Comparative Effectiveness Amendment Failed

Another amendment that would prevent the federal government from using certain data for comparative effectiveness data research.

The amendment and vote:


KYL-ROBERTS-CRAPO-CORNYN AMENDMENT #D8 America’s Healthy Future Act of 2009


Short Title: The PATIENTS Act Description: The amendment would add
the “Preserving Access to Targeted, Individualized, and Effective New
Treatments and Services (PATIENTS) Act of 2009” (S.1259).

SECTION 1. SHORT TITLE.

This Act may be cited as the `Preserving Access to Targeted,
Individualized, and Effective New Treatments and Services (PATIENTS)
Act of 2009' or the `PATIENTS Act of 2009'.

SEC. 2. PROHIBITION ON CERTAIN USES OF DATA OBTAINED FROM COMPARATIVE
EFFECTIVENESS RESEARCH; ACCOUNTING FOR PERSONALIZED MEDICINE AND
DIFFERENCES IN PATIENT TREATMENT RESPONSE.

(a) In General- Notwithstanding any other provision of law, the
Secretary of Health and Human Services--

(1) shall not use data obtained from the conduct of comparative
effectiveness research, including such research that is conducted or
supported using funds appropriated under the American Recovery and
Reinvestment Act of 2009 (Public Law 111-5), to deny coverage of an
item or service under a Federal health care program (as defined in
section 1128B(f) of the Social Security Act (42 U.S.C. 1320a-7b(f)));
and

(2) shall ensure that comparative effectiveness research conducted or
supported by the Federal Government accounts for factors contributing
to differences in the treatment response and treatment preferences of
patients, including patient-reported outcomes, genomics and
personalized medicine, the unique needs of health disparity
populations, and indirect patient benefits.

(b) Rule of Construction- Nothing in this section shall be construed
as affecting the authority of the Commissioner of Food and Drugs under
the Federal Food, Drug, and Cosmetic Act or the Public Health Service
Act.


Offset: None

Republicans
CHUCK GRASSLEY -yes
ORRIN G. HATCH -yes
OLYMPIA J. SNOWE- yes
JON KYL -yes
JIM BUNNING -yes
MIKE CRAPO -yes
PAT ROBERTS -yes
JOHN ENSIGN -yes
MIKE ENZI -yes
JOHN CORNYN -yes

Democrats
MAX BAUCUS -no
JOHN D. ROCKEFELLER -no
KENT CONRAD -no
JEFF BINGAMAN -no
JOHN F. KERRY -no
BLANCHE L. LINCOLN -no
RON WYDEN -no
CHARLES E. SCHUMER -no
DEBBIE STABENOW -no
MARIA CANTWELL -no
BILL NELSON -no
ROBERT MENENDEZ -no
THOMAS CARPER -no

Not Agreed to (10-13)

2nd Public Option Senate Finance Amendment Dead

The second shot at a public health insurance option died in the Senate Finance Committee. It was offered by Senate Chuck Schumer (D-NY):

Schumer Amendment #C1 to Title I, Subtitle E-

Short Title: Level Playing Field Public Option

Description of Amendment:

Strike Title I, Subtitle E, Health Care Cooperatives and replace with a national ―level playing field‖ public health insurance option with negotiated reimbursement rates to enhance competition for consumers within the Exchange.

The new national level playing field public option must adhere to the same rules (actuarial reporting, community rating and guaranteed issue) as all other plans in the Exchange and must be self-sustaining with premiums and copayments covering claims. Like private plans, the ―level playing field‖ public option would also be required to establish a reserve fund. Aside from covering some initial start-up costs, general revenues or annual appropriations may not support the ongoing operation of the plan.

The government must not use existing programs like Medicare as a stick to compel providers to participate in the public option. Instead, doctors and hospitals should be able to voluntarily opt-in to participate in the public option.

Offset:

Increase annual fee on for-profit health insurance providers by amount necessary to offset the increase in spending.

