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April 15, 2019

MACPAC Unanimously Recommends Changes in Medicaid Definitions
The advisory panel’s June report to Congress will recommend that Congress clarify the statutory language that governs how to calculate the maximum amount of Medicaid DSH payments that can be disbursed to individual hospitals. The recommendation calls for excluding costs and payments for Medicaid-eligible patients in the definition of Medicaid shortfall when Medicaid is not the primary payer. Hospital associations had asked the commissioners to defer action while litigation over the Medicaid shortfall definition moves through the courts. A 2018 court ruling is currently on appeal at the US Court of Appeals for the DC Circuit. The Commissioners, however, view this as a policy matter, not a legal matter, and believe the proposed change would be easier for CMS to administer and may increase DSH payments for safety-net hospitals that serve a high share of Medicaid-only and uninsured patients.  Congress could consider this recommendation when it considers DSH later this year. Click here for the MACPAC staff presentation.

  • A new report from America’s Essential Hospitals shows that 75-percent of essential hospitals’ patients were uninsured or covered by Medicaid or Medicare and had an average margin of 1.6-percent, click here.

CMS Poised To Cover CAR-T Cell Therapy; Insurers Want Restrictions
In a major test case, Medicare is poised to cover a promising but expensive new type of cancer treatment, with significant restrictions meant to hold down the cost.  Cancer patients, doctors and drug companies are urging the Trump administration to remove the restrictions and broaden coverage so more patients can benefit from the treatment, known as CAR T cell therapy, or CAR-T. But insurance companies are pushing for the restrictions. The FDA has approved two CAR-T products to treat certain blood cancers: Kymriah, made by Novartis, with a list price of $373,000 or $475,000, depending on the type of cancer, and Yescarta, made by Gilead Sciences, with a list price of $373,000. Click here for the NYTimes report.

  • The pace of change in cancer therapy has been staggering over the past five years. The increased availability of new treatment options — often with better chances of remission and fewer side effects — is good for patients. But for many of them and their physicians, it can be difficult to keep up with all the changes.  Click here for the story.

Bernie Sanders Introduces Medicare-For-All; Legislation Could Reduce Hospital Revenues by 16 Percent
Presidential Candidate Sen. Bernie Sanders (I-VT) has introduced his Medicare-For-All legislation with 14 Democratic Senators including other Presidential Candidates Cory Booker (D-NJ), Kirsten Gillibrand (D-NY), Kamala Harris (D-CA), and Elizabeth Warren (D-MA). S. 1129 would create a federal universal health insurance program to provide coverage for all inpatient and outpatient health care. This comes after a recent study published in JAMA that states Medicare-For-All would result in a net revenue loss of $150 billion for hospitals nationwide or a16 percent loss. Click here for the legislation and here for the JAMA study.

  • Not all top Senate Democrats are on board with Medicare for All.  Click here for an inside look on how Democrats are dealing with the issue.
  • Obamacare is now more popular than ever.  Click here for the story.

Lawmakers On the Attack Over Rising Insulin Prices
The Energy and Commerce Subcommittee on Oversight and Investigations last week went after insulin manufacturers and pharmacy benefit managers over the rising prices of the life-saving diabetic drug. Both parties harshly criticized drug and pharmacy benefit manager executives during the hearing, many of whom appeared to threaten to blow up the entire drug pricing system. The witnesses, who included Eli Lilly, Novo Nordisk, Sanofi, Cigna’s Express Scripts, United Healthcare’s Optum, and CVS, pointed to each other over the dramatic price increases, leading to anger from the subcommittee members who suggested that the government should just set prices. Subcommittee Chair Diana DeGette (D-CO) stated that she plans to invite executives from the drug companies and PBMs back to testify in June or September once there are legislative ideas to discuss. To view the hearing and read the prepared testimony, click here.

  • One expert explores ways to address paying the high cost of drugs through alternative payment mechanisms, such as health care loans or drug mortgages, click here.

