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April 1, 2019

Administration Seeks to Repeal ACA, Republican Leaders Back Away, Democrats Move Legislation To Strengthen It
The Trump Administration has announced it would support a court ruling in the case of Texas v. Azar that declared the Affordable Care Act unconstitutional and should be scrapped. Meanwhile, House Democratic Leadership unveiled a draft bill that seeks to lower health care costs for people who get insurance coverage through the federal and state marketplaces. The main objective of the bill is to protect coverage for pre-existing conditions and increase the financial assistance people receive under the ACA. The bill would also strengthen the tax credits that help marketplace enrollees within a certain income level afford their monthly premiums and would raise the income level threshold for qualifying for those subsidies. Click here for a detailed summary of the ACA litigation, here to view the Democratic draft, and here for the Committee summary.  President Trump says the case “will probably end up in the Supreme Court,” click here.  Hill Republicans are backing away from any effort to repeal and replace Obamacare, click here.
  • The Health Subcommittee of the Energy and Commerce Committee approved several additional bills to strengthen the ACA. Click here for Chairman Pallone’s briefing memo; click here to review all amendments offered and final disposition.
  • In an op-ed piece last week, CMS Administrator Seema Verma makes the case against “Medicare-for-All,” click here.
  • A new report from the Urban Institute finds that full repeal of the ACA in 2019 would result in an increase in uncompensated care and a decrease in federal healthcare spending, click here.
  • Sign-ups for ACA plans fell by three percent in 2019 during open enrollment, according to CMS’ final enrollment report, click here.
Court Rules Administration’s Association Health Plan Rule Unlawful
The U.S. District Court for the District of Columbia ruled late last week tha the Administration’s plan to expand association health plans oversteps the administration’s authority under the Employee Retirement Security Income Act. The rule, which was finalized last summer, would allow employers to join or form AHPs and purchase insurance on the large group market. The rule did not require these plans to meet ACA standards, leading critics to describe them as “junk plans.” The Judge declared that the rule is a deliberate and illegal “end-run” around the federal health care law. The case was brought about by 12 states last July shortly after the rule was finalized. To view the ruling, click here. The House Education and Labor Committee is schedule to hold its first hearing on the issue this week.

Analysis Looks at Prevalence of Surprise Billing by State and Specialty
The Health Care Cost Institute recently reviewed commercial insurance claims of almost 620,000 in-network inpatient admissions and all associated professional claims across 37 states and the District of Columbia in 2016 to determine prevalence of surprise billing. They found a wide variation from state to state with Florida patients seeing the worst rate at 26% of hospital admissions ending with an out-of-network bill and Minnesota with the lowest rate of surprise billing, at less than 2%. Additionally, HCCI found that anesthesiologists were the biggest offenders by sending more of these bills than any other specialty, followed by primary care and emergency medicine. Click here to review all the data.

CMS Made Nearly $28 Billion in Improper Payments through Medicare and Medicaid in 2017
The Government Accountability Office found that due to little or no documentation, CMS made more than $23 billion in improper payments through Medicare and $4.3 billion through Medicaid in fiscal year 2017. CMS estimates improper payments, in part, by conducting medical reviews, reviews of provider-submitted medical record documentation to determine whether the services were medically necessary and complied with coverage policies.  Payments for services not sufficiently documented are considered improper payments. In recent years, CMS estimated substantially more improper payments primarily due to insufficient documentation. GAO recommended that CMS assess and ensure the effectiveness of documentation requirements, and that the agency take steps to ensure medical reviews effectively address causes of improper payments and result in appropriate corrective actions. To view the report, click here.

First Drug Ad to Feature Price Started Airing Last Week
Following a Trump Administration rule requiring pharmaceutical companies include the price of drugs, Johnson & Johnson started last Friday with a TV commercial for its bloodthinner Xarelto. The ad, a version of which has already been on the air without mentioning price, will now end by briefly showing its list price of $448 a month. Additionally, the commercial states that most patients pay between zero and $47 a month, depending on insurance coverage and eligibility for financial-assistance programs which about 75% of patients pay within that range according to J&J. Click here for more.

  • Sen. Rick Scott (R-FL) introduced the Transparent Drug Pricing Act of 2019 that would stipulate that drug companies cannot charge U.S. consumers more for prescription drugs than customers in “other industrialized nations” such as France and Germany, click here.

