30 Sep September 30, 2019

New CMS Mandate To Collect 340B Drug Cost Data, Signals New Payment Reduction Efforts

CMS quietly issued a notice last week that it will begin collecting data on 340B drug acquisition costs.  This likely signals that the agency is preparing for a new payment reduction scheme in the event it loses its court appeal or that it will win its appeal and is preparing data to support additional payment reductions. According to the Paperwork Reduction Act filed in the Federal Register, the agency plans to collect data on the actual prices that hospitals pay for drugs under the 340B program to calculate average sales prices and make the cuts by submitting responses through the new Hospital Survey for Specified Covered Outpatient Drugs. This all comes as the appeals hearing was set for Nov. 8 and the hospitals have also filed their brief on the appeal. Comments on the proposed data collection are due in November as well. Click here for the notice, and here for the hospital brief on the 340B appeal.

Medicaid DSH Cuts Delayed Until November 21
$4 billion in cuts to the Medicaid Disproportionate Share Hospital program has been delayed until November 21. The president has signed a short-term funding bill keeping the government open until then. The legislation also contains funding for community health centers, Medicaid in Puerto Rico and other territories, National Health Service Corps, teaching health centers’ graduate medical education programs, diabetes programs, and the Patient-Centered Outcomes Research Trust Fund, among others. Click here for the bill and here for the summary.

• The bill included H.R. 3276, the Fair and Accurate Medicaid Pricing Act, a bipartisan policy that ensures drug companies do not overcharge taxpayers for drugs in the Medicaid program which is expected to save about $3.1 billion over the next decade, click here.
• In response to the potential delay in funding, community health centers have had to reduce their resources by freezing hiring, reducing staff hours, or laying off staff. Click here for more.

New CMS Rule Cuts Provider Red Tape, Saves $700M+ a Year
CMS has issued a final rule aimed at giving heath-care providers more time with their patients and less time on paperwork through a reduction of excessive Medicare compliance requirements. The rule, first proposed last year, is expected  to save an estimated 4.4 million hours annually previously spent on paperwork, as well as $8 billion in health care spending over the next 10 years. CMS overhauls the Conditions of Participation and Conditions of Coverage for hospitals, home health providers, transplant centers, ambulatory surgical centers, among others, by removing regulations that CMS deemed burdensome or unnecessary. Click here for the final rule, and here for the fact sheet.

• Of note, the final rule will remove the outcomes requirement for transplant center re-approval process, something called for by the donation and transplant community for years, click here.

Interest Groups Ramp Up Surprise Billing Campaign
Several advocacy groups on both sides of the surprise billing issue are taking their arguments to the public through multi-million dollar advertising campaigns on TV, radio, and print media. The Coalition Against Surprise Medical Billing, made up mostly of insurance companies, states that arbitration proposals will benefit private equity firms that own physician practices and drive up costs. A coalition of 14 consumer groups, that includes Families USA, the AFL-CIO, and patient advocacy groups, launched a campaign last week to urge Congress to pass legislation by the end of the year that would ban surprise medical billing for people with all types of insurance, do it in a way that contains costs, and make sure the protections are applied nationwide. To read more on the Coalition Against Surprise Medical Billing, click here, and for the Families USA groups, click here.

• California’s surprise billing law has led to an increase in care delivered by in-network providers, according a new study, click here.
• The theory that high deductible plans would make patients better health care consumers is not working according to a new report in the LA Times, click here.

Discharge Planning Rules Finalized Nearly 4 Years After Proposed
Under the Improving Medicare Post-Acute Care Transformation Act of 2014 (IMPACT Act), CMS was required to issue regulations to create new discharge planning requirements for acute care hospitals, long-term care hospitals, critical access hospitals, inpatient rehabilitation facilities, and home health agencies. CMS released a proposed rule the following year that was criticized for its overly burdensome requirements. Now the final rule, almost four years later, made several modifications, lessening many of the discharge instructions with a simple requirement that providers must discharge or transfer patients with all necessary medical information relevant to the patient’s illness or course of treatment, discharge goals, and treatment preferences.  For the final rule, click here, and for the CMS fact sheet, click here.

Congress Moves Forward on New Drug Price Reduction Bills
Senate Finance Committee Chairman Chuck Grassley (R-IA) released his long-awaited drug pricing plan last week that closely mirrors what the Committee voted on in July, including controversial provisions such as a measure to cap price increases in Medicare Parts B and D at the rate of inflation, and requiring transparency, such as rebate disclosures, from pharmacy benefit managers. The bill (S. 543), cosponsored by the Committee’s top Democrat Ron Wyden (D-OR), was approved with a bipartisan, two-thirds majority by the Committee; however, Grassley is reported to have said that drug pricing legislation will most likely be pushed to next year. Meanwhile, the House Energy and Commerce Committee sparred over various bills that would allow, among other things, Medicare to negotiate prescription drug costs with manufacturers, a Trump Administration proposal that would tie U.S. drug prices to those paid by other wealthy countries, as well as the similar Grassley provision to cap price increases to the rate of inflation. For the Senate Finance bill language, click here, and the summary, click here. To view the Energy and Commerce hearing and read testimony, click here.

