Life Science Compliance Update

« September 2009 | Main | November 2009 »

39 posts from October 2009

October 30, 2009

Physician Payment Sunshine Act: House Affordable Health Care for America Act Sunshine Provision

The US House of Representatives released their latest version of the “Affordable Health Care for America Act,” which contains new language regarding the Physician Payments Sunshine Provision. The final bill language in the house version (starting on page 889 of 1990 pages) is summarized below.


The bill establishes a new section regarding “Financial Reports on Physicians Financial Relationships with Manufacturers and Distributors of Covered Drugs, Devices, Biologicals, or Medical Supplies Under Medicare, Medicaid, or CHIP and with Entities that Bill for Services Under Medicare.”


Differences between this bill and previous version introduced in July include:


The House moved the start date for this provision from 2011, to begin reporting of all information and payments made in 2010  and reporting on April 1, 2011 (but throughout the Bill there are different non corresponding dates) which would be an impossible task by any measure.


Added to the preemption criteria should not pre-empt state laws that require the disclosure of any type of information by any person or entity other than an applicable manufacture.


Added a GAO report to review the extent of reporting, and under reporting, the impact of federal pre-emption, changes to the patterns of payments as an effort to evade reporting, description of financial relationships subject to delayed reporting, and improvement in collection, and analysis.


Added Inclusion Criteria:


o   Payments associated with medical supplies to be reported.


o   Reporting of donations by manufactures and suppliers to self insured health plans.


o   Physician ownership interest by physicians or immediate family members in a manufacturer, group purchasing organization or distributor.


o   Broadly defining group practices to include group practices and hospitals.  

o   ”Any organization that purchases, arranges for or negotiates the purchase of a covered drug device biological or medical supply.


o   Establishes a study, to be conducted by the Comptroller General of the United States, to evaluate the extent of use of physician self-referral arrangements and the effects of such arrangements on the cost of providing advanced diagnostic imaging and radiation oncology services to Medicare beneficiaries.  This report will be submitted to Congress no later than July 1, 2011


o   Any entity under common ownership which sells medical products or provides assistance and support  to a manufacture or GPO, with respect to the production, preparation, propagation, compounding, conversion, processing, marketing or distribution of a covered drug device or medical supply. 



§  This would mean that even the microscope manufactures, the advertising agencies, the realtor who sold the building to create the product and on and on, the manufacture would be liable if they failed to report if they bought lunch for the lab techs.


§  If a CME provider is owned by an advertising agency or connected with an organization involved in promotion would have to report any payments over five dollars to a physician or other healthcare provider.


§  Hospitals, and other health care entities (group practices), privately held manufactures, distributors, and group purchasing organizations are required to report physician ownership


Added Exclusion Criteria:


· Exempted retail pharmacies from reporting payments to physicians for prescribing generic drugs


· Exempted wholesale pharmacies from reporting


· Exclusion from reporting of payments made to a physician or hospital by a health plan for medical services provided to employees and family members of manufactures


· Exclusion for all indirect payments that is made to a covered recipient , where the manufacture is unaware of the identity of  recipient and not used to market product


· Exempted self insured health plans for employees of manufactures



A summary of the provisions is as follows:


Accordingly, manufacturers or distributors must provide in electronic form, all payments or transfers of value to a covered recipient, or to an entity or individual, no later than March 31, 2011, with the following information:


-   The recipient’s name, business address, physician specialty, and national provider identifier;


-   The value of the payment or transfer of value (other than a drug sample);


-   The date when the payment or transfer was made;


-   The name of the related drug, device, or supply, if available, to the level of specificity available;


-    A description of its form, indicated (as appropriate for all that apply) as— (I) cash or a cash equivalent; (II) in-kind items or services; and (III) stock, a stock option, or any other ownership interest, dividend, profit, or other return on investment; and


-   With respect to a drug sample, the name, number, date, and dosage units of the sample.


The term ‘payment or other transfer of value’ as defined by the bill means a transfer of anything of value for or of any of the following:


    (i) Gift, food, or entertainment

    (ii) Travel or trip

    (iii) Honoraria

    (iv) Research funding or grant

    (v) Education or conference funding

    (vi) Consulting fees

    (vii) Ownership or investment interest and royalties or license fee


Included under this definition are speaking fees, dividends, profit distribution, stock or stock option grant, or any ownership or investment interest held by a physician in a manufacturer (excluding a dividend or other profit distribution from, or ownership or investment interest in, a publicly traded security or mutual fund).


