Providers Struggle to Meet Stage 2 Requirements for Electronic Health Records

BACKGROUND ON FINANCIAL INCENTIVES FOR THE "MEANINGFUL USE" OF CERTIFIED EHR TECHNOLOGY TO IMPROVE PATIENT CARE   

(From CMS)

On September 4 2012, CMS published a final rule that specifies the Stage 2 criteria that eligible professionals (EPs), eligible hospitals, and critical access hospitals (CAHs) must meet in order to continue to participate in the Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs. All providers must achieve meaningful use under the Stage 1 criteria before moving to Stage 2.

www.cms.gov

The Medicare and Medicaid EHR Incentive Programs provide financial incentives for the “meaningful use” of certified EHR technology to improve patient care. To receive an EHR incentive payment, providers have to show that they are “meaningfully using” their EHRs by meeting thresholds for a number of objectives. CMS has established the objectives for “meaningful use” that eligible professionals, eligible hospitals, and critical access hospitals (CAHs) must meet in order to receive an incentive payment.  

The Medicare and Medicaid EHR Incentive Programs are staged in three steps with increasing requirements for participation. All providers begin participating by meeting the Stage 1 requirements for a 90-day period in their first year of meaningful use and a full year in their second year of meaningful use. After meeting the Stage 1 requirements, providers will then have to meet Stage 2 requirements for two full years. Eligible professionals participate in the program on the calendar years, while eligible hospitals and CAHs participate according to the federal fiscal year.

THE CURRENT PROBLEM

The Stage 2 criteria are scheduled to kick in Oct. 1 for hospitals, and Jan. 1 for physicians and other eligible professionals.  These start dates have already been pushed back one year, but there are still providers who fear noncompliance. In fact, The American Medical Association, the American Hospital Association, the National Rural Health Association, the College of Healthcare Information Management Executives, the Medical Group Management Association, the American College of Physicians, and the Tennessee Medical Association have all weighed in calling for a Stage 2 delay or adjustment. Vendors particularly face problems developing EHR systems capable of performing calculations for measure providers must report to the CMS under the Stage 2 meaningful-use requirements, experts say. 

"A Modern Healthcare review of the Certified Health IT Product List compiled by HHS' Office of the National Coordinator for Health Information Technology shows that just 79 companies, providers and other organizations have developed software and had it tested and certified to ONC-determined software functionality standards for Stage 2 meaningful-use requirements. In comparison, there were 988 developers of health information technology systems tested and certified for Stage 1."

Too Many Rules for Med Devices?

New rules for medical device makers, both in the U.S. and abroad, may make it more difficult for medical device companies to succeed, some say.

Both Sides of the Aisle Oppose Medical Device Tax

On Capitol Hill, GOP senators are trying to attach a repeal of a medical device tax to a government spending measure.  The repeal is part of an ongoing effort to defund the ACA.  The healthcare law imposes a 2.3% excise tax to help pay for the healthcare overhaul.

Lawmakers on both sides of the aisle express dislike for the tax.  However, it is most unpopular among Republicans in both houses, marked by Sen. Orrin Hatch's (Utah) lively description of the tax a "stupid dumb-ass thing."  Sen. Hatch and other opponents of the tax say it would put tens of thousands of jobs at risk, and hinder the health IT industry that creates pacemakers and artificial hearts. Among the democrats who oppose the tax are Sens. Amy Klobuchar (Minn.), Al Franken (Minn.), Kay Hagan (N.C.) and possibly Whip Dick Durbin - though Durbin would only support a repeal of the tax if it didn't negatively affect the overall funding for the healthcare law.

Supporters of the 2.3% medical device tax argue the healthcare law could eventually offset at least some of the cost of the tax.  As the number of insured grows, supporters say, so would the demand for medical devices and health tech innovation.

EU Rules May Slow U.S. Approvals

The European Parliament will soon vote on new regulations to close loopholes in their medical device laws. Currently, the EU has a much easier process for medical device companies to test their products and accumulate patient data.  It is precisely this simpler process that facilitates faster device approval in the U.S. - health tech companies can more easily gather the data they require in Europe to then get approval in the U.S., the world's most profitable health care market with the most stringent approval process.

