefits that Exchange plans are required to cover and, on average, have annual deductibles about $1700 higher. We won’t know the total enrollment for those plans for a while, but so far we do know Exchange enrollment is lagging about 8% behind last year. Signups end Friday- but there are extensions for those who logged in on healthcare.gov or contacted a live source but could not get through.

Read more about those signing up for these plans

Study: 4.2 million uninsured people eligible for free ObamaCare coverage: Continuing the same theme as the above article is the number of those who are eligible for free coverage.

Read more about this study

About human resources:

Financially Well Employees Buoy the Bottom Line: I have been reading about corporate initiatives for employee wellness over the past 6 months. One theme that consistently arises is employees’ concerns about their finances. According to a John Hancock study, 69% of employees are “stressed over their finances, leading to a range of behaviors that can cost companies approximately $2,000 in excess labor costs per employee. Most respondents (72%) admitted to worrying about personal finances while at work, with one-third doing so more than once per week.” The message here is that financial counseling is an important part of workplace wellness programs.

Read more about this study 

Today's News

About Medicare:

CMS Hospital Value-Based Purchasing Program Results for Fiscal Year 2019: In its shift to more value-based payments, CMS continues to reduce DRG payments and add potential bonuses by using measures from a Total Performance Scorecard. The metrics come equally from four areas: Clinical Care, Safety, Person and Community Engagement, and Efficiency and Cost Reduction. CMS estimates “that the total amount available for value-based incentive payments in FY 2019 will be approximately $1.9 billion.”

Read more from VMS about these payments


About public health:

Colorectal Cancer ControlWhere Have We Been and Where Should We Go Next?:
Screening for colorectal cancer (CRC) has been proven to save lives. The problem is getting the tests to patients and having them use the tests. The most common screen measures fecal blood (FBT). A meta analysis published in JAMA Internal Medicine sheds light on what needs to be done to increase screening rates. In an accompanying editorial, the conclusion is:
”We can now safely say that, in general, no more studies are needed to demonstrate that outreach with FBT and patient navigation* increase CRC screening. Instead, we need research in other areas of the CRC control continuum, including how best to implement evidence-based strategies and adaptations needed for different settings and populations, how to ensure follow-up after a positive CRC test result, what interventions increase adherence to ongoing CRC screening, and ultimately, what association CRC control programs have with CRC incidence, mortality, and health equity.”
* “Patient navigation is a barriers-focused intervention whereby a trained individual guides a patient through a complex health care system, addressing sociocultural, educational, and logistical barriers with the main goal of minimizing loss to follow-up.”

Now that we have workable strategies, they ned to be implemented.

Read the editorial analysis. 

2018 Update on Medical Overuse: Many services are overused or inappropriately used- leading not only to increased costs but followup with potentialy harmful interventions. This fifth annual review of the topic of overuse should be studied by healthcare policy, insurance and health system professionals to make sure patients receive exactly the care they deserve.

Read the article

About clinical studies:

Evaluating Progression-Free Survival as a Surrogate Outcome for Health-Related Quality of Life in Oncology: When evaluating an out of intervention, what measures are appropriate to gauge success? Sometimes we use actual endpoints, such as death rates. At other times we use surrogate endpoints, such as reduction of blood pressure or cholesterol. But the effect on surrogate endpoints does to always translate to actual endpoint results. In this literature review, the authors found that the “progression-free interval” after cancer treatment does not correlate well with measures of health-related quality of life. They argue that the latter measure is important and needs to be incorporated in discussions of the effectiveness of cancer treatments.

Read the article about use of these endpoints

About insurance:

Insurer-backed coalition forms to push efforts to stem 'surprise bills': If patients obtain care outside their insurance’s network of contracted providers, they can receive a bill that is multiples of what would have been paid. Since the care was not authorized, the patient often bears most of the cost. Nine major healthcare organizations have formed a coalition to combat such “surprise bills.” Their recommendations call on more federal intervention to implement protections. A few questions should be addressed first. What is the patient’s responsibility for knowing how their health plan works? What is the provider’s responsibility to know patient benefits? In cases of emergency care, providers cannot refuse care because of the patient’s insurance or lack of it (see EMTALA rules).
All would agree that the situation where patients absolutely need protection is during emergencies when they cannot reasonably ask all involved about their contracted status.
Precedent exists for this protection- from the start of Medicare risk plans (now called Medicare Advantage) health plans were able to pay hospitals using DRGs and physicians using the RBRVS (nationally determined fees modified for geography) if non contracted providers were involved in emergency care. While private insurance is regulated by states, perhaps the federal ACA can be amended to correct this deplorable practice.