PBMs Under Fire in the Senate
Pharmacy benefit managers also took a beating from the Senate Finance Committee last week on their drug coverage practices. Senators grilled PBMs on the role they played in high drug costs and raised concerns over spread pricing where PBMs reimburse pharmacies less than what they charge health plans for the drugs. Following the hearing, the Chairman and Ranking Member of the Committee requested that the HHS Inspector General investigate PBMs’ practice of spread pricing, specifically in Medicaid programs that can result in an 8 percent markup for drugs according to their letter to the OIG. Click here to view the hearing and read the prepared testimony, and here for the OIG letter.

  • The House Ways and Means Committee unanimously advanced legisaltion to address high drug costs that includes a requirement that PBMs report information about manufacturers rebates, as well as how much of those rebates are passed on to health plans to be posted on CMS’ website, click here.

Amazon’s Alexa Wants to Help Manage Your Health; Will Info Stay Safe?
Amazon announced that the Alexa smart speaker can help manage your health, including scheduling urgent-care appointments, monitoring blood sugar levels, tracking when your prescriptions have shipped, and checking health insurance benefits. Five companies so far have joined this initiative including Cigna Corp., Express Scripts, Livongo, and major hospital systems.  While the company says Alexa meets all health privacy requirements under federal law, the announcement comes as it has been reported that the company employs thousands of full-time workers and contractors in several countries, including the United States, Costa Rica and Romania, to listen to what customers say to Alexa. To read the Amazon blog, click here, and for more on Amazon employees listening to customers, click here.

Suicide Care to be Included in Opioid Treatment Programs
With increasing links between suicides and opioid use, a 40% correlation according to the CDC, new guidelines recommended by the National Action Alliance for Suicide Prevention will become facilities’ minimum standard of care for patients in both inpatient and outpatient addiction treatment. These guidelines will be implemented in June; currently there is no standard of care for suicide prevention in opioid treatment programs. Click here to read the newly released recommendations for standard care for suicide prevention.

  • FDA announced new requirements for opioid labels  to help health care providers safely decrease the dose in patients who are dependent on the pain medications, click here.
  • SAMSHA to award up to $550,000 to up to 11 entities to develop and disseminate training and technical assistance for rural communities to address opioid issues, click here.

HHS Cybersecurity Called Into Question by Senate Chairman
After a Inspector General report found last month that cybersecurity netoworks at HHS “needs improvement,” Senate Finance Committee Chairman Chuck Grassley (R-IA) sent at letter to the Secretary requesting information on the Department’s policies. The letter discusses the findings in the report that state that the OIG was able to access various devices on HHS networks, getting “personally identifiable information for more than 9,000 records, which included phone numbers, address information, case information, and some photographs.” The letter asks for answers to detailed questions by April 23rd followed by a Committee briefing no later than the 30th of this month. To view the OIG report, click here, and for Grassley’s letter, click here.

Medicare Coverage on Ambulatory Blood Pressure Reexamined 
CMS proposed last week to expand Medicare to cover ambulatory blood pressure tests. ABPM is a non-invasive diagnostic test that uses a device to track blood pressure over 24-hour cycles. Ambulatory monitoring allows blood pressure to be measured over entire days rather than at a single moment in time.  The current national coverage determination for ABPM, issued in 2001, covers the diagnostic test only for those patients under certain condition. Click here for the latest information.

USDA, FDA, and EPA Announce Plan to Reduce Food Waste
The three agencies have announced plans to work together to create a federal interagency strategy to address food waste and work with state, local and community leaders and other stakeholders on how all levels of government can reduce food waste. The interagency strategy includes six key priority areas the agencies will work together on over the next year: (1) Enhance Interagency Coordination; (2) Increase Consumer Education and Outreach Efforts; (3) Improve Coordination and Guidance on Food Loss and Waste Measurement; (4) Clarify and Communicate Information on Food Safety, Food Date Labels, and Food Donations; (5) Collaborate with Private Industry to Reduce Food Loss and Waste Across the Supply Chain; and (6) Encourage Food Waste Reduction by Federal Agencies in their Respective Facilities. Click here to read more on the strategy.

