Health Care: A Year in Review

Hello from sunny San Diego!

Since Saturday evening, I have been attending various meetings and lectures at the American Health Lawyers Association (AHLA) Annual Meeting.  Yesterday I sat alongside in-house counsel from around the country learning about how the ACA, Mobile Health, ACOs, and HIPAA are affecting generals counsel of health care organizations.

Today, the AHLA Annual Meeting kicks off with a "Year in Review." Here are some highlights from the past year in healthcare law:

     - More U.S. Supreme Court cases than ever before in the area of health care.

     - An avalanche of regulations in every area of health care.

     - Americans are dead last, because they are dead first:

          -- Americans have the shortest life expectancy in the developed world.

          -- US men rank last and women rank next to last.

     - Unnecessary medical services add up to $210 billion, an amount that would cover all 

        uninsured Americans. (Institute of Medicine)

     - "[T]he American health care market has transformed tax-exempt 'nonprofit' hospitals into the 

        towns' most profitable businesses and largest employers, often presided over by the regions'  

        most richly compensated executives." (Steven Brill, The Bitter Pill)

     - Under Medicare, a procedure is billed 3x more if the doctor is a hospital employee, than if the  

       hospital is independent.

     - Computers out-perform doctors in treating patients. (ModernHealthcare.com, 2/14/13)

     - Miracle of the Year: 20 y.o. Canadian woman delivers baby is 3 degree weather before she can    

       get to the hospital. The baby is pronounced dead and covered up by a sheet until the coroner can 

       get there...only to realize later that the sheet was moving and the baby was actually alive!

     - Patient Dumping: Nevada buses 1,500 mental patients out of state since 2008. (USA Today, 

       4/26/13)

     - People hated more than lawyers: Congress!  A poll has shown that Congress is less favorably 

       liked than cockroaches, brussel spouts, colonoscopies, and NFL replacement reps (but they did 

       better than Lindsay Lohan). 

     - The House has voted to repeal Obamacare 37 times, to no avail. (Washington Post, 5/17/13)

          -- Most ACA challenges in the courts have failed.

     - Some Health Reform changes over the past year:

          -- Young adults are on their parents' policies to age 26.

          -- 17 states and DC are establishing exchanges.

          -- Medicaid expansion is supported in 27 states (expanded to adults in 7 states).

          -- Health home has been option adopted by 10 states.

          -- Access to Primary Care: increased Medicare and Medicaid payments to primary care 

             providers, increased state health center patient capacity.

    

     - The contraceptive mandate debate: under the ACA, health plans must cover women's 

       preventative care services, including all contraceptive methods (with an exception for religious 

       employers).

That's all for now! I will continue to blog from the conference over the next few days, so check back in for the latest summaries of meeting and break-out sessions.

Friday Variety: NO Smoking and MORE Abortion News

On Tuesday, the FDA finally stood up to the Tobacco industry.  Four years ago, President Obama signed a tobacco bill granting the FDA authority to exercise its power to regulate cigarettes and other tobacco products.  

Under the law, the F.D.A. is able to set product standards and ban some chemicals in tobacco products, but not totally ban addictive nicotine. The F.D.A. also set up a new tobacco regulatory office financed by industry fees, which totaled $85 million in the first year and as much as $700 million annually within 10 years.
The F.D.A. has had the power not only to consider changing existing products, but also to ban new products unless the agency found they contributed to overall public health. 

Exercising this power, the FDA has allowed two products to be sold - metholated versions of Newport cigarettes - and rejected four others.  According to the LA Times "Science Now" blog, "those products, which the FDA is legally forbidden to identify, raised questions of public health that have not been substantially answered by studies of existing products."

The FDA has stated it will continue to allow more products if they are similar enough to ones already on the market.

Abortion, again?

Delaware, North Dakota and Texas all made headlines this week for their abortion law efforts:

Delaware: In a unanimous vote, the Delaware Senate aproved a bill (discussed here last Friday) that more tightly regulates abortion clinics. The measure will now go the House.

