Friday, July 25, 2014

Morning Consult Health: IRS Posts Employer Mandate Forms; First Biosimilar Filed With FDA

 

By Jonathan Easley (@joneasley)

 

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Today’s Washington Brief:

 

Today’s Business Brief:

Today's Chart Review:

 

Healthier States More Likely To Expand Medicaid

from Advisory Board by Dan Diamond

 

Mark Your Calendars (All Times Eastern):

 

Friday: National Committee for Quality Assurance primary care briefing @9am

Friday: Quarterly Earnings – AbbVie, Aon, Covidien, LifePoint Hospitals, Magellan Health

 

NEWS ARTICLES

 

1-8: General

9-14: Payers

15-17: Providers

18-21: Pharma/Biotech/Device

22: Health IT

 

OPINIONS, EDITORIALS, PERSPECTIVES

 

23-24: Morning Consult
25-26: CNN
27: Forbes
28: New York Times
29: Avalere Health

 

RESEARCH REPORTS, ISSUE BRIEFS, CASE STUDIES

 
30: U.S. Congress

 

 

NEWS ARTICLES

 

General 

 
1) IRS Prepping To Move Ahead With Employer Mandate In 2015

from Politico by Jennifer Haberkorn and Kelsey Snell

 

The Obama administration signaled Thursday it’s not backing down from the controversial health law employer mandate that has been delayed twice and is the centerpiece of the House’s lawsuit against the president. The IRS posted drafts of the forms that employers will have to fill out to comply with the Obamacare requirement that employers provide health insurance to workers. Some business groups said the information was still too tentative and too incomplete to let them prepare for new obligations under the health law. “Our immense frustrations with the IRS continue,” Christine Pollack, vice president of Government Affairs at the Retail Industry Leaders Association, said in a statement.


2) States Opposing Obamacare Implementation May Need It the Most

from Advisory Board by Dan Diamond

 

Reformers hoped that the Affordable Care Act would empower the states to experiment with their health systems. And sure—there's a "private option" here, a coordinated care organization demo there. But rather than lend itself to 50 different laboratories, Obamacare is generally setting up a stark divide across the nation…About half of the nation's Americans are living under the ACA's full coverage expansion. The other half is missing out, as their state's leaders have opted out. Two-dozen states have said no to Medicaid. Three dozen have decided not to run their own exchanges, which could become a much bigger deal pending the outcome of Halbig v. Burwell and this week's associated court cases. Like a funhouse mirror, where the states stand on Obamacare has led to two versions of American health care that increasingly look very different.


3) Obama Says Tax Laws Need To Stop ‘Corporate Deserters’

from Bloomberg by Lisa Lerer and Richard Rubin

 

President Barack Obama attacked companies that use cross-border mergers to escape U.S. taxes, accusing them of being “corporate deserters who renounce their citizenship to shield profits.” In remarks at a technical college in Los Angeles today, the president called for a new “economic patriotism” from companies. He also decried those that use corporate inversions to benefit economically by being in the U.S. while adding to the tax burden of middle-income families.


4) Obamacare Fight Carries Risks For Republicans In Swing States

from Bloomberg by Mike Dorning

 

To appreciate the complex political calculations Republicans now face in attacking Obamacare, consider this: Almost 1.4 million people could lose coverage in Ohio, Florida and Virginia, the three largest presidential battleground states, if the courts side with the law’s critics. In Florida alone, 984,000 residents enrolled through Obamacare to get health-insurance coverage, with 91 percent receiving tax credits to lower their premiums. Those subsidies are the subject of several lawsuits brought by opponents of the Affordable Care Act. 