Republicans
CHUCK GRASSLEY -no
ORRIN G. HATCH -no
OLYMPIA J. SNOWE -no
JON KYL -no
JIM BUNNING -no
MIKE CRAPO -no
PAT ROBERTS -no
JOHN ENSIGN -no
MIKE ENZI -no
JOHN CORNYN -no

Democrats
MAX BAUCUS -no
JOHN D. ROCKEFELLER -yes
KENT CONRAD -no
JEFF BINGAMAN -yes
JOHN F. KERRY -yes
BLANCHE L. LINCOLN -no
RON WYDEN -yes
CHARLES E. SCHUMER -yes
DEBBIE STABENOW -yes
MARIA CANTWELL -yes
BILL NELSON -yes
ROBERT MENENDEZ -yes
THOMAS CARPER -yes


Not Agreed to (13-10)

1st Public Option Amendment in Senate Finance Committee Dead

The first public health insurance option offered in the Senate Finance Committee died. This was offered by Senate Jay Rockefeller (D-WV).

The details:

Rockefeller Amendment #C6 to Title I, Subtitle C (Making Coverage Affordable)

Short Title: Consumers Health Care Act (S. 1278), as modified

Description of Amendment:

This amendment would add a strong public health insurance option, the Consumer Choice Health Plan (CCHP), to the exchange to compete directly with private plans. Like private health plans, CCHP would be offered to all individuals and businesses purchasing health insurance through the national health insurance exchange. To guarantee plan availability nationwide, public program provider networks will be used.

The Consumer Choice Health Plan will be financially self-sustaining (subject to an annual third party audit). The plan administrator will establish and fund a contingency reserve for CCHP in a manner similar to that of the contingency reserve established by OPM for the Federal Employees Health Benefits Plan. Funds to operate the plan shall be derived from premiums for individuals enrolled under the plan.

To help enrollees afford the cost of coverage, the same premium subsidies would be provided to enrollees in CCHP as those offered to consumers enrolled in private health plans. Any additional revenue gained under this public plan option would be reinvested in CCHP in the form of reduced premiums and cost-sharing or increased benefits.

At a minimum, the Consumer Choice Health Plan would be required to follow the same insurance regulations as private plans operating in the exchange. CCHP would also be required to offer the same type of plans as private plans participating in the exchange. Minimum benefit requirements for children would be based on the pediatric care guidelines provided by Bright Futures, which offers evidenced-based direction on the provision of well-child and other primary health care services. The provider payment rates for the first two years of CCHP would be based on Medicare provider payment rates, including new delivery models enacted as part of health reform. For subsequent plan years beyond the first two years, CCHP would be required to determine competitive provider payment rates based on public and private best practices, integrated models of care delivery (such as medical home and chronic care coordination), evidence-based practices, quality improvement, and the use of health information technology.

This amendment would also establish America‘s Health Insurance Trust to give consumers a voice in health insurance oversight. This nonprofit, consumer-driven organization will evaluate and give ratings to all health insurance products offered through the national health insurance exchange based on factors such as affordability, adequacy, transparency, consumer satisfaction, provider satisfaction, and quality.

The CCHP shall not include abortion, except in cases of rape, incest, or the life of the mother. It also prohibits the expenditure of Federal funding for abortion and it requires the segregation of funds to ensure that no Federal dollars pay for abortions.