The different between the system in the EU and U.S. stems from the government agency that oversees device approvals. In the U.S., the approval process is handled by the Food and Drug Administration.  In the EU, private reviewers known as "notified bodies" are hired by manufacturers to vet products and grant so-called CE marks that allow devices to be sold in the EU.

"If the rest of the world begins to raise the bar of approval to the U.S. level , it will surely damage investment in innovation and patient progress will plateau," said Kevin Sidow, CEO of Moximed of Hayward, CA, whose knee-implant system was approved in Europe.

ACA Could Survive a Government Shutdown

States that run their own insurance exchanges say they expect to be able to function in the face of a federal government shutdown.  
However states whose exchanges are being run by the Feds may not. The possibility of a federal government shutdown became more late last week, when congressional Republicans voted to fund the government but not the implementation of the Affordable Care Act.  Although the Democrat-controlled Senate is unlikely to follow suit, if the two legislative bodies cannot agree on a spending bill by next Monday, the government will shut down on Oct. 1.

While state-run exchanges could continue to operate with state funds and federal grants already paid to them, states are uncertain about whether they will have access to draw-down grants and other grants awarded but not yet deposited in the state's bank account.

The White House Office of Management and Budget (OBM) stated that entitlement programs could continue to run because funding for those programs comes from an "indefinite appropriation."  In other words, there are some permanent programs that do not require annual appropriations from Congress to operate. This was seen during the longest government shutdown, from Dec. 16, 1995 - Jan. 6, 1996, when Social Security continued to operate as a "permanent program."

IMPACT ON ACA'S INFORMATION TECHNOLOGY

One of the major concerns is how a shutdown would affect the IT component of the ACA, called the federal data services hub.  The hub is responsible for shepherding personal information from IRS databases, other federal agencies and private data companies back to the state exchanges to determine eligibility for premium subsidies.

"The OBM says that a contractor responsible for running the IT part of the state exchanges 'may continue to proceed with its work' during a shutdown if the agency they are working for 'already obligated funds representing the entire price under a contract' before the shutdown." (Reuters.)

CMS declined to say whether the IT contracts for Obamacare meet that criterion.

Google Unveils Calico

Search giant Google has launch a new health technology company, Calico, to focus on aging and aging-related diseases.  Calico will be run and operated separately and independently from Google, with Arthur Levinson, Chairman and former CEO of Genentech and Chairman of Apple, as Calico's CEO and founding investor.

This announcement may be surprising to those who remember the short-lived Google Health (2008-11) - a personal health information centralization service that allowed Google users to volunteer their health records in order to obtain a merged health record from Google. However Calico is not a consumer-driven endeavor but, rather, one of research and scholarship.

Calico's research aims to analyze the biological mechanisms behind aging. Levinson has stated that "much of that early research might be done by providing money to academic scientists, though Calico might also hire its own researchers."

ACA's Contraception Mandate May Be Headed for SCOTUS

Three Circuit Court of Appeals have now weighed in on the Affordable Care Act's mandate for coverage of contraception services.  Under the ACA, employers are required to cover a range of birth control methods on their employee health plans. Currently, explicit exemption from the contraception mandate exists for churches and houses of worship. Employees of such places will, however, be able to obtain birth control directly from their insurance companies.

[citizensproject.org]

Yesterday, the 6th Circuit Court of Appeals upheld the new law in Autocam v. Sebelius, Autocam is owned by the Kennedy family, practicing Roman Catholics, who argued this mandate would violate their religious beliefs. The court sent the case back to the district court with orders to dismiss the company's challenge, stating that Autocam lacked standing to challenge the ACA under the Religious Freedom Restoration Act, as it is a company and not an individual. (A somewhat surprising holding in light of Citizens United.)

This case is just one of several dozens across the country challenging the rule mandating contraception coverage since the regulations were announced in 2011.

In late July, the 10th Circuit Court of Appeals in Denver found an arts and crafts chain, Hobby Lobby, may be exempt from the requirement. Taking the opposite approach one week later, the 3rd Circuit held that a Pennsylvania Mennonite cabinet-making company could not be exempt because corporations cannot exercise religious freedom like a person can.