Read more about this coalition

About healthcare trends:

Top health industry issues of 2019: PwC just issued its 13th annual report on projections in healthcare for the following year. Reappearing on this list is rising consumer demands for service quality like they expect in other sectors.


Read the report

Today's News

About pharmaceuticals:
Investigation of generic ‘cartel’ expands to 300 drugs:When is it not good to “play nicely in the sandbox?” If the sandbox is code for the the generic drug market and manufacturers are colluding to fix prices. Attorneys general from 47 states are suing at least 16 companies over anticompetitive behavior involving about 300 drugs.

Read more about these investigations

E.U. high court says Britain can unilaterally reverse Brexit, boosting pro-Europe campaigners:
What does Brexit have to do with pharma? Among other functions, the European Medicines Agency (EMA) approves all biologicals for the E.U. market. With Brexit in the works, the EMA is moving from London to Amsterdam. I anticipate some disruption in this transition that will slow drug approvals. If Britain reverses itself on Brexit, the EMA will probably still move to Amsterdam. Perhaps all this uncertainty will create a rush to approval by biotech companies before the separation,

Read more about the E.U. high court decision

What These Medical Journals Don’t Reveal: Top Doctors’ Ties to Industry:
Authors of medical journal articles are supposed to reveal any payments they receive from pharma companies whose products they mention in their studies. Despite this requirement, many prominent opinion leaders are not forthcoming with this information. The federal government has a website of physician payments form these companies- even as small as a lunch. However, most recent data is for 2017.
The questions that arise now are: Do we need stricter and more timely governmental reporting or can the private sector handle this problem?

Read more about this issue

About insurance:
CMS finalizes rule on the risk adjustment program for the 2018 benefit year: The ACA mandates that exchange health plans with healthier patients pay CMS; those amounts are used to compensate plans that care for sicker patients. The process is called “risk adjustment.” In February, a US District Court for the District of New Mexico issued a decision vacating the use of statewide average premiums as the basis for risk adjustments. Since then CMS has not acted on this program; but it has now issued its rules for this year. The decision is not permanent because litigation continues.

Read the CMS announcement

Read full details in the Congressional Record


Trump administration could leverage waivers for state CON law repeals:
The late Milton Roemer posited that “a built bed is a filled bed.” To avoid rising costs due to facility construction, federal and state governments enacted certificate of need (CON) laws. The federal government did away with them in the 1970s but thirty-six states and the District of Columbia still have CON laws in place. (Federal law still regulates physician-owned hospitals that want to construct or expand facilities.)
The federal government has issued a path for states to develop innovative insurance products- the 1332 waiver process. Apparently the process will be easier for states to get this waiver if they relax or repeal their CON laws/regulations.

Read more about the current status of state CONs and 1332 waivers


Studies Show Medicaid Expansion Is Improving Health, While Jury Still Out on Chronic Disease:
Many claims have been made about health benefits due to the ACA’s Medicaid expansion. This article summarizes the data on this topic. While many short-term metrics have improved (such as smoking cessation and earlier cancer diagnoses), benefits from the expansion have yet to be shown for chronic disease.

Read more about this issue


About technology:

Hospital Beds Get Digital Upgrade
: We have heard about “wearables” that can track respirations and heart rate, Now hospital bed manufacturer Hill-Rom has come up with a bed that does the same measurements up to 100 times an hour and be synched to an electronic medical record. These vital signs can save some patients from being disturbed when sleeping and free up nursing time. Like many of these “peripherals,” the system is open to hacking.

Read more about this bed

Today's News

About insurance:

The Cost of Employer Insurance Is a Growing Burden for Middle-Income Families: As healthcare costs (premiums and out-of-pocket payment) continue to rise, individuals and families are bearing greater financial responsibility. This study, by the Commonwealth Fund, details the changes for 2017, the most recent year available. Key findings include:

-Average premiums for employer health plans rose sharply in 2017. For example, family premiums rose $20,000 or higher in seven states and D.C. These increases resulted in higher employee contributions: ranging from $675 in Hawaii to $1,747 in Massachusetts for individual plans; from $3,646 in Michigan to $6,533 in Delaware for family plans.