Republicans
CHUCK GRASSLEY -no
ORRIN G. HATCH -no
OLYMPIA J. SNOWE -no
JON KYL -no
JIM BUNNING -no
MIKE CRAPO -no
PAT ROBERTS -no
JOHN ENSIGN -no
MIKE ENZI -no
JOHN CORNYN -no

Democrats
MAX BAUCUS -no
JOHN D. ROCKEFELLER -yes
KENT CONRAD -no
JEFF BINGAMAN -yes
JOHN F. KERRY -yes
BLANCHE L. LINCOLN -no
RON WYDEN -yes
CHARLES E. SCHUMER -yes
DEBBIE STABENOW -yes
MARIA CANTWELL -yes
BILL NELSON -no
ROBERT MENENDEZ -yes
THOMAS CARPER -no

Not Agreed to (15-8)

Patient-Centered Outcomes Amendment Fails in Senate Finance Committee

Senator Pat Roberts (R-Kansas) offered an amendment to strike the patient-centered outcomes program in the Senate Finance health care overhaul bill. It failed on a mostly party-line vote (Olympia Snowe defected).

Roberts Amendment # D4 to Title III, Subtitle F, Patient-Centered Outcomes Research Act of 2009



Short Title: To protect patients and doctors



Description of Amendment: Strike Title III, Subtitle F, Patient-Centered Outcomes Research Act of 2009



COST: $0


OFFSET: n/a

Republicans
CHUCK GRASSLEY -yes
ORRIN G. HATCH -yes
OLYMPIA J. SNOWE -no
JON KYL -yes
JIM BUNNING -yes
MIKE CRAPO -yes
PAT ROBERTS -yes
JOHN ENSIGN -yes
MIKE ENZI -yes
JOHN CORNYN -yes

Democrats
MAX BAUCUS -no
JOHN D. ROCKEFELLER -no
KENT CONRAD -no
JEFF BINGAMAN -no
JOHN F. KERRY -no
BLANCHE L. LINCOLN -no
RON WYDEN -no
CHARLES E. SCHUMER -no
DEBBIE STABENOW -no
MARIA CANTWELL -no
BILL NELSON -no
ROBERT MENENDEZ -no
THOMAS CARPER -no

Not Agreed to (9-14)

Cardiologists' Overhead Going Up According to MedAxiom

A study by MedAxiom found that cardiologists' overhead came in at a new high of $710,000 in 2008. Office visits to cardiologists increased by 12 percent and return visits by patients increased 34 percent. Cardiologists tended to perform at least one echocardiography test per day in 2008. That's a 43 percent increase over the number of echocardiograms performed five years ago.

ER Waiting Times Now Online

In a response to consumer demand, several hospitals are now posting ER waiting times online. Part of this could be due to the new competition coming from free-standing ERs.

More from The Hartford Courant: http://tinyurl.com/qg2mhs

Upcoming MedPAC Meeting - Fast Medicare Growth

MedPAC will be meeting later this week in Washington. The two most interesting panels on Friday will be:

10:30 AM – 11:15 AM

Comparative effectiveness: physician perspectives and ongoing initiatives


11:15 AM – 12:15 PM

Episodes that account for the greatest share of Medicare spending and fastest growth

More to follow.

Free-Standing ERs Licensed in Texas Soon

The 2009 Texas Legislature passed a new law (HB 1357) that will regulate free-standing ERs in Texas. It's hard to tell how many there are, but it appears that there are about 40 free-standing ERs in Texas. Also, it's important to not confuse these with the walk-in retail clinics (CVS, etc.).

The licensing of free-standing ERs in Texas will begin in September 2010. The regulators are in the process of drafting regulatory measures.

Some of the key issues include:

* Whether or not you can have two different types of facilities licensed at the same address (you can't currently do that under Texas law). But there are probably a few health care facilities that would like to add a free-standing ER to their building.

* Another big question is what should the credentials of the physicians at the ERs be. Currently, a physician does not have to have special emergency medicine credentials to work in a free-standing ER (or even in a hospital ER).

* Pediatric credentials for an RN will be a big measure that needs to be addressed. (Should a nurse with pediatric emergency credentials be in the facility at all times?)

* Perhaps the most interesting issue that will have to be addressed involves that of laboratory services. The proposed rules suggest three types of labs: waiver, moderate, and high-end. The latter two require strong credentials for the lab director (MD or PHD and additional training). The question in this case ultimately becomes: What will lab services look like in a few years? Should the government prescribe a lot of standards now and then turn around and those standards will be out-of-date in a few years?