Medicare Shared Savings Program Application Deadlines
ACOs must submit an intent to apply if they wish to participate in Medicare Shared Savings Program in 2020. The period during which the notice of intent can be submitted is June 11 – June 28, 2019. The application period runs from July 1 to July 29, 2019; however ACOS can submit sample agreements and documentation to receive feedback from CMS prior to the application period. For more information, see the application tool kit, here or email SPACO_Applications@cms.hhs.gov.

Progress Made on Treating Major Brain Injuries
More than 3 million Americans live with disabling brain injuries. On Saturday, a team of scientists reported a glimmer of hope. Using an implant that stimulates activity in key areas of the brain, they restored near-normal levels of brain function to a middle-aged woman who was severely injured in a car accident 18 years ago. Click here for the details.

New, Less Stringent Guidelines Issued for Aging Diabetics
About a third of Americans over age 65 have diabetes; last month, the Endocrine Society unveiled new guidelines for their treatment.  Its recommendations included higher glucose and A1c targets for older people with diabetes, particularly those with several other chronic illnesses and cognitive impairment, or those having difficulty handling daily activities. Click here for more.

Incidence of Colorectal Cancer in Younger People on the Rise
Colorectal cancer incidences and deaths have been increasing in the past 30 years in people under 50.  While the disease in younger people remains a relatively small fraction of the total, it is rising at an alarming rate. This is in striking contrast to the situation for older people, in whom colorectal cancer is decreasing. These findings brought the young adult issue into focus and raised public awareness of its existence. Click here for details.

Major Pharmacy Chain To Stop Selling e-Cigarettes and Vaping Products
Rite Aid, one of the country’s biggest pharmacy chains, will stop selling e-cigarettes and vaping products because of concern that they are fueling tobacco use among middle and high school students across the United States.  Rite Aid said it would remove the products from its more than 2,400 stores over the next 90 days. The chain will continue to sell regular tobacco products, a decision that some public health advocates criticized.  Click here for details.

Medical Facilities Curtains Could Harbor Antibiotic-Resistant Organisms
Nearly a quarter of privacy curtains at skilled nursing facilities in Michigan found that they harbor bacteria, including MRSA, according to a new study .  The study collected more than 1500 samples in 625 rooms and found that 22 percent of samples had multidrug-resistant organisms. The same germs were also found on 16 percent of patients with privacy curtains which are high-touch surfaces, and cleaned infrequently. In fact, the researchers found that between days 10 and 14 after being hung, curtains showed increased MRSA and other pathogens that facilities should be encouraged to clean or replace the curtains on a regular basis. Click here, to read the full study.

FDA Issues Rule on OTC Hand Sanitizers
The FDA issued a final rule establishing what is safe and effective to include in OTC hand sanitizers. This ruling finalized the FDA’s previous ruling regarding 28 active ingredients  being ineligible for OTC evaluation as well as three active ingredients: benzalkonium chloride, ethyl alcohol, and isopropyl alcohol, requiring further evaluation. OTC hand sanitizers typically use ethyl alcohol as the active ingredient, and according to the FDA less than 3% of the marketplace will be affected by this ruling. To view the FDA Statement click here.

Traffic-related Air Pollution Linked With Asthma in Children
A recent study by GWU Milken Institute School of Public Health researchers suggests that pediatric asthma could be prevented in cities by investing in cleaner forms of transportation, and reducing air pollution. The study looked at asthma incidence rates from 2010-2015 and found that 64-percent of asthma cases occur in urban areas. Additionally, about 4 million pediatric asthma cases occur every year, and are attributable to the inhalation of nitrogen dioxide air pollution – which primarily comes from motor vehicle exhaust. Researchers also found that 92-percent of asthma cases occurred in areas that met the WHO guidelines on limits of air pollutants. Leading to the researchers suggesting the guidelines be re-evaluated to better protect children’s health. To read the study, click here.

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