5) IRS: Uninsured Face Fine of Nearly $2,500

from The Hill by Ferdous al-Faruque

 

The Internal Revenue Service said Thursday individuals who fail to get health insurance this year will be fined a maximum of $2,448 and families with five or more members can be fined up to $12,240. Under the Affordable Care Act’s individual mandate, people are either required to obtain health insurance or risk a tax penalty from the IRS. People who don’t buy health insurance plans that meet the ACA’s minimum standards are fined 1 percent of their annual household income if they make more than $19,650. However if they make less, they are fined a flat rate of $95 annually or are not fined if they make less than $10,150.


6) Boehner’s Obamacare Lawsuit Moves Forward

from The Hill by Elise Viebeck

 

The House Rules Committee on Thursday approved a resolution that would authorize Speaker John Boehner's (R-Ohio) lawsuit against President Obama over his use of executive power. The panel voted along party lines to move forward with legal against Obama over his delay of the healthcare law's employer mandate, which Republicans say was outside his authority as president. The House is expected to approve the lawsuit before lawmakers leave town next week for a five-week summer recess. The final vote is likely to be contentious, as Democrats have portrayed the lawsuit as a "political stunt" intended to channel GOP opposition to ObamaCare ahead of the midterm elections.


7) Some Gaming Anti-Fraud Laws To Profit Off Healthcare Fraud

from Wall Street Journal by Peter Loftus

 

Dr. LaCorte is a so-called serial whistleblower, one of the more-prolific plaintiffs among a growing number of Americans who use the U.S. False Claims Act to finger alleged wrongdoing. Critics say the act's incentives go too far, encouraging people to file suits that often go nowhere. Of the 5,400 suits filed from fiscal 1987 through 2010 that had outcomes, 74% didn't result in settlements or judgments, Justice Department statistics show. Government agencies say they rely on citizen suits under the act to help find misdeeds. They are "instrumental in bringing to the government allegations of fraud that might otherwise go undetected," a Justice Department spokeswoman says.


8) U.S. Stock-Index Futures Little Changed As Amazon Falls

from Bloomberg by Anna Hirtenstein

 

U.S. stock-index futures were little changed, after the Standard & Poor’s 500 Index extended a record, as earnings at Amazon.com Inc to Visa Inc. missed estimates and investors awaited data on durable-goods orders. Amazon dropped 10 percent in premarket trading in New York after trailing analysts’ predictions for the second successive quarter. Visa fell 1.7 percent after lowering its full-year revenue forecast. Pandora Media Inc. slid 8.1 percent in early trading after the number of active listeners reported by the biggest Internet radio service missed some analysts’ estimates. Baidu Inc. rose 8.4 percent after earnings topped projections. Futures on the S&P 500 expiring in September slipped 0.2 percent to 1,977.3 at 7:12 a.m. in New York. The equity gauge is heading for a second weekly gain as investor concern over a crisis in Ukraine eased and companies posted better-than-estimated earnings. Dow Jones Industrial Average contracts lost 21 points, or 1 percent, to 16,977 today.

 

Payers

 
9)
Insurers Not Panicking Over Halbig Yet

from Bloomberg by Alex Wayne

 

Americans are unlikely to lose Obamacare subsidies any time soon, at least, and not in most states.  A three-judge panel of a federal appeals court in Washington ruled July 22 that subsidies to help people pay insurance premiums are illegal in 36 states that use the federal healthcare.gov system. The ruling, in a case brought by political opponents of the health law, rattled advocates who painted doomsday scenarios of broken insurance markets across the country. That probably won’t happen, health-care industry executives and analysts said in interviews. The ruling is likely to be reversed, and even if it isn’t, a way to work around the court decision might be as simple as a bit of legislation in statehouses.


10) Insurers Worried Consumers Won’t Pay Premiums Because of Obamacare Loophole

from Vox by Sarah Kliff

 

A loophole in Obamacare regulations has health plans worried that people who bought coverage on the federal marketplace could skip their December payment and insurers would have few tools available to recoup that missed premium. The loophole stems from federal guidance published July 16. The underlying regulations are meant to protect consumers' rights as health insurance shoppers — but which could have the unintended consequence of making it easier for subscribers to skip out on a payment.