New Medicare Physician Fee Schedule & Cardiologists

CMS is expected to release its final rule for the 2010 physician fee schedule on November 1, 2009. They gave us a preview of what it could look like earlier this summer. The big story is that it could result in large cuts for specialties and increase payments to primary care physicians.

Those specialties that have a strong emphasis on imaging could see the biggest cuts. In particular, cardiologists could be hit hard.

Here's a look at what the proposed rule could mean for cardiologists:

Practice Expense (PE)
CMS has proposed incorporating the AMA's Physician Practice Information Survey (PPIS) to update the practice expense component of physician fees. This could result in a 10 percent decrease in PE RVU changes (leading to a grand total of a negative 11 percent combined impact on cardiology in the 2010 physician payment fee schedule). Other specialties fare better: anesthesia, family practice and ophthalmology would see increases.

Potential Cuts to Cardiology:

- 42 percent Transthoracic Echo Proposed Cuts
- 24 percent Left Heart Catheterization Proposed Cuts
- 21 percent ECG Payment Proposed Cuts
- 40 percent Technical Component of CT, MR and IMRT Proposed Cuts
- 11 percent Proposed Increase for Office Visits (Level 4 Established Patient Office Visit - 99214)

Consultation Codes
The proposal would stop payments for consultation codes and use existing E/M service codes. CMS claims that the "savings" would be re-distributed to E/M service codes.

Equipment Utilization: 50 percent to 90 percent
CMS proposes to adopt MedPAC's recommendation regarding medical equipment that costs more than $1 million. It would be assumed that the equipment is being used 90 percent of the time that the office is open (as opposed to the current 50 percent).

Other interesting aspects include the idea of separating administered drugs from the physician fee schedule. Physicians will also face a massive cut of over 20 percent if the SGR formula is not updated.

Red Flag Rules Enforcement Pushed Back Again

Red Flag Rules
By Brant Crouch and Jason Lavender

We've all heard a horror story about identity theft - or perhaps you have been a victim yourself. But did you know that you (individually) and your hospital could be found guilty of stealing someone else's identity without even knowing that you did it? You read correctly. Any institution or individual who HANDLES personal non-public information is at risk of breaking new Federal and State Identity Theft Legislation. Non-compliance carries strong consequences such as fines, criminal and civil litigation and up to 10 years in prison.

This article focuses on one particular area known as the Red Flag Regulations. Enforcement has been delayed until May 1, 2009. In late 2007, the Federal Trade Commission ("FTC") issued sweeping regulations aimed at deterring, detecting and preventing identity theft. Under these rules, known as the Red Flag Regulations, 16 C.F.R. § 681.1 et seq. and Final Rule ("Red Flag Regulations") financial institutions and creditors of covered accounts must establish a program to detect, prevent and mitigate identity theft. For more information go to http://www.ftc.gov/bcp/edu/pubs/articles/art11.shtm.

Most health care providers fall under the regulation due to its definition of Creditor. It applies to personal accounts that are paid after the service is rendered or if the service is intended to be paid in installments. Most health care accounts or charges are not paid in advance of service. However, even if a provider generally provides care on a pre-paid basis, accepting patient payments plus insurance payments amounts to a multiple payment account would make the provider subject to the Red Flag regulations. It's important to note that the American Medical Association (AMA) and several other healthcare associations are making efforts to get the FTC to remove health care providers from the definition of Creditor. However, it appears that the FTC will continue to broaden the scope of who will need to comply versus narrowing it. In a February 4, 2009 response to the AMA, the FTC specifically addressed this issue by reinforcing that providers will not be excluded and cites several reasons why. To obtain a copy of this letter or more information you may email the authors of this article.