The above information must be complied by the manufacturer or distributor to include the aggregate amount of all payments or other transfers of value provided by the manufacturer or distributor to covered recipients, and to entities or individuals during the year involved. This includes all payments and transfers of value regardless of whether such payments or transfers of value were individually disclosed.


Recipients to Report Payments to Include:


  • Physician
  • Physician Group Practices
  • Any other prescriber of a covered drug, device, biological or medical supply (adds nurses, nurse practitioners, lab techs, physician assistants, nurse midwifes and anyone ordering drug or supplies)
  • Pharmacies and Pharmacists
  • Health Insurance, group health plan including employees of health plans
  • Pharmacy Benefit Managers and employees of PBM’s
  • Hospitals
  • Medical Schools
  • Sponsors of Continuing Medical Education
  • Patient Advocacy or Disease Specific Groups
  • Organizations of Health Professionals (Medical Specialty Societies)
  • Biomedical Researchers
  • Group Purchasing Organizations




Exclusions: Manufacturers and distributors are not required to report:


  • Any payments under $5;


  • The loan of a covered device for a short-term trial period, not to exceed 90 days, to permit evaluation of the covered device by the covered recipient;


  • Items or services provided under a contractual warranty, including the replacement of a covered device, where the terms of the warranty are set forth in the purchase or lease agreement for the covered device;


  • A transfer of anything of value to a covered recipient when the covered recipient is a patient and not acting in the professional capacity of a covered recipient;


  • In-kind items used for the provision of charity care;


  • A dividend or other profit distribution from, or ownership or investment interest in, a publicly traded security and mutual fund;


  • Compensation paid by an applicable manufacturer or distributor to a covered recipient who is directly employed by and works solely for such manufacturer or distributor;


  • Payments made to a covered recipient by an applicable manufacturer or by a health plan affiliated with an applicable manufacturer for medical care provided to employees of such manufacturer or their dependents;


  • Any discount (including a rebate);


  • Any payment or other transfer of value (I) in which the applicable manufacturer is unaware of the identity of the covered recipient and is not using such activity or service to market its product to the covered recipient; and (II) that is not designed to market or promote the product to the covered recipient;


Product Development


The bill also establishes that payments under a product development agreement must be reported for services furnished in connection with the development of a new drug, device, biological, or medical supply, and must also be reported with the following information:


  • The date of the approval or clearance of the covered drug, device, biological, or medical supply by the Food and Drug Administration; and


  • Payments made two calendar years after this date


Clinical Investigations


Payments by the manufacturer or distributor must be reported in connection with a clinical investigation regarding a new drug, device, biological, or medical supply with the following information:


  • The date that the clinical investigation is registered on the website maintained by the National Institutes of Health pursuant to section 671 of the Food and Drug Administration Amendments Act of 2007; and


  • Payments made two calendar years after this date


Product development and clinical investigation payments will be confidential, and will not be subject to disclosure, and will not be made available until or after the date, in which the information is made public.


General Provisions


The bill does not require the disclosure of a payment or other transfer of value to a physician by a self-insured health plan.


Hospitals and other health care entities that bill under Part A or Part B of Medicare for services must also report on the ownership shares of each physician who, directly or indirectly, owns an interest in the entity.


Manufacturers and distributors must also report any investment or ownership interest (other than an ownership or investment interest in a publicly traded security and mutual fund) by a physician (or an immediate family member of such physician) during the preceding year with the following information:


  • The value and terms of each such ownership or investment interest.


  • The dollar amount invested by each physician holding such an ownership or investment interest.



Drug Samples


Information regarding the use of free drug samples will not be made public but may be made available outside the Department of Health and Human Services by the Secretary for research or legitimate business purposes pursuant to data use agreements.




Any reporting entity that fails to submit the payment information outline above in a timely manner will be subject to a civil money penalty of not less than $1,000, but not more than $10,000, for each payment or other transfer of value or ownership or investment interest not reported. The total amount of civil money penalties will not exceed $150,000. Knowingly failing to submit payment information will result in a civil money penalty of not less than $10,000, but not more than $100,000, for each payment. The penalty will not exceed $1,000,000, or, if greater, 0.1 percentage of the total annual revenues of the reporting entity.




