Informed Consent or Blurred Lines?

You may be familiar with the flyers, perhaps from your college days: NEED EXTRA CASH? ENROLL IN THIS STUDY.  You may have even participated and, when you did, you signed a form to give "informed consent" to your participation in the study. Like many legal documents, this form likely contained complicated clauses and statements that purported to explain the risks and benefits of the research study to you.

[motherwoman.org]

The ambiguous and jargon-filled language of study consent forms may, in fact, be due for a makeover. Yesterday, at a Health and Human Services public meeting in Washington D.C., federal informed consent regulations were under the microscope as stakeholders weighed in on how these regulations should be applied to participant-based research studies.

The catalyst for the public meeting? A national premie study with 20 participating research centers that looks at how much supplemental oxygen premies should receive.  The HHS Office of Human Research Protections raised a red flag earlier this year when they determined that prominent research centers at Yale, Stanford, Duke, and Emory didn't advise parents that their babies faced potential risks of blindness, neurological damage, or death.

"It would have been appropriate for the consent for to explain that the study involves substantial risks and that by participating in this study, the level of oxygen an infant receives would in many instances be changed from what they would have otherwise received," HHS said.

This public meeting is only the beginning of HHS's evaluation of the informed consent process.

Read more here: http://www.kansascity.com/2013/08/27/4441247/study-of-premature-babies-with.html#storylink=cpy

Read more here: http://www.kansascity.com/2013/08/27/4441247/study-of-premature-babies-with.html#storylink=cpy

Providers May Need To Re-Enroll To Get Medicare Reimbursements

New Medicare enrollment requirements for medical providers and suppliers may post serious billing issues if applications are not filled out properly and timely.

[amberusa.com]

Section 6401 (a) of the Affordable Care Act established a requirement for all Medicare-enrolled providers and suppliers to revalidate their enrollment information under new enrollment screening criteria. This revalidation effort applies to those providers and suppliers that were enrolled prior to March 25, 2011. Newly enrolled providers and suppliers that submitted their enrollment applications to CMS on or after March 25, 2011, are not impacted. 

One Kansas health department suffers the consequences of an untimely revalidation application.  The Lawrence-Douglas County health department is currently unable to bill Medicare for healthcare services it provides to seniors.  This self-proclaimed "personnel issue" has already cost the department upwards of $6,000.  

Between now and March 23, 2015, MACs will send out notices on a regular basis to begin the revalidation process for each provider and supplier. Providers and suppliers must wait to submit the revalidation only after being asked by their Medicare Administrative Contractor (MAC) to do so. Please note that 42 CFR 424.515(d), part of the rules issued by CMS under its rulemaking authority, provides CMS the authority to conduct these off-cycle revalidations.

Same Care, Higher Bill

Medicare Patients Hospitalized but not "Admitted" Can Face Higher Costs

The front page of the Boston Globe yesterday detailed how some hospitals charge Medicare patients different prices depending upon how the hospital classifies their care.  For instance, a patient admitted for "medical observation" receives a much larger bill than one whose stay is classified as "inpatient."  This is true even though the observation patient "usually share rooms with regular inpatients and receive care from the same doctors and nurses, making their status invisible to them."

[voxxi.com]

Although hospitals do not accept blame for these classification differences, the Globe's article showed that hospitals increasingly keep patients in "observation" status longer than the typical 24 to 48 hours.  This can have a startling effect on Medicare billing.

Medicare covers the cost of rehabilitation care in a nursing home if the patient was admitted to a hospital for at least three days of inpatient care.  However, the days that a patient under "observation" do not count toward the three-day minimum needed for Medicare coverage.  As a result, Medicare patients are getting stuck with bills in the thousands, forcing some seniors to file for bankruptcy.

Out of concern for this, Medicare issued regulations this summer they believe will help hospitals clarify this issue. But others, like Toby Edelman, senior policy attorney at the Center for Medicare Advocacy in Washington D.C., believe the regulations do not provide any clarity.  Edleman believes hospitals may be trying to avoid readmission penalties under the ACA for patients readmitted within 30 days of discharge.

Friday Variety: College Student Healthcare, An Arizona Law Bites the Dust, & Texas and California Agree on ACA

So Many Health Plans for College Students

Under the ACA, college students have many health plans to choose from.  First, if you're under 26 years old, the law allows you to stay on your parents plan if they have health insurance that offers coverage for family members.  Whether you're financially independent, single, or married, a person under 26 can stay on their parents' plan.

cheapscholar.org

Second, students can elect to purchase a health plan offered by their college.  However college students should be aware that self-insured schools -- that is, schools who who pay claims directly, instead of hiring an insurance company to do so -- do not have to meet the ACA's essential benefits requirement that otherwise mandates health plans to provide the full menu of "essential" health benefits.

Third, recent federal government regulations clarified that even if students who are eligible for student health plans at self-insured schools, they may still qualify for subsidized coverage on a state Marketplace, or exchange. Coverage purchased on the exchange would start in January, however, so college students would need to obtain coverage elsewhere for the Fall 2013 semester.

Finally, an even lower-cost option for college students may be Medicaid - the federal-state insurance program for low-income people.  Prior to the ACA, Medicaid coverage was reserved for children, pregnant women, and people with disabilities. However since the passage of federal healthcare reform, some states have expanded Medicaid coverage to include low-income adults, including college students.