So now what can health care providers do to get in compliance as quick as possible and most cost effectively? Much of what needs to be done to comply can be done internally using your own staff. Many compliance plan templates are available for free and some at a nominal cost. However, the multiple steps required to comply fully with the regulation involve employee training for ALL staff, third party vendor notification, and possibly more heavy lifting. One option is to utilize an outside resource to assist in providing the employee training. TPHAC has a resource available to all members that provides these services at no cost.

Many medical facilities around the country have taken pro-active measures to ensure that they protect and educate their own staff and the public they serve by enforcing a solid privacy policy as one way to minimize internal risks. One CEO said, "We take pride in the fact that we are taking the reasonable steps necessary to protect our staff, patients and private records. Our employees have found significant value in the Identity Theft awareness training and related employee benefits we now provide."

One of the leading publications for business legal issues, Business & Legal Reports, writes:

"One solution that provides an affirmative defense against potential fines, fees, and lawsuits is to offer some sort of identity theft protection as an employee benefit. An employer can choose whether or not to pay for this benefit. The key is to make the protection available, and have a mandatory employee meeting on identity theft and the protection you are making available, similar to what most employers do for health insurance."

John Gardner, a former member of the South Carolina House of representatives and 23-year veteran attorney explains that, "The government says that an institution must have four things: a written privacy policy, someone to oversee that policy, training for your employees on the true problem of identity theft, and a mitigation plan in place."

Many health care providers either don't know about these laws or falsely believe that they are exempt from them. Some state governments like Texas have taken the aggressive approach of sending investigators out to businesses to look for violations.

"Identity theft is one of the fastest growing crimes in the United States," Attorney General Greg Abbott said. "Texans expect their personal information to be protected. The Office of the Attorney General will take all necessary steps to ensure that consumers are protected from identity thieves." And they have; making examples of many companies from large ones like Radio Shack and EZ Corp, to smaller businesses like modeling agencies and beauty colleges.

While there's no doubt that health care providers simply do not need any more government compliance headaches, it's clear that when it comes to identity theft there will be no letting up. The AMA will continue to contest this issue with the FTC. In the meantime, it is important to take immediate steps regarding compliance and providing identity theft protection to your patients and employees might be the best way to address these challenges.

Brant Couch, CPA and Vice President with HealthSure, Inc. is located in Austin,Texas. He can be reached at 512-292-3315 or brantc@healthsure.com.

Jason Lavender, Managing Partner & Certified Identity Theft Risk Management Specialist with ID Theft Solutions of America, is located in Austin, Texas. He can be reached at 512-514-6598 or jlavender@idtsoa.com.

Hospital-Acquired Infection Policy Change Makes Little Impact on Medicare

CMS recently created a new policy in which it would penalize health care facilities for the extra costs of treating hospital-acquired infections. Today's Wall Street Journal (09/09/09) found that it might not make a difference:

"The government won't save much from Medicare's year-old policy of refusing to pay hospitals' extra costs to treat hospital-acquired infections and injuries such as bedsores, a new study concludes. Medicare adopted the policy last year with the goal of saving lives and cutting costs. Each year, about 1.7 million Americans acquire infections while in the hospital, and 99,000 of them die, according to the federal Centers for Disease Control and Prevention. Medicare . . . stopped paying the extra costs of treating 10 hospital injuries and infections beginning Oct. 1, 2008"

The state of Texas is following Medicare's lead and passed legislation in the 2009 Legislature that would require state-run programs (for example, Medicaid) to adopt a similar policy. However, it is not clear when this will go into effect considering the fact that money was not appropriated to enforce this policy.

House Bill 2256 - Facility-Based Physician Disclosure

House Bill 2256 is a new law that requires Texas health care facilities to disclose to their patients that facility-based physicians may be out-of-network. And it also sets up a mediation process as well.

The new law also places the burden on the facility-based physician as well. A facility-based physician who bills a patient covered by a PPO or HMO and does not have a contract with the patient's plan is required to send a notice to the patient regarding the mediation process that is available.