North Dakota: On Tuesday, a women's rights group filed a lawsuit in Federal court to bock a North Dakota ban on abortions. The ban makes illegal abortions as early as six weeks into pregnancy, a law the New York Times calls "the country's most stringest abortion law." The law, enacted in March, forbids abortions once a fetal heartbeat is "detectable."  This can be as early as six weeks and even before many pepole know they are pregnant.  The complaint states that the law seeks "to interfere directly in personal, private medical decisions that the Constitution and more than 40 years of US Supreme Court precedent guarantee to women as a fundamental right."

Texas: After the widely publicized and acclaimed fillabuster by Wendy Davis, a Democratic senator, Texas Governor Rick Perry called the state legislature back in session July 1 to give state lawmakers another chance to pass a measure that may close most of the state's abortion clinics.

DOMA Opens Doors for LGBT Americans

Yesterday's post announced The Supreme Court's ruling striking down DOMA and effectively restoring marriage equality in California. Here are more details on how the death of DOMA will affect healthcare for LGBT Americans across the country:

• Same-sex households will now be eligible to share the benefits of employer-based health insurance. 

• Same-sex partners will now have the authority to make medical decisions on behalf of a spouse.

• The cost of healthcare for same-sex couples will likely go down, as they are now eligible for federally guaranteed rights Medicare and Medicaid.

• Same-sex couples in states that recognize their marriage can now qualify for the Family and Medical Leave Act, which gives covered employees 12 work weeks of unpaid leave in a 12-month period for various reasons including the birth of a child, receiving a child through adoption or foster care and for caring for their spouse or child who has a serious health condition.

• In a lot of cases, children of same-sex couples will have expanded access to insurance and various other government protections and benefits that will come automatically as a result of having two legal parents.

• Surviving spouses are now entitled to their deceased spouse's benefits,  such as Social Security payments, and tax-free property left to the surviving spouse that would help the spouse to keep a family afloat.

• But for some same-sex couples, being counted as "one family unit" can negatively affect whether they qualify for various benefits under the law.  For example, same-sex partners who each have an income of $40,000 may be eligible for the premium assistance tax credits under the ACA (the discounts on premiums for low-income-eligible Americans) -- but only if they remain single. (Calculate your premium subsidy HERE!)

HHS Secretary Kathleen Sebelius has vowed "The Department of Health and Human Services will work with the Department of Justice to review all relevant federal statutes and ensure this decision is implemented swiftly and smoothly."

Same-Sex Spousal Dependents for Health Insurance

I'm not naive enough to think that the definition of "spouse" has automatically been changed for everyone this morning.  But I will stand a little taller today knowing that gay married couples and those in same-sex unions will be afforded the same legal and economic protections as straight couples.

This morning, SCOTUS announced two important decisions involving gay rights.  First, it struck down the Defense of Marriage Act (DOMA).  In a 5-4 decision, the majority held section 3 of the 1996 law unconstitutional.  The decision reads:

DOMA violates basic due process and equal protection principles applicable to the federal government. Under DOMA same-sex married couples have their lives burdened, by reason of government decree, in visible and public ways.

(http://www.supremecourt.gov/opinions/12pdf/12-144_8ok0.pdf.) 

For health care law, this means same-sex couples that are either married or in a civil union can, among many others, list their spouses or partners as dependents on their health insurance plans.

The Court also vacated the 9th Circuit's ruling on Proposition 8 and remanded the case to the District Court, effectively striking down California's same-sex marriage ban imposed by voter initiative.

San Francisco City Attorney Dennis Herrera has stated that there will be a 25-day waiting period for the losing side to petition for a rehearing. If the petition is not granted, or filed, by the end of that waiting period, gay marriage will be legal in California and county clerks can begin issuing marriage licenses to same-sex couples immediately.

Now get out there and celebrate!

(For a better understanding of standing, see this helpful article on ScotusBlog.)

Blinding FDA Approval

Final Score:

Generic Drug Industry - 1

Consumer Safety - 0

 In a 5-4 Opinion announced this Monday, the Supreme Court ruled that as long as the brand-name version of a drug receives FDA approval, the generic manufacturers of the same treatment cannot be sued for the drug's design defects in state court.