Arizona Cannot Cut Planned Parenthood out of its Medicaid Program

The 9th Circuit struck down struck down an Arizona law that attempted to bar Medicaid patients from receiving care from medical providers who perform elective abortions, such as Planned Parenthood. The three-judge panel ruling was unanimous.

Texas and California Agree: Long Live the ACA

http://bit.ly/1f7gqve

Elected officials from both Texas and California traveled throughout their respective states yesterday to tout the ACA.  Rep. Lloyd Doggett (D-TX) sang the ACA's praises to constituents in East Austin.  Doggett also took time to criticize Texas Senator Ted Cruz for his attempts to defund the law.

http://lat.ms/14Lh3pg

Simultaneously, CA Sen. Barbara Boxer spoke to a health center in North Hollywood about the importance of spreading the word about the ACA.  She emphasized that insuring CA's 7 million uninsured residents will have a big effect on the success of the law.  "California is key." Boxer said.  "As California goes, I think so goes the Affordable Care Act."

UPS Drops Spousal Healthcare Coverage, Cites ACA

flintriver-home.com

The United Parcel Service (UPS) announced plans to drop 15,000 employee spouses from its healthcare plan.  UPS said "rising medical costs, 'combined with the costs associated with the Affordable Care Act, have made it increasingly difficult to provide the same level of health care benefits to our employees at an affordable cost.'" (Washington Times, 8/22.)  UPS spokesman Andy McGowan says the company expects the move to save $60 million a year.

CNBC notes that according to a recent Towers Watson survey, "mid- to large-sized companies overwhelmingly expect health-care costs to increase under Obamacare--and most are eyeing possible changes to their health insurance offerings because of a looming excise tax for pricier plans under the health-care reform law."  In fact, the survey revealed that 40 percent of the 400+ companies surveyed said they will be changing the design of their insurance plans in 2014.  Nearly 60 percent of those companies see the state health insurance Marketplaces as a possible way to control costs by shifting the work of insuring their employees onto the Marketplaces in the future.

In response to the UPS announcement, FedEx Corp. "isn't travelling the same route as delivery competitor UPS when it comes to trying to cut out health benefits for spouses and other family members. (Pittsburgh Business Times, 8/22.)

Is Your Xerox Machine Violating HIPAA?

The next time you go visit your doctor's office and notice an employee using the office copy machine, consider the type and volume of data that has crossed through that device -- consider how many patients' protected health information (PHI) is stored in the copier hard drives.

This is a consideration that New York-based Affinity Health Plan, Inc. failed to make before returning its leased copiers back to the leasing company.  As luck would have it, CBS Evening News was the subsequent purchaser of those copiers.  Much to their surprise, CBS discovered the PHI of 344,559 individuals on the copier's hard drive.  

Affinity settled the claim of the alleged massive HIPAA breach for $1,215,780 and the promise to institute a corrective action plan.  

"Electronic equipment with any type of memory or storage media has the capacity to retain data passed through it long after the data is believed to be removed or deleted." (Kevin Alonso, Esq., Arant Boult Cummings LLP, Nashville, TN.)  In light of the risks that newer technologies pose to the privacy and security of PHI, covered entities (health care providers, health plans or health care clearinghouses who transmit any information in electronic form), and now business associates (one who contracts to help a covered entity carry out its health care activities and functions), must do more than empty their computers' Recycling Bins in order to remain HIPAA compliant.

New ACA Roll-Outs: Abortion Coverage on the Hill, Medicare House Calls & Colorado Marketplace Rates

As full implementation of the Affordable Care Act approaches, many new programs and state Marketplaces continue to roll out daily.

Taxpayer-Funded Abortion Coverage for Congress

menudoreport.com

An amendment by Iowa Republican Senator Charles E. Grassley requires lawmakers and their staff to obtain coverage through the same insurance Marketplaces that many uninsured Americans will use.  However, many abortion opponents, including Sen. Grassley, worry that this will give members of Congress access to abortion coverage.  Currently, that benefit is denied to members of Congress and all federal employees who receive health insurance through a federal government plan.  Rep. Christopher H. Smith (R-NJ), who authored the abortion-funding ban for federal employee plans, says that requiring Congress to purchase health insurance in the Marketplace would be "a radical deviation and departure from current federal law."


Under the Affordable Care Act, every state must have at least one plan that does not cover abortion.  But the decision as to whether a state must have one plan that provides abortion coverage is left completely up to the individual state. So far, 23 states have barred or restricted abortion coverage in Marketplace plans; 27 states, and the D.C., have no such restrictions.

Medicare Doctors Make House Calls

www.nytimes.com

Under an ACA program called "Independence at Home," the Centers for Medicare and Medicaid Services contracted with 20 providers or provider groups nationwide to incentivize primary care providers who accept Medicare payments to make house calls to "medically complex patients."  The goal of the program is to improve quality of care and prevent future, more expensive treatments by encouraging doctors to invest in their Medicare patients up front.  The ACA authorizes expanding the program if this goal is met -- if quality of care improves at the same or lower cost and with the same or better outcomes.

Colorado Releases Marketplace Insurance Rates

Colorado's Division of Insurance released next year's rates under the ACA.  Colorado's Marketplace will house a whopping 18 different insurers providing 541 different plans for both individuals and small businesses.  The Denver Business Journal reported that these rates prove Colorado will not experience "rate shock," meaning consumers will likely not see higher sticker prices on the state's Marketplace than they do for presently available insurance options.  Like many states, the rates will depend on the region in Colorado where the customer lives.