The difference of opinion could mean the Supreme Court is slated to decide the fate of the mandate.

Confused about Obamacare? Ask your local pharmacy!

Pharmacies across the country are becoming part of the effort to educate the public about the Affordable Care Act.

As part of a partnership between HHS (The Department of Health and Human Services) and Rite-Aid, licensed insurance agents will be available in nearly 2,000 Rite-Aid Stores to give FREE advice about Obamacare.

Agents will provide answers to questions about health benefits under the new law, as well as help people apply for coverage, financial assistance, or Medicaid coverage starting October 1 - the first day of open enrollments on health insurance exchanges.

Other U.S. pharmacy chains have also announced their plans to help provide health insurance enrollment.

• CVS Caremark will provide free health insurance enrollment at its stores.

• Walgreens has teamed up with Blue Cross/Blue Shield to promote the new healthcare law benefits.

• SoloHealth, which operates more than 3,200 digital health screening kiosks in Walmart, Sam's Club, and Safeway, announced Monday that it now includes information about the new healthcare law on it's screens.

• Winn-Dixie Pharmacy, Thrift White Pharmacy, and BI-LO Pharmacy will also help customers learn about Obamacare.

 

Mobile Health, Meet Your Biggest Obstacle: HIPAA.

More and more, doctors are using smartphones, iPads, Dropbox and other mobile devices and cloud storage to share electronic patient health information ("ePHI") with colleagues and to diagnose. In fact, health care reform incentivises the increased use of patient data to improve patient outcomes as one avenue to decrease health care spending.

Technology can facilitate more expedient second opinions, generate better patient outcomes with fewer resources and, therefore, save money.  However it can also expose providers and their business associates with huge fines if usage of this technology violates HIPAA.

Recent reports by Manhattan Research found that a 9% increase in physician smartphone use in 2010 resulted in a 32% increase in data breaches.  Each data breach carries a $50,000 fine, that can be increase drastically if the breach is not remedied.

What Is HIPAA and Who Does it Affect? 

HIPAA is short for the Health Insurance Portability and Accountability Act.  Title I of HIPAA protects health insurance coverage for workers and their dependants when they change or lose their jobs. Title II establishes national standards for electronic health care transactions to protect the privacy of individually identifiable health information that is "created, received, used, or maintained" by a covered entity or its business associate.  The regulations associated with Title II of HIPAA govern the recent increased use of smart phones and cloud storage of ePHI.

A covered entity is a health care provider, health plan, or health care clearninghouse that transmits any information in an electronic form.  A business associate is an individual or business with whom the covered entity engages to help it carry out its health care activities and functions.  Entities that do not meet the definition of either covered entity or business associate do not have to comply with HIPAA.

Common Causes of HIPAA Violations:

Cause	In 2010	In 2011
Lost or stolen computing device	41%	49%
Third-party problem	34%	46%
Unintentional employee action	45%	41%
Technical glitch	31%	33%
Criminal attack	21%	30%
Malicious insider	15%	14%
Intentional nonmalicious employee action	10%	9%

What Can Physicians Do?

1. Safeguard Mobile Devices. 
• Encrypt, encrypt, encrypt. Software is readily available that will encrypt smartphones and mobile devices.  Encryption means that information is sent in non-readable form, and must be unlocked by a key on the device of the person wishing to view it.
• Conduct periodic risk assessments. Document which devices are being used to transmit ePHI, whether proper encryption exists, and what physical protections are in place to secure ePHI.
• Password Protect All Devices. The lack of authentication on mobile devices presents a risk that any user of the device could access ePHI stored on the device 
2. Set policies on mobile use in your practice or at your hospital.  Pay special attention to security measures, such as antivirus software and password protection.  Small physician practices who don't have technology professionals thinking through these issues for them, like hospitals do, should sit down and review their technology policies.  Consider quarterly training meetings for physicians and staff to reinforce these policies.
3. Have a Secure Wi-Fi Connection.  Mobile devices that use public Wi-Fi or unsecure cellular networks to send and receive information risk exposing ePHI. Unless mobile device users connect to a secure website to transmit data or connect using a VPN ("virtual private networking"), which encrypts data to and from the mobile device, there is a risk ePHI could be compromised.