The ruling overturned a $21 million jury award to Karen Bartlett, a New Hampshire woman who suffered severe burns and lost nearly all of her eyesight after she began taking Mutual Pharmaceutical's generic version of Merck's nonsteroidal anti-inflammatory drug, Clinoril (sulindac), for shoulder pain.

Also released on Monday was a study by Public Citizen which found that current FDA regulations "do not adequately allow for generic drug manufacturers to update their labels if new dangers are revealed once a drug is on the market." The study added that there are at least 52 FDA-approved medications that have "required new warnings for serious or life-threatening risks in the last 5 years." Since generics account for 80% of all prescriptions filled last year, Public Citizen urged the FDA to "allow drug producers to report updated safety information." This reporting would ensure warnings are up to date and also correct a disparity in legal rights for consumers.

So now's the time Congress to re-evaluate the protections given to generic drug manufacturers. And they better do it now, or there will be more Karen Bartletts to come.

Translation: No Translation

While the ACA, when fully implemented, aims to expand insurance coverage to 27 million previously uninsured Americans, it does not offer health insurance to illegal immigrants.  However, the immigrant communities that may not purchase the newly-available health insurance are not all illegal immigrants.   Researchers at UC Berkeley and UCLA estimate that three-quarters of the remaining uninsured population after Covered California takes effect, will be U.S. Citizens, or lawfully present immigrants.

As KQED's The California Report broadcasted this morning, selling healthcare reform to the nation's immigrant communities may prove difficult. Apparently the health insurance applications through Covered California, the state's health insurance exchange website, are only available in English and Spanish.  Because the first open enrollment period begins October 1, 2013, there is likely not enough time to expand applications to more languages this time around. This marketing hole will likely serve to alienate large groups of non-English speaking communities because of language barriers, such as the neighborhood of Little Saigon in Orange County - home to one of the state's largest Vietnamese populations.

Many immigrant community organizers have received grants from Covered California to expand outreach efforts to non-English speaking communities, including over a dozen organizations that will reach the state's Asian populations.  These efforts must include education about basic insurance terms, such as co-pay and deductible, as well as assurances that the ACA is not a scam to take their money. Many Asian immigrant communities, KQED reported, have a heightened sensitivity to such scams and may be extremely wary of organizations touting "Cheap Health Insurance."  

California's massive marketing campaign to enroll all eligible Californians is set to kick off next month.

Friday Variety: SCOTUS, Gay Blood Donors, and Planned Parenthood

The Federal Government Must Obey the 1st Amendment

US Agency for International Development v. Alliance for Open Society

In a 6-2 decision, the Supreme Court ruled Thursday that it is in violation of the 1st Amendment for the Federal government to mandate humanitarian groups to endorse the government's views opposing prostitution and sex-trafficking in order to receive funding to combat HIV/AIDS overseas.  

The ruling struck down a 2003 law that imposed two conditions on private groups that received billions in Federal aid to fight HIV/AIDS: (1) the money may not be used to promote or advocate the legalization or practice of prostitution and sex trafficking; and (2) Recipients must include a policy explicitly opposing prostitution and sex trafficking. Only the legality of the second was challenged in court.

In the majority opinion, Chief Justice John Roberts cited a 70 year old Supreme Court opinion by Justice Robert Jackson which struck down a law requiring schoolchildren, including Jehovah's Witnesses, to salute the American flag. Roberts repeated:

"If there is any fixed star in our constitutional constellation, it is that no official, high or petty, can prescribe what shall be orthodox in politics, nationalism, religion, or other matters of opinion or force citizens to confess by work or act their faith therein."

Roberts was joined by all Justices except Thomas and Scalia, who dissented, and Justice Kagan, who recused herself as she defended the law while US solicitor general.

Gay Blood Donor Ban Opposed by American Medical Association

As ABC News reported, the AMA has condemned the long-standing ban on gay male blood donors as "discriminatory" and "not based on sound science."  AMA officials are recommending that the FDA amend its policy to evaluate gay men on an individual basis, rather than collectively deeming all gay men a "high-risk" category as the current policy reads. 

The original ban, put into place in 1983, was in response to the AIDS epidemic. At that time, no tests existed to check blood donations for HIV.  Now that much more is known about the virus, legitimate tests are in place to check every blood donation for HIV. 

