26 Nov November 26, 2018

HHS Moves on Stark, Anti-Kickback Reforms; New Congress Wants More Health Care Changes

Health care providers of all types are urging officials to waive or roll back the requirements of federal fraud and abuse laws so they can join forces and coordinate care, sharing cost reductions and profits in ways that would not otherwise be allowed. From hundreds of letters sent to the government by health care executives and lobbyists in the last few weeks, some themes emerge: Federal laws prevent insurers from rewarding Medicare patients who lose weight or take medicines as prescribed. And they create legal risks for any arrangement in which a hospital pays a bonus to doctors for cutting costs or achieving clinical goals.  HHS officials are busy on developing significant Stark Law reforms, with a proposal expected soon.  Click here for more from the NYTimes.

• Looking ahead to the next Congress, those that are most likely to be chosen as committee chairs are set to dramatically change the focus in health care policy. For a brief overview, click here
• Sen. Bernie Sanders (I-VT) released a new bill last week that would require drug companies to lower prices to match prices from other countries or lose market exclusivity, very similar to the recently released plan by President Trump, click here for a bill summary, and here for the bill language.

Three Weeks into Open Enrollment, Sign-Ups Still Slow for ACA Marketplace Plans

CMS’ “snapshot” of weekly enrollment for the ACA insurance plans through Healthcare.gov are showing that sign-ups continue to significantly lag behind last year’s numbers. By Nov. 17th, 1.9 million people had signed up, down from the 2.3 million during virtually the same period last year. The agency also released a State-by-State snapshot of the enrollment showing that Florida has signed up the most customers by far, with nearly 490,000 individuals enrolling which is more than double Texas, which had the second most sign-ups through the first 17 days at just over 240,000. To view the more of the data on week three, click here.

• According to Kaiser Family Foundation, premium changes vary widely by location and level, including premium increases in a number of counties and plans, click here.
• Medicaid continues to be the largest health program in the United States as measured by enrollment, view the market analysis and trends, click here.

House to Vote on Bill to Create Public-Private Partnership to Identify Health Care Waste, Fraud, and Abuse

While Congress continues the lame duck session, the House is set to vote this week on a bill that will create a public-private partnership of health plans, Federal and State agencies, law enforcement agencies, health care anti-fraud organizations, and others to assist with detecting and preventing health care waste, fraud, and abuse. The bill (H.R. 6753), was passed out of the Energy and Commerce Committee in September and is sponsored by both the Chairman Greg Walden (R-OR) and Ranking Member Frank Pallone (D-NJ). The Strengthening the Health Care Fraud Prevention Task Force Act of 2018 is among several other minor bills to be voted on this week while the Democrats have their leadership elections. Click here to view the bill.

• HHS Inspector General warns pharmaceutical manufacturer Mallinckrodt against giving its H.P. Acthar Gel drug to hospitals for free to certain patients, because doing so “would present more than a minimal risk of fraud and abuse,” click here.
• HHS Inspector General found that in the second quarter of 2018, nine drugs met CMS’s price substitution criteria by exceeding the 5 percent over average manufacturer prices threshold for 2 consecutive quarters, click here.
• Senate report shows that Kaleo raised the price of Naloxone more than 600 percent between 2014 and 2017, which cost the federal government more than $142 million, click here.

Senators Warn Extreme Increase in Insulin Prices Will Hurt Diabetics

Sens. Susan Collins (R-ME) and Jeanne Shaheen (D-NH), Co-Chairs of the Senate Diabetes Caucus, warned insurers that a 240% insulin price increase over the last decade “could place an essential diabetes treatment out of reach for some Americans.” The Senators sent the warning in letters to the three largest insurance companies, United Healthcare, Anthem, and Aetna while requesting information on insulin prices and rebates. Specifically, the two Senators are looking for information on the role that insurance plans play in promoting affordable access to insulin products for people with diabetes. To view the letters, click here.

• Blue Cross Blue Shield report shows that spending on prescription drugs represents over 20 percent of overall healthcare spending for their commercially insured members, click here.

HHS Wants Help Fighting Antibiotic Resistant Bugs

HHS late last week released a request for information from the industry on efforts and strategies to combat Antibiotic Resistance. The request specifically comes from the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria which provides advice, information, and recommendations to the Secretary regarding programs and policies intended to support and evaluate the implementation of U.S. government activities related to combating antibiotic-resistant bacteria. Health officials are hoping to build upon previous work done by the Council as the CDC estimates each year more than 2 million people in the United States contract infections resistant to antibiotics, and at least 23,000 die. Public comments are open until Jan. 6. For more information on the Council, click here, to view the RFI, click here.

• CDC warns against consuming romaine lettuce do to an extensive E. coli outbreak across the U.S. and Canada, click here.

Walgreens and Humana Set to Form a Partnership

Drug store giant Walgreens Boots Alliance Inc and health insurer Humana Inc are in preliminary discussions to take equity stakes in each other, according to media reports. Back in June, the two companies partnered to operate senior-focused Humana primary care clinics inside two Walgreens stores in Kansas, this would be an expansion of that venture, among other options. To read the WSJ article (subscription required), click here, to read a synopsis by Reuters, click here.

 

Hospitals Cracking Down on Sales Reps in the Operating Room

Many hospitals across the country are beginning to put rules on medical device sales representatives in operating rooms and in some cases out-right banning them, but it is not for the reason that many would think, according to news reports. Hospital executives are leaving sales reps outside so that they will not encourage surgeons, especially orthopedic surgeons, to use more expensive products. While many within the OR claim that it is helpful to have the expertise on certain products in the room, such on the latest hip replacement or knee joints, when they are allowed the room, executives insist that sales reps can not attempt to sell products during a procedure. To read the full article, click here.

• The FDA boosted medical device inspections significantly over the past decade, leading to improved compliance from manufacturers, according to its Center for Devices and Radiological Health, click here.
• Hospitals are following drug makers lead and using TV spots to attract lucrative patients into their hospitals as health care costs and industry competition escalate, click here.

U.S. Infant Mortality Rates Downward Trend Stalling: CDC

The CDC says that the overall infant mortality rate in the United States did not change much from 2011 through 2016, after declining 10% from 2007 through 2011. The total infant mortality rate declined from 6.75 infant deaths per 1000 births in 2007 to 6.07 in 2011, but was relatively stable through 2016 at 5.87 deaths per 1000 births. The report also found that infant, neonatal, and postneonatal mortality rates continue to vary by maternal characteristics such as mother’s race and Hispanic origin and age. Neonatal mortality rates were highest among infants of non-Hispanic black women (7.41), while postneonatal mortality rates were highest among infants of non-Hispanic black (3.81) and American Indian or Alaska Native (3.93) women, and neonatal mortality rates were highest among infants born to women younger than age 20 and women  40 years and older. To view the CDC report, click here.

 

New Drug Could Be Promising Treatment for Children with Peanut Allergies
Peanut allergy sufferers may finally have an answer to the many time life threatening condition as Aimmune Theraputics conducts a three-phase test on their new peanut allergy drug. AR101 contains a peanut protein that will help patient build up tolerance against peanuts. The experiment showed that 67% of children were able to ingest at least 2 peanut kernels before side effects and about 50% were able to ingest at least 3 or 4 peanut kernels.  The results were less significant for adults, which suggest AR101 might only be efficient in children. The FDA will review the data to decide about approval of AR101. Click here for more.