11) Consumers Worry Over Varying Health Premiums

from Associated Press by Kelli Kennedy

 

The Associated Press interviewed insurance agents, health counselors and attorneys around the country who said they received varying subsidy amounts for the same consumers. As consumers wait for a resolution, some have decided to go without health insurance because of the uncertainty while others who went ahead with policies purchased through the exchanges worry they are going to owe the government money next tax season.


12) Health Insurers To Pay $330 Million In Rebates

from Reuters by Caroline Hummer

 

U.S. health insurers will send out about $330 million in rebates to employers and individuals this summer under President Barack Obama's healthcare law, the U.S. Department of Health and Human Services said on Thursday. The law, often called Obamacare, requires insurance companies to refund customers when they spend less than 80 percent or 85 percent of healthcare premiums they collect for medical care.


13) From Republicans, A New Approach To Safety-Net ‘Accountability’

from New York Times by Josh Barro

 

The plan aims to resolve a complaint Republicans have long had about anti-poverty programs: They can create a significant disincentive to work. As people earn more income from their work, they gradually lose eligibility for programs like Medicaid, food stamps and housing assistance…There are two obvious fixes for this. One is to phase benefits out more slowly or even not at all. For example, instead of Medicaid and insurance subsidies for the middle class, we could have single-payer health care available to people at all incomes. This would remove a disincentive to work, but it would also be very expensive, so Republicans reject this approach. The other approach is to reduce the baseline level of benefits, so there is less to phase down from. Republicans have advocated this approach in the past; past Republican plans for Medicaid have revolved around drastically reducing overall spending on the program over time. But they reject that philosophy in Thursday’s document, on the grounds that it “would mean deep cuts for the most vulnerable.”


14) Colorado’s Exchange Chief Leaves For Cigna

from Denver Post by Electa Draper

 

The state health insurance exchange's chief executive, Patty Fontneau, announced Thursday she will leave Connect for Health Colorado to take a job as president of Private Exchange Business for Cigna. She will leave her post in mid August. The exchange's board of directors said they plan to name an interim CEO within a week.

 

Providers


15) Patient Privacy Laws Misused To Protect Medical Centers

from ProPublica by Charles Ornstein

 

When the federal Health Insurance Portability and Accountability Act passed in 1996, its laudable provisions included preventing patients' medical information from being shared without their consent and other important privacy assurances. But as the litany of recent examples show, HIPAA, as the law is commonly known, is open to misinterpretation – and sometimes provides cover for health institutions that are protecting their own interests, not patients'.


16) New Doctors Leaving New York To Work Elsewhere

from Crain’s by Irina Ivanova

 

There has long been a gap between the number of doctors who train in New York state and the number who practice here. But new research shows that more newly minted M.D.s are leaving the state to work elsewhere. A report prepared by the Center for Health Workforce Studies at the University at Albany and paid for by the Greater New York Hospital Association found that last year, 55% of doctors who completed residency in New York left the state to practice. That number is 10 percentage points higher than it was 1999. Nationwide, 17% of active physicians trained in New York state.


17) Doctors Pressured To Accept Risk-Based Reimbursement

from HealthLeaders Media by Jacqueline Fellows

 

As insurers step up efforts to cover more lives with value- and performance-based contracts, physicians are under the gun to adapt to an altered reimbursement reality. Cigna has met its goal of covering 1 million healthcare consumers under its quality and performance-based reimbursement model called Collaborative Accountable Care (CAC) arrangements, the insurer announced this month.

 

Pharma/Biotech/Device


18) Gilead Pressed To Defend Sovaldi Price

from Inside Health Policy

 

Sovaldi-maker Gilead hasn't complied with a request from House Democrats to justify the $84,000-per-course treatment of the hepatitis C drug, Energy & Commerce Ranking Democrat Henry Waxman (CA) said Wednesday, but a Gilead official said the company is complying with a similar request for information from the Senate Finance Committee.