Overall this is a punitive provision which will require an army of employees and contractors to collect data at every level.  Of which most of this data will be of little use to anyone. It is designed to shut down commerce between manufactures, physicians and group purchasing organizations. 


The physician ownership provision is especially punitive in requiring disclosure of ownership in everything a physician may be involved in.


For CME it will require reporting of payments to CME providers, by manufactures and health plans, and may limit ownership by advertising agencies and health plans in continuing medical education companies.


In the end, I am not sure what “problem” they are attempting to resolve and with all the additional reporting by everyone, it does not sound like much in the area of drug development will be accomplished.  Before congress takes such drastic steps they should step back and consider the damage this could do to the entire healthcare industry.


Given that the healthcare reform bill has grown from 1,000 pages to 2,000 pages, expansion of government control of the economy and limiting choices appears to be the theme of the day.  The Sunshine Provisions are just one more example of that.


US House of Representatives


Sunshine Provisions House Bill


House Healthcare Reform Physician Payment Sunshine Provisions 10-29-09


House Healthcare Reform Physician Payment Sunshine Provisions 7-14-09,


House Healthcare Reform Draft Physician Payment Sunshine Provision 6-22-09


Policy and Medicine


House Versions


Physician Payment Sunshine Act: House American's Affordable Health Choices Act of 2009, Physician Payment Sunshine Provision


Physician Payment Sunshine Act: Democrat House Draft for Healthcare Reform -- Physician Payment Sunshine Provisions


Senate Versions


Physician Payment Sunshine Act: Senate Finance Chairman’s Mark - America’s Health Future Act of 2009 – Physician Payment Sunshine Provision





October 29, 2009

JAMA: Reform of Continuing Medical Education - Still Living in 1910

A recent commentary published in the Journal of American Medicine (JAMA) begins its call for reforming continuing medical education (CME) by citing The 1910 Flexner Report, as if Abraham Flexner is alive and well today.  


Flexner an unemployed school principle had never physically been in a medical school prior to embarking on his research.  He claimed to have investigated 69 medical schools during a 90 day period.  At that time meant train travel throughout the country.


Abraham Flexner in his research to his own admission failed to utilize standardized research criteria.  His goal was to reduce the number of physicians, close all non-allopathic medical schools, and abolished proprietary medical schools (medical schools run as businesses).  In addition he failed to take into account any of the advances that these private institutions had contributed to medicine.


The report was full of utopian altruism, less known is Flexner's recommendation that medical schools appoint full-time clinical professors. Holders of these appointments would become "true university teachers, barred from all but charity practice, in the interest of teaching."


Compliance to the Flexner report which was embraced by the American Medical Association and state regulatory boards drastically reduced the supply of physicians in the US, and significantly increased the cost of medicine.  Rural and areas with poorer patients were especially hard hit by the lack of physicians that resulted from shutting down most of the countries medical schools. 


The report was particularly discriminatory towards women and African American physicians resulting in the closing of all women only medical schools and reducing the number of African American schools to 2 and in 1964 fifty years later largely as result of his report subsequent regulation less than 3% of students entering medical school were African American’s and we still see extremely low numbers today.


The commentary, titled “Reform of Continuing Medical Education: Investments in Physician Human Capital,” was written by Eric G. Campbell, PhD who by his own words lasts December received $150,000 for this “research” from the Josiah Macy Foundation that would more than likely get published in JAMA (such confidence in his connections). 

His “research” is part of a full scale initiative by the Macy Foundation which hired Campbell, IOM and AAMC to write complementary reports on CME.   Eric outlined at the IOM hearing in December how he was going to find a new system of funding for CME.   In his own words “CME was expendable”(Audio Files of his talk).


Moreover, JAMA editor Katherine De Angelis, MD is an active participant in several Macy Foundation fully funded initiatives including the IOM committee on a Planning a Healthcare Continuing Medical Education Institute, and was a participant in the Macy Conference held in Bermuda and subsequent Monograph on Continuing Education in the Health professions.  The Director of the JAMA oversight committee Jordan Cohen, MD is a member of the Macy Foundation Board of Directors.


The results of Eric’s “study” are less than impressive and his subsequent commentary requires a strong response.