• According to the House Ways and Means Committee, drug prices in the U.S. are nearly four times higher than the combined average prices in 11 other similar countries, click here.
• The Federal Trade Commission has sent letters to seven personal injury law firms over concerns that some television ads that solicit clients for lawsuits against drug manufacturers may be deceptive or unfair as the ads may lead consumer to believe they are government-sanctioned alerts, click here.

Over 800 Confirmed Vaping Illnesses and 12 Confirmed Deaths: CDC
The Centers for Disease Control confirms that 805 cases of illness caused by vaping spans 46 states and the Virgin Islands. 10 states have reported deaths linked to vaping. While officials have not yet identified a single product or substance linked to all cases, the FDA and CDC project that about 70 percent of all cases involved vapes containing THC, the psychoactive part of marijuana. Additionally, the CDC is reporting that nearly three quarters of all cases involve men and two-thirds are between the ages of 18 and 34 years old. The CDC projects that hundreds more will fall ill and the number of deaths will rise in the coming months. The FDA and DEA have been investigating the supply chain, and officials are warning people to avoid buying products on the black market or modifying them in any way. Click here for the full report from the CDC.

• The American Medical Association called on the media to reject ads from e-cig and vaping companies in light of the growing public health epidemic, click here.
• The Governor of Massachusetts declared an emergency and temporarily banned the sale of all vaping products in the state through Jan. 25th, click here.
• E-cigarette maker Juul announced last week that the CEO would step down and the company would cease lobbying efforts against the looming ban of flavored vaping products, click here.

Medicare Advantage and Part D Premiums Set to Decline to Lowest Levels in 13 Years
CMS announced last week that people with Medicare who enroll in a Medicare Advantage plan for 2020 will have a premium that is 14 percent lower to an estimated $23 per month. The cost will be the lowest it has been since 2007. Enrollment for next year is expected to increase to 24.4 million from its current 22.2 million. Additionally, the average monthly basic Part D premiums will decline 13.5-percent, their lowest point since 2013. CMS also said that about 500 Medicare Advantage plans will offer expanded health-related supplemental benefits in 2020 to approximately 2.6 million enrollees, including adult day care services, in-home support services, and caregiver support services. Also, about 250 plans will offer access to additional benefits such as meal delivery, transportation or home environmental services to an estimated 1.2 million seniors with chronic conditions. For more from CMS, click here. For an AP article describing the new benefits, click here.

NIH funds $945 Million to Combat Opioid Addiction with HEAL Initiative
The NIH allocated $945 million to its HEAL Initiative, a research effort that aims to address the nation’s current opioid crisis by improving treatments for chronic pain as well as decreasing the prevalence of opioid use disorder (OUD) and helping those achieve long term recovery from addiction. The trans-NIH research effort hopes to address the issues that have previously slowed efforts in aiding the current opioid crisis; these issues include patients not receiving the proper treatment for OUD or maintaining a treatment program for long-term recovery, not knowing which pain management treatments work best for different types of pain, and not having a standardized protocol in treating infants who were exposed to opioids in utero. Click hereto read the NIH release.

Study: Low Dose of Addiction Medication Can Be Successful in Treating Chronic Pain
New research has found that the nonopioid, Naltrexone, can be used to treat some nonmalignant, chronic pain syndromes. The study, conducted by researchers in Tennessee, suggests using an off-label form of Naltrexone, which is typically used to treat addiction. Usually, naltrexone is prescribed in 50-150 mg doses to treat addiction. However, it is used in 1-5mg doses to successfully treat chronic pain. Currently, the prescribing of Naltrexone to treat chronic pain is not yet approved by the FDA. Click here to for the study.

Average Cost of Employer-Sponsor Health Coverage Over $20,000 for First Time
According to the Kaiser Family Foundation’s 2019 Employer Health Benefits Survey, the average cost of family employer-sponsored health insurance climbed by 5 percent this year to exceed $20,000 for the first time. This continues an eight year trend of increases to health plans, up 54 percent from 10 years ago when the average cost was $13,375. On average, an employee with a family plan pays $6,015 towards their premiums. People are also paying more in deductibles; almost half of small business employees and 28 percent of all employees pay at least $2,000 in deductibles. Click here for the full report.