19) Sovaldi Provokes Uncomfortable But Important Debate

from Washington Post by Jason Millman

 

Expensive specialty drugs aren’t new to health care. But Sovaldi stands out because it is aimed at helping millions of Americans who carry hepatitis C, and a large share of those infected are low-income and qualify for government coverage. Its arrival also coincides with the aggressive expansion of Medicaid and private coverage under the Affordable Care Act, whose purpose was to extend health care to tens of millions Americans who previously couldn’t afford it.


20) New Generation of Cheaper Drugs Is On the Way

from Washington Post by Jason Millman

 

With the high cost of specialty drugs capturing so many headlines these days, here's a bit of a change of pace: A new wave of cheaper drugs marked a major milestone Thursday. The Food and Drug and Administration for the first time has accepted an application for a copycat version of what's known as a biologic, which is a complex drug made from proteins of living organisms. These biologics are cutting-edge therapies that can be more effective than regular drugs made from chemicals — and, not surprisingly, they also can be expensive. For example, some biologics to combat rheumatoid arthritis, a disease affecting about 1 percent of the adult population, can cost more than $5,000 a week.


21) Are Drugmakers Using FDA Safety Program To Thwart Generics?

from Wall Street Journal by Ed Silverman

 

Are brand-name drug makers hiding behind a mandated safety program to thwart aspiring generic rivals? This question is at the heart of several lawsuits in which generic drug makers have accused brand-name drug makers of exploiting an FDA program known as Risk Evaluation and Mitigation Strategies, or REMS, which are designed to boost safety. The FDA often requires drug makers to develop such a plan when a drug is approved for use. Typically, these plans educate physicians and monitor distribution. Over the last couple of years, though, generic drug makers claim they have increasingly been denied access to samples of brand-name drugs needed to conduct product testing in order to win FDA approval for their copycat versions. Brand-name drug makers, they allege, have resisted providing samples or restricted distribution by arguing that REMS programs do not permit such sharing.

 

Health IT

 
22) Bipartisan Call For Investigation Into Health IT Problems

from Politico by David Pittman

 

Senate Democrats have joined Republicans in demanding an investigation into whether heavily subsidized electronic health records systems are blocking the free exchange of patient health information that was a major objective of the multibillion-dollar federal program. The comments, accompanying a spending bill, signaled that dissatisfaction with the meaningful use program among doctors and health IT professionals was bubbling up in both houses of Congress, though it wasn’t clear whether it would lead to any short-term action.


From Hope to Cures:

 

Hepatitis C attacks the liver of more than three million Americans, and is directly linked to 15,000 deaths each year. But America’s biopharmaceutical companies are fighting back – with new and forthcoming breakthrough treatments curing more than 90% of patients
 

OPINIONS, EDITORIALS, PERSPECTIVES


23) Republicans Will Run on Obamacare Replacement In 2016, Will Democrats?

from Morning Consult by Ben Domenech

 

One of the lazier memes of Democratic politicians and a few too many members of the media over the past several years has been the myth that Republicans have no alternative to Obamacare. This is the sort of thing that doesn’t pass even the most basic assessment of accuracy in reporting – here is a list of the health care reforms introduced by Republican House members in 2012, and here’s one for 2013. While their plans vary in scope, there are eight things Republicans generally agree about when it comes to health care reform…


24) Will Courts Save Or Dismantle Obamacare?

from Morning Consult by Ipsita Smolinski

 

Probably not. Two highly-anticipated Obamacare legal decisions were released on July 22. At issue was the legality of federal dollars (“subsidies”) flowing from the federally run health exchanges to individuals who need help affording health insurance. States were originally expected to run their own exchanges, but as Republican governors refused to implement the health law, and some Democratic states couldn’t handle the complexity of a state exchange, most opted to let HealthCare.gov operate their state’s exchange instead. There are 36 federal exchanges today. Going into these two Affordable Care Act (ACA) court decisions, the outlook for the Obama administration looked grim: that is, the ACA never explicitly stated that federal exchange subsidies should be allowed. However, the Internal Revenue Service (IRS), via regulation, allowed tax credits to be awarded to low income uninsured individuals seeking insurance.