-Overall, combining premiums and potential out of pocket expenses, meant that families spent 11.7 percent of median income on healthcare in 2017. 

Read the full report

National Health Care Spending In 2017: Growth Slows To Post–Great Recession Rates; Share Of GDP Stabilizes:
Some good news is slowing of the rate of growth of healthcare spending. However each percent increase comes on top of last year’s growth- think about compound interest. We will not make any progress in helping individuals and families with their costs (as explained above) until rates are negative: “Bending the growth curve” is good but we need to bend it down.
The overall findings of this study were: “Total nominal US health care spending increased 3.9 percent to $3.5 trillion in 2017, slowing from growth of 4.8 percent in 2016. The rate of growth in 2017 was similar to the increases between 2008 and 2013…”

The source of this study is Health Affairs, which requires a subscription. If you are not part of an academic institution that subscribes, it is worth purchasing.

Read more details about where costs are growing see also:
The NY Times report about this finding


About pharmaceuticals:
Drug Maker Pays $360 Million to Settle Investigation Into Charity Kickbacks: One technique pharmaceutical companies use to keep prices high and maximize reimbursement is providing patients with coupons to meet their out of pocket expenses. This practice results in insurance companies (or pharmaceutical benefit management companies- PBMs) footing the rest of the inflated charge. In a variation on this scheme, some companies set up non-profit foundations to help patients pay for the drugs pharma companies are selling. Actelion Pharmaceuticals (now owned by J&J) has agreed to a $360 settlement for such practices.

Read about the details of this case

AG’s Ask Supreme Court to Affirm States Power to Sue Drugmakers Over Misleading Labeling:
The big issue in these legal proceedings is whether states have powers to prosecute pharmaceutical companies (for actions such as misleading statements) or if federal laws and FDA actions not only have precedence but are the final words.

Read more about this issue

A Common Childbirth Drug Doubles in Price as Shortages Drag On: The law of supply and demand is one reason some drugs cost so much. In recent years there have been shortages due to such factors as natural disasters (like in Puerto Rico), plants being shut down for violations of Good Manufacturing Practices, and withdrawal from the market by companies who found certain products were not profitable. Sometimes these drugs are only benefit a few. Others are needed because of their common use.

Read here for more on this topic and

Here

Today's News

About Public Health:
41 Percent of Americans Do Not Intend to Get a Flu Shot this Season:
This finding creates an opportunity for social marketing experts to influence public health. Of course market segmentation is important to solving this problem since the reasons for not getting vaccinated vary as do intent by age group.Top reasons cited [for not being vaccinated]
were not expecting to get the flu, lack of confidence in efficacy of vaccine, and concern about side effects from the vaccine.” 62% of those over 60 plan to get vaccinated while only 31% in the group 19-29 plan to do so.
Read more about this problem

About Quality:
New CMS star ratings ignore socio-economic factors:
How can we have confidence in quality reports if they are not risk adjusted? Recent research studies have shown that such adjustments should not only be based on differences in severity of illness, but also include disparities in socio-economic factors of a hospital’s population. This article highlights the fact that CMS ratings, reported in hospitalcompare.gov do not adjust for those population characteristics.
Read more about this issue

About Genomics:
WHO looks at standards in 'uncharted water' of gene editing:
Many recent research projects have used gene editing to attempt treatment of patients with identifiable DNA abnormalities. In the past week, much discussion has occurred over a different kind of gene editing. Chinese scientist “He Jiankui said he used a gene-editing technology known as CRISPR-Cas9 to alter the embryonic genes of the twin girls born this month. He said gene editing would help protect them from infection with HIV, the virus that causes AIDS.” The use of anticipatory genetic manipulation to produce “superhuman” has raised many ethical concerns.
Read more about WHO actions on this issue
For more about this issue, read this editorial in Nature

FDA Recognizes First Human Genetic Variant Database: Continuing genetic news is the announcement that, for the first time, the FDA has recognized “a publicly available genetic variants database that can be used to support clinical claims in diagnostic tests.” The source of these data is ClinGen. Funded by the National Institutes of Health (NIH), its purpose is to build “an authoritative central resource that defines the clinical relevance of genes and variants for use in precision medicine and research.” 
Read about this announcement

About Medicare:
Carelinx launches home-care service for Medicare Advantage plans:
Picking up on yesterday’s report about Medicaid and Medicare expanded benefits, firms are already marketing themselves to health plans providing care to those beneficiaries. This article about one home care company illustrates this marketing opportunity.