Accordingly, his editorial on CME, which cites only 8 references, (2 news stories, 2 editorials, 1 report based on editorial, 1 survey, 1 review, 1 research paper on GME) is nothing more then a clearly unsubstantiated “opinion paper,” that should be properly disclosed or retracted.


Regardless of this error, Mr. Campbell goes on to make the claim that “CME should apply new knowledge and skills that directly benefit patient and societal outcomes (e.g. providing high-quality, efficient, and cost-effective care).” Completely disregarding the breakthroughs CME programs have provided to physicians and patients over the past few decades (e.g. how to use new medical devices, instruction on new treatments and medicines), he claims that traditional CME does not focus on these outcomes. One wonders in all of his paid research whether Mr. Campbell even attended a CME program.


Instead, Mr. Campbell would rather focus on a century old report that could not have predicted the impact that medical device and pharmaceutical companies would play in creating life saving treatments and breakthroughs. He tries to downplay such breakthroughs so that he can call for “sweeping reform” in CME that provides a “productive means of investing in physician human capital.” What exactly does human capital refer to? He calls this capital, “knowledge and skills.”


Such knowledge and skills are inherent throughout all CME because these programs are created by medical professionals, for medical practitioners to educate doctors on ways to better serve society by making people healthier through new research and ways to practice medicine. 


The only human capital Mr. Campbell is referring to is an attempt to remove industry investment, which he believes may be potentially biased. To make such a claim using a century old report and no evidence, is clearly more biased than any industry involvement in CME.  


Excessive Commercialization


He cites numbers which show that CME has high profit margins (23.5%) which can be attributed to the fact that most CME providers are hospitals, universities and medical societies which attribute all income from CME for accreditation as (profit) and do not include their overhead and staff time in their reports as expenses.  But in fairness to Eric he would not know this unless he worked in CME which he does not.


He attributes the profit  to commercial support, which the ACCME annual report does not, which accounts for 58% of income of accredited CME provider organizations.   Of course he uses the 2007 data and not the most current data, which shows a precipitous $200 million drop in CME funding.


If industry did not provide such support then who would? How much would physicians and patients suffer with only 42% support of CME from other non-profit sources?


The reality of commercialization is that today, for a new drug or device to become useful to help treat patients is a multi-stage, multi-million dollar, multi-year process that few investors are willing to take the risk of, even when it means saving lives. So then why criticize those companies that take on all the risk, when their sole purpose is to save lives and make people healthier?


Unstandardized Curricula


As is the case for all highly trained professionals, physicians must fulfill a designated number of accredited CME credits to maintain their licenses in most states. Mr. Campbell’s criticism that “physicians have broad autonomy in selecting course topics types of learning experience, and activity locations” sounds like government controlled medicine.  His ethical dilemma is Eric’s and JAMA’s editors firmly held belief that physicians should not have broad autonomy that they are unable to think for themselves, that medical practice should be restricted by academia and the government.


CME is voluntary, and no doctor would choose to lose the income from his practice, or the risk of losing a patient if such a program or educational opportunity was not of great importance. Furthermore, there is no way to standardize the practice of each program because every patient is different, and each person requires different sorts of medical attention and treatments. Since this is the case, CME delivered only as a standardized curricula would prevent doctors from the necessary experience to identify complex problems and provide critical decisions for pressing issues that are increasingly a matter of life or death.   It also limits the


Additionally, his call for CME to represent a “mastery of an essential core set of knowledge and competencies” is precisely what CME does. There are numerous professional organizations, associations and medical journals that provide endless scholarship in every area of medicine. CME simply represents another facet for physicians to use to help them master their core set of knowledge and skills. The fact that there are a “diversity of CME offerings that provide benefits to physicians” should reassure patients that physicians are carefully choosing programs that will truly benefit them the most, not because the doctors have a paid trip to a nice hotel.


Lack of Effect on Patient Care


The idea that CME today is analogous to a century old report is laughable. Programs that discuss the outcomes of clinical studies, show physicians how to use medical devices, and discuss the future and present needs in medicine in an open and experienced forum is nothing like lectures and note memorization in medical school. Perhaps the reason why such programs are held at various locations is for that exact reason: to remove doctors from the classroom experience and provide more practical experiences.