25) Costly Hepatitis Drugs Save Money

from CNN by John Castellani

 

As a result of market dynamics and generic drug usage, the cost of medicines overall has grown more slowly in recent years than other health care costs, and makes up just 10% to 12% of total health care spending.The same can happen with treatments for hepatitis C, whose value becomes even more apparent when considering the cost consequences of not acting. Although critics say the price of a promising new hepatitis C drug raises the cost of insurance, research from Milliman in 2009 projected that, without a cure for hepatitis C, annual U.S. medical costs associated with the disease will nearly triple over 20 years -- from $30 billion to $85 billion -- indicating that curing the disease can help reduce future medical costs.


26) Court’s Blow To Obamacare Won’t Stick

from CNN by Brianne Gorod

 

On Tuesday morning, the U.S. Court of Appeals for the District of Columbia Circuit killed a regulation that is key to making Obamacare work. Its decision in Halbig v. Burwell, if it were the last word on the matter, would have significant -- and damaging -- consequences for millions of Americans who purchase health insurance on exchanges established and run by the federal government. Fortunately, it won't be the last word on the matter.


27) Obamacare Architect Admits States With Federal Exchanges Shouldn’t Get Subsidies

from Forbes by Michael Cannon

 

The plaintiffs’ interpretation became even more plausible with the discovery of a January 2012 presentation by Massachusetts Institute of Technology economist Jonathan Gruber. I’ll get to why Gruber is significant in a moment. For now, note how he unequivocally agrees with the plaintiffs’ interpretation: the PPACA only allows tax credits in states that establish Exchanges. Here’s the relevant excerpt:


28) The Phony Narrow Network Scare

from New York Times by Editorial Board

 

Republicans contend that the Affordable Care Act is a failure because many of the plans sold on the online health exchanges limit a consumer’s choice of doctors and hospitals. Many plans do, indeed, limit choice — deliberately so, to keep premiums down. But a vast majority of consumers can almost always buy a plan with a broad array of doctors, hospitals and other providers if they are willing to pay more for the policies.

29) First Biosimilar Filing

from Avalere Health by Dan Mendelson

 

The first FDA filing of a biosimilar is a key step to the U.S. having biosimilars. With their approval (maybe as early as 1Q15) we will learn whether or not these new market entries will provide competition in the specialty drug market and enable payers to hold down costs.

 

From Hope to Cures:

 

Without new treatments and cures for Hepatitis C, annual U.S. medical costs associated with the disease are projected to nearly triple over the next 20 years – from $30 billion to $85 billion. But now new and forthcoming treatments are curing more than 90% of patients and driving down future medical costs like liver transplants – which often cost more than $500,000. 

 

RESEARCH REPORTS, ISSUE BRIEFS, CASE STUDIES


30) Reps. Introduce Bipartisan VBID For Better Care Act

from U.S. Congress by Reps. Diane Black and Earl Blumenauer

 

Today, Reps. Diane Black (R-TN-06) and Earl Blumenauer (D-OR-03), both members of the House Ways and Means Committee, introduced H.R. 5183 -- the Value-Based Insurance Design (VBID) for Better Care Act of 2014 -- a bipartisan measure that would establish a regional demonstration program for high-quality Medicare Advantage (MA) plans to utilize V-BID to reduce the copayments or coinsurance for beneficiaries with specific chronic conditions. In doing so, beneficiaries are provided with increased access to the care they need to ensure better health outcomes. V-BID allows plans with the flexibility needed to offer the best possible care coordination for disease management, and provides the right incentives for beneficiaries.

 

 

 

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