Stringent Regulations in the US Pharmaceutical and Medical Devices Market: Ken Research

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Stringent Regulations in the US Pharmaceutical
and Medical Devices Market Ken Research
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Ken research announced recent publication on,
"Country Focus Healthcare, Regulatory and
Reimbursement Landscape in US". The report is an
essential source of information on and analysis
of the healthcare, regulatory and reimbursement
landscape in the US. It identifies the key trends
in the country's healthcare market and provides
insights into its demographic, regulatory, and
reimbursement landscape and healthcare
infrastructure. Most importantly, the report
provides valuable insights into the trends and
segmentation of its pharmaceutical and medical
device markets. It uses data and information
sourced from proprietary databases, secondary
research, and in-house analysis by team of
industry experts.
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• Profiles and SWOT analyses of the major players
  in the pharmaceutical market gives exceptional
  market view. The effective sales and marketing
  strategies can be understood by understanding the
  competitive landscape and analysing competitors'
  performance help gain competitive advantage. It
  is a very useful tool to organize your sales and
  marketing efforts by identifying the market
  categories and segments that present the most
  opportunities for consolidation, investment and
  strategic partnership
• HEALTHCARE LANDSCAPE
• The population of the US in 2015 was 326 million,
  having grown at a CAGR of 1 from 2008. In 2015,
  the government spent 17.5 of GDP in 2015 on
  medical and health science and exported USD 32.8
  billion of pharmaceutical products. These
  positive growth trends can be primarily
  attributed to
• Availability of latest drugs and technologies
• Universal health coverage
• Access to healthcare facilities

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• Major players in the medical device market
  include Johnson and Johnson, GE Healthcare,
  Siemens, Medtronic, and Philips Healthcare.
  Health care in the United States is provided by
  many distinct organizations. Health care
  facilities are largely owned and operated by
  private sector businesses. 58 of US community
  hospitals are non-profit, 21 are government
  owned, and 21 are for-profit. According to the
  World Health Organization (WHO), the United
  States spent more on health care per capita, and
  more on health care as percentage of its GDP,
  than any other nation in 2011. Health spending
  was paid for by the government in 2013, funded
  via programs such as Medicare, Medicaid, the
  Children's Health Insurance Program, and the
  Veterans Health Administration. People aged under
  67 acquire insurance via their or a family
  member's employer, by purchasing health insurance
  on their own, or are uninsured. Health insurance
  for public sector employees is primarily provided
  by the government In the U.S. Ownership of the
  health care system is mainly in private hands,
  though federal, state, county, and city
  governments also own certain facilities.

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• REGULATORY AND LICENSING LANDSCAPE
• Healthcare is subject to extensive regulation at
  both the federal and the state level, much of
  which "arose haphazardly". Under this system, the
  federal government cedes primary responsibility
  to the states under the McCarran-Ferguson Act. E
  Essential regulation includes the licensure of
  health care providers at the state level and the
  testing and approval of pharmaceuticals and
  medical devices by the U.S. Food and Drug
  Administration (FDA), and laboratory testing. The
  non-profit hospitals share of total hospital
  capacity has remained relatively stable for
  decades. There are also privately owned
  for-profit hospitals as well as government
  hospitals in some locations, mainly owned by
  county and city governments. The Hill-Burton Act
  was passed in 1946, which provided federal
  funding for hospitals in exchange for treating
  poor patients. These regulations are designed to
  protect consumers from ineffective or fraudulent
  healthcare.

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• Additionally, states regulate the health
  insurance market and they often have laws which
  require that health insurance companies cover
  certain procedures although state mandates
  generally do not apply to the self-funded health
  care plans offered by large employers, which
  exempt from state laws under pre-emption clause
  of the Employee Retirement Income Security Act.
• In 2010, the Patient Protection and Affordable
  Care Act (PPACA) was passed by President Barack
  Obama and includes various new regulations, with
  one of the most notable being a health insurance
  mandate which requires all citizens to purchase
  health insurance. While not regulation per se,
  the federal government also has a major influence
  on the healthcare market through its payments to
  providers under Medicare and Medicaid, which in
  some cases are used as a reference point in the
  negotiations between medical providers and
  insurance companies. State governments maintain
  state health departments, and local governments
  (counties and municipalities) often have their
  own health departments, usually branches of the
  state health department. Regulations of a state
  board may have executive and police strength to
  enforce state health laws. In some states, all
  members of state boards must be health care
  professionals.

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Members of state boards may be assigned by the
governor or elected by the state committee The
McCarranFerguson Act, which cedes regulation to
the states, does not itself regulate insurance,
nor does it mandate that states regulate
insurance. "Acts of Congress" that do not
expressly purport to regulate the "business of
insurance" will not preempt state laws or
regulations that regulate the "business of
insurance." The Act also provides that federal
anti-trust laws will not apply to the "business
of insurance" as long as the state regulates in
that area, but federal anti-trust laws will apply
in cases of boycott, coercion, and intimidation.
REIMBURSEMENT LANDSCAPE The healthcare
reimbursement system is an extremely multifaceted
framework of obtaining payment for services. One
of the most problematic issues is that the
rules governing healthcare reimbursement change
frequently, with government payers sometimes
changing on a day-to-day basis. n addition, the
price for the service is not the retail price
that the provider charges for it.
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Payers have a maximum allowed payment for every
CPT code, which is the beginning point (not the
end point) of determining what they will pay. The
payer then adjusts the maximum allowed payment
with claim edits, which they use to disqualify
payment for some services, and payment rules,
which usually reduce payments for some services.
The American Medical Association (AMA) describes
how payments are affected by these two
rules. Key Factors Considered in the Report US
Healthcare Industry Research US Pharmaceutical
Industry Research Pharmaceutical Market Revenue
US US Pharmaceutical Market Imports Export
Volume Of Pharmaceutical Products US US Medical
Devices Market Research Healthcare IT Market
Research US US Cardiovascular Device Market
Future Outlook US Orthopedic Devices Market
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For more coverage click on the link below
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icals/co untryfocus-healthcare-regulatory-us/80510
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om/healthcare/pharmaceuticals/canada-united-states
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earch.com/healthcare/pharmaceuticals/japan-proton-
therapy-market-forecast/81991-91.html Contact
Us Ken Research Ankur Gupta,
Head Marketing Communications
Ankur_at_kenresearch.com 91-9015378249
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