Still, Mr. Campbell’s claim that “traditional CME is not adequately focused on improving patient outcomes” is a blatant distortion of the truth. In fact, he uses a source an AHRQ study that says exactly the opposite of his claim that “there is scant evidence that CME actually improves patient outcomes.” Specifically, researchers in the AHRQ study concluded that:


    “CME appears to be effective at the acquisition and retention of knowledge,     attitudes, skills, behaviors and clinical outcomes.”


Contrary to this case of academic misrepresentation, Mr. Campbell calls for a new model of CME, one with a purpose to “maintain and improve the quality and efficiency of the US health care system.” What evidence states at present that CME has a different purpose than this? The problems of quality and efficiency in the US health care system are not caused by CME, they are alleviated. Without CME, health care would be in much worse shape. So what changes are needed to give physicians more skills and knowledge (human capital)?


First, Mr. Campbell thinks there should be “financial incentives for more meaningful CME. “ He notes that “currently, most physicians are not paid based on the quality or efficiency of their practice.” This is a problem of the health care system (e.g. reimbursement rates, fee for service, insurance company practices). While the idea of incentivizing CME is important, has assisted in incentivizing CME by providing grants for higher quality education than non funded education.  The only thing that providers of CME need to refocus is how to avoid burdensome regulations and policies that make it almost impossible to continue staying in the business of educating doctors on how to save more lives.


Second, Mr. Campbell asserts that “making maintenance of certification a mandatory requirement for licensure should be strongly considered.” This point is already accomplished by CME programs which do “embody continual engagement with the process of professional improvement through accredited programs. Interestingly, the editorial calls for more CME credits, calling the current minimum of 20-50 CME credits per year “too low.” More CME is exactly what will provide patients with better care and physicians more knowledge and skills. Since Mr. Campbell, as do most critics, offer no way in which the additional programs and courses will be offered and funded, surely industry and providers will gladly foot the bill, not because of the profits but for the lives they will change.


Campbell’s third idea to use health information technology (HIT) has already been discredited numerous times. Enhancing physician learning from their routine clinical duties means having more meaningful interactions with patients, and attending more programs where physicians can interact with researchers and scientists to share experience. Using electronic health records will reduce the amount of time doctors have to see patients, and will result in no cost savings. Furthermore, the training of staff, potential for error, and privacy issues all outweigh any potential gains. Finally, “CME activities that include clinical problems encountered in day-to-day practice” already exist.


Financing the New CME


While claims like CME are “too reliant on industry funding” and “tend to promote a narrow focus on products,” once again, what is the alternative source for money? To create a broader “education on alternative strategies for managing health conditions and other important issues” without industry is highly unlikely. If Mr. Campbell wants to reorient CME away from “marketing drugs,” what system of funding will he use?


His idea that physicians should personally invest in their own CME is already the case: although required by most states to maintain their license, doctors choose which programs to attend often giving up large amounts of personal time and traveling great distances to meetings and conferences at their own personal expense. How would we reward physicians for “practicing high-quality, efficient medicine” or “performance-based incentives?” Who would determine such rewards?


How is the use of specialty boards, also accredited organizations, any different than accredited CME providers? Having a large infrastructure to operate and enforce large-scale maintenance-of-certification programs guarantees nothing (e.g. AMA’s CEJA Report is on round three).


The use of funded and provided by medical schools and teaching hospitals should be highly valued and increased in use but, where is the money coming from?  Will this shift the current focus from therapy and treatment to diagnostics and referral from local physicians for high end procedures?  How many physicians in Montana have access to a program only offered in one place, as is the case for many rural states? Physicians need CME to come to them, and medical schools cannot provide such a service.




There is only one problem with CME today: there are not enough programs to address the growing needs of patients and physicians. The continued use of commercial support to fill in this gap is necessary to help physicians treat patients. The suggestions outlined by Mr. Campbell suggest a complete misunderstanding of the significance of CME today.   


Mr. Campbell and other “reformers” pride themselves on repeating Abraham Flexner’s accomplishments; proposing to limit the choices of physicians.  Perhaps they should also consider theirs and Flexner’s shortcomings at the same time.


Perhaps he should focus less on 1910 and more on 2010 and read some of our stories here on the success of CME.   

Letters from Grassley: Health Information Technology and Medical Errors

With talk of health care reform overshadowing many of the important details of how to change the health care system, there is already $19.5 billion designated from the Stimulus package to expand the use of electronic medical records. Under the stimulus program, hospitals and physicians can claim millions of dollars for IT purchases, and will be penalized if they do not go digital by 2015.