Planned Parenthood: Abortion Laws

Kansas 
Planned Parenthood filed a lawsuit Thursday over a new Kansas law requiring doctors to inform women seeking abortions that they are ending the life of a "whole, separate, unique, living human being," the AP reported. The Overland Park, KS, clinic contends that the law violates doctors' free speech rights, and requires doctors to make "a misleading statement of philosophical and/or religious belief."

Kansas Attorney General Derek Schmidt vows to vigorously defend the Kansas statute.

Delaware
Meanwhile, the Delaware Senate is considering a bill authorizing tighter regulations on abortion clinics. The bill proposal follows a recent citation of a Wilmington Planned Parenthood for unsafe and unsanitary practices that are a "clear and immediate danger to the public." Two former nurses of the same clinic have also come forward, stating that the facilities are unclean and put women at risk of blood-born illnesses and bacterial infections. 

The bill would allow abortion clinic employees, in addition to patients, to file complaints for investigations by the Dept. of Health and Social Services. It would also require abortion clinics to be accredited by a state-approved independent accrediting organization with no conflict of interest.

Cut Waste, Save Money

Shannon Brownlee's 2007 book "Overtreated" reframed the debate over healthcare reform by exposing the unnecessary procedures and treatments that contribute to the staggeringly expensive cost of healthcare. Seven years later, the state of California takes a page from Brownlee to help doctors and patients make better choices, cut waste and make healthcare more affordable.

 

Covered California, the state's health insurance exchange, disseminated a press release yesterday announcing their collaboration with "Choosing Wisely," a partnership of the American Board of Internal Medicine Foundation, Consumer Reports, and leading national medicine societies.  The newly forged partnership aims to provide evidence-based recommendations to help physicians and patients make wise decisions about appropriate care based on individual situations.

Lists of commonly ordered (but not always necessary) procedures and tests that could cause undue harm, both physically and financially, are already being distributed to physicians and patients through consumer advocacy partners.  If successful, this effort will reduce duplication (when doctors run the same tests on patients due to incomplete medical records or misinformation) and waste (unnecessary procedures based on uninformed decision-making), and makes sure each patient receives the most appropriate care.  

For more information on Covered CA's outreach and education, visit www.CoveredCA.com.

A Woman's [Dwindling] Right To Choose

On Tuesday, abortion was the word of the day:

Federal Level

The House passed an anti-abortion bill that would limit nearly all abortions to the first 20 weeks after conception. The vote count, which broken down mostly along party lines, was 228-to-196.  (Note: only 19 of the 234 Republican House  members are women.) Most print news outlets reported that the measure has no chance of becoming law under the Obama administration because (1) it has not scheduled a vote on it, and (2) the White House issued a veto threat Monday, calling the bill an "assault on a woman's right to choose."

State Level

On the same day, the Texas Senate passed a bill that may result in massive closures of abortion clinics across the state.  The pending legislation requires abortions to be done in ambulatory surgical centers by doctors with admitting privileges at a hospital within 30 miles of their clinic.  Only 5 out of 42 clinics meet the proposed guidelines.

Michigan, too, followed suit, when it's Republican-led Senate Judiciary Committee approved legislation that could make it more difficult for a minor to end a pregnancy by abortion without parental consent.  As it stands, Michigan law bars clinics from performing an abortion on a minor without parental written consent (or a waiver from a judge).  This new law would close that supposed loophole, which supporters of the bill claim allows minors to "waiver shop," going to court multiple times until they find a judge willing to grant them permission.  The bill seeks to deny a minor from obtaining a waiver in family court if a previous judge denied a request involving the same pregnancy.

Lastly, New York Governor Andrew Cuomo conceded that "enshrining abortion rights more firmly into state law"--one of his top two priorities--were not likely to be taken up by the Legislature this year. 

Cuomo, a Democrat, has proposed passing an abortion measure as part of a 10-part Women's Equality Act.  His proposal was supported in the Democrat-controlled Assembly, but not in the more conservative Senate.  After a recent objection by Republicans to the abortion language of the Act, a bill was introduced Sunday omitting the abortion provision, which intended to codify the Supreme Court's Roe v. Wade ruling into state law.