Read about this company’s initiative as an example of this opportunity


Early Participants And Focus Areas In BPCI-Advanced: The Bundled Payments for Care Improvement (BPCI) Initiative is CMS’s attempt to control costs by paying one fee for many/all services related to an episode of care. When the program was launched, it was not known how many participants would choose this option for payment and which specialties/treatment categories would be involved. This article provides answers to both questions and offers guidance to those who seek information on competitive positioning and opportunities for partnerships in these areas.

Read more about participant specialties and disease categories they will cover


About Hospitals:

Moody's: US NFP [Not For Profit], public healthcare outlook to remain negative on flat to slightly down operating cash flow:
The outlook for these hospitals in 2019 is “negative,” according to this rating service. Moody’s gives two reasons for this projection: cash flow will be flat or decline by up to 1% and revenue growth will be hit by lower volumes and a rise in bad debt. This forecast should make hospitals more aggressive in lobbying for such measures as preventing neutral site payment changes (see yesterday’s blog).

Read the announcement



Today's News

About Benefits:
Americans Favor Workplace Benefits 4 to 1 over Extra Salary
: AICPA Survey American Institute of CPAs’s 2018 employment poll shows that “employed adults estimate, on average, their benefits represent 40 percent of their total compensation;” however, per the Bureau of Labor Statistics, the “benefits actually average 31.7 percent of a total compensation package.” The result of this perception is that Americans “would choose a job with benefits over an identical job that offered 30 percent more salary but no benefits.” Given this preference and the tax deductibility of healthcare benefits, further tax reform that reduces the deductibility of health insurance will be very difficult to implement.
Read more about this study

About Diabetes:
Management of Hyperglycemia in Type 2 Diabetes, 2018:
The management of diabetes has gotten much better in the past decade; however, improvements have introduced a new level of treatment complexity. From a business perspective, this complexity makes it difficult to predict healthcare costs. From a quality review perspective, the complexity likewise makes assessment of appropriateness of care more difficult. This article, from the American Diabetes Association, is the best current review of the subject and will be useful for clinicians and those who pay for and evaluate care.
Read these treatment evaluations and recommendations

Cost-Related Insulin Underuse Among Patients With Diabetes:
One quarter of patients on insulin who receive their care at the Yale Diabetes Center reported that they under-dose themselves (take less than recommended dose or decrease the frequency) or do not fill their prescription because of medication costs. This study highlights two principles. First, although out of pocket expenses generally reduce healthcare costs, these expenses can lead to reduced necessary care, resulting in longer term increased costs. Second, proponents for value-based care correctly posit that essential medications (like those for diabetes and hypertension) should be free from out of pocket charges.
Read this study on the effect of cost on insulin compliance

About Medicaid:
Mississippi Medicaid increasing visits to doctors’ offices:
This article is interesting from two perspectives. First, it highlights the variability of Medicaid benefits from state to state. This state is increasing the number of annual physician visits for which Medicaid will pay from 12 to 16. Second, the reason this change was made is that officials believe paying for more visits will result in more preventive care and save money.
Read more about reasons for this Medicaid expansion

About Health Insurance
Health Plans with More Restrictive Provider Networks Continue to Dominate the Exchange Market:
This finding by Avalere should not come as a surprise. When exchange plans are increasingly restricted from raising premiums and out of pocket expenses, and need to offer a fixed set of benefits (to comply with ACA requirements), the only tool they have left to control costs is offering more narrow network choices.
Read this study on restrictive networks

AHA, AAMC sue Trump administration over site-neutral payment rule:
The American Hospital Association and Association of American Medical Colleges are suing the federal government (CMS) because proposed payment changes would eliminate extra payments to hospitals. Services performed at hospitals (or facilities they own) are paid more than if delivered at other sites, such as a physician-owned office or surgical center. Hospitals claim they need to extra money to overcome inadequate payments from Medicare. However, Medicare beneficiaries end up paying more out of pocket for these higher charges. According to CMS, “site-neutral payments for clinic visits will lower out-of-pocket costs for beneficiaries and save the program as much as $380 million in 2019.”
Read more about this issue
Read the CMS payment rule

Trump administration looks to take Medicaid outside the doctor's office:
CMS is allowing medicare Advantage plans to offer extended and non medical benefits starting in 2019. Such benefits can include home-delivered meals and homemakers. Recognizing the health implications of these services, CMS is now looking at allowing Medicaid to offer such services.