Claims that such investments will save billions of dollars are overshadowed by many “doctors, academics, patients and computer programmers who already indicate that computer systems can increase errors, add hours to doctors' workloads and compromise patient care.” These issues are further exacerbated by the fact that many current systems are “clunky, counterintuitive, and in some cases dangerous,” especially since many are incompatible with each other.  There is also the problem of effectively training staff, updating software, and data entry error, according to the Washington Post.

For example, “researchers at the University of Minnesota found in March that electronic records prevented only two infections a year.” Another study from a “2005 report in the journal Pediatrics found that deaths at the children's hospital at the University of Pittsburgh Medical Center more than doubled in the five months after a computerized order-entry system went online.”

Other doctors spoke of cluttered screens, unresponsive vendors and illogical displays. More than one in five hospital medication errors reported last year -- 27,969 out of 133,662 -- were caused at least partly by computers, according to data submitted by 379 hospitals to Quantros Inc., a health-care information company. Paper-based errors caused 10,954 errors, the data showed.

Such a controversy surrounding the effectiveness of billions of dollars from taxpayers prompted Senator Charles Grassley (R-IA) of the Senate Finance Committee to gather “testimony alleging serious computer flaws from doctors, patients and engineers unhappy with current systems.”

As a result, the Senator wrote to 10 major suppliers of electronic record systems on October 16, 2009, demanding to know, for example, what steps they had taken to safeguard patients. Companies that received letters included: 3M, Allscripts, Cerner, Cognizant, Computer Sciences Corp., Eclipsys, Epic Systems, McKesson, Perot Systems and Philips Healthcare. (The Washington Post this weekend mentioned the Cerner letter.)

Mr. Grassley specifically told the companies that "every accountability measure ought to be used to track the stimulus money invested in health information technology." Accordingly the Committee, in cooperation with the Food and Drug Administration (FDA) asked for disclosures including:

-   Faulty software that miscalculated intracranial pressures and mixed up kilograms and pounds.    

-   A computer system that systematically gave adult doses of medications to children.       

-   An IT program designed to warn physicians about wrong dosages that was disconnected when the vendor updated the system, leading to incorrect dosing.   

-   A software bug that misdiagnosed five people with herpes.

In order to measure whether such problems outweigh the “meaningful use” of HIT, David Blumenthal, the head of health technology at the Department of Health and Human Services (HHS), will work on the standard that hospitals and physicians will have to reach before qualifying for health IT stimulus funds.

Giving oversight to Mr. Blumenthal, Senator Grassley has stressed in his letters the “complaints he has received about systems that allow doctors to enter medical orders by computer. (Here’s a copy of the letter.) He even wants to know whether the companies typically include legal provisions in their contracts that “shift responsibility for errors in the … systems to physicians, nurses, pharmacists, and other health care providers” according to the Wall Street Journal.

Such policies Grassley cites “include ‘gag orders,’ which prohibit health care providers from disclosing system flaws and software defects.” He asks the companies how many settlement agreements they’ve executed in the last 18 months. (Several of Grassley’s allegations echo themes in this essay published earlier this year in JAMA.)

While an investigation into the effectiveness of HIT and electronic medical records is important, it is a very small piece of the puzzle. With “barely 8 percent of hospitals using a basic electronic medical system, and only 17 percent of physicians using electronic records,” it seems obvious the drawbacks outweigh the benefits.

For example, 20 percent of physician groups in Arizona are uninstalling HIT software, according to a June survey by HealthLeaders-InterStudy. In Britain, a $20 billion program to digitalize medicine across the National Health Service is five years behind schedule and heavily over budget. Other complaints include losing time with patients because of data entry, causing physician productivity and satisfaction to fall.

Ultimately, because electronic medical records are not classified as medical devices, and thus hospitals are not required to report problems, these issues may continue to grow. Accordingly, HIT should be heavily reconsidered and studied at greater length because physicians did not go through years of training to have their ability to take care of patients destroyed by devices that are an impediment to medical care.  



Preview | Powered by FeedBlitz


April 2018
Sun Mon Tue Wed Thu Fri Sat
1 2 3 4 5 6 7
8 9 10 11 12 13 14
15 16 17 18 19 20 21
22 23 24 25 26 27 28
29 30