CMS Announces More Flexibilty To TAVR Policy
CMS has proposed to update its national coverage policy for Transcatheter Aortic Valve Replacement (TAVR), a procedure for a condition known as “aortic stenosis” in which the heart valve that propels blood from the heart to the rest of the body becomes narrowed. Under the coverage proposal announced last week, CMS would continue to cover TAVR under CED when furnished according to an FDA-approved indication. However, CMS is updating the coverage criteria for hospitals and physicians to begin or maintain a TAVR program. The proposed decision provides more flexibility in how providers can meet the requirements for performing TAVR, while continuing to ensure good health outcomes for patients receiving the procedure. Click here for details from CMS.

FDA Seeks Authority to Develop New Opioid Standards
In testimony before the Senate Appropriations Committee last week, outgoing FDA Commissioner Scott Gottlieb requested authority from Congress authority to develop a new standard for opioid approvals that would require products to demonstrate an advantage over existing opioids. Gottlieb argued that new opioids should have to show they can address pain more effectively or are safer than existing treatments and any new opioid should have to demonstrate it is superior to an already approved opioid. Currently, FDA is required to approve drugs deemed to have benefits that outweigh their risks and manufacturers do not have to show they are safer or better than current offerings. To view the testimony, click here.

  • A new CMS blog details “new Medicare Part D opioid safety policies to reduce prescription opioid misuse while preserving medically necessary access to these medications,” click here.

First Ever Living Donor HIV-to-HIV Kidney Transplant
On March 25, a multidisciplinary team from Johns Hopkins Medicine completed the first ever living donor HIV-to-HIV kidney transplant. Prior to 2016, HIV-positive organs were never transplanted, however the HIV Organ Policy Equity Act (the HOPE Act) changed that policy leading to 100 HIV-positive organs being transplanted from braindead donors in two years. With this new advancement, living HIV donors also have the potential of providing organs for HIV-positive patients in need of a transplant. The physicians will continue to closely monitor the recipient and the donor and are optimistic that long-term HIV control and kidney function will be excellent. To read more on the living donation, click here, and here for more on the transplants since the HOPE Act.

FDA Issues Proposed Rules for Mammography Quality Standards
The U.S. Food and Drug Administration has announced new steps to modernize breast cancer screening and give patients with more information when they are considering issues regarding their breast health care. Within the rule, the FDA proposed requiring mammogram providers to tell women with dense breast tissue that the condition could make it harder to interpret their screening tests and to recommend that they talk with their physicians about whether they should have additional tests to check for cancer. According to the National Cancer Institute, dense breasts have relatively high amounts of glandular and fibrous connective tissue with relatively low amounts of fatty tissue, almost half of women ages 40 and older who get mammograms are found to have dense breasts. Since these types of tissue appear white on a mammogram, the same as cancer, it can obscure malignancies. Under the FDA proposal, a minimum standard is established that would apply nationwide, but states could retain more stringent requirements if they wished. Click here for the FDA announcement and here for the proposed regulation.

Major Insurer Centene Set to Buy Smaller WellCare
Insurance giant Centene has announced it had agreed to buy WellCare, a smaller publicly held insurer based in Florida, for about $15.3 billion. If the deal were to be approved, it would create a health care behemoth that specializes in offering private health plans under both Medicare and Medicaid. This would lead to a combined company with revenues expected to approach $100 billion in 2019 that would cover 22 million people in all 50 states. For more on the deal, click here.

Researchers Tracking Sewage for Antibiotic Resistance to Determine Health Trends in Cities
European scientists recently published an article highlighting how tracking antibiotic resistance in wastewater could help public health officials understand antibiotic resistance in a city. The researchers were able to prove this method by tracking trends of antibiotic resistance already known in various cities. Current methods include tracking hospitals and clinics, but this is considered to be too late as the bacteria will have already caused harm. Public health officials cite antibiotic resistance as one of the largest growing health problems in recent years. Click here, for the full study.

Gene Mutation Leads to Woman Not Feeling Any Pain, Could Help with Pain Treatments
By studying a 71-year-old woman, and her inability to feel pain, Scottish scientists have discovered a mutation in a previously unidentified gene that they hope will lead to new pain treatments. They also believe that this mutation may be connected to why the patient has felt little anxiety or fear throughout her life and why her body heals quickly. The researchers said they would now focus on trying to better understand how the gene – that everyone has – works so that they can design a gene therapy or other pain intervention around it. Click here for the study.

Eating Red and Processed Meats May Increase Risk of Early Death
A recent study to investigate the effect of low levels of red and processed meat intake conducted by Loma Linda University Health of 96,000 men and women in the U.S. and Canada, suggested moderately higher risks of mortality. Study participants were followed up for 11.8 years, during which there were 7961 deaths, 2598 were related to cardiovascular disease, and 1873 were cancer deaths. Researchers concluded that the combined intake of red and processed meat was associated with higher risks of cardiovascular disease deaths, as well as all-cause mortality. To read the study, click here.

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