Amazon, Walmart Ramp Up Health Care Services
Amazon announced a pilot program for a new way that employees and their families can access health care services. “Amazon Care” will provide virtual and in-person services including video care, text chat with providers, mobile care visits on demand, and prescription deliveries. The services would be available 7 days a week during the day. Amazon says the program will help with non-emergent issues such as colds, minor injuries, and more. The pilot program will be available to employees and their families if they are at least 18 years old, enrolled in Amazon’s insurance plan, and live and work in Seattle. To read the full report, click here.

• Walmart announced that employees will be able to apply for its Live Better U program to pursue one of seven bachelor’s degrees and two career diplomas in a health care related field — for $1 a day, click here.

GAO Report Criticizes CMS’ Quality Measures Tracking Efforts
A new report from the Government Accountability Office says that CMS needs to do better with tracking program funding and whether or not quality measures are meeting their goals. GAO claims that CMS is unaware of its funding allocations and that they are not monitoring whether each quality measure meets its eight goals. A number of reports from CMS were missing the goals or quality measures all together, which can have consequences on the providers in need of funding. Other programs received too much funding and it went unused. GAO urges CMS to address these issues. To see the full report, click here.

HHS, DOJ Target Nationwide Genetic Testing Fraud Schemes
The HHS Inspector General continues to tackle fraudulent genetic testing schemes across the country resulting in 35 individuals being charged for their alleged involvement in healthcare fraud schemes. Among those who were charged, 10 were medical professionals, and nine were doctors. According to the charges, the 35 individuals fraudulently billed Medicare for more than $2.1 billion for the genetic tests. Click here for the HHS IG report.  The Justice Department announced that it brought charges against the 35 people identified in the IG report, click here.

Webinar This Week on Social Determinants of Health
The Root Cause Coalition, a national nonprofit dedicated to achieving health equity, will host a webinar on Oct. 1, 1:30pm-2:30pm ET. The webinar, entitled “How to Understand that Determinants Don’t Have to Be Destiny: A Trauma-Informed Understanding of the Social Determinants of Health” will be led by experts from Alive and Well Communities and the CEO of the St. Louis Integrated Health Network. The webinar will center on the importance of a trauma-informed perspective to address the social determinants of health, and how doing so can improve health outcomes for patients. To register for the webinar, click here.

New Report Addresses Social Determinants of Health with Recommendations for Improvement 
The National Acdemy of Sciences report highlights the importance of addressing upstream factors such as stable housing, transportation, and diet in maintaining health. The expert committee proposes five recommendations ranging from integrating social care in healthcare training, delivery, and continuing education to developing a digital infrastructure that allows providers and consumers from both the health and social care systems to share information with each other. The report also addresses the financial barriers to social care, which include how healthcare is legally defined. To read the full report, click here. To read a summary of the recommendations click here.

Research Examines Link Between Air Pollution and Pediatric Psychiatric Disorders
A study from Environmental Health Perspectives looked at the association between exposure to fine, ambient particulate matter and psychiatric emergency department utilization. The researchers analyzed psychiatric patient visits and then followed the concentration of PM2.5 in their residential areas. The researchers saw that whenever there were increases in PM2.5, there would be an increase in psychiatric visits within the next several days to follow. Additionally, the study found that children of lower socioeconomic status were more vulnerable to the harmful effects of the air pollution increases, specifically the disorders of anxiety and suicidal thoughts. For the study, click here.

Allergists Debate Anticipated First FDA-approved Peanut Allergy Drug
In response to the recent recommendation to the FDA to approve Aimmune Therapeutics’ new drug, Palforzia, for treating peanut allergies in children and teens, professionals in the medical community are debating the benefits of the drug. If this drug is approved, it will become the first FDA-approved drug to treat peanut allergies. Those who support the approval of a new treatment highlight how allergists already use oral immunotherapy treatments using products from retail vendors and the idea of a standardized product that would improve patients’ safety when slowly being exposed to peanut products. The introduction of an FDA-approved treatment could also reduce the amount of patients that have to pay out of pocket for the current treatments. However, health professionals worry about the risk of medical professionals not being properly trained to treat peanut allergies with this new drug, they worry that a standardized product may allow for less experienced physicians to prescribe the drug without being fully trained in monitoring the patient’s progress. For more on the debate click here.

Excessive Exercise Affects More Than Just the Body: Study
A new study looking at training regimens of triathletes found that over exertion leads to not only physical fatigue, but mental as well due to the same area of the brain being affected. Called “overtraining syndrome,” burnout can lead to decreased mental performance and poor decision making, demonstrated by the athlete’s impulsiveness during the study. The study concludes that it is just as important to rest your brain as it is to rest your muscles and joints to avoid burnout from excessive exercise. Athletes are encouraged to learn their physical and mental limits to create a balance with planned and controlled workouts. To read a summary of the report, click here. To read the study, click here.