Read more about this proposal

Reforming America’s Healthcare System Through Choice and Competition:
This report was issued as a result of a presidential executive order a year ago and is intended to spur competition and aid consumer choice and affordability. Among its more than fifty recommendations are proposals that would allow individuals to set up Health Savings Accounts with insurance products other than High Deductible Plans and allow for expanded use to permit payment for insurance premiums from those funds. Other recommendations range from removing restrictions on expansion of doctor-owned hospitals to enhancing cross-state physician licensure.

Read this (114 page) report

About Hospitals:
Are 'community benefit programs' enough to let nonprofit hospitals off the hook for taxes?:
Do hospitals (or any nonprofit) provide enough community benefits to justify their tax exemption? This question has existed for decades and is still being discussed. The ACA requires hospitals conduct community-based research to determine healthcare needs and develop plans to address them. Failure to do so (or if the plan is not acceptable to the HHS secretary), can result in loss of federal tax-exempt status. State and local exemptions are very variable. This article discusses calculation of net community benefit- at least in monetary terms.

Read more about nonprofit hospitals and whether they provide enough community benefit

About Telemedicine:
Virtual Visits Partially Replaced In-Person Visits In An ACO-Based Medical Specialty Practice: This study of telemedicine use at t a Massachusetts-based ACO found that “the use of virtual visits reduced in-person visits by 33 percent but increased total visits (virtual plus in-person visits) by 80 percent over 1.5 years.” This finding has been seen before and questions the hype over telemedicine as one cure for healthcare costs. This increased volume has two implications. First, it can mitigate the cost savings from replacing in-person with virtual visits. Second, if healthcare professionals have to field an increasing volume of encounters, telemedia may make accessibility worse.
Read this telemedicine study


About Technology:
Statement from FDA Commissioner Scott Gottlieb, M.D., on how modern predicates can promote innovation and advance safety and effectiveness of medical devices that use 510(k) pathway:
Medical devices are often approved using the so-called 510(k) pathway. This process allows low or medium risk devices to get speedier approval if they can compare themselves to an already-approved similar product (called a predicate). The problem is that many of these newer devices compare themselves to predicates that are more than 10 years old and hence have further developed their technology. In a major revision of approval process, these newer devices must compare themselves to predicates less than 10years old.

Read more about this proposal

About Healthcare IT:
Strategy on Reducing Regulatory and Administrative Burden Relating to the Use of Health IT and EHRs:
The healthcare community has come to terms with the fact that electronic health records have added to the time and cost of documenting encounters. In an attempt to remedy these problems, The Office of the National Coordinator (ONC) issued this document to address four issues: (1) Clinical Documentation; (2) Health IT Usability and the User Experience;
(3) EHR Reporting; and (4) Public Health Reporting. The recommendations are open to comment until 1/28/19.
See the document for details and where to send comments.

About Quality:
AHIP, CMS, and NQF partner to promote measure alignment and burden reduction:
America’s health Insurance Plans, CMS and National Quality Forum have formalized their commitment to The Core Quality Measures Collaborative (CQMC). The CQMC "is a multi-stakeholder, voluntary effort created to promote measure alignment and harmonization across public and private payers.” In other words, the purpose of this collaborative is to reduce confusion and duplication among measures used by different evaluation entities. Core measures cover ACOs and patient centered medical homes as well as seven clinical areas. However, “It’s important to note that CQMC has not developed any payer’s exact measures, but rather a ‘parsimonious set of measures’ that they can use as a springboard within their individual quality improvement programs, explained Danielle Lloyd, AHIP’s senior vice president of clinical affairs.” What this caveat means is that the general measures will be similar but exact reporting requirements will still be different. Until quality measures are truly harmonized. the cost of gathering and reporting them will remain an impediment to assessment of care.